ALS CareKosh Research library

Evidence-based research

ALS Research Updates

Last updated:

Recent developments

Milestones in context

The evidence library

Approved medicines

5 entries

Jurisdiction and indication matter. ALS-directed medicines and treatment for pseudobulbar affect are shown separately.

Rilutek · oral formulations

Riluzole

Established ALS treatment

An oral treatment with randomized evidence of a modest survival benefit in ALS.

What the evidence says

The pivotal trial studied 959 people. A Cochrane synthesis estimated roughly two to three months of median survival benefit in the trial populations; that average is not a prediction for an individual.

Keep in perspective

It does not regenerate motor neurons. Treatment choice, formulation and monitoring belong in a discussion with the treating neurologist.

Sources, India & access2 sources

For readers in India

Ask the prescribing team and a licensed pharmacy about the appropriate formulation, current supply and a written price quotation.

  1. Dose-ranging study of riluzole in amyotrophic lateral sclerosis Lacomblez et al. · The Lancet · Randomized trial
    25 May 1996
  2. Riluzole for ALS / motor neuron disease Cochrane · Systematic review
    1 July 2021
Latest dated source: [1][2]

Radicava · Radicava ORS

Edaravone

US approval: IV and oral

Edaravone is approved in the US for ALS. The oral suspension provides an alternative to intravenous administration and can also be given through a feeding tube.

What the evidence says

FDA describes evidence of less decline in daily functioning in a six-month trial. Oral approval used comparable drug exposure to the IV product. This supports slowing decline in the studied population, not recovery of lost function.

Keep in perspective

Limited evidence in a particular disease stage does not prove that every person outside the trial criteria cannot benefit. Avoid blanket exclusions based on wheelchair or ventilator use.

Sources, India & access1 source

For readers in India

Verify the exact product and route locally. US approval of Radicava ORS does not establish its routine availability in India.

  1. FDA approves oral edaravone for adults with ALS FDA · Regulator
    12 May 2022
Latest dated source: [3]

Qalsody · SOD1-targeted antisense therapy

Tofersen

US accelerated approval

Approved for adults with ALS and a SOD1 mutation. The FDA decision was based on lowering blood neurofilament light (NfL), a marker of nerve injury.

What the evidence says

The 28-week VALOR trial did not establish a significant primary clinical benefit. Longer follow-up associated earlier treatment with less decline, but the open-label comparison has limitations. Clinical benefit remains under confirmatory study.

Keep in perspective

A biomarker response is not proof of a cure or predictable recovery. Intrathecal treatment requires a specialist team. Investigation in non-SOD1 ALS does not expand the approved indication.

Sources, India & access2 sources

For readers in India

Confirm the genetic result with a specialist. Local authorization, supply, import permission and funding must be checked for the individual patient.

  1. Approval of tofersen for ALS associated with a SOD1 mutation FDA · Regulator
    25 April 2023
  2. Long-Term Tofersen in SOD1 Amyotrophic Lateral Sclerosis Miller et al. · JAMA Neurology · Trial and open-label extension
    22 December 2025
Latest dated source: [4][5]

Rozebalamin · development code E0302

High-dose mecobalamin

Japan-specific approval

Japan approved this injectable methylcobalamin formulation for slowing functional impairment in ALS. It is distinct from routine vitamin B12 supplementation.

What the evidence says

JETALS found less ALSFRS-R decline over 16 weeks in a selected early-stage Japanese population. The PMDA review supports the indication while documenting the studied population and safety requirements.

Keep in perspective

Do not generalize the short trial to all stages or substitute ordinary supplements. Rozebalamin is mecobalamin (E0302), not MT-1186.

Sources, India & access3 sources

For readers in India

Japanese authorization does not mean approval or reliable supply in India. Discuss product identity and any lawful access route with the clinical team.

  1. Rozebalamin (mecobalamin): review and deliberation report PMDA / MHLW · Regulator
    3 September 2024
  2. Rozebalamin approved in Japan on 24 September 2024 Eisai · Sponsor update
    16 October 2024
  3. Efficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage ALS Oki et al. · JAMA Neurology · Randomized trial
    9 May 2022

Nuedexta · pseudobulbar affect

Dextromethorphan / quinidine

Symptom treatment

US-approved for pseudobulbar affect: episodes of involuntary laughing or crying that can occur in neurological conditions, including ALS.

What the evidence says

The FDA indication addresses pseudobulbar affect. It is not an approval for slowing ALS progression or extending survival.

Keep in perspective

Suitability and interactions need a prescribing clinician. Symptom benefit should not be counted as disease modification.

Sources, India & access1 source

For readers in India

Local availability and alternatives should be discussed with the neurologist; no current Indian price or supply guarantee is established here.

  1. Nuedexta approval letter: pseudobulbar affect FDA · Regulator
    29 October 2010
Latest dated source: [8]

The evidence library

Clinical trials & development

25 entries

Recruiting studies, follow-up cohorts and planned programs. A trial phase or regulatory designation does not establish efficacy.

FUNCtion ALS · UNC13A restoration

TRCN-1023

Recruiting

A new Phase 1/2 study evaluates a medicine intended to restore UNC13A function in ALS.

What the evidence says

The registry was updated on 9 September 2026. It describes a randomized, blinded, placebo-controlled trial assessing safety, tolerability and early signals after intrathecal administration.

Keep in perspective

No results are posted. A newly recruiting trial is an opportunity to test a hypothesis, not evidence of clinical benefit.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07674667 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Germany, Netherlands, United Kingdom
  1. FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS Trace Neuroscience, Inc. · ClinicalTrials.gov · Trial registry
    9 September 2026
Latest dated source: [53]

PREVAiLS · sigma-1 receptor agonist

Pridopidine

Recruiting

The Phase 3 PREVAiLS study tests pridopidine in people with early, rapidly progressive ALS.

What the evidence says

First enrollment was announced on 30 March 2026; the registry still lists recruiting. The earlier HEALEY trial did not meet its primary endpoint. Subgroup observations motivated a more focused confirmatory trial.

Keep in perspective

Subgroup findings are hypothesis-generating. PREVAiLS has not yet established efficacy or supported ALS marketing approval.

Sources, India & access3 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07322003 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
  1. First participant enrolled in the PREVAiLS Phase 3 study Prilenia and Ferrer · Sponsor update
    30 March 2026
  2. Pridopidine in Amyotrophic Lateral Sclerosis HEALEY ALS Platform Trial · JAMA · Randomized trial
    17 February 2025
  3. Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS Prilenia · ClinicalTrials.gov · Trial registry
    25 August 2026

Clene · gold nanocrystal suspension

CNM-Au8

Application planned

An investigational therapy targeting cellular energy pathways; CNM-Au8 remains under development for ALS.

