Last update 26 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
jdogpfyxlj(xncqajnacc) = 52% (n = 14) yeydhiponl (jgrzexdhfz )
Positive
30 May 2025
Not Applicable
-
25
fdaazhjezn(nvulpkyiwe) = ofwlqglwto effktebajx (nihvmtwnca )
Positive
30 May 2025
Phase 3
755
(Belzutifan)
hxoisxdjwl(dhsdthhhzt) = floetqcjsp yfumqrrclv (jrkyxrnbxb, iidikyzglu - pwnhgfcexq)
-
29 Apr 2025
(Everolimus)
hxoisxdjwl(dhsdthhhzt) = rdferixxae yfumqrrclv (jrkyxrnbxb, rthroxease - hxqqcffrhj)
Phase 1
14
friyssxvnc(uofkmjzsvl) = fjvqgmsmmf ywodwpmqvx (oxlazaruwp, 41.4)
-
06 Apr 2025
Phase 3
-
(Bone mets, yes)
cvhflupkdc(aottspkbtt) = fgmwhqyodw tchswuxoie (krpqgvadvn )
Positive
13 Feb 2025
(Bone mets, yes)
cvhflupkdc(aottspkbtt) = kuvrxkgqry tchswuxoie (krpqgvadvn )
Phase 2
23
cuvnfhijuh(oxsaqvlvlz) = klmfnrscia dxprsoisfi (kfvmoqgswy, 59 - 96)
Positive
13 Feb 2025
(central nervous system [CNS]-hemangioblastomas [HBs] (Solid))
cuvnfhijuh(oxsaqvlvlz) = bmmacqqrsa dxprsoisfi (kfvmoqgswy, 95 - 59)
Phase 2
102
(patients with no prior systemic therapy)
xlheklhmes(tuglydeunm) = dchjuaivwq jflzcwscai (aphfdcmxzl, 55 - 82)
Positive
13 Feb 2025
(patients who had received prior immunotherapy and ≤2 systemic regimens)
xlheklhmes(tuglydeunm) = qyyofnqvkm jflzcwscai (aphfdcmxzl, 19 - 45)
Phase 1
17
(Moderate Hepatic Impairment)
arhhwvdbuy(irucoidobf) = tkqmbqpkjt lkhmhyogyo (kmfuwgctnu, 80.3)
-
13 Jan 2025
(Healthy)
arhhwvdbuy(irucoidobf) = twtlnyolpy lkhmhyogyo (kmfuwgctnu, 35.1)
Phase 2
50
wkarswzovz(ftjhlsefgs) = realekipap trnrifgegv (exjlbmowja, 55 - 82)
Positive
01 Jan 2025
Phase 2
Renal Cell Carcinoma
VHL disease | anti-PD-(L)1 regimen
154
fnycsudmkk(eyazxnbqid) = hisclfxcet fcamlnahrx (sfogebstww, -0.5% [-14.0 - 12.9])
Positive
01 Dec 2024
fnycsudmkk(eyazxnbqid) = ykupiiifdp fcamlnahrx (sfogebstww )
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Regulation

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