NDAORALCAPSULEPriority Review
Approved
Sep 2025
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
48
Data completeness
7/8 — Comprehensive
Priority Review
KOSELUGO (selumetinib) by AstraZeneca is mitogen-activated protein kinase kinase 1 inhibitors [moa]. Approved for neurofibromatosis type 1. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KOSELUGO (selumetinib) is an oral kinase inhibitor that selectively targets mitogen-activated protein kinase kinase 1 (MEK1), approved by the FDA on September 10, 2025. It is a small-molecule therapeutic designed for oncology indications where MEK pathway inhibition provides clinical benefit. As a MEK inhibitor, selumetinib works by blocking downstream signaling in the MAPK pathway, which is frequently dysregulated in various cancers. The product represents AstraZeneca's entry in the competitive kinase inhibitor space.
$0.0BPart D
2.5 years to LOEMechanism of Action
Mitogen-Activated Protein Kinase Kinase 1 Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications (1)
Clinical Trials (48)
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.