What the evidence says

Clene’s 14 August update targets an accelerated-approval application in early Q4 2026. Its HEALEY trial did not show significant benefit on the primary 24-week progression endpoint. Later biomarker and survival analyses underpin the planned submission.

Keep in perspective

A planned application, FDA meeting or exploratory analysis is not approval. RESTORE-ALS should not be described as enrolling without a verified launch.

Sources, India & access2 sources

For readers in India

No routine Indian access or local trial site is established by these sources. Expanded access is distinct from marketing approval.

  1. Second quarter 2026 results and CNM-Au8 regulatory update Clene · SEC exhibit · Sponsor update
    14 August 2026
  2. CNM-Au8 in Amyotrophic Lateral Sclerosis HEALEY ALS Platform Trial · JAMA · Randomized trial
    17 February 2025
Latest dated source: [13][14]

ENDURANCE · autologous cell therapy

NurOwn / debamestrocel

Not yet recruiting

ENDURANCE is the planned confirmatory study of cells prepared from a participant’s own bone marrow.

What the evidence says

The August 2026 sponsor update describes preparations to open the study; the registry lists not yet recruiting. An FDA-agreed Special Protocol Assessment concerns trial design and does not establish that the treatment works.

Keep in perspective

The new trial has no posted results. Do not present NurOwn as an approved stem-cell treatment or imply that protocol agreement guarantees approval.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT06973629 ↗
Recorded status
Not yet recruiting
Registry updated
Countries listed
United States
  1. Second quarter 2026 results and ENDURANCE preparation BrainStorm Cell Therapeutics · Sponsor update
    14 August 2026
  2. Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY) Brainstorm-Cell Therapeutics · ClinicalTrials.gov · Trial registry
    22 May 2025
Latest dated source: [15][55]

AB23005 · add-on to standard care

Masitinib

Not yet recruiting

A confirmatory Phase 3 study is registered for this investigational kinase inhibitor.

What the evidence says

The registry lists not yet recruiting. In April 2026 AB Science described the ALS study as not yet started and a temporary European trial halt. EMA’s earlier refusal cited unreliable study data and insufficiently demonstrated benefit.

Keep in perspective

Post-hoc or preprint survival analyses do not overturn the regulatory refusal or establish an approved treatment.

Sources, India & access3 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07174492 ↗
Recorded status
Not yet recruiting
Registry updated
Countries listed
Greece
  1. Masitinib AB Science: refusal of marketing authorisation European Medicines Agency · Regulator
    22 January 2025
  2. Clinical program update: planned AB23005 and temporary European trial halt AB Science · Sponsor update
    16 April 2026
  3. Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients AB Science · ClinicalTrials.gov · Trial registry
    3 October 2025

FUSION · FUS-targeted antisense therapy

Ulefnersen / ION363

Active, not recruiting

A Phase 3 trial in ALS associated with pathogenic FUS mutations.

What the evidence says

The July 2026 registry lists active follow-up with enrollment closed and no results posted. The study evaluates efficacy and safety of lowering FUS protein.

Keep in perspective

This genetically defined program cannot be generalized to all ALS. An anticipated readout is not a completed positive result.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT04768972 ↗
Recorded status
Active not recruiting
Registry updated
Countries listed
Belgium, Brazil, Canada, Germany, Ireland, Italy, Japan, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
  1. FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS) Ionis Pharmaceuticals, Inc. · ClinicalTrials.gov · Trial registry
    21 July 2026
Latest dated source: [57]

ANQUR · STMN2 restoration

QRL-201

Active, not recruiting

An antisense approach intended to restore stathmin-2 expression affected by TDP-43 dysfunction.

What the evidence says

QurAlis reported interim target-engagement and biomarker findings in February 2026, with an overall trend and subgroup signals in function. The sponsor calls ANQUR Phase 1/2; the registry classifies it Phase 1 and lists enrollment closed.

Keep in perspective

Interim and subgroup results are not confirmatory efficacy. A proposed 2027 Phase 3 program remains a plan.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT05633459 ↗
Recorded status
Active not recruiting
Registry updated
Countries listed
Belgium, Canada, Germany, Ireland, Netherlands, United Kingdom
  1. Interim ANQUR data for QRL-201 QurAlis · Sponsor update
    23 February 2026
  2. A Study Evaluating the Safety and Tolerability of QRL-201 in ALS QurAlis Corporation · ClinicalTrials.gov · Trial registry
    15 May 2026
Latest dated source: [16][58]

NeuroSense · extended-release combination

PrimeC

Pivotal study planned

An investigational fixed-dose formulation of ciprofloxacin and celecoxib.

What the evidence says

On 31 August 2026 NeuroSense announced plans to optimize PARAGON into a smaller, shorter pivotal study, subject to FDA alignment. A Canadian submission is targeted for December 2026. Neither milestone should be described as completed.

Keep in perspective

Earlier clinical and biomarker signals require confirmation. The formulation is not interchangeable with self-combining its component medicines.

Sources, India & access1 source

For readers in India

An Indian approval, launch date or price is not established by this development announcement.

  1. Revised strategy for PrimeC and planned PARAGON study NeuroSense · Sponsor update
    31 August 2026
Latest dated source: [17]

ALSTARS · immune regulation

COYA 302

Recruiting

A combination biologic strategy intended to enhance regulatory T-cell activity.

What the evidence says

The August update reports continuing enrollment and targets topline data in Q1 2027. The sponsor describes ALSTARS as Phase 2; ClinicalTrials.gov lists Phase 2/3. Both descriptions refer to the same study.

Keep in perspective

No randomized efficacy results are posted. Trial phase and Fast Track designation are not evidence of approval.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07161999 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Canada, United States
  1. Second quarter 2026 results and ALSTARS update Coya Therapeutics · Sponsor update
    11 August 2026
  2. Study of COYA 302 for the Treatment of ALS Coya Therapeutics · ClinicalTrials.gov · Trial registry
    6 August 2026
Latest dated source: [18][59]

HEALEY Regimen I · S-monepantel

NUZ-001

Active, not recruiting

An investigational oral medicine designed to support clearance of harmful cellular proteins.

What the evidence says

The HEALEY trial center reports enrollment complete, consistent with the July 2026 registry status. The Phase 2/3 cohort is now in follow-up; no efficacy results are posted.

Keep in perspective

Small earlier safety studies and open-label observations do not establish slowing of ALS progression.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07410806 ↗
Recorded status
Active not recruiting
Registry updated
Countries listed
United States
  1. HEALEY ALS Platform Trial: study drugs and enrollment Mass General Brigham · Trial center
    Publication date not stated
  2. HEALEY ALS Platform Trial - Regimen I NUZ-001 Merit E. Cudkowicz, MD · ClinicalTrials.gov · Trial registry
    20 July 2026
Latest dated source: [19][60]

Spinogenix · synaptic function

SPG302 / tazbentatol

Early study completed

A small molecule being studied for effects on synaptic function; clinical benefit in ALS remains unconfirmed.

