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 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RHAPSIDO (remibrutinib) is an oral Bruton's Tyrosine Kinase (BTK) inhibitor small molecule approved by FDA on September 30, 2025. It selectively targets BTK to modulate B-cell and myeloid cell signaling, with applications across hematologic and autoimmune conditions. The drug represents Novartis's entry into the competitive BTK inhibitor class with a novel mechanism designed for improved selectivity and tolerability.
Launch16.3 years to LOE
As a newly launched product, the brand team is in build-out phase with aggressive market development and sales force expansion planned through 2026-2027.
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 of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Started Mar 2027
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
Started Nov 2026
382 enrolled
Chronic Spontaneous Urticaria
A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Started Oct 2026
180 enrolled
Chronic Pruritus of Unknown Origin
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
Started Aug 2026
576 enrolled
IgE-Mediated Food AllergyPeanut AllergyCow Milk Allergy+1 more
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
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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.