Belzutifan clinical trials
Belzutifan is named as an intervention in 24 current clinical trials in our USA, France, Spain, South Korea, UK, Australia, Israel, Canada, Brazil, China, Germany, Italy, Denmark, Poland, Czechia, Taiwan, Netherlands, Japan, Belgium, Turkey, Ireland, Sweden, Mexico, Singapore, Norway, Austria, Switzerland, Egypt and Portugal registers. 10 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Merck Sharp & Dohme LLC (16). The most-studied condition is Renal Cell Carcinoma. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Belzutifan is approved
All regulators →Of the three regulators tracked here, the first to approve Belzutifan was the US, on 13 Aug 2021. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Belzutifan patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Belzutifan, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 30 Jun 2042 (US 12358870).
- Latest patent on the drug substance itself: 5 Sep 2034 (US RE49948).
- Exclusivity I-994: New indication: in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the adjuvant treatment of adult pati…, until 12 Jun 2029.
- Exclusivity ODE-364: Orphan drug exclusivity: treatment of adult patients with von hippel-lindau (vhl) disease who require therapy for associated renal cell car…, until 13 Aug 2028.
- Exclusivity I-968: New indication: treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromoc…, until 14 May 2028.
- Exclusivity I-931: New indication: treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-…, until 14 Dec 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Belzutifan
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Belzutifan works
All drug targets →- Endothelial PAS domain-containing protein 1 inhibitor InhibitorTarget: EPAS1 endothelial PAS domain protein 1✓ In ChEMBL and the Guide to Pharmacology
- Clear cell renal carcinomaPhase 3
- Biliary tract cancerPhase 2
- Breast cancerPhase 2
- Colorectal cancerPhase 2
- Endometrial cancerPhase 2
- Esophageal squamous cell carcinomaPhase 2
- Hepatocellular carcinomaPhase 2
- Pancreatic ductal adenocarcinomaPhase 2
- ParagangliomaPhase 2
- PheochromocytomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4585668, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11251, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Belzutifan
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Belzutifan. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Belzutifan for treating tumours associated with von Hippel-Lindau disease NICE TA1011 | Recommended (Cancer Drugs Fund) | 16 Oct 2024 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Belzutifan
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: WeliregEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Belzutifan
24 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Belzutifan in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Belzutifan. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
LIGHTBEAM-U01 Substudy 01E: A Phase 2 Substudy to Evaluate the Safety and Efficacy of Belzutifan in Participants With Solid Tumors
2025-524515-37-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Ongoing | Merck Sharp & Dohme LLC | Belgium, Spain, Denmark + 2 more |
|
A randomized phase 2 trial of neoadjuvant pembrolizumab plus belzutifan with or without lenvatinib in patients with localized renal cell carcinoma. The moonlanding trial
2024-519673-18-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Vall D Hebron Institute Of Oncology | Spain |
Belzutifan across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Belzutifan on the HPRA medicines list.
- WELIREG 40 mg film-coated tabletsMerck Sharp & Dohme BV, · EU/1/24/1893/001-002
Supply shortages
No entry for Belzutifan in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Belzutifan
29 conditionsAll 29 conditions
| Condition (as registered) | Trials |
|---|---|
| Renal Cell Carcinoma | 6 |
| Carcinoma, Renal Cell | 6 |
| Von Hippel-Lindau Disease | 2 |
| Kidney Cancer | 2 |
| Malignant Neoplasms | 1 |
| Metastatic Breast Cancer | 1 |
| Pheochromocytoma/Paraganglioma | 1 |
| Pancreatic Neuroendocrine Tumor | 1 |
| Advanced Gastrointestinal Stromal Tumor | 1 |
| VHL - Von Hippel-Lindau Syndrome | 1 |
| VHL Gene Mutation | 1 |
| VHL Syndrome | 1 |
| VHL Gene Inactivation | 1 |
| Malignant Neoplasm | 1 |
| Malignant Neoplam | 1 |
| Advanced Solid Tumors | 1 |
| Renal Cell Carcinoma (RCC) | 1 |
| Clear Cell Renal Cell Carcinoma (ccRCC) | 1 |
| Renal Cancer | 1 |
| Neoplasm Malignant | 1 |
| Pheochromocytoma and Paraganglioma (PPGL) | 1 |
| Von Hippel Lindau | 1 |
| Von Hippel Lindau Disease | 1 |
| Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma | 1 |
| Hemangioblastoma (HB) of the Central Nervous System (CNS) | 1 |
| Locally Advanced Clear Cell Renal Cell Carcinoma | 1 |
| ccRCC | 1 |
| RCC | 1 |
| Clear Cell Renal Cell Carcinoma | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Merck Sharp & Dohme LLC | 16 |
| Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 3 |
| HiberCell, Inc | 1 |
| Longfei Liu，MD | 1 |
| Vall d'Hebron Institute of Oncology | 1 |
| José Claudio Casali da Rocha | 1 |
| Peter MacCallum Cancer Centre, Australia | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Belzutifan trials
How many clinical trials are testing Belzutifan?
24 current trials in our USA, France, Spain, South Korea, UK, Australia, Israel, Canada, Brazil, China, Germany, Italy, Denmark, Poland, Czechia, Taiwan, Netherlands, Japan, Belgium, Turkey, Ireland, Sweden, Mexico, Singapore, Norway, Austria, Switzerland, Egypt and Portugal registers name Belzutifan (also registered as MK-6482) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Belzutifan trials recruiting patients?
Yes. 10 of the 24 trials are recruiting: 8 with sites in USA, 6 with sites in France, 6 with sites in Spain, 6 with sites in South Korea, 5 with sites in UK, 4 with sites in Australia, 4 with sites in Israel, 4 with sites in Canada, 4 with sites in Brazil, 3 with sites in China, 3 with sites in Germany, 3 with sites in Italy, 4 with sites in Denmark, 4 with sites in Poland, 3 with sites in Czechia, 3 with sites in Taiwan, 3 with sites in Netherlands, 2 with sites in Japan, 3 with sites in Belgium, 2 with sites in Turkey, 1 with sites in Ireland, 1 with sites in Sweden, 1 with sites in Mexico, 2 with sites in Singapore, 1 with sites in Norway, 1 with sites in Austria, 1 with sites in Switzerland and 1 with sites in Portugal. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Belzutifan clinical trials?
Merck Sharp & Dohme LLC (16), Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (3), HiberCell, Inc (1) and Longfei Liu，MD (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Belzutifan clinical trials in Ireland?
Yes. 4 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Belzutifan licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Belzutifan, for example WELIREG 40 mg film-coated tablets (Merck Sharp & Dohme BV,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Belzutifan shortage?
Not in the lists we track: Belzutifan has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Belzutifan works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Belzutifan works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Belzutifan (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.