What the evidence says

The early study is registered as completed. The sponsor reported Phase 2a findings in November 2025. A separate US expanded-access protocol is listed as available (NCT07088159).

Keep in perspective

Early functional observations and access outside a trial do not prove synapse regeneration or reliable functional recovery in people with ALS.

Sources, India & access3 sources

For readers in India

The US expanded-access protocol is not an Indian approval or a guarantee that an overseas patient can join.

Study record
NCT05882695 ↗
Recorded status
Completed
Registry updated
Countries listed
Australia
  1. Topline Phase 2a clinical trial results for SPG302 Spinogenix · Sponsor update
    4 November 2025
  2. Study of SPG302 in Healthy Volunteers and ALS Participants Spinogenix · ClinicalTrials.gov · Trial registry
    29 June 2025
  3. Intermediate-size Patient Population Expanded Access Protocol Spinogenix · ClinicalTrials.gov · Trial registry
    17 July 2026

Alchemab / Lilly · antibody program

ATLX-1282

Early clinical development

A therapeutic antibody program derived from research into biological resilience.

What the evidence says

Alchemab announced a first-in-human Phase 1 trial on 9 September 2025. The program was licensed to Lilly. No later ALS efficacy result was established in this review.

Keep in perspective

A licensing agreement does not validate efficacy. Current patient recruitment and a Phase 2 start date have not been verified.

Sources, India & access1 source

For readers in India

No Indian trial site or commercial access is verified. Corporate presence in India does not establish future access.

  1. Initiation of Phase 1 clinical trial of ATLX-1282 Alchemab Therapeutics · PR Newswire · Sponsor update
    9 September 2025
Latest dated source: [21]

SEALS · neuroprotective peptide

NX210c

Active, not recruiting

A Phase 2 study of an intravenous peptide approach to neuroprotection and blood–brain barrier function.

What the evidence says

June 2026 preliminary results cover 82 randomized participants. Axoltis reported exploratory functional and biomarker trends; the cited early NfL comparison was not statistically significant.

Keep in perspective

Preliminary conference findings need the full controlled analysis. Biomarker trends must not be presented as proven survival benefit.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT06365216 ↗
Recorded status
Active not recruiting
Registry updated
Countries listed
France
  1. SEALS preliminary results at ENCALS 2026 Axoltis Pharma · Sponsor update
    24 June 2026
  2. ALS Phase II Study of NX210c Axoltis Pharma · ClinicalTrials.gov · Trial registry
    24 December 2025
Latest dated source: [22][63]

XellSmart · iPSC-derived neural progenitor cells

XS-228 / XS228CN

Recruiting

A Phase 1 ALS study in China evaluates induced-pluripotent-stem-cell-derived motor neuron progenitor cells.

What the evidence says

The ALS-specific record NCT07118319 lists recruiting and no posted results. Separate XS228 spinal-cord-injury trials must not be used as evidence of benefit in ALS.

Keep in perspective

Safety, integration of transplanted cells and clinical benefit remain experimental. There is no established restoration of lost motor neurons or function.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07118319 ↗
Recorded status
Recruiting
Registry updated
Countries listed
China
  1. The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · ClinicalTrials.gov · Trial registry
    21 November 2025
Latest dated source: [64]

LUMINA · calpain-2 antisense therapy

AMX0114

Recruiting

A Phase 1 study of an antisense medicine targeting calpain-2.

What the evidence says

Amylyx’s June 2026 update reported no drug-related serious adverse events in the lowest-dose cohort, while the measured biomarkers remained near baseline. Higher-dose cohorts are being evaluated.

Keep in perspective

Tolerability at a low dose is not evidence of clinical efficacy. Dose-escalation findings are still early.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT06665165 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Canada, United States
  1. LUMINA cohort and biomarker update at ENCALS Amylyx Pharmaceuticals · Sponsor update
    23 June 2026
  2. AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis Amylyx Pharmaceuticals Inc. · ClinicalTrials.gov · Trial registry
    14 April 2026
Latest dated source: [23][65]

Nura Bio · SARM1 inhibitor

NB-4746

Recruiting

SARM1 inhibition has now entered ALS patient testing with this oral investigational drug.

What the evidence says

Nura Bio announced the first ALS participant dosed in June 2026. The Phase 1b/2a program measures safety, drug exposure and biomarkers; registry sites are in Australia and Canada.

Keep in perspective

The biological rationale and healthy-volunteer findings do not yet demonstrate benefit in ALS. This program is distinct from preclinical ASHA-624.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07369076 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Australia, Canada
  1. First ALS participant dosed with NB-4746 Nura Bio · GlobeNewswire · Sponsor update
    22 June 2026
  2. A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis. Nura Bio · ClinicalTrials.gov · Trial registry
    22 June 2026
Latest dated source: [24][66]

KOANEWA · TDP-43-directed gene therapy

CTx1000

Recruiting in cited record

An early gene-therapy study intended to clear pathological TDP-43.

What the evidence says

Celosia announced first dosing in March 2026 at Macquarie University Hospital. The Phase 1b study is open-label and focuses on safety and tolerability. The recruiting registry record was last updated in February.

Keep in perspective

The registry is older than the dosing announcement: confirm current enrollment directly. Reversal in animal models is not evidence of reversal in people.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07401121 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Australia
  1. First patient dosed in the Phase 1b CTx1000 trial Celosia Therapeutics · PR Newswire · Sponsor update
    23 March 2026
  2. Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis Celosia Therapeutics Pty Ltd · ClinicalTrials.gov · Trial registry
    10 February 2026
Latest dated source: [25][67]

SOD1-targeted siRNA

RAG-17

Phase 1 evidence

A July 2026 Nature Medicine paper reports early human testing of an RNA-silencing approach for SOD1 ALS.

What the evidence says

The published first study involved six participants and examined safety, exposure and preliminary biological or clinical observations. A separate Phase 1 trial is registered as recruiting.

Keep in perspective

Six participants without a definitive controlled efficacy comparison cannot establish survival benefit or superiority to tofersen. Enrollment status needs confirmation because the cited registry update is older.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT06556394 ↗
Recorded status
Recruiting
Registry updated
Countries listed
China
  1. Oligonucleotide–siRNA conjugate for SOD1 ALS: a phase 1 trial Chen et al. · Nature Medicine · Early clinical study
    15 July 2026
  2. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene Mutation Ractigen Therapeutics. · ClinicalTrials.gov · Trial registry
    8 January 2025
Latest dated source: [26][68]

UNITE-ALS · Zydus

Usnoflast

Recruiting

A Phase 2b randomized study of an oral NLRP3 inflammasome inhibitor.

