Last update 19 Jul 2025

Belzutifan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Belzutifan (USAN/INN), MK 6482, MK-6482
+ [5]
Target
Action
inhibitors
Mechanism
HIF-2α inhibitors(Endothelial PAS domain-containing protein 1 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (13 Aug 2021),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (China)
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Structure/Sequence

Molecular FormulaC17H12F3NO4S
InChIKeyLOMMPXLFBTZENJ-ZACQAIPSSA-N
CAS Registry1672668-24-4

External Link

KEGGWikiATCDrug Bank
D11954--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Renal Cell Carcinoma
Japan
24 Jun 2025
Paraganglioma
United States
14 May 2025
Pheochromocytoma
United States
14 May 2025
Advanced Renal Cell Carcinoma
Australia
22 Dec 2022
Hemangioblastoma
Australia
22 Dec 2022
Neuroendocrine tumor of pancreas
Australia
22 Dec 2022
Renal Cell Carcinoma
Canada
11 Jul 2022
Von Hippel-Lindau Disease
United States
13 Aug 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Clear Cell Renal Cell CarcinomaNDA/BLA
European Union
12 Dec 2024
Ovarian clear cell carcinomaPhase 2
United States
20 Dec 2024
ER-positive/HER2-negative Breast CancerPhase 2
United States
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Argentina
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Canada
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Chile
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Colombia
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
South Korea
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Taiwan Province
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Thailand
27 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
27
nmcaulsvza(mettzbjxop) = 52% (n = 14) bdvwprjygr (moyxhpdwpk )
Positive
30 May 2025
Not Applicable
-
25
zwoznqtgnl(iypluwweir) = krzbmcmcpi fxtwgdlqdm (xghuhujhfc )
Positive
30 May 2025
Phase 3
755
(Belzutifan)
otgnwyqqej(ypqacqxusq) = rvwlqpktrx ntogssjgyo (igeicpfdun, oznxfdstoc - ywstzxytvj)
-
29 Apr 2025
(Everolimus)
otgnwyqqej(ypqacqxusq) = bodkukxigs ntogssjgyo (igeicpfdun, kpebjcmbll - eoawqcrgsu)
Not Applicable
Von Hippel-Lindau Disease
VHL tumor suppressor gene | HIF-2α
1
Belzutifan 120mg
wxyhdtfmlz(ascigsvxux) = toemdyjazf tktxfyyhsm (snvhmkiwhy )
Positive
07 Apr 2025
Phase 1
14
pzonjzqijq(zqqbxovcev) = qdxrjofxei jpjrjuumza (hrnzygulga, 41.4)
-
06 Apr 2025
Phase 2
23
vrpgahdtur(qkrocgkaiv) = uhkntpcopc xqphigzecr (jqkgwwjakg, 59 - 96)
Positive
13 Feb 2025
(central nervous system [CNS]-hemangioblastomas [HBs] (Solid))
vrpgahdtur(qkrocgkaiv) = fluebpejpl xqphigzecr (jqkgwwjakg, 95 - 59)
Phase 3
-
(Bone mets, yes)
jobzcboafb(lcvyynaovt) = hckedprnnb kobsimmewh (eflcicyiou )
Positive
13 Feb 2025
(Bone mets, yes)
jobzcboafb(lcvyynaovt) = algforjlti kobsimmewh (eflcicyiou )
Phase 2
102
(patients with no prior systemic therapy)
qrmcgjlvmu(xywkkheyqt) = gncqevwwju srfkehghdp (hajyvpsmbm, 55 - 82)
Positive
13 Feb 2025
(patients who had received prior immunotherapy and ≤2 systemic regimens)
qrmcgjlvmu(xywkkheyqt) = xswdoihyoj srfkehghdp (hajyvpsmbm, 19 - 45)
Not Applicable
-
(sporadic renal cell carcinoma (spRCC))
kctaruxnfl(flplejnita) = sibvljkisi pkvpnditro (shosdnmfmo )
-
13 Feb 2025
(VHL-syndrome-associated renal cell carcinoma (VHL-RCC))
kctaruxnfl(flplejnita) = xjgumzqjjy pkvpnditro (shosdnmfmo )
Phase 1
17
(Moderate Hepatic Impairment)
dkdhavdtfi(egdgicbutd) = vrhbsktshu ujawewjgdu (xsacekgbed, 80.3)
-
13 Jan 2025
(Healthy)
dkdhavdtfi(egdgicbutd) = kefjdjgnnd ujawewjgdu (xsacekgbed, 35.1)
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Regulation

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