Midostaurin

Orphan DrugFDA Approved

Description

Midostaurin is a kinase inhibitor used in the treatment of acute myeloid leukemia (AML) with certain genetic mutations. It works by blocking the activity of specific enzymes that promote cancer cell growth.

Indications & Therapeutic Use

Acute Myeloid Leukemia (AML) with FLT3 mutation

Global Availability (3 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

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

Fulfilment Partner
Midostaurin
Generic NameMidostaurin
Brands1 brand available
Active IngredientMidostaurin
Drug ClassAcute Myeloid Leukemia (AML) with FLT3 mutation
ManufacturerNovartis
Dosage FormsCapsule, 25 mg
Medical CodeL01XE26
Orphan StatusYes — Orphan Drug
Cold ChainNot Required
Lead Time14 days
Reg. StatusFDA Approved
Clinical TrialNCT00651261
Countries3 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations4 Validated Nodes