What the evidence says

The 1 September 2026 registry update lists recruiting, with multiple countries participating and no results posted. This is an investigational ALS program associated with an Indian-origin sponsor.

Keep in perspective

Sponsor origin does not mean a trial is taking place in India or that the medicine is approved there.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07023835 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden, United States
  1. Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis Zydus Therapeutics Inc. · ClinicalTrials.gov · Trial registry
    1 September 2026
Latest dated source: [69]

SOD1-targeted RNA interference

ALN-SOD

Recruiting

A first-in-human Phase 1/2 study for adults with a SOD1 mutation.

What the evidence says

The July 2026 registry lists ongoing recruitment and evaluates safety and pharmacological effects of an RNA-interference approach.

Keep in perspective

No results are posted. This is a separate investigational product from approved tofersen and from RAG-17.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT06351592 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Australia, Belgium, Canada, Germany, Japan, Poland, South Korea, Sweden, Taiwan
  1. First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS) Regeneron Pharmaceuticals · ClinicalTrials.gov · Trial registry
    22 July 2026
Latest dated source: [70]

PIONEER-ALS · gene therapy

VTx-002

Recruiting

A first-in-human Phase 1/2 program using a vectorized antibody approach directed at TDP-43 pathology.

What the evidence says

The registry updated on 10 September 2026 lists recruiting at sites in Europe and the US. It is an open-label ascending-dose study with clinical and biomarker assessments.

Keep in perspective

No results are posted. Small uncontrolled gene-therapy studies establish early safety information, not a proven ALS treatment. The older sponsor mechanism page still says preclinical; use the dated registry for current trial status.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07287397 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Belgium, Netherlands, United Kingdom, United States
  1. VTx-002 vectorized antibody mechanism VectorY Therapeutics · Sponsor update
    Publication date not stated
  2. Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS Vector Y Therapeutics · ClinicalTrials.gov · Trial registry
    10 September 2026
Latest dated source: [50][71]

Insmed · investigational genetic therapy

INS1202

Recruiting

A single-dose Phase 1 study in adults with SOD1 ALS or ALS without a known ALS-related genetic mutation.

What the evidence says

The September 2026 registry lists recruiting in the US. The study evaluates safety, tolerability and pharmacodynamic effects after intrathecal administration.

Keep in perspective

There are no posted efficacy results. Eligibility is protocol-specific and must be confirmed by the study team.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07290062 ↗
Recorded status
Recruiting
Registry updated
Countries listed
United States
  1. A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS) Insmed Gene Therapy LLC · ClinicalTrials.gov · Trial registry
    1 September 2026
Latest dated source: [72]

Investigator-led Phase 2 study

Tofersen in non-SOD1 ALS

Recruiting

An exploratory trial tests whether tofersen has biological or clinical effects beyond genetically confirmed SOD1 ALS.

What the evidence says

The registry updated in June 2026 lists a US Phase 2 study and excludes SOD1- and FUS-associated disease. This is a research question with no posted results.

Keep in perspective

The FDA-approved indication remains SOD1 ALS. This trial is not evidence to prescribe tofersen broadly for sporadic ALS.

Sources, India & access1 source

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07294144 ↗
Recorded status
Recruiting
Registry updated
Countries listed
United States
  1. Tofersen in Non-SOD1 ALS Washington University School of Medicine · ClinicalTrials.gov · Trial registry
    25 June 2026
Latest dated source: [73]

DAZALS · glucocorticoid receptor modulation

Dazucorilant

Phase 3 planned

DAZALS missed its primary functional endpoint. Corcept is pursuing further study after secondary and exploratory survival findings.

What the evidence says

The April 2026 sponsor report describes two-year survival analyses and a planned Phase 3 trial. The long-term comparisons include selected participants who did or did not enter the extension. The registry still says recruiting, which should not be read as enrollment in the planned pivotal study.

Keep in perspective

Survival signals after a failed primary endpoint need confirmation, especially with selection into an extension. No results posted in a registry does not mean results have not been reported elsewhere. Confirm any enrollment directly.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT05407324 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Belgium, Canada, France, Germany, Ireland, Netherlands, Poland, Spain, United Kingdom, United States
  1. Two-year DAZALS results and planned Phase 3 study Corcept Therapeutics · Sponsor update
    30 April 2026
  2. Dazucorilant in Patients With Amyotrophic Lateral Sclerosis Corcept Therapeutics · ClinicalTrials.gov · Trial registry
    16 June 2026
Latest dated source: [51][74]

NeurALS · SPTLC1-targeted antisense therapy

LTX-002

Recruiting

A new Phase 1/2 study investigates an RNA-targeted approach to abnormal lipid metabolism in ALS.

What the evidence says

Leal announced first dosing in June 2026. The August registry lists a blinded, placebo-controlled dose-escalation study assessing safety, tolerability and pharmacological effects.

Keep in perspective

The rationale extends to sporadic and genetic ALS, but clinical benefit has not been established. This is a first-in-human program with no posted results.

Sources, India & access2 sources

For readers in India

No Indian site is listed in the cited record. Recruitment elsewhere does not guarantee eligibility, travel support or access from India.

Study record
NCT07660614 ↗
Recorded status
Recruiting
Registry updated
Countries listed
Germany, Italy, Netherlands, Sweden
  1. First participant dosed in NeurALS Phase 1/2 Leal Therapeutics · PR Newswire · Sponsor update
    23 June 2026
  2. A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis Leal Therapeutics, Inc · ClinicalTrials.gov · Trial registry
    18 August 2026
Latest dated source: [52][75]

The evidence library

Early science & discovery

4 entries

Laboratory findings and development candidates. The path from a biological idea to a useful treatment remains uncertain.

Preclinical

ASHA-624 is a molecular-glue strategy designed to hold SARM1 inactive and protect axons.

What the evidence says

The identified funder announcement supports preclinical studies in an inherited optic-nerve disease. It does not establish an ALS clinical trial or human ALS efficacy.

Keep in perspective

Do not equate promising work in another disease model with an available ALS therapy. NB-4746 is the distinct SARM1 program now in ALS clinical testing.

Sources, India & access2 sources

For readers in India

Research only; no verified clinical access for ASHA-624.

  1. Preclinical ASHA-624 research in autosomal dominant optic atrophy Advancium Health Network · Research funder
    Publication date not stated
  2. First ALS participant dosed with NB-4746 Nura Bio · GlobeNewswire · Sponsor update
    22 June 2026
Latest dated source: [35][24]

C9ORF72-linked ALS / FTD

RNA-targeting CRISPR

Preclinical

Researchers are investigating precise removal of disease-associated repeat RNA while preserving normal gene activity.

What the evidence says

A 2025 Nature Communications study used a high-fidelity Cas13 system in experimental models of C9ORF72-linked disease and reduced molecular abnormalities.

Keep in perspective

This is laboratory and animal-model evidence. Delivery, off-target effects and long-term safety need evaluation before claims of human benefit.

