NDAORALCAPSULEPriority Review
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Mechanism of Action
Mitogen-Activated Protein Kinase Kinase 1 Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
Study of Cabozantinib With Selumetinib for Plexiform Neurofibromas
Started Aug 2026
30 enrolled
Neurofibromatosis 1Plexiform Neurofibroma
Real-World Treatment Study of Koselugo (Selumetinib)
Started Jun 2024
200 enrolled
Neurofibromatosis 1Neurofibroma, Plexiform
Observational Study to Evaluate the Effect and Safety of Selumetinib in Pediatric Patients With NF1-PNs
Started Dec 2023
409 enrolled
Neurofibroma, Plexiform
Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, PhaseⅡ, Double-Blinded, Placebo-Controlled Study
Started Aug 2023
0Neurofibromatosis Type 1Plexiform NeurofibromasPost-operative
Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia
Started Mar 2023
150 enrolled
Neurofibroma
Loss of Exclusivity
LOE Date
Mar 26, 2029
37 months away
Patent Expiry
Mar 26, 2029
Exclusivity Expiry
Nov 19, 2028