Belzutifan

Orphan DrugFDA Approved

Description

Belzutifan is a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for the treatment of von Hippel-Lindau disease-associated tumors. It works by blocking HIF-2α, which is constitutively activated in VHL disease, leading to tumor growth. The drug has demonstrated efficacy in reducing the size of renal cell carcinomas, central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors in VHL patients.

Indications & Therapeutic Use

von Hippel-Lindau disease-associated renal cell carcinoma, central nervous system hemangioblastomas, pancreatic neuroendocrine tumors

Linked Diseases:

Global Availability (5 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

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

Fulfilment Partner
Belzutifan
Generic NameBelzutifan
Brands1 brand available
Active IngredientBelzutifan
Drug Classvon Hippel-Lindau disease-associated renal cell carcinoma
ManufacturerMerck & Co.
Dosage FormsOral tablet, 40mg
Medical CodeL01EX
Orphan StatusYes — Orphan Drug
Cold ChainNot Required
Lead Time14 days
Reg. StatusFDA Approved
Clinical TrialNCT03401788
Countries5 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations6 Validated Nodes