Sources, India & access1 source

For readers in India

No approved CRISPR treatment for ALS is established by this study.

  1. High-fidelity CRISPR-Cas13 for C9ORF72-linked ALS/FTD McCallister et al. · Nature Communications · Preclinical paper
    8 January 2025
Latest dated source: [36]

C9ORF72-linked ALS / FTD

Blocking toxic repeat translation

Preclinical

A 2026 study separates the toxicity of repeat-derived proteins from the effects of the repeat RNA itself.

What the evidence says

The Science paper reports rescue of disease-related phenotypes in models by blocking repeat-associated translation without removing the repeat RNA.

Keep in perspective

Mechanistic advances can identify future targets, but do not demonstrate an effective medicine in patients.

Sources, India & access1 source

For readers in India

A research finding, not a clinical treatment or enrollment offer.

  1. Blocking RAN translation without altering repeat RNAs rescues C9ORF72-related ALS and FTD phenotypes Science · PubMed · Preclinical paper
    5 February 2026
Latest dated source: [37]

Dewpoint Therapeutics

TDP-43 condensate modulation

Development candidate

Small molecules are being developed to correct abnormal TDP-43 condensates and restore RNA-processing functions.

What the evidence says

Dewpoint selected a development candidate in January 2026 on the basis of cell and animal-model findings.

Keep in perspective

A development candidate is not a tested or approved ALS treatment. No human efficacy result is established in the cited announcement.

Sources, India & access1 source

For readers in India

No clinical access is established by the cited preclinical program.

  1. TDP-43 condensate modulator development candidate Dewpoint Therapeutics · Sponsor update
    8 January 2026
Latest dated source: [38]

The evidence library

Negative trials & withdrawn medicines

9 entries

Negative findings remain part of the evidence. A failed endpoint, a stopped program and a market withdrawal are different outcomes.

AMX0035 · sodium phenylbutyrate / taurursodiol

Relyvrio / Albrioza

Withdrawn from market

The medicine was removed from the US and Canadian markets after its confirmatory trial failed.

What the evidence says

Amylyx announced withdrawal in April 2024 following PHOENIX, which did not meet its prespecified primary and secondary endpoints.

Keep in perspective

Earlier approval and positive small-study results do not outweigh a failed confirmatory trial. Current care should be discussed with the treating clinician.

Sources, India & access1 source

For readers in India

Do not present this as a currently marketed ALS treatment or recommend purchasing a substitute combination.

  1. Formal intention to remove RELYVRIO / ALBRIOZA from the market Amylyx Pharmaceuticals · Sponsor update
    4 April 2024
Latest dated source: [27]

ABBV-CLS-7262 · HEALEY Regimen F

Fosigotifator

Primary endpoint not met

The tested eIF2B activator did not establish efficacy in the HEALEY study.

What the evidence says

Calico reported in January 2025 that neither the primary nor exploratory higher dose met the primary endpoint. Key secondary endpoints for the primary dose also were not significantly different from placebo.

Keep in perspective

Exploratory findings cannot be presented as an approved benefit. A negative trial does not, by itself, prove every future study of the mechanism must fail.

Sources1 source
  1. Fosigotifator HEALEY trial results Calico · Sponsor update
    6 January 2025
Latest dated source: [28]

HEALEY Regimen G · eIF2B activation

DNL343

Primary endpoint not met

DNL343 did not demonstrate slowing of ALS progression in the tested regimen.

What the evidence says

The January 2025 announcement reports that the primary combined function/survival endpoint and key strength and respiratory secondary endpoints were not met at 24 weeks.

Keep in perspective

Safety or a biological rationale cannot substitute for a demonstrated clinical effect.

Sources1 source
  1. Topline results for HEALEY Regimen G (DNL343) Denali Therapeutics · Sponsor update
    6 January 2025
Latest dated source: [29]

ALSpire · ataxin-2 antisense therapy

BIIB105 / ION541

Development discontinued

Biogen and Ionis ended development following the Phase 1/2 ALSpire study.

What the evidence says

The May 2024 announcement reports target lowering without evidence sufficient to support continued development for ALS.

Keep in perspective

Lowering a target protein alone does not establish that patients function better or live longer.

Sources1 source
  1. BIIB105 development discontinued after ALSpire Biogen and Ionis · Sponsor update
    16 May 2024
Latest dated source: [30]

HIMALAYA · RIPK1 inhibitor

SAR443820 / DNL788

Trial terminated

The HIMALAYA Phase 2 program did not meet its ALS efficacy objective.

What the evidence says

The study registry records termination for lack of efficacy. This entry concerns the ALS study, not results from the separate multiple-sclerosis program.

Keep in perspective

Evidence from a different disease cannot be used to imply efficacy in ALS.

Sources1 source
Study record
NCT05237284 ↗
Recorded status
Terminated
Registry updated
Countries listed
Belgium, Canada, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
  1. Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS) Sanofi · ClinicalTrials.gov · Trial registry
    21 March 2025
Latest dated source: [76]

HEALEY Regimen A · complement C5

Zilucoplan

Stopped for futility

The HEALEY trial stopped this regimen after a prespecified futility analysis.

What the evidence says

The published randomized study did not establish benefit on ALS progression.

Keep in perspective

Approval or benefit in another condition does not imply an ALS indication.

Sources1 source
  1. Efficacy and Safety of Zilucoplan in ALS Paganoni et al. · JAMA Network Open · Randomized trial
    17 February 2025
Latest dated source: [31]

HEALEY Regimen B · myeloperoxidase

Verdiperstat

Primary endpoint not met

The published randomized HEALEY study did not demonstrate slowing of ALS.

What the evidence says

Neither the prespecified primary endpoint nor the secondary endpoints differed significantly between active treatment and placebo.

Keep in perspective

This negative result belongs alongside other unsuccessful programs, rather than in a list of proven options.

Sources1 source
  1. Verdiperstat in ALS: results from the randomized HEALEY trial HEALEY ALS Platform Trial · JAMA Neurology · Randomized trial
    17 February 2025
Latest dated source: [32]

HEALEY Regimen E · autophagy

Trehalose

No demonstrated benefit

The intravenous trehalose regimen did not show evidence of slower ALS progression than placebo.

What the evidence says

The 2025 Lancet Neurology publication found no significant benefit in secondary clinical or biomarker measures either.

Keep in perspective

Laboratory effects on protein clearance do not establish clinical benefit, and oral supplements are not equivalent to the trial intervention.

Sources1 source
  1. Safety and efficacy of trehalose in ALS HEALEY ALS Platform Trial · The Lancet Neurology · Randomized trial
    June 2025
Latest dated source: [33]

C9ORF72-targeted antisense therapy

BIIB078

Development discontinued

Development ended after the Phase 1 randomized study in C9ORF72-associated ALS.

