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 11h ago · AI intelligence enriched 1mo 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.
Growth16.5 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)
A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Started Aug 2026
180 enrolled
Chronic Pruritus of Unknown Origin
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Started Jul 2026
80 enrolled
Papulopustular Rosacea
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Started Jul 2026
470 enrolled
Chronic Spontaneous Urticaria
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
Started Jul 2026
710 enrolled
Hidradenitis Suppurativa
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
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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.