NDAORALCAPSULEPriority Review
Approved
Sep 2025
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
34
Data completeness
7/8 — Comprehensive
Priority Review
KOSELUGO (selumetinib) by AstraZeneca is mitogen-activated protein kinase kinase 1 inhibitors [moa]. First approved in 2025.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KOSELUGO is an oral mitogen-activated protein kinase kinase 1 (MEK1) inhibitor approved by the FDA on September 10, 2025. It is a small-molecule kinase inhibitor developed by AstraZeneca for the treatment of neurofibromatosis type 1 (NF1) and related conditions. The drug works by blocking MEK1 signaling, which is dysregulated in NF1-associated tumors.
$15MPart D
LOE Approaching2.3 years to LOEEarly commercial stage with modest Part D spending ($15M, 776 claims in 2023) signals limited current patient volume; brand teams should prepare for narrow indication management and specialist-focused commercialization.
Mechanism of Action
Mitogen-Activated Protein Kinase Kinase 1 Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (34)
Study of Cabozantinib With Selumetinib for Plexiform Neurofibromas
Started Aug 2026
30 enrolled
Neurofibromatosis 1Plexiform Neurofibroma
Selumetinib for NF2-Related Schwannomatosis
Started Jul 2026
20 enrolled
Neurofibromatosis Type 2NF2NF2-related Schwannomatosis+3 more
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
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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.