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Welireg FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 25, 2021.

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

Welireg (belzutifan) is a selective inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α) for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

  • Von Hippel-Lindau disease is a rare genetic disease caused by a genetic mutation in the VHL tumor suppressor gene. When VHL is inactivated, proteins known as hypoxia-inducible factors can accumulate, leading to the growth of both benign and malignant tumors.
  • Welireg works by reducing transcription and expression of hypoxia-inducible factor 2 alpha (HIF-2α) target genes associated with cellular proliferation, angiogenesis and tumor growth.
  • Welireg tablets are administered once daily with or without food.
  • Welireg may cause serious side effects including anemia and hypoxia. Common side effects include decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.

Development timeline for Welireg

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

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