NDAORALCAPSULEPriority Review
Approved
Sep 2025
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
34
Data completeness
6/8 — Strong
Priority Review
KOSELUGO (selumetinib) by AstraZeneca is mitogen-activated protein kinase kinase 1 inhibitors [moa]. First approved in 2025.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KOSELUGO (selumetinib) is an oral MEK1/2 kinase inhibitor approved by the FDA on September 10, 2025. It is indicated for neurofibromatosis type 1 (NF1) and works by inhibiting mitogen-activated protein kinase signaling to suppress tumor growth. The drug represents a precision oncology approach targeting a specific genetic driver.
$15MPart D
LOE Approaching2.0 years to LOEEarly-stage commercialization with modest Part D spending signals a niche indication and small specialized sales team focused on rare disease centers of excellence.
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)
Selumetinib for NF2-Related Schwannomatosis
Started Dec 2026
20 enrolled
Neurofibromatosis Type 2NF2NF2-related Schwannomatosis+3 more
Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)
Started Sep 2026
800 enrolled
Neurofibromatosis Type 1 (NF1)
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
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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.