Independent reference. Not affiliated with, endorsed by, or speaking for the U.S. Food and Drug Administration.
FDA Medication Tracker

← All approvals · Immune & inflammatory · 2025

Rhapsido (remibrutinib)

The FDA approved Rhapsido (remibrutinib) on September 30, 2025 to treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment.
Brand name
Rhapsido
Generic name
remibrutinib
FDA approval date
September 30, 2025
Approved use (FDA wording)
To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment
Company
Novartis
Application
NDA218436
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Kinase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Immune & inflammatory

Indications and usage, from the FDA label

RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. ( 1 ) Limitations of Use: Not indicated for other forms of urticaria. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.