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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELIREG (belzutifan) is an oral hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor developed by Merck & Co. and approved by the FDA on August 13, 2021. It represents a novel mechanism targeting HIF-2α signaling pathways implicated in certain cancers and genetic conditions. The drug is positioned as a targeted therapy for patients with specific HIF-driven malignancies and hereditary conditions.
$0.1BPart D
16.2 years to LOEMechanism 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.