What the evidence says

The published trial found no reduction in neurofilament and no clinical benefit relative to placebo.

Keep in perspective

This result applies to this product and study; other approaches to C9ORF72 biology remain under investigation.

Sources1 source
  1. BIIB078 in C9orf72-associated ALS: phase 1 study van den Berg et al. · The Lancet Neurology · Randomized trial
    August 2024
Latest dated source: [34]

The evidence library

Communication tools

3 entries

Assistive technology can support independence and expression. It does not slow ALS biology.

PCEye · TD I-Series · TD Pilot

Tobii Dynavox AAC

Assistive communication

Dedicated eye-gaze and speech-generating products can provide communication and computer access as movement changes.

What the evidence says

Manufacturer documentation distinguishes a computer eye tracker from integrated Windows and iPad-based speech devices. Selection depends on positioning, vision, fatigue and the person’s preferred communication system.

Keep in perspective

Product documentation describes capabilities, not a guarantee of individual performance. Assess with an AAC professional and trial the exact setup.

Sources, India & access1 source

For readers in India

Request a local assessment and written quotation covering hardware, mount, software, warranty, repairs and language support.

  1. Assistive communication solutions for ALS Tobii Dynavox · Manufacturer documentation
    Publication date not stated
Latest dated source: not stated[43]

Wearable eye-tracking communication

EyeControl

Specialist assessment needed

A wearable, screen-free approach uses eye movements with audio feedback to communicate needs.

What the evidence says

An ALS feasibility study is registered, while current manufacturer documentation also describes a bedside hospital platform. Product configurations and clinical use cases must be distinguished.

Keep in perspective

A completed feasibility study does not guarantee reliable use for every person with advanced ALS. Verify the specific product and evidence with the supplier.

Sources, India & access2 sources

For readers in India

Current Indian distribution, home-use suitability and support have not been verified; contact the clinical team and manufacturer before purchase.

  1. How the eye-tracking communication platform works EyeControl · Manufacturer documentation
    Publication date not stated
  2. Safety and Feasibility of the EyeControl Device Eyefree Assisting Communication Ltd · ClinicalTrials.gov · Trial registry
    28 August 2019
Latest dated source: [44][77]

Open-source Windows communication software

OptiKey with an eye tracker

Version compatibility matters

OptiKey supports typing, speech output and computer control using compatible input devices.

What the evidence says

The maintainers explicitly removed support for Tobii Eye Tracker 5, EyeX and 4C in OptiKey 4. Legacy OptiKey 3.2.x supports these older use cases.

Keep in perspective

Do not assume the latest OptiKey works with the Tobii Eye Tracker 5 setup elsewhere in this project. Verify hardware, driver, Windows and application versions together.

Sources, India & access1 source

For readers in India

Assess the existing hardware first. Budget for setup and assistance even where the software is free.

  1. Optikey versions and eye-tracker compatibility OptiKey maintainers · Project documentation
    14 May 2025
Latest dated source: [45]

The evidence library

Emerging communication technology

5 entries

Separate experimental interfaces and custom prototypes from established, individually assessed AAC.

Wearable gaze data · custom software

Pupil Labs Neon integrations

Research hardware

Neon provides gaze and other eye signals for researchers and developers; it is not a complete ALS communication system.

What the evidence says

The official real-time API can stream data to custom applications on the same network. That capability enables prototyping but does not establish clinical reliability for ALS.

Keep in perspective

Building a usable communication interface requires software, calibration/positioning work and individual testing. Do not equate raw gaze streaming with ready-to-use AAC.

Sources, India & access1 source

For readers in India

Consider established AAC assessment first. A custom integration needs sustained technical support and a backup communication method.

  1. Neon ecosystem and real-time API Pupil Labs · Manufacturer documentation
    Publication date not stated
Latest dated source: not stated[46]

Enable Viacam · alternative computer access

Webcam head tracking

Individual assessment

Head-tracking software can move a cursor using movements observed by a webcam.

What the evidence says

Enable Viacam’s documentation describes camera and tracking-area configuration. This is an access method for someone who can comfortably produce the required movements.

Keep in perspective

It is head tracking, not eye tracking. Weakness, fatigue and positioning can limit use; these tools are not established replacements for eye-gaze AAC.

Sources, India & access1 source

For readers in India

Trial comfort and accuracy with an assistive-technology professional. Maintain a simple communication backup.

  1. Configuration wizard and head tracking Enable Viacam · Project documentation
    Publication date not stated
Latest dated source: not stated[47]

Prototype concepts · including AprilTag setups

DIY marker and smartphone tracking

ALS evidence not established

Marker-based and smartphone experiments should be treated as engineering prototypes.

What the evidence says

No ALS-specific clinical validation or supported complete communication product was established for the older page’s proposed DIY setup. The Pupil Labs API documentation supports only the general feasibility of custom data integrations.

Keep in perspective

Do not present a prototype, price estimate or working demo as reliable daily communication for a person with ALS.

Sources, India & access1 source

For readers in India

Keep prototypes optional and supervised. They should not replace a dependable way to express urgent needs.

  1. Neon ecosystem and real-time API Pupil Labs · Manufacturer documentation
    Publication date not stated
Latest dated source: not stated[46]

Implanted brain–computer interfaces

Brain-to-voice neuroprostheses

Early human research

Research systems have enabled an individual with ALS to produce synthetic speech directly from recorded brain activity.

What the evidence says

UC Davis reported real-time voice synthesis in June 2025 in a participant with ALS. This is a communication milestone rather than restoration of natural speech muscles.

Keep in perspective

Small participant numbers, implanted hardware and intensive specialist support limit generalization. These systems are not established routine home products.

Sources, India & access1 source

For readers in India

Access is through formal research eligibility. Maintain practical AAC planning alongside interest in BCI research.

  1. Real-time speech neuroprosthesis in a participant with ALS UC Davis Health · Research institution
    11 June 2025
Latest dated source: [48]

Paradromics · implanted BCI

Connexus / Connect-One

Recruiting feasibility study

A 2026 early-feasibility study evaluates an implanted interface for communication and computer control.

What the evidence says

The trial registry lists recruiting in the US and includes people with severe speech or movement impairment. Safety and device feasibility are central objectives.

Keep in perspective

A research authorization is not commercial approval. Surgery, long follow-up and strict eligibility distinguish this from buying an eye tracker.

Sources, India & access1 source

For readers in India

No Indian study site is listed. Contact a formal research center about eligibility rather than relying on commercial availability claims.

Study record
NCT07357428 ↗
Recorded status
Recruiting
Registry updated
Countries listed
United States
  1. Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) Paradromics · ClinicalTrials.gov · Trial registry
    14 April 2026
Latest dated source: [78]

The evidence library

India research & access

3 entries

Local research participation and practical questions about genetics, trials and access to treatment.

