Belzutifan is under clinical development by Merck & Co and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Belzutifan’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 23 May 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 23 May 2022 increased Belzutifan’s LoA and PTSR for Colorectal Cancer, increased LoA and PTSR for Gallbladder Cancer, and increased LoA and PTSR for Hepatocellular Carcinoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Belzutifan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Belzutifan overview

Belzutifan (Welireg), is an inhibitor of hypoxia-inducible factor-2α (HIF-2α). It is formulated as film coated tablets for oral route of administration. Welireg is indicated 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.

MK-6482 (PT-2977) is under development for the treatment of clear cell renal cell carcinoma (ccRCC), von Hippel-Lindau disease-associated renal cell carcinoma, pancreatic ductal adenocarcinoma, hepatocellular carcinoma, endometrial cancer, esophageal squamous cell carcinoma, colorectal cancer, bile duct cancer (cholangiocarcinoma), gallbladder cancer, clear cell renal cell carcinoma, metastatic renal cell carcinoma, advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), recurrent glioblastoma multiforme and rare cancers. It is a small molecule. It is administered through oral route. The drug candidate targets hypoxia-inducible factor-2 alpha (HIF-2alpha). It was also under development for the treatment of iron overload (hemosiderosis) and pulmonary arterial hypertension.

Merck & Co overview

Merck & Co (Merck) is a biopharmaceutical company focused on the discovery, development, manufacturing and marketing of prescription medicines, biologic therapies, vaccines and animal health products. It offers prescription products for therapy areas related to cardiovascular, cancer, immune disorders, infectious, respiratory and women’s diseases, and diabetes. The company provides animal health products such as vaccines, poultry products, livestock products and aquaculture products. Merck sells medicines to drug wholesalers, retailers, hospitals, government agencies and managed health care providers; and animal health products to veterinarians, distributors and animal producers. The company and its subsidiaries operate in the Americas, Europe, the Middle East, Africa, Asia Pacific, and Latin America. Merck is known as MSD outside the US and Canada and is headquartered in Kenilworth, New Jersey, the US.

Quick View Belzutifan LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Belzutifan
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Genetic Disorders
  • Non Malignant Disorders
  • Oncology
  • Respiratory
  • Undisclosed
Key Developers
  • Sponsor Company: Merck & Co
  • Originator: University of Texas Southwestern Medical Center
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.