Treats von Hippel-Lindau (VHL) disease. NDA 215383, held by Merck Sharp Dohme. Belzutifan.
As of Nov 14, 2026, NDA 215383 (Welireg), held by Merck Sharp Dohme, was first approved by FDA on Aug 13, 2021, with 9 approved supplements and 0 published complete response letters.
WELIREG is a hypoxia-inducible factor inhibitor indicated: von Hippel-Lindau disease for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
| Sep 24, 2026 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2026 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2025 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Apr 15, 2025 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2023 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Aug 13, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Welireg40MG · tablet;oral | Belzutifan | RxReference drug |
| Nov 6, 2026 | Supplement 18Labeling · Standard review | Approved | |
| Sep 24, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Sep 24, 2026 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2026 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2025 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Apr 15, 2025 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 26, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Dec 14, 2023 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Aug 13, 2021 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
