NDAORALTABLETPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
25
Mechanism of Action
Bruton's Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
Remibrutinib Open Label Roll-over Post-trial Access Protocol
Started Apr 2026
212 enrolled
Indication of the Parent Protocol
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Started Apr 2026
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
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
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
Started Jan 2026
350 enrolled
Chronic Spontaneous Urticaria
Loss of Exclusivity
LOE Date
Jan 20, 2043
205 months away
Patent Expiry
Jan 20, 2043
Exclusivity Expiry
Sep 30, 2030