Drug profile · INN
remibrutinib
RHAPSIDO
remibrutinib (RHAPSIDO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.
Drug details — remibrutinib
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L04)
- Route
- ORAL
- Patents
- 0
- Programs
- 12
- Data quality
- 0.84
Quick answer
remibrutinib (RHAPSIDO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.
Key facts
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
Recent coverage
Novartis remibrutinib wins Phase 3 in CSU: what it means
Novartis remibrutinib is an oral, highly selective BTK inhibitor with Phase 3 success in chronic spontaneous urticaria. This plan frames the catalyst for BD teams, investors, and analysts, including efficacy, safety, and next milestones.
Novartis remibrutinib wins Phase 3 in chronic spontaneous urticaria
Novartis remibrutinib has Phase 3 support in chronic spontaneous urticaria, with evidence of early symptom improvement and sustained efficacy through 52 weeks. This plan frames the result for BD teams, investors, and analysts, including regulatory context and what to watch next.
IMVT-1402 and 7 Other Late-Stage Drugs Transform Generalized Myasthenia Gravis Treatment Pipeline in 2026
Eight promising late-stage drugs including IMVT-1402 from Immunovant signal breakthrough era for generalized myasthenia gravis patients with novel mechanisms.
Congress & event coverage
- PresentationPharma Manufacturing World
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is remibrutinib?
remibrutinib (RHAPSIDO) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for remibrutinib?
RHAPSIDO is a marketed brand name for remibrutinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of remibrutinib?
remibrutinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.