Multiple Sclerosis, Relapsing-Remitting
Recent clinical, regulatory, research and industry developments relating to this disease.
Heightened Epstein-Barr virus immunity and potential cross-reactivities in multiple sclerosis.
Identification and management of subclinical disease activity in early multiple sclerosis: a review.
Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Alterations of the human gut microbiome in multiple sclerosis.
The relation between inflammation and neurodegeneration in multiple sclerosis brains.
B-cell depletion with rituximab in relapsing-remitting multiple sclerosis.
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.
- 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)
- Q4 2030A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With 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 16Hide
- 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
- 2026-07-13A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple SclerosisResults expected Q4 2030
- 2026-07-08Ublituximab 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
- 2026-06-18An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisResults expected Q2 2032
- 2026-02-23A 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)Results expected Q4 2026
- 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
- 2025-11-04Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMSCompleted
- 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
- 2025-09-08A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)Terminated
- 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
- 2026-07-13ClinicalA Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple SclerosisResults expected Q4 2030
- 2026-07-08ClinicalUblituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)Results expected Q1 2030
- 2026-06-23ClinicalA Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple SclerosisResults expected Q2 2031
- 2026-06-18ClinicalAn Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisResults expected Q2 2032
- 2026-05-19ClinicalOpen-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
- 2026-04-03ClinicalA 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
- 2026-02-27ClinicalAGNOS: 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
- 2026-02-23ClinicalA 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)Results expected Q4 2026
- 2026-02-23ClinicalA 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
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Riulvy is indicated for the treatment of adult and paediatric patients aged 13 years and… (2025)
Approval — Dimethyl fumarate Mylan is indicated for the treatment of adult and paediatric patients a… (2024)
Approval — Tyruko is indicated as single disease modifying therapy in adults with highly active rela… (2023)
Approval — Teriflunomide Accord is indicated for the treatment of adult patients and paediatric pati… (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
- Antibodies, Viral1
- Cognitive Dysfunction1
- Epstein-Barr Virus Infections1
- Gastrointestinal Microbiome1
- Herpesvirus 4, Human1
- Multiple Sclerosis1
- Multiple Sclerosis, Relapsing-Remitting1
- Nerve Degeneration1
Leading journals5
- The New England journal of medicine2
- Brain : a journal of neurology1
- Journal of neurology1
- Nature communications1
- PLoS pathogens1
Leading researchers8
- Arnold DL2
- Bar-Or A2
- Chitnis T2
- Hauser SL2
- Agarwal S1
- Antel J1
- Belachew S1
- Bramow S1
Affiliations (unnormalised)6
- Ann Romney Center for Neurologic Diseases1
- Brigham Multiple Sclerosis Center1
- Center for Brain Research1
- Center for Clinical and Translational Metagenomics1
- Dudley Group of Hospitals NHS Foundation Trust1
- From the University of California1
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.
Relapsing-remitting multiple sclerosis is the most common clinical form of multiple sclerosis. It is characterized by recurrent acute episodes of neurologic dysfunction followed by partial or complete recovery. Common manifestations include loss of visual, motor, sensory, or bladder function, and attacks can involve the optic nerves, spinal cord, brain stem, and cerebellum.
The disease involves acute episodes of demyelination in the central nervous system. These episodes can occur at multiple sites, including the optic nerves, spinal cord, brain stem, and cerebellum, and are associated with neurologic dysfunction that may improve partially or completely after relapse. The supplied grounding also indicates that early disease activity may include subclinical processes such as cognitive impairment, brain atrophy, fatigue, and silent progression not fully captured by relapse or MRI lesion activity.
The supplied grounding supports early treatment initiation in multiple sclerosis to help prevent irreversible neurological damage and disability progression. Management is described at the level of drug therapy and disease monitoring, with assessment commonly based on relapse rates and MRI lesion activity. The literature also emphasizes treatment and monitoring aimed at detecting and addressing ongoing disease activity, including subclinical progression.
AI-generated summary grounded in MeSH and 1 peer-reviewed source. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)
- 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.