NDAORALSUSPENSIONPriority Review
Approved
Aug 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Protein 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
Started Feb 2026
3,280 enrolled
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Started Feb 2026
505 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
Jun 14, 2039
161 months away
Patent Expiry
Jun 14, 2039
Exclusivity Expiry
Feb 24, 2030