Belzutifan
As of the edition of 20 October 2026, Belzutifan is a small molecule: marketed, first approved in 2021 (US); acts on EPAS1; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Welireg
- First approved
- 13 August 2021 (US)
- Approvals on record
- 5 in 5 regions
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 40, 0 stopped early
- Disease areas
- Cancer; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Inherited and neonatal; Nervous system
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Merck & Co..
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product13 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Belzutifan.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EPAS1 | Endothelial PAS domain-containing protein 1 | Q99814 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 12 | 7 | 5 | 0 |
| Phase 2 | 20 | 1 | 19 | 0 |
| Phase 3 | 8 | 0 | 8 | 0 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 2014 to now |