Amyotrophic Lateral Sclerosis (ALS)

Neurology
9
Pipeline Programs
6
Companies
12
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
3
4
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 11 programs with unclassified modality

Competitive Landscape

6 companies ranked by most advanced pipeline stage

BrainStorm Cell Therapeutics
3 programs
1
2
Debamestrocel - MSC-NTFPhase 31 trial
NurOwn®Phase 31 trial
Nurown MSC-NTF cellsPhase 21 trial
Active Trials
NCT02017912Completed48Est. Jul 2016
NCT06973629Not Yet Recruiting200Est. May 2029
NCT03280056Completed196Est. Sep 2020
AS
AB ScienceFrance - Paris
2 programs
1
1
Masitinib 4.5 mg/kg/dayPhase 31 trial
MasitinibPhase 2/3Small Molecule1 trial
Active Trials
NCT02588677CompletedEst. Mar 2018
NCT07174492Not Yet RecruitingEst. Dec 2029
Cytokinetics
CytokineticsSOUTH SAN FRANCISCO, CA
1 program
1
tirasemtivPhase 31 trial
Active Trials
NCT02936635Completed280Est. Oct 2018
E
EisaiChina - Liaoning
2 programs
2
E0302Phase 2/31 trial
E0302Phase 2/31 trial
Active Trials
NCT00444613Completed373Est. Jul 2014
NCT00445172Completed135Est. Mar 2017
Synapse Biomedical
Synapse BiomedicalOH - Oberlin
3 programs
1
NeuRx® Diaphragm Pacing System™Phase 21 trial
Intramuscular diaphragm electrodesN/A1 trial
NeuRx Diaphragm Pacing SystemN/A1 trial
Active Trials
NCT00420719UnknownEst. Oct 2009
NCT01605006CompletedEst. Feb 2017
NCT01938495CompletedEst. Apr 2017
Design Therapeutics
1 program
sampling bloodN/A1 trial
Active Trials
NCT07099066Not Yet RecruitingEst. Jun 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
AB ScienceMasitinib 4.5 mg/kg/day
BrainStorm Cell TherapeuticsDebamestrocel - MSC-NTF
BrainStorm Cell TherapeuticsNurOwn®
Cytokineticstirasemtiv
AB ScienceMasitinib
EisaiE0302
EisaiE0302
BrainStorm Cell TherapeuticsNurown MSC-NTF cells
Synapse BiomedicalNeuRx® Diaphragm Pacing System™
Design Therapeuticssampling blood
Synapse BiomedicalNeuRx Diaphragm Pacing System
Synapse BiomedicalIntramuscular diaphragm electrodes

Clinical Trials (12)

Total enrollment: 1,232 patients across 12 trials

NCT07174492AB ScienceMasitinib 4.5 mg/kg/day

Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients

Start: Jan 2026Est. completion: Dec 2029
Phase 3Not Yet Recruiting
NCT06973629BrainStorm Cell TherapeuticsDebamestrocel - MSC-NTF

Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)

Start: Jun 2025Est. completion: May 2029200 patients
Phase 3Not Yet Recruiting
NCT03280056BrainStorm Cell TherapeuticsNurOwn®

Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

Start: Aug 2017Est. completion: Sep 2020196 patients
Phase 3Completed
NCT02936635Cytokineticstirasemtiv

A Study for Patients Who Completed VITALITY-ALS (CY 4031)

Start: Oct 2016Est. completion: Oct 2018280 patients
Phase 3Completed
NCT02588677AB ScienceMasitinib

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Start: Apr 2013Est. completion: Mar 2018
Phase 2/3Completed
NCT00445172EisaiE0302

A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

Start: Feb 2008Est. completion: Mar 2017135 patients
Phase 2/3Completed
NCT00444613EisaiE0302

A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

Start: Apr 2007Est. completion: Jul 2014373 patients
Phase 2/3Completed
NCT02017912BrainStorm Cell TherapeuticsNurown MSC-NTF cells

Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS

Start: May 2014Est. completion: Jul 201648 patients
Phase 2Completed
NCT01938495Synapse BiomedicalNeuRx® Diaphragm Pacing System™

Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)

Start: Aug 2013Est. completion: Apr 2017
Phase 2Completed
NCT07099066Design Therapeuticssampling blood

Generation of Cell Banks and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (ALS) (HCD-SLA)

Start: Sep 2025Est. completion: Jun 2026
N/ANot Yet Recruiting
NCT01605006Synapse BiomedicalNeuRx Diaphragm Pacing System

Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis

Start: Jul 2012Est. completion: Feb 2017
N/ACompleted
NCT00420719Synapse BiomedicalIntramuscular diaphragm electrodes

Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)

Start: Oct 2004Est. completion: Oct 2009
N/AUnknown

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
6 companies competing in this space

Related Indications

Multiple Sclerosis(274)Schizophrenia(255)Epilepsy(242)Parkinson Disease(171)Alzheimer's Disease(165)Parkinson's Disease(160)Alzheimer Disease(117)Stroke(102)Relapsing-Remitting Multiple Sclerosis(83)Depression(82)