selumetinib

Orphan DrugFDA Approved, EMA Approved

Description

Selumetinib is a kinase inhibitor that targets MEK1 and MEK2. It was approved for pediatric patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. The drug represents the first approved treatment specifically for this rare genetic condition.

Indications & Therapeutic Use

neurofibromatosis type 1, plexiform neurofibromas

Linked Diseases:

Global Availability (4 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
selumetinib
Generic Nameselumetinib
Brands1 brand available
Active Ingredientselumetinib sulfate
Drug Classneurofibromatosis type 1
ManufacturerAstraZeneca
Dosage FormsOral capsules, 10mg and 25mg
Medical CodeL01EE04
Orphan StatusYes — Orphan Drug
Cold ChainNot Required
Lead Time14 days
Reg. StatusFDA Approved, EMA Approved
Clinical TrialNCT01362803
Countries4 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations5 Validated Nodes