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Belzutifan - Merck & Co

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Drug Profile

Belzutifan - Merck & Co

Alternative Names: MK 6482; PT-2977; WELIREG; WELIREGTM

Latest Information Update: 09 Mar 2026

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At a glance

  • Originator Peloton Therapeutics
  • Developer Eisai Inc; Merck & Co; Merck Sharp & Dohme; Peloton Therapeutics
  • Class Antineoplastics; Benzonitrile; Fluorobenzenes; Indenes; Small molecules; Sulfones
  • Mechanism of Action Endothelial PAS domain-containing protein 1 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Von Hippel-Lindau disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Paraganglioma; Phaeochromocytoma; Renal cell carcinoma; Von Hippel-Lindau disease
  • Preregistration Neuroendocrine tumours
  • Phase II Gastrointestinal stromal tumours; HER2 negative breast cancer; Solid tumours
  • Phase I/II Prostate cancer
  • Discontinued Iron overload

Most Recent Events

  • 28 Feb 2026 Preregistration for Renal cell carcinoma (Combination therapy, Adjuvant therapy) in USA (PO)
  • 28 Feb 2026 Preregistration for Renal cell carcinoma (Second-line therapy or greater, Late-stage disease, Metastatic disease, Inoperable/Unresectable, Combination therapy) in USA (PO) (NCT04586231)
  • 28 Feb 2026 FDA assigns PDUFA action date of 04/10/2026 for Belzutifan in combination with lenvatinib for Renal cell carcinoma

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