Belzutifan

Generic Name: Belzutifan

Brand Names: Welireg, 维利瑞

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₂F_₃NO_₄S

CAS Number: 1672668-24-4

Unique Ingredient Identifier: 7K28NB895L

Background: Belzutifan is an inhibitor of hypoxia-inducible factor 2α (HIF-2α) used in the treatment of von Hippel-Lindau (VHL) disease-associated cancers. The HIF-2α protein was first identified in the 1990s by researchers at UT Southwestern Medical Center as a key player in the growth of certain cancers. Initially considered to be undruggable, a binding pocket was eve...

Indication: Belzutifan is indicated for the 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), who do not require immediate surgery.

Associated Conditions: Hemangioblastoma, Pancreatic Neuroendocrine Cancer, Renal Cell Carcinoma (RCC)

Associated Therapies: -

Clinical Trials

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Phase 2

Recruiting

Conditions: Pheochromocytoma/Paraganglioma
HIF-2α Mutated Cancers
Pancreatic Neuroendocrine Tumor
Von Hippel-Lindau Disease
Advanced Gastrointestinal Stromal Tumor

Interventions: Drug: Belzutifan

First Posted Date: 2021-06-11

Last Posted Date: 2024-12-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 322

Registration Number: NCT04924075

Locations: 🇳🇴
Oslo Universitetssykehus Radiumhospitalet ( Site 2400), Oslo, Norway
🇺🇸
Cedars-Sinai Medical Center ( Site 0110), Los Angeles, California, United States
🇺🇸
University of Iowa ( Site 0104), Iowa City, Iowa, United States

and more 69 locations

A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)

Phase 1

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Belzutifan

First Posted Date: 2021-04-15

Last Posted Date: 2024-11-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 52

Registration Number: NCT04846920

Locations: 🇺🇸
University of Michigan ( Site 1006), Ann Arbor, Michigan, United States
🇺🇸
Beth Israel Deaconess Medical Center ( Site 1002), Boston, Massachusetts, United States
🇺🇸
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1005), Nashville, Tennessee, United States

and more 1 locations

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Biological: Pembrolizumab
Biological: Pembrolizumab/Quavonlimab
Drug: Belzutifan
Drug: Lenvatinib

First Posted Date: 2021-02-03

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1653

Registration Number: NCT04736706

Locations: 🇺🇸
Hartford Hospital ( Site 0024), Hartford, Connecticut, United States
🇺🇸
Cedars Sinai Medical Center ( Site 0027), Los Angeles, California, United States
🇺🇸
New England Cancer Specialists ( Site 0082), Scarborough, Maine, United States

and more 259 locations

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

Phase 1

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Biological: Favezelimab/Pembrolizumab
Biological: Pembrolizumab
Biological: Pembrolizumab/Quavonlimab
Drug: Belzutifan
Biological: MK-4830
Drug: Lenvatinib

First Posted Date: 2020-11-12

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 370

Registration Number: NCT04626518

Locations: 🇺🇸
UTSW Medical Center ( Site 3003), Dallas, Texas, United States
🇺🇸
University of Chicago ( Site 3013), Chicago, Illinois, United States
🇺🇸
Yale-New Haven Hospital-Yale Cancer Center ( Site 3011), New Haven, Connecticut, United States

and more 48 locations

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Phase 1

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Biological: Favezelimab/Pembrolizumab
Biological: Pembrolizumab
Biological: Pembrolizumab/Quavonlimab
Drug: Belzutifan
Drug: Vibostolimab/Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2020-11-12

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 400

Registration Number: NCT04626479

Locations: 🇳🇱
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402), Amsterdam, Noord-Holland, Netherlands
🇨🇱
CIDO SpA-Oncology ( Site 2106), Temuco, Araucania, Chile
🇬🇧
The Christie NHS Foundation Trust ( Site 1400), Manchester, United Kingdom

and more 52 locations

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Cabozantinib
Drug: Belzutifan
Drug: Lenvatinib

First Posted Date: 2020-10-14

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 708

Registration Number: NCT04586231

Locations: 🇺🇸
Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061), Wenatchee, Washington, United States
🇺🇸
Georgetown University Medical Center ( Site 0006), Washington, District of Columbia, United States
🇺🇸
Memorial Sloan Kettering Cancer Center ( Site 0055), New York, New York, United States

and more 181 locations

A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

Phase 2

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Belzutifan

First Posted Date: 2020-07-28

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 154

Registration Number: NCT04489771

Locations: 🇺🇸
Weinberg Cancer Institute at Franklin Square ( Site 0007), Baltimore, Maryland, United States
🇺🇸
University of Texas Southwestern Medical Center at Dallas ( Site 0004), Dallas, Texas, United States
🇺🇸
Inova Schar Cancer Institute ( Site 0001), Fairfax, Virginia, United States

and more 45 locations

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Belzutifan
Drug: Everolimus

First Posted Date: 2019-12-12

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 755

Registration Number: NCT04195750

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514), Baltimore, Maryland, United States
🇺🇸
The University of Chicago Medical Center ( Site 1539), Chicago, Illinois, United States
🇺🇸
Cleveland Clinic ( Site 1504), Cleveland, Ohio, United States

and more 169 locations

A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

Phase 2

Active, not recruiting

Conditions: Renal Cell Carcinoma (RCC)
Clear Cell Renal Cell Carcinoma (ccRCC)
Kidney Cancer
Renal Cancer
Renal Cell Carcinoma
Renal Cell Cancer Metastatic
Renal Cell Carcinoma Recurrent
Renal Cell Cancer, Recurrent
Kidney

Interventions: Drug: Belzutifan
Drug: Cabozantinib

First Posted Date: 2018-08-16

Last Posted Date: 2024-12-20

Lead Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 118

Registration Number: NCT03634540

Locations: 🇺🇸
Tennessee Oncology, PLLC ( Site 0024), Chattanooga, Tennessee, United States
🇺🇸
Swedish Cancer Institute ( Site 0018), Seattle, Washington, United States
🇺🇸
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035), Seattle, Washington, United States

and more 7 locations

A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Belzutifan

First Posted Date: 2018-02-26

Last Posted Date: 2020-11-09

Lead Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 16

Registration Number: NCT03445169

Locations: 🇺🇸
Spaulding Clinical, West Bend, Wisconsin, United States

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