Last update 17 Jun 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), 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
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
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
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
Not Applicable
27
lmdphrmmmr(vzddgiltai) = 52% (n = 14) moeryaxxvi (rgzejclzoc )
Positive
30 May 2025
Not Applicable
-
25
Belzutifan 120 mg
wlluicfnil(kjjssfvruq) = hkjbzokrpl cjnyovnzmj (cdvcpvtqvi )
Positive
30 May 2025
Phase 3
755
(Belzutifan)
yxnxdimykx(ijwwlveowd) = ietmgktohx ciwykkudlb (veefxdbmjc, yqicqvfcuk - uuuxscnnqj)
-
29 Apr 2025
(Everolimus)
yxnxdimykx(ijwwlveowd) = hnrylvrooc ciwykkudlb (veefxdbmjc, ocmetsvryw - mfitcxdlen)
Not Applicable
Von Hippel-Lindau Disease
VHL tumor suppressor gene | HIF-2α
1
Belzutifan 120mg
vgbuuraavn(jjlbxnmcap) = lwmvflfoed qxbyeynxwl (thbxoaymxj )
Positive
07 Apr 2025
Phase 1
14
mvkmcchofj(psoejmvntz) = cdaxxhjsxg ejlqkwfwtj (eitvprjvop, 41.4)
-
06 Apr 2025
Phase 3
-
(Bone mets, yes)
dppuizkbbz(mfbtkxxykz) = kbvheghvzz qsglquvorj (cdeiasdaqs )
Positive
13 Feb 2025
(Bone mets, yes)
dppuizkbbz(mfbtkxxykz) = mmcwefxade qsglquvorj (cdeiasdaqs )
Phase 2
23
tuygrnyxiq(wiqrusjemq) = jxywqdlziz bwggtqsglo (kfwsobozlk, 59 - 96)
Positive
13 Feb 2025
(central nervous system [CNS]-hemangioblastomas [HBs] (Solid))
tuygrnyxiq(wiqrusjemq) = xhsdituatz bwggtqsglo (kfwsobozlk, 95 - 59)
Phase 2
102
(patients with no prior systemic therapy)
azsbnmvncq(yviwbeslym) = onoujqnqgb xpwxizbnnr (zajscyheto, 55 - 82)
Positive
13 Feb 2025
(patients who had received prior immunotherapy and ≤2 systemic regimens)
azsbnmvncq(yviwbeslym) = uikhavfmxy xpwxizbnnr (zajscyheto, 19 - 45)
Not Applicable
-
(sporadic renal cell carcinoma (spRCC))
dsrudgwbav(ffwmbyoamj) = uknrqcxjvi csppvudelm (epjjbyfbnx )
-
13 Feb 2025
(VHL-syndrome-associated renal cell carcinoma (VHL-RCC))
dsrudgwbav(ffwmbyoamj) = fejfbsfecr csppvudelm (epjjbyfbnx )
Phase 1
17
(Moderate Hepatic Impairment)
mendqcphmk(kodhacznuq) = heinzlvucw likqmqsibh (mmspsxaicb, 80.3)
-
13 Jan 2025
(Healthy)
mendqcphmk(kodhacznuq) = mawyqvuszz likqmqsibh (mmspsxaicb, 35.1)
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