NDAORALTABLETPriority Review
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
WELIREG (belzutifan) by Merck & Co. is hypoxia-inducible factor 2 alpha inhibitors [moa]. Approved for hypoxia-inducible factor inhibitor [epc]. First approved in 2021.
Drug data last refreshed 26m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELIREG (belzutifan) is an oral, small-molecule HIF-2α inhibitor approved by the FDA in August 2021 for treating hypoxia-inducible factor-driven cancers. It works by inhibiting HIF-2 alpha, a key regulator of tumor growth and angiogenesis in certain malignancies. The drug represents a novel mechanism of action targeting a previously underexploited pathway in oncology.
$60MPart D
Peak16.0 years to LOEProduct is at peak commercial maturity with modest Part D penetration; commercial teams are focused on market expansion and indication broadening rather than launch activities.
Mechanism of Action
Hypoxia-inducible Factor 2 alpha Inhibitors
Pharmacologic Class:
Hypoxia-inducible Factor Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Started Apr 2026
758 enrolled
Carcinoma, Renal Cell
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Started Mar 2026
450 enrolled
Von Hippel-Lindau DiseaseCarcinoma, Renal Cell
Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)
Started Dec 2025
10 enrolled
Clear Cell Renal Cell Carcinoma
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Started Nov 2025
904 enrolled
Renal Cell Carcinoma
A Study of Belzutifan (MK-6482) and Metformin in Healthy Adult Participants (MK-6482-039)
Started Aug 2025
14 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.