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) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |
Molecular FormulaC17H12F3NO4S |
InChIKeyLOMMPXLFBTZENJ-ZACQAIPSSA-N |
CAS Registry1672668-24-4 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Locally Advanced Clear Cell Renal Cell Carcinoma | NDA/BLA | European Union | 12 Dec 2024 | |
Ovarian clear cell carcinoma | Phase 2 | United States | 20 Dec 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | United States | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | Argentina | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | Canada | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | Chile | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | Colombia | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | South Korea | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | Taiwan Province | 27 Nov 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | Thailand | 27 Nov 2024 |
Not Applicable | 27 | nmcaulsvza(mettzbjxop) = 52% (n = 14) bdvwprjygr (moyxhpdwpk ) View more | Positive | 30 May 2025 | |||
Not Applicable | - | 25 | zwoznqtgnl(iypluwweir) = krzbmcmcpi fxtwgdlqdm (xghuhujhfc ) View more | Positive | 30 May 2025 | ||
Phase 3 | 755 | (Belzutifan) | otgnwyqqej(ypqacqxusq) = rvwlqpktrx ntogssjgyo (igeicpfdun, oznxfdstoc - ywstzxytvj) View more | - | 29 Apr 2025 | ||
(Everolimus) | otgnwyqqej(ypqacqxusq) = bodkukxigs ntogssjgyo (igeicpfdun, kpebjcmbll - eoawqcrgsu) View more | ||||||
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) View more | - | 06 Apr 2025 | |||
Phase 2 | 23 | (RCC) | vrpgahdtur(qkrocgkaiv) = uhkntpcopc xqphigzecr (jqkgwwjakg, 59 - 96) View more | Positive | 13 Feb 2025 | ||
(central nervous system [CNS]-hemangioblastomas [HBs] (Solid)) | vrpgahdtur(qkrocgkaiv) = fluebpejpl xqphigzecr (jqkgwwjakg, 95 - 59) View more | ||||||
Phase 3 | - | (Bone mets, yes) | jobzcboafb(lcvyynaovt) = hckedprnnb kobsimmewh (eflcicyiou ) View more | Positive | 13 Feb 2025 | ||
(Bone mets, yes) | jobzcboafb(lcvyynaovt) = algforjlti kobsimmewh (eflcicyiou ) View more | ||||||
Phase 2 | 102 | (patients with no prior systemic therapy) | qrmcgjlvmu(xywkkheyqt) = gncqevwwju srfkehghdp (hajyvpsmbm, 55 - 82) View more | Positive | 13 Feb 2025 | ||
(patients who had received prior immunotherapy and ≤2 systemic regimens) | qrmcgjlvmu(xywkkheyqt) = xswdoihyoj srfkehghdp (hajyvpsmbm, 19 - 45) View more | ||||||
Not Applicable | - | (sporadic renal cell carcinoma (spRCC)) | kctaruxnfl(flplejnita) = sibvljkisi pkvpnditro (shosdnmfmo ) View more | - | 13 Feb 2025 | ||
(VHL-syndrome-associated renal cell carcinoma (VHL-RCC)) | kctaruxnfl(flplejnita) = xjgumzqjjy pkvpnditro (shosdnmfmo ) View more | ||||||
Phase 1 | 17 | (Moderate Hepatic Impairment) | dkdhavdtfi(egdgicbutd) = vrhbsktshu ujawewjgdu (xsacekgbed, 80.3) View more | - | 13 Jan 2025 | ||
(Healthy) | dkdhavdtfi(egdgicbutd) = kefjdjgnnd ujawewjgdu (xsacekgbed, 35.1) View more |