NIMHANS · India–UK collaboration

ALS genetics in South Asia

Observational research

India’s participation in a Target ALS-funded genome-wide association study broadens the ancestry represented in ALS genetics.

What the evidence says

The funder describes an India–UK collaboration involving NIMHANS, with genetic analysis and longitudinal samples. This is research into disease risk and biology, not a treatment trial.

Keep in perspective

Research participation is not a guarantee of free clinical genetic testing, a diagnosis or access to a targeted medicine.

Sources, India & access1 source

For readers in India

Ask the treating neurology center about genetic counseling, clinically appropriate testing and any currently open research protocol.

  1. Unlocking ALS risk in South Asian populations Target ALS · Research funder
    13 May 2025
Latest dated source: [39]

Target ALS · AIIMS New Delhi · NIMHANS

Longitudinal samples and natural history

Research infrastructure

Following participants over time can connect molecular changes with clinical progression.

What the evidence says

The 2025 Global Natural History / Longitudinal Biofluid Study poster identifies AIIMS New Delhi and NIMHANS among participating institutions. Target ALS’s January 2026 update also describes tissue and genomic research resources.

Keep in perspective

Institutional involvement does not prove that a specific clinic is recruiting today or providing experimental treatment.

Sources, India & access2 sources

For readers in India

Confirm the exact protocol and recruitment status directly with the institution before arranging travel.

  1. Global Natural History / Longitudinal Biofluid Study poster Target ALS · Research poster
    December 2025
  2. Research cores: global discovery and long-read sequencing Target ALS · Research funder
    23 January 2026
Latest dated source: [40][41]

Approval · enrollment · personal import

Treatment and trial access from India

Check case by case

A treatment’s approval abroad, a company’s Indian presence and trial eligibility are separate questions.

What the evidence says

CDSCO provides a personal-use import process: Form 12A is the application and Form 12B is the permit. Permission, prescription, product supply and clinical suitability require separate confirmation.

Keep in perspective

Import permission is not Indian marketing approval or evidence that a medicine works. This page does not certify current prices, reimbursement or supply.

Sources, India & access1 source

For readers in India

Work with the treating team and licensed supply channels. Obtain written confirmation before committing to treatment-related travel or expense.

  1. Drugs for personal use: Form 12A, Form 12B and import procedure CDSCO · Regulator
    21 May 2015
Latest dated source: [42]

Bring the evidence into your care conversation.

This review supports discussion with your ALS team. Individual suitability, genetic results and local access need clinical assessment. Research participation is voluntary, and a study listing does not guarantee eligibility.

Explore caregiver FAQs

Transparency matters

How to read this review

A curated review of all previously included programs, with selected important additions. It is not an exhaustive registry of every ALS study worldwide.

01

Approval has a specific scope

Check the country, indication and patient population. Accelerated approval can depend on a biomarker while clinical benefit is still being confirmed.

02

A signal needs confirmation

Small studies, subgroup findings and open-label extensions can guide future trials. They carry different weight from a positive, controlled primary endpoint.

03

Plans can change

Enrollment, submissions and readouts are dated milestones. A sponsor’s planned next step is shown as a plan until there is evidence it happened.

Review method & limitations
  • Evidence cutoff: 10 September 2026. Sources were retrieved on 11 September 2026; dated developments after the cutoff are excluded.
  • Regulators establish approved indications. Trial registries establish the recorded design, phase and recruitment status. Registry dates are shown because records can lag behind events.
  • Published controlled results take precedence over subgroup claims. Sponsor announcements are labeled and used for operational milestones or explicitly preliminary findings.
  • Undated manufacturer pages describe product capabilities only; they do not establish a dated approval or verified availability on the cutoff date.
  • A biomarker measures a biological process. A change in NfL, TDP-43 or another marker is not automatically a demonstrated clinical benefit.
  • No medical specialist sign-off is claimed. Treatment suitability, genetic findings, access and current recruitment should be confirmed with the relevant clinical team.
What changed in this edition
  • Replaced unsupported stage-by-duration rules and blanket treatment recommendations with study-population and evidence limitations.
  • Separated Nuedexta symptom treatment from the four ALS-directed medicines reviewed here; clarified jurisdiction-specific approvals.
  • Corrected Rozebalamin to mecobalamin / E0302; removed the incorrect MT-1186 identification.
  • Corrected CNM-Au8, NurOwn, masitinib, PrimeC and NUZ-001 milestones using dated sources and registry records.
  • Added newer UNC13A, SARM1, RNA, gene-therapy and communication studies; kept every original topic or a clearly explained successor entry.
  • Made the previously hidden withdrawal, communication and experimental-technology content visible.
  • Removed unsupported Indian price, import-access and future availability promises; corrected Form 12A versus Form 12B.
  • Corrected OptiKey 4 versus legacy Tobii compatibility and removed unsourced device approval and superiority claims.
Research terms, in plain language
ALSFRS-R
A questionnaire used to track everyday functions such as speech, swallowing, movement and breathing.
Neurofilament light (NfL)
A marker associated with nerve injury. A lower level alone does not establish that someone functions better or lives longer.
Primary endpoint
The main outcome a trial is designed to test. Other or subgroup findings need careful interpretation when this outcome is not met.
Open-label extension
Follow-up in which participants and researchers know the treatment being given; comparisons are less protected from bias.
AAC
Augmentative and alternative communication: tools and strategies that support expression when speech is difficult.
Go to the original evidenceSource library78 references

All sources retrieved 11 September 2026. Dates below are publication or registry-update dates; undated pages are identified. External links may change after this review.

  1. 1
    Randomized trialDose-ranging study of riluzole in amyotrophic lateral sclerosis

    Lacomblez et al. · The Lancet · 25 May 1996

  2. 2
    Systematic reviewRiluzole for ALS / motor neuron disease

    Cochrane · 1 July 2021

  3. 3
  4. 4
  5. 5
    Trial and open-label extensionLong-Term Tofersen in SOD1 Amyotrophic Lateral Sclerosis

    Miller et al. · JAMA Neurology · 22 December 2025

  6. 6
  7. 7
    Randomized trialEfficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage ALS

    Oki et al. · JAMA Neurology · 9 May 2022

  8. 8
  9. 9
    RegulatorMasitinib AB Science: refusal of marketing authorisation

    European Medicines Agency · 22 January 2025

  10. 10
  11. 11
    Sponsor updateFirst participant enrolled in the PREVAiLS Phase 3 study

    Prilenia and Ferrer · 30 March 2026

  12. 12
    Randomized trialPridopidine in Amyotrophic Lateral Sclerosis

    HEALEY ALS Platform Trial · JAMA · 17 February 2025

  13. 13
    Sponsor updateSecond quarter 2026 results and CNM-Au8 regulatory update

