Treats von Hippel-Lindau (VHL) disease. Sold as Welireg. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Belzutifan (sold as Welireg), first approved Aug 13, 2021, with 6 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Welireg | Part D | $334M | +62% | 2,666 |
| Safety and Efficacy of Belzutifan in Preoperative Preparation for Patients With Pheochromocytoma/Paraganglioma (PPGL)Pheochromocytoma and Paraganglioma (PPGL) · Longfei Liu,MD | Phase 4 | Recruiting | Oct 30, 2026 |
| Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant ErythrocytosisErythrocytosis, Pulmonary Hypertension · University of Utah | Phase 2 | Not yet recruiting | Oct 26, 2026 |
| Neoadjuvant Belzutifan Plus Pembrolizumab in High-Risk, Locally Advanced Clear Cell Renal Cell CarcinomaLocally Advanced Clear Cell Renal Cell Carcinoma · Peter MacCallum Cancer Centre, Australia | Phase 2 | Not yet recruiting | Sep 24, 2026 |
| A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)Malignant Neoplam, Advanced Solid Tumors · Merck Sharp & Dohme LLC | Phase 2 | Recruiting | Aug 31, 2026 |
| A Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01)Malignant Neoplasm · Merck Sharp & Dohme LLC | Phase 2 | Recruiting | Jul 14, 2026 |
| An Experimental Study of Belzutifan Impact on Catecholamine MetabolismPheochromocytoma and Paraganglioma (PPGL), Pheochromocytoma Malignant · Cambridge University Hospitals NHS Foundation Trust | Phase 2 | Recruiting | Jul 2, 2026 |
| Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell CarcinomaRenal Cell Carcinoma · Vall d'Hebron Institute of Oncology | Phase 2 | Not yet recruiting | May 18, 2026 |
| Belzutifan VHL RCC HK Prospective RegistryVHL - Von Hippel-Lindau Syndrome · Chinese University of Hong Kong | — | Recruiting | Apr 28, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 13, 2021 | WeliregNDA 215383 · New molecular entity | Merck Sharp Dohme | 9 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA