Which multiple sclerosis drugs are in Phase 3?

Phase 3 (or later) programs for multiple sclerosis include Tolebrutinib and Masitinib.

How many clinical trials are recruiting for multiple sclerosis?

100 drug-interventional multiple sclerosis trials are currently recruiting participants, out of 1,154 registered interventional trials.

Neurological Disorders

Multiple sclerosis drug pipeline

ICD-11 8A40
MeSH D009103

2 compounds from 2 companies are in active clinical development for multiple sclerosis, including 2 at Phase 3 or beyond.

2Compounds

2Companies

2Phase 3+

136Trials recruiting

Phase 31

MasitinibAB ScienceKIT Inhibitor

Approved1

TolebrutinibSanofiBTK Inhibitor

Mechanisms: Small molecule (2)

Pipeline data compiled September 2026 · every fact sourced.

Upcoming readouts & recent results

2025-12-15ReportedTolebrutinibTopline datamissedNCT04458051
PERSEUS Phase 3 missed its primary endpoint in primary progressive MS: tolebrutinib did not delay time to 6-month composite confirmed disability progression vs placebo (n=767, 2:1); Sanofi will not pursue regulatory registration in PPMS. ↗
2024-09-20ReportedTolebrutinibFull resultsmetNCT04411641
HERCULES full results at ECTRIMS 2024: 31% delay in time to onset of 6-month confirmed disability progression vs placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026); confirmed disability improvement nearly doubled (10% vs 5%; HR 1.88; nominal p=0.021). ↗
2024-09-02ReportedTolebrutinibTopline datametNCT04411641
HERCULES Phase 3 met its primary endpoint: tolebrutinib delayed time to onset of 6-month confirmed disability progression vs placebo in non-relapsing secondary progressive MS - the first Phase 3 win in this population. ↗
2024-09-02ReportedTolebrutinibTopline datamixedNCT04410978
GEMINI 1 Phase 3 missed its primary endpoint: tolebrutinib did not reduce annualized relapse rate vs teriflunomide in relapsing MS; pooled GEMINI 1+2 key secondary showed a 29% delay in 6-month confirmed disability worsening (HR 0.71; 95% CI 0.53-0.95; nominal p=0.023). ↗

See the full catalyst calendar →

Compounds in development (2)

Compound	Company	Phase	Status	Mechanism
TolebrutinibFDA Breakthrough Therapy (Non-Relapsing Secondary Progressive MS; Granted 2024-12-13)FDA Priority Review (NrSPMS NDA; Accepted 2025-03-25)	Sanofi	Approved	Approved	BTK Inhibitor
Masitinib	AB Science	Phase 3	Suspended	KIT Inhibitor

Trials recruiting now (100)

100 drug-interventional multiple sclerosis trials recruiting now, of 1,154 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications
100% Oxygen
Jay C. Buckey Jr.n=100Started Aug 2026NCT07240649
Phase 4A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
OCR SC
Genentech, Inc.n=100Puerto Rico, United States · 11 sitesStarted Jul 2026NCT07609719
Phase 4Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
Tulane Universityn=20United States · 1 siteStarted Jun 2026NCT04601233
Phase 4Silodosin for Urinary Symptoms in Female Patients With Multiple Sclerosis
Silodosin 8 mg, Placebo
Atlantic Health Systemn=60United States · 1 siteStarted Apr 2026NCT07614321
Phase 4Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
Ublituximab, Ocrelizumab
Johns Hopkins Universityn=50United States · 1 siteStarted Feb 2026NCT07389590
Phase 4Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Ublituximab
Northwestern Universityn=40United States · 1 siteStarted Nov 2025NCT07225361
Phase 4A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)
Dimethyl Fumarate Enteric-coated Capsules
Qilu Pharmaceutical (Hainan) Co., Ltd.n=50Started Sep 2025NCT07138833
Phase 4A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
Ocrelizumab
F. Hoffmann-La Roche Ltdn=60China · 17 sitesStarted Jul 2025NCT07483450
Phase 4Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
Ocrelizumab
University of California, San Franciscon=5United States · 1 siteStarted Feb 2025NCT06495593
Phase 4Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
Ozanimod
University of Colorado, Denvern=100United States · 3 sitesStarted Jul 2024NCT06529406
Phase 4Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Dalfampridine 10 MG [Ampyra]
MGH Institute of Health Professionsn=48United States · 1 siteStarted Jun 2024NCT06136728
Phase 4Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Ocrelizumab, Placebo for Ocrelizumab
National Institute of Allergy and Infectious Diseases (NIAID)n=123United States · 13 sitesStarted Jan 2023NCT05285891

Showing the 12 most advanced of 100 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for multiple sclerosis?: 2 compounds from 2 companies are in active clinical development for multiple sclerosis, including 2 at Phase 3 or beyond.
Which multiple sclerosis drugs are in Phase 3?: Phase 3 (or later) programs for multiple sclerosis include Tolebrutinib and Masitinib.
How many clinical trials are recruiting for multiple sclerosis?: 100 drug-interventional multiple sclerosis trials are currently recruiting participants, out of 1,154 registered interventional trials.