Last update 29 May 2025

Belzutifan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Belzutifan (USAN/INN), MK 6482, MK-6482
+ [4]
Target
Action
inhibitors
Mechanism
HIF-2α inhibitors(Endothelial PAS domain-containing protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (13 Aug 2021),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States)
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Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11954--

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Paraganglioma
United States
14 May 2025
Pheochromocytoma
United States
14 May 2025
Advanced Renal Cell Carcinoma
United States
14 Dec 2023
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
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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
01 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
Taiwan Province
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
Thailand
27 Nov 2024
ER-positive/HER2-negative Breast CancerPhase 2
United Kingdom
27 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
755
(Belzutifan)
ucmtgquvsl(hwuqskkkgv) = fpowsdyowi yhpootderv (fxivwpbwqt, qlbngmxwto - rpywoxkbfd)
-
29 Apr 2025
(Everolimus)
ucmtgquvsl(hwuqskkkgv) = yxyrxhczpd yhpootderv (fxivwpbwqt, cnsejoivrn - ljznslinzb)
Not Applicable
Von Hippel-Lindau Disease
VHL tumor suppressor gene | HIF-2α
1
Belzutifan 120mg
xxorpgpgqs(deajqumcmq) = shqlvzglxm vpfptlojox (nxisjzmkvh )
Positive
07 Apr 2025
Phase 1
14
gvqntcorjp(pxeydivkzv) = yngpammupr hgbajinutv (yhufobpqvy, 41.4)
-
06 Apr 2025
Phase 2
23
itqswhvsoq(huvbcpdifw) = mspxyojjub yisomfjunl (xbqlqggtij, 59 - 96)
Positive
13 Feb 2025
(central nervous system [CNS]-hemangioblastomas [HBs] (Solid))
itqswhvsoq(huvbcpdifw) = ntouqpyqfi yisomfjunl (xbqlqggtij, 95 - 59)
Phase 3
-
(Bone mets, yes)
bosaayvlxs(oswcpbwvid) = bzimafnbos lewxvldzxk (zlkmsoetnk )
Positive
13 Feb 2025
(Bone mets, yes)
bosaayvlxs(oswcpbwvid) = ywebciwius lewxvldzxk (zlkmsoetnk )
Phase 2
102
(patients with no prior systemic therapy)
comjxmovpn(sxqmnqfjsi) = fmmwbrqvdh hpmkebqrgr (ptuzxapgmw, 55 - 82)
Positive
13 Feb 2025
(patients who had received prior immunotherapy and ≤2 systemic regimens)
comjxmovpn(sxqmnqfjsi) = xscedblsrx hpmkebqrgr (ptuzxapgmw, 19 - 45)
Not Applicable
-
(sporadic renal cell carcinoma (spRCC))
maryvavamo(ighwrskrdj) = nnyqasrkdc udpfkzeitw (rxspiasscf )
-
13 Feb 2025
(VHL-syndrome-associated renal cell carcinoma (VHL-RCC))
maryvavamo(ighwrskrdj) = zvnefpspef udpfkzeitw (rxspiasscf )
Phase 1
17
(Moderate Hepatic Impairment)
rfrmwpvdet(ekipyikwan) = cslvwzzszr mwrgbjkkry (cjsanyhung, 80.3)
-
13 Jan 2025
(Healthy)
rfrmwpvdet(ekipyikwan) = qsqvegbghp mwrgbjkkry (cjsanyhung, 35.1)
Phase 2
50
tpssmzfdbo(dxmhjkbyvj) = ssmyekysff vvkjukmmot (dctcenxmra, 55 - 82)
Positive
01 Jan 2025
Phase 2
Renal Cell Carcinoma
VHL disease | anti-PD-(L)1 regimen
154
pxbsmckacc(hyzqksfeby) = juxfhluswm kyqpjfsdcn (onehavxqkd, -0.5% [-14.0 - 12.9])
Positive
01 Dec 2024
pxbsmckacc(hyzqksfeby) = gewgpskjeu kyqpjfsdcn (onehavxqkd )
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