Drugs / Belzutifan

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (4) US (FDA) WELIREG 2023-12-14 – 2026-06-12 fda.gov
Approved · conditional EU (EMA) Welireg 2025-02-12 europa.eu
Approved US (FDA) WELIREG 2021-08-13 fda.gov

Trials 38 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT07179770 Sep 2025 → Sep 2027 expected clear cell renal carcinoma NYU Langone Health Recruiting No outcome recorded
Phase 1 NCT07121959 Aug → Sep 2025 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06903715 Mar → May 2025 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06234605 Apr 2024 → Nov 2026 expected renal cell carcinoma HiberCell, Inc. Recruiting No outcome recorded
Phase 1 NCT04994522 Jul 2022 → Apr 2024 end stage renal failure, impaired renal function disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT04995484 Jun 2022 → Dec 2023 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT05030506 Oct 2021 → Jun 2027 expected renal cell carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 1 NCT04846920 Jun 2021 → Apr 2026 clear cell renal carcinoma Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT04627064 Dec 2020 → Feb 2024 clear cell renal carcinoma Dana-Farber Cancer Institute Completed No outcome recorded
Phase 1 NCT03445169 Feb → May 2018 Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT07049926 Jul 2025 → Oct 2031 expected renal cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT05468697 Aug 2022 → Jul 2026 overdue renal cell carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 1/2 NCT04626518 Dec 2020 → Jul 2026 overdue clear cell renal carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 1/2 NCT04626479 Dec 2020 → Jul 2026 overdue renal cell carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 1/2 NCT02861573 Nov 2016 → Oct 2027 expected castration-resistant prostate carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 214 trials
Phase 2 NCT07700758 Nov 2026 → Jan 2034 expected cancer Merck Sharp & Dohme LLC Not yet recruiting No outcome recorded
Phase 2 NCT07593040 Jun 2026 → Jan 2028 expected renal cell carcinoma Vall d'Hebron Institute of Oncology Not yet recruiting No outcome recorded
Phase 2 NCT07680205 Apr 2026 → Apr 2027 expected pheochromocytoma, pheochromocytoma-paraganglioma Cambridge University Hospitals NHS Foundation Trust Recruiting No outcome recorded
Phase 2 NCT07187778 Dec 2025 → Jul 2027 expected clear cell renal carcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT07023432 Nov 2025 → Apr 2028 expected clear cell renal carcinoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06677190 Dec 2024 → Dec 2026 expected cervical cancer, endometrial cancer, ovarian carcinoma, vaginal cancer +1 Dana-Farber Cancer Institute Recruiting No outcome recorded
Phase 2 NCT06428396 Nov 2024 → May 2027 expected breast cancer Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 2 NCT05574712 Jan 2024 → Jan 2025 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Withdrawn No outcome recorded
Phase 2 NCT07167329 Jan 2024 → Feb 2026 overdue clear cell renal carcinoma, endolymphatic sac tumor, hemangioblastoma, perifoveal exudative vascular anomalous complex +3 José Claudio Casali da Rocha Recruiting No outcome recorded
Phase 2 NCT04976634 Aug 2021 → Mar 2027 expected cancer Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 38 trials
Phase 3 NCT07489495 Apr 2026 → Nov 2030 expected renal cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 3 NCT07405164 Mar 2026 → Jan 2034 expected cancer, von Hippel-Lindau disease Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 3 NCT07227402 Nov 2025 → Feb 2032 expected renal cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 3 NCT05899049 Jul 2022 → Jun 2027 expected clear cell renal carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 3 NCT05239728 Mar 2022 → Oct 2026 expected renal cell carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 3 NCT04736706 Apr 2021 → Oct 2026 expected clear cell renal carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 3 NCT04586231 Feb 2021 → Feb 2026 overdue renal cell carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 3 NCT04195750 Feb 2020 → Apr 2024 overdue renal cell carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT02293980 Background Nov 2014 → Jan 2017 overdue clear cell renal carcinoma Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Active not recruiting No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 40 sources stand behind the page.

FieldValueCited text
Known as Belzutifan “These dosages are as follows: leuprolide acetate 22.5 mg depot injection x one dose, abiraterone acetate 1000 mg by mouth daily, and belzutifan120 mg administered by mouth once daily.” NCT05574712
36

NCT04626518

NCT07167329

NCT05468697

NCT04994522

NCT06428396

NCT07049926

NCT05899049

NCT04736706

NCT07680205

NCT04586231

NCT04489771

NCT04846920

NCT04195750

NCT07227402

NCT07179770

NCT02974738

NCT07489495

NCT06234605

NCT04924075

NCT04976634

NCT05239728

NCT03445169

NCT07023432

NCT07700758

NCT07187778

NCT05030506

NCT03401788

NCT04995484

NCT02861573

NCT03634540

NCT06903715

NCT07121959

NCT07405164

NCT04626479

NCT06677190

NCT07593040

Known as Bezlutifan ClinicalTrials.gov intervention name — accepted as the source's own label NCT02293980
Known as MK-6482 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04627064
Known as PT-2977 ChEMBL registry synonym — accepted as the source's own label CHEMBL4585668
Known as WELIREG “oral Belzutifan (WELIREG™)” NCT07167329
Action Inhibit inhibits the function of the HIF-2α transcription factor” NCT02974738
Modality Small molecule “a highly selective small moleculeNCT02974738
Route Oral “belzutifan 120 mg once daily (QD)” NCT02293980
Target HIF2A “MK-6482 is an oral, first-in-class selective small-molecule inhibitor that targets hypoxia-inducible factor (HIF)-2a” NCT04627064