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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELIREG (belzutifan) is an oral small-molecule hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor approved by the FDA in August 2021. It is indicated for patients with HIF-driven cancers, particularly renal cell carcinoma and other solid tumors where HIF pathway dysregulation drives disease progression. The drug works by selectively inhibiting HIF-2α, a transcription factor that promotes tumor angiogenesis, proliferation, and metabolic adaptation under hypoxic conditions.
$60MPart D
Peak15.8 years to LOEProduct is in peak revenue phase with stable Medicare utilization; brand team focus remains on market penetration and indication expansion 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 Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01)
Started Nov 2026
15 enrolled
Malignant Neoplasm
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 DiseaseMalignant Neoplasms
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
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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.