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Drug

Remibrutinib

Approved medicine
ResearchActive indication expansion

Also known as Rhapsido.

RxNorm2724365ChEMBLCHEMBL4483575ATCL04AA60UNIII7MVZ8HDNU
12
Active clinical trials
3
Regulatory events
Latest activity
beta

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

Remibrutinib Cuts Multiple Sclerosis Relapse Rates in Phase III Trials

Clinical trial2026-10-25Trial news · MedPage Today — Neurology

Remibrutinib Earns Approval for More Itch Relief

Regulatory2026-10-08Regulatory news · Medscape Medical News

Rhapsido is first drug cleared for chronic hives disorder SD

Industry2026-10-07pharmaphorum

Indication expansion: REMIBRUTINIB (NDA218436)

Regulatory2026-10-06FDA

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 trial2026-09-28Results expected Q3 2027 · 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 trial2026-09-25Results 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 trial2026-09-25Results expected Q1 2033 · ClinicalTrials.gov

Novartis' Rhapsido safer than rivals, Phase 3 multiple sclerosis data suggest

Clinical trial2026-09-01Trial news · Endpoints News

Novartis claims MS win as Rhapsido clears phase 3 with ‘no liver safety signal’

Clinical trial2026-09-01Trial news · Fierce Pharma

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 trial2026-08-26Results expected Q3 2029 · ClinicalTrials.gov

Marketing authorisation: Rhapsido (EMA)

Regulatory2026-04-23EMA

Approval: REMIBRUTINIB (NDA218436)

Regulatory2025-09-30FDA

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
ATC codes
L04AA60
UNII
I7MVZ8HDNU
Regulatory jurisdictions
fdaema

Regulatory timeline

3 events

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.

Approval / market entry confirmed across FDA and EMA (2025-09-30 → 2026-10-06)
Earliest approval
2025-09-30
Latest approval
2026-10-06
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-10-06Indication expansionMulti-authority
Indication expansion: REMIBRUTINIB (NDA218436)
Evidence ↗
2025-09-30ApprovalMulti-authority
Approval: REMIBRUTINIB (NDA218436)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2026-04-23Original application approvalMulti-authority
Marketing authorisation: 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 ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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=4002031
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.