Multiple Sclerosis
Recent clinical, regulatory, research and industry developments relating to this disease.
Neuroinflammation across neurological diseases.
Market withdrawal: Extavia (EMA)
A disease-specific convergence of host and Epstein-Barr virus genetics in multiple sclerosis.
The role of the adaptive immune system in the initiation and persistence of multiple sclerosis.
Exploring the Pathophysiology, Diagnosis, and Treatment Options of Multiple Sclerosis.
Generic medicine authorisation: Dimethyl fumarate Accord (EMA)
Market withdrawal: Dimethyl fumarate Accord (EMA)
Market withdrawal: Dimethyl fumarate Teva (EMA)
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 6 clinical trials expected to report results, the earliest in Q4 2026.
- 12 industry developments reported.
- Q4 2026A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)
- Q4 2026A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-2)
- Q1 2030Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
- Q2 2030A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis
- Q2 2031A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
Clinical MilestonesView all 14Hide
- 2026-05-19Open-Label, Randomized, Multicenter, Multiple-Dose, Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label ExtensionResults posted
- 2026-02-27AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.Results posted
- 2026-10-07A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple SclerosisResults expected Q2 2030
- 2026-10-01A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-2)Results expected Q4 2026
- 2026-09-23An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisResults expected Q2 2032
- 2026-09-21Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)Results expected Q1 2030
- 2026-06-23A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple SclerosisResults expected Q2 2031
- 2025-11-14A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)Completed
- 2025-11-11An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With OcrelizumabCompleted
- 2027-01-01A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple SclerosisWithdrawn
- 2026-04-03A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.Terminated
- 2026-01-31Open-Label Multicenter Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple SclerosisWithdrawn
- 2025-11-28Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)Withdrawn
Industry & MarketView all 12Hide
- 2026-11-02Patient dies in CAR T trial for multiple sclerosisTrial news · Healio Neurology
- 2026-10-25Remibrutinib Cuts Multiple Sclerosis Relapse Rates in Phase III TrialsTrial news · MedPage Today — Neurology
- 2026-10-23STAT+: Novartis multiple sclerosis treatment cuts rates of relapse in pivotal trialsTrial news · STAT News
- 2026-10-21OCT to Assess Risk of Progression of Multiple SclerosisIndustry · Ophthalmology (AAO)
- 2026-10-15Periventricular gradient pathology is linked to ependymal reactivity and cell adhesion disruption in multiple sclerosisIndustry · Nature Neuroscience
Regulatory UpdatesViewHide
- 2026-06-19Original application approval — TolebrutinibCenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
- 2027-01-01ClinicalA Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple SclerosisWithdrawn
- 2026-11-02IndustryPatient dies in CAR T trial for multiple sclerosisTrial news · Healio Neurology
- 2026-10-27IndustryFenebrutinib May Curb Chronic Active Lesions in Multiple SclerosisIndustry · MedPage Today — Neurology
- 2026-10-25IndustryRemibrutinib Cuts Multiple Sclerosis Relapse Rates in Phase III TrialsTrial news · MedPage Today — Neurology
- 2026-10-24IndustryPatient Death Reported in Multiple Sclerosis CAR-T StudyResearch news · MedPage Today — Neurology
- 2026-10-23IndustrySTAT+: Novartis multiple sclerosis treatment cuts rates of relapse in pivotal trialsTrial news · STAT News
- 2026-10-23IndustryMultiple Sclerosis Anti-CD20 Drug Linked to Bowel Disease RiskIndustry · MedPage Today — Neurology
- 2026-10-22IndustryMultiple Sclerosis Diagnostic Delays Linked to Specialist, MRI AccessIndustry · MedPage Today — Neurology
- 2026-10-21IndustryChristina Applegate Says Her Multiple Sclerosis Diagnosis Was IncorrectIndustry · MedPage Today — Neurology
- 2026-10-21IndustryOCT to Assess Risk of Progression of Multiple SclerosisIndustry · Ophthalmology (AAO)
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Original application approval — Cenrifki is indicated for the treatment of adult patients with secondary progressive mult… (2026)
Product authorisation ended — Extavia is indicated for the treatment of: patients with a single demyelinating event wi… (2025)
Generic approval — Riulvy is indicated for the treatment of adult and paediatric patients aged 13 years and… (2025)
Generic approval — Dimethyl fumarate Mylan is indicated for the treatment of adult and paediatric patients a… (2024)
Biosimilar approval — Tyruko is indicated as single disease modifying therapy in adults with highly active rela… (2023)
Original application approval — Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple… (2023)
Generic approval — Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patie… (2022)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Multiple Sclerosis40
- Alzheimer Disease6
- Gastrointestinal Microbiome6
- Encephalomyelitis, Autoimmune, Experimental5
- Brain4
- Neurodegenerative Diseases4
- Parkinson Disease4
- Autoimmune Diseases3
Leading journals6
- Frontiers in immunology4
- International journal of molecular sciences4
- Gut microbes3
- Neurology3
- Proceedings of the National Academy of Sciences of the United States of America3
- Cells2
Leading researchers8
- Barkhof F3
- Baranzini SE2
- Clarke JWE2
- Cole JH2
- Ding Y2
- Kuhle J2
- Levin MC2
- Li H2
Affiliations (unnormalised)6
- Center for Molecular Medicine2
- College of Medicine2
- College of Pharmacy2
- Imperial College London2
- Karolinska Institutet2
- Lerner Research Institute2
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Multiple sclerosis is an autoimmune disorder of the central nervous system that primarily affects young adults. It is characterized by sharply demarcated areas of demyelination in the white matter and by a clinical course that often involves recurrent attacks with partial recovery, although acute fulminating and chronic progressive forms also occur.
The underlying cause of multiple sclerosis is not fully defined in the supplied material. The literature grounding supports complex gene-environment interactions, with epidemiologic associations involving low vitamin D levels, smoking, childhood obesity, and Epstein-Barr virus infection.
Multiple sclerosis is an inflammatory demyelinating disease in which immune-mediated injury targets myelin in the central nervous system. The grounding also supports roles for cytokine and interleukin signaling, innate immunity, oxidative stress, signal transduction, and impaired remyelination, with some literature debating whether neurodegeneration contributes to irreversible disability.
The supplied literature identifies low serum vitamin D, smoking, childhood obesity, and Epstein-Barr virus infection as likely risk factors for disease development. Genetic susceptibility is also supported by the grounding through polymorphism and quantitative trait loci.
The grounding supports disease-modifying treatment at the drug-class level, including immunomodulatory therapy such as glatiramer acetate. It also supports broader treatment approaches aimed at controlling inflammatory disease activity and addressing relapsing or progressive clinical courses, but does not provide enough detail to specify additional standard modalities beyond this.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.