WELIREG
PeakNDAORALTABLETPriority Review
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 14h ago · AI intelligence enriched 1mo 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
Peak15.7 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
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
Started Apr 2024
80 enrolled
Renal Cell Carcinoma
Career Relevance
Working on WELIREG offers stability within a peak-stage, first-in-class oncology product with strong intellectual property protection and no direct generic threat until the mid-2030s. Roles emphasize market penetration, indication expansion, physician education, and payer management rather than launch activities, making it suitable for professionals seeking established product expertise and patient access impact.
Brand Manager
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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.