Skip to main content

Welireg FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 2, 2024.

FDA Approved: Yes (First approved August 13, 2021)
Brand name: Welireg
Generic name: belzutifan
Dosage form: Tablets
Company: Merck
Treatment for: Von Hippel-Lindau Syndrome, Renal Cell Carcinoma

Welireg (belzutifan) is a selective inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α) for the treatment of von Hippel-Lindau (VHL) disease and advanced renal cell carcinoma.

Development timeline for Welireg

Dec 14, 2023Approval FDA Approves Merck’s Welireg (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI
Aug 13, 2021Approval FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
Mar 16, 2021Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.