Drug profile · INN
belzutifan
WELIREG
belzutifan (WELIREG) is a endothelial pas domain-containing protein 1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: oral. Current US regulatory status: approved.
Drug details — belzutifan
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- ORAL
- Patents
- 0
- Programs
- 11
- Data quality
- 0.84
Quick answer
belzutifan (WELIREG) is a endothelial pas domain-containing protein 1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
Endothelial PAS domain-containing protein 1 inhibitor
Primary target: Endothelial PAS domain-containing protein 1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
Recent coverage
FDA approves belzutifan plus pembrolizumab for adjuvant RCC
The FDA approved belzutifan plus pembrolizumab as adjuvant therapy for clear cell renal cell carcinoma at high risk of recurrence after nephrectomy. The catalyst is based on phase 3 LITESPARK-022 data and adds another regulatory milestone for belzutifan.
FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC
The FDA granted priority review to supplemental applications for belzutifan plus pembrolizumab in adjuvant renal cell carcinoma. The move extends Merck’s renal cancer catalyst path after evidence showed improved disease-free survival versus pembrolizumab alone.
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is belzutifan?
belzutifan (WELIREG) is a endothelial pas domain-containing protein 1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for belzutifan?
WELIREG is a marketed brand name for belzutifan. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of belzutifan?
belzutifan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.