NDAORALTABLETPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
20
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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RHAPSIDO (remibrutinib) is an oral small-molecule Bruton's Tyrosine Kinase (BTK) inhibitor approved by the FDA on September 30, 2025. It selectively inhibits BTK signaling to treat B-cell malignancies and autoimmune conditions. The drug represents Novartis's entry into a crowded kinase inhibitor space with differentiated BTK selectivity.
Growth16.6 years to LOE
Early-stage launch product with no IRA price negotiations yet; commercial team buildout and market education are underway.
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 (20)
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Started Jul 2026
470 enrolled
Chronic Spontaneous Urticaria
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Started Jun 2026
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
Remibrutinib Open Label Roll-over Post-trial Access Protocol
Started Apr 2026
212 enrolled
Indication of the Parent Protocol
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Started Feb 2026
505 enrolled
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice
Started Feb 2026
3,280 enrolled
Chronic Spontaneous Urticaria
Worked on RHAPSIDO at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.