Belzutifan is being evaluated across numerous clinical trials spanning Phase 1, Phase 2, and Phase 3 protocols to assess its safety, pharmacokinetics, and therapeutic efficacy. Encompassing active, recruiting, and completed statuses, these studies focus on clear cell renal cell carcinoma, von Hippel-Lindau syndrome-associated malignancies, advanced solid tumors, and renal impairment. Investigations are sponsored by pharmaceutical developers like Merck Sharp & Dohme and Peloton Therapeutics, alongside academic institutions such as the Dana-Farber Cancer Institute and M.D. Anderson Cancer Center.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07405164 | RECRUITING | Von Hippel-Lindau Disease; Malignant Neoplasms |
Merck Sharp & Dohme LLC |
2026-03-23 | PHASE3 |
| NCT07700758 | NOT_YET_RECRUITING | Malignant Neoplasm |
Merck Sharp & Dohme LLC |
2026-11-23 | PHASE2 |
| NCT07227402 | RECRUITING | Renal Cell Carcinoma |
Merck Sharp & Dohme LLC |
2025-11-26 | PHASE3 |
| NCT07049926 | RECRUITING | Renal Cell Carcinoma |
Merck Sharp & Dohme LLC |
2025-07-20 | PHASE1; PHASE2 |
| NCT07489495 | RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2026-04-09 | PHASE3 |
| NCT04924075 | RECRUITING | Pheochromocytoma/Paraganglioma; Pancreatic Neuroendocrine Tumor; Von Hippel-Lindau Disease; Advanced Gastrointestinal Stromal Tumor; HIF-2α Mutated Cancers |
Merck Sharp & Dohme LLC |
2021-08-12 | PHASE2 |
| NCT07793942 | NOT_YET_RECRUITING | Malignant Neoplam; Advanced Solid Tumors |
Merck Sharp & Dohme LLC |
2026-09-29 | PHASE2 |
| NCT07179770 | RECRUITING | Metastatic Clear Cell Renal Cell Carcinoma |
NYU Langone Health |
2025-09-15 | PHASE1 |
| NCT07023432 | RECRUITING | Active Surveillance; Clear Cell Renal Cell Carcinoma |
M.D. Anderson Cancer Center |
2025-11-17 | PHASE2 |
| NCT07377526 | SUSPENDED | Pancreatic Cancer |
M.D. Anderson Cancer Center |
2026-05-26 | PHASE1; PHASE2 |
| NCT07593040 | NOT_YET_RECRUITING | Renal Cell Carcinoma |
Vall d'Hebron Institute of Oncology |
2026-06 | PHASE2 |
| NCT02861573 | ACTIVE_NOT_RECRUITING | Metastatic Castration-Resistant Prostate Cancer |
Merck Sharp & Dohme LLC |
2016-11-17 | PHASE1; PHASE2 |
| NCT07187778 | RECRUITING | Clear Cell Renal Cell Carcinoma |
M.D. Anderson Cancer Center |
2025-12-19 | PHASE2 |
| NCT05030506 | ACTIVE_NOT_RECRUITING | Renal Cell Carcinoma |
Merck Sharp & Dohme LLC |
2021-10-13 | PHASE1 |
| NCT06428396 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
Merck Sharp & Dohme LLC |
2024-11-27 | PHASE2 |
| NCT03401788 | ACTIVE_NOT_RECRUITING | VHL - Von Hippel-Lindau Syndrome; VHL Gene Mutation; VHL Syndrome; VHL Gene Inactivation; VHL-Associated Renal Cell Carcinoma; VHL-Associated Clear Cell Renal Cell Carcinoma |
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2018-05-02 | PHASE2 |
| NCT07680205 | RECRUITING | Pheochromocytoma and Paraganglioma (PPGL); Pheochromocytoma Malignant; Pheochromocytoma, Metastatic; Pheochromocytoma/Paraganglioma; Pheochromocytoma |
Cambridge University Hospitals NHS Foundation Trust |
2026-04-27 | PHASE2 |
| NCT04976634 | ACTIVE_NOT_RECRUITING | Neoplasm Malignant |
Merck Sharp & Dohme LLC |
2021-08-18 | PHASE2 |
| NCT03634540 | ACTIVE_NOT_RECRUITING | Renal Cell Carcinoma (RCC); Clear Cell Renal Cell Carcinoma (ccRCC); Kidney Cancer; Renal Cancer; Renal Cell Carcinoma; Renal Cell Cancer Metastatic; Renal Cell Carcinoma Recurrent; Renal Cell Cancer, Recurrent; Kidney |
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2018-09-27 | PHASE2 |
| NCT06677190 | RECRUITING | Ovarian Cancer; Ovarian Carcinoma; Endometrial Cancer; Uterine Cancer; Cervical Cancer; Vulvar Cancer; Gynecologic Cancer; Vaginal Cancer |
Dana-Farber Cancer Institute |
2024-12-20 | PHASE2 |
| NCT06234605 | RECRUITING | Renal Cell Carcinoma |
HiberCell, Inc. |
2024-04-29 | PHASE1 |
| NCT05239728 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2022-03-15 | PHASE3 |
| NCT05468697 | ACTIVE_NOT_RECRUITING | Renal Cell Carcinoma |
Merck