    Clene · SEC exhibit · 14 August 2026

  14. 14
    Randomized trialCNM-Au8 in Amyotrophic Lateral Sclerosis

    HEALEY ALS Platform Trial · JAMA · 17 February 2025

  15. 15
    Sponsor updateSecond quarter 2026 results and ENDURANCE preparation

    BrainStorm Cell Therapeutics · 14 August 2026

  16. 16
    Sponsor updateInterim ANQUR data for QRL-201

    QurAlis · 23 February 2026

  17. 17
    Sponsor updateRevised strategy for PrimeC and planned PARAGON study

    NeuroSense · 31 August 2026

  18. 18
    Sponsor updateSecond quarter 2026 results and ALSTARS update

    Coya Therapeutics · 11 August 2026

  19. 19
    Trial centerHEALEY ALS Platform Trial: study drugs and enrollment

    Mass General Brigham · Publication date not stated

  20. 20
    Sponsor updateTopline Phase 2a clinical trial results for SPG302

    Spinogenix · 4 November 2025

  21. 21
    Sponsor updateInitiation of Phase 1 clinical trial of ATLX-1282

    Alchemab Therapeutics · PR Newswire · 9 September 2025

  22. 22
    Sponsor updateSEALS preliminary results at ENCALS 2026

    Axoltis Pharma · 24 June 2026

  23. 23
    Sponsor updateLUMINA cohort and biomarker update at ENCALS

    Amylyx Pharmaceuticals · 23 June 2026

  24. 24
    Sponsor updateFirst ALS participant dosed with NB-4746

    Nura Bio · GlobeNewswire · 22 June 2026

  25. 25
    Sponsor updateFirst patient dosed in the Phase 1b CTx1000 trial

    Celosia Therapeutics · PR Newswire · 23 March 2026

  26. 26
    Early clinical studyOligonucleotide–siRNA conjugate for SOD1 ALS: a phase 1 trial

    Chen et al. · Nature Medicine · 15 July 2026

  27. 27
    Sponsor updateFormal intention to remove RELYVRIO / ALBRIOZA from the market

    Amylyx Pharmaceuticals · 4 April 2024

  28. 28
    Sponsor updateFosigotifator HEALEY trial results

    Calico · 6 January 2025

  29. 29
    Sponsor updateTopline results for HEALEY Regimen G (DNL343)

    Denali Therapeutics · 6 January 2025

  30. 30
    Sponsor updateBIIB105 development discontinued after ALSpire

    Biogen and Ionis · 16 May 2024

  31. 31
    Randomized trialEfficacy and Safety of Zilucoplan in ALS

    Paganoni et al. · JAMA Network Open · 17 February 2025

  32. 32
    Randomized trialVerdiperstat in ALS: results from the randomized HEALEY trial

    HEALEY ALS Platform Trial · JAMA Neurology · 17 February 2025

  33. 33
    Randomized trialSafety and efficacy of trehalose in ALS

    HEALEY ALS Platform Trial · The Lancet Neurology · June 2025

  34. 34
    Randomized trialBIIB078 in C9orf72-associated ALS: phase 1 study

    van den Berg et al. · The Lancet Neurology · August 2024

  35. 35
    Research funderPreclinical ASHA-624 research in autosomal dominant optic atrophy

    Advancium Health Network · Publication date not stated

  36. 36
    Preclinical paperHigh-fidelity CRISPR-Cas13 for C9ORF72-linked ALS/FTD

    McCallister et al. · Nature Communications · 8 January 2025

  37. 37
  38. 38
    Sponsor updateTDP-43 condensate modulator development candidate

    Dewpoint Therapeutics · 8 January 2026

  39. 39
    Research funderUnlocking ALS risk in South Asian populations

    Target ALS · 13 May 2025

  40. 40
    Research posterGlobal Natural History / Longitudinal Biofluid Study poster

    Target ALS · December 2025

  41. 41
    Research funderResearch cores: global discovery and long-read sequencing

    Target ALS · 23 January 2026

  42. 42
  43. 43
    Manufacturer documentationAssistive communication solutions for ALS

    Tobii Dynavox · Publication date not stated

  44. 44
    Manufacturer documentationHow the eye-tracking communication platform works

    EyeControl · Publication date not stated

  45. 45
    Project documentationOptikey versions and eye-tracker compatibility

    OptiKey maintainers · 14 May 2025

  46. 46
    Manufacturer documentationNeon ecosystem and real-time API

    Pupil Labs · Publication date not stated

  47. 47
    Project documentationConfiguration wizard and head tracking

    Enable Viacam · Publication date not stated

  48. 48
    Research institutionReal-time speech neuroprosthesis in a participant with ALS

    UC Davis Health · 11 June 2025

  49. 49
    Sponsor updateRozebalamin approved in Japan on 24 September 2024

    Eisai · 16 October 2024

  50. 50
    Sponsor updateVTx-002 vectorized antibody mechanism

    VectorY Therapeutics · Publication date not stated

  51. 51
    Sponsor updateTwo-year DAZALS results and planned Phase 3 study

    Corcept Therapeutics · 30 April 2026

  52. 52
    Sponsor updateFirst participant dosed in NeurALS Phase 1/2

    Leal Therapeutics · PR Newswire · 23 June 2026

  53. 53
    Trial registryFUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS

    Trace Neuroscience, Inc. · ClinicalTrials.gov · 9 September 2026

  54. 54
    Trial registryPridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

    Prilenia · ClinicalTrials.gov · 25 August 2026

  55. 55
  56. 56
  57. 57
  58. 58
    Trial registryA Study Evaluating the Safety and Tolerability of QRL-201 in ALS

    QurAlis Corporation · ClinicalTrials.gov · 15 May 2026

  59. 59
    Trial registryStudy of COYA 302 for the Treatment of ALS

    Coya Therapeutics · ClinicalTrials.gov · 6 August 2026

  60. 60
    Trial registryHEALEY ALS Platform Trial - Regimen I NUZ-001

    Merit E. Cudkowicz, MD · ClinicalTrials.gov · 20 July 2026

  61. 61
    Trial registryStudy of SPG302 in Healthy Volunteers and ALS Participants

    Spinogenix · ClinicalTrials.gov · 29 June 2025

  62. 62
    Trial registryIntermediate-size Patient Population Expanded Access Protocol

    Spinogenix · ClinicalTrials.gov · 17 July 2026

  63. 63
    Trial registryALS Phase II Study of NX210c

    Axoltis Pharma · ClinicalTrials.gov · 24 December 2025

  64. 64
    Trial registryThe Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis

    XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · ClinicalTrials.gov · 21 November 2025

  65. 65
    Trial registryAMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis

    Amylyx Pharmaceuticals Inc. · ClinicalTrials.gov · 14 April 2026

  66. 66
  67. 67
    Trial registrySafety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis

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