NDAORALTABLETPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
21
Data completeness
5/8 — Partial
Priority Review
RHAPSIDO (remibrutinib) by Novartis is bruton's tyrosine kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2025.
Drug data last refreshed 21h ago
Mechanism of Action
Bruton's Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Remibrutinib Open Label Roll-over Post-trial Access Protocol
Started Apr 2026
212 enrolled
Indication of the Parent Protocol
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Started Apr 2026
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
Remibrutinib in Real-world Clinical Practice
Started Feb 2026
3,280 enrolled
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Started Feb 2026
505 enrolled
Chronic Spontaneous Urticaria
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
Started Jan 2026
350 enrolled
Chronic Spontaneous Urticaria
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.