Back to discover
Drug

Remibrutinib

Approved · EMA
Late-stage development

Also known as Rhapsido.

RxNorm2724365ChEMBLCHEMBL4483575UNIII7MVZ8HDNU
12
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ Rhapsido

Industry2026-07-29Acquisition · Fierce Biotech

A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Clinical trial2026-07-23Primary completion · ClinicalTrials.gov

A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Clinical trial2026-07-23Primary completion · ClinicalTrials.gov

A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)

Clinical trial2026-07-15Results expected Q3 2027 · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

Clinical trial2026-07-13Results expected Q4 2030 · ClinicalTrials.gov

A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines

Clinical trial2026-07-10Results expected Q1 2027 · ClinicalTrials.gov

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.

Clinical trial2026-07-08Results expected Q1 2033 · ClinicalTrials.gov

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

Clinical trial2026-06-26Results expected Q3 2029 · ClinicalTrials.gov

A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical trial2026-06-24Results expected Q4 2031 · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase

Clinical trial2026-06-01Results expected Q1 2028 · ClinicalTrials.gov

An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)

Clinical trial2026-05-20Results expected Q4 2030 · ClinicalTrials.gov

Approval: Rhapsido (EMA)

Regulatory2026-04-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Remibrutinib
Aliases & brands
Rhapsido
RxNorm CUI
2724365
ChEMBL ID
CHEMBL4483575
UNII
I7MVZ8HDNU
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-04-23
Latest approval
2026-04-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-04-23Approval
Approval: Rhapsido (EMA)

Indication: Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2025
12
Active studies
8
Recruiting
10
Late-stage (III+)
1
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 14
Phase 11Phase 23Phase 310

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

RecruitingPH IIIKey trialNovartis Pharmaceuticalsn=1,2752034

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase

RecruitingPH IIINovartis Pharmaceuticalsn=1802033

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.

RecruitingPH IIINovartis Pharmaceuticalsn=6482033

A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Not yet recruitingPH IIINovartis Pharmaceuticalsn=7102031

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

RecruitingPH IIINovartis Pharmaceuticalsn=3602031
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.