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 in Recurrent Clear Cell Ovarian Carcinoma

Phase 2

Not yet recruiting

Conditions: Ovarian Cancer
Ovarian Carcinoma

Interventions: Drug: Belzutifan

First Posted Date: 2024-11-06

Last Posted Date: 2024-11-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 32

Registration Number: NCT06677190

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

Phase 2

Recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Belzutifan
Drug: Everolimus
Drug: Fulvestrant
Drug: Exemestane

First Posted Date: 2024-05-24

Last Posted Date: 2024-12-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT06428396

Locations: 🇨🇱
Centro de Investigación del Maule ( Site 4106), Talca, Maule, Chile
🇺🇸
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011), Marietta, Georgia, United States
🇺🇸
CHRISTUS Highland ( Site 0005), Shreveport, Louisiana, United States

and more 8 locations

A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma

Phase 1

Recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: HC-7366
Drug: Belzutifan

First Posted Date: 2024-01-31

Last Posted Date: 2024-11-22

Lead Sponsor: HiberCell, Inc.

Target Recruit Count: 80

Registration Number: NCT06234605

Locations: 🇺🇸
University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
University of California San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 12 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, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study

Phase 3

Active, not recruiting

Conditions: Carcinoma, Renal Cell

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

First Posted Date: 2023-06-12

Last Posted Date: 2024-06-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 249

Registration Number: NCT05899049

Locations: 🇨🇳
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000), Beijing, Beijing, China
🇨🇳
Chongqing University Cancer Hospital ( Site 6009), Chongqing, Chongqing, China
🇨🇳
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003), Guangzhou, Guangdong, China

and more 14 locations

A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)

Phase 1

Recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Belzutifan
Drug: Palbociclib

First Posted Date: 2022-07-21

Last Posted Date: 2024-12-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 180

Registration Number: NCT05468697

Locations: 🇮🇱
Emek Medical Center-oncology ( Site 3003), Afula, Israel
🇮🇱
Rambam Health Care Campus-Oncology ( Site 3000), Haifa, Israel
🇮🇱
Shaare Zedek Medical Center-Oncology ( Site 3002), Jerusalem, Israel

and more 9 locations

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Biological: Pembrolizumab
Drug: Belzutifan
Drug: Placebo

First Posted Date: 2022-02-15

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1800

Registration Number: NCT05239728

Locations: 🇺🇸
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C, Columbus, Ohio, United States
🇺🇸
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro, Los Angeles, California, United States
🇺🇸
UT Southwestern Medical Center ( Site 3529), Dallas, Texas, United States

and more 282 locations

A Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010)

Phase 1

Active, not recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Belzutifan
Drug: Lenvatinib
Biological: Pembrolizumab

First Posted Date: 2021-09-01

Last Posted Date: 2023-01-30

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 45

Registration Number: NCT05030506

Locations: 🇨🇳
Tianjin Medical University Cancer Institute and Hospital ( Site 0003), Tianjin, Tianjin, China
🇨🇳
Beijing Cancer hospital-Digestive Oncology ( Site 0001), Beijing, Beijing, China
🇨🇳
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S, Nanjing, Jiangsu, China

and more 2 locations

Belzutifan (MK-6482) Hepatic Impairment Study (MK-6482-020)

Phase 1

Completed

Conditions: Moderate Hepatic Impairment

Interventions: Drug: Belzutifan

First Posted Date: 2021-08-09

Last Posted Date: 2024-01-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 17

Registration Number: NCT04995484

Locations: 🇺🇸
The Texas Liver Institute ( Site 0002), San Antonio, Texas, United States
🇺🇸
Orlando Clinical Research Center ( Site 0001), Orlando, Florida, United States

A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)

Phase 1

Completed

Conditions: Renal Impairment
End Stage Renal Disease

Interventions: Drug: Belzutifan

First Posted Date: 2021-08-06

Last Posted Date: 2024-04-29

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 14

Registration Number: NCT04994522

Locations: 🇺🇸
Orlando Clinical Research Center ( Site 0001), Orlando, Florida, United States

Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)

Phase 2

Recruiting

Conditions: Biliary Tract Neoplasms
Colorectal Neoplasms
Pancreatic Ductal Adenocarcinoma
Endometrial Neoplasms
Carcinoma, Hepatocellular
Esophageal Neoplasms

Interventions: Drug: Pembrolizumab
Drug: Belzutifan
Drug: Lenvatinib

First Posted Date: 2021-07-26

Last Posted Date: 2024-12-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 730

Registration Number: NCT04976634

Locations: 🇺🇸
University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047), Tucson, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center ( Site 5002), Duarte, California, United States
🇺🇸
Cedars-Sinai Medical Center ( Site 5045), Los Angeles, California, United States

and more 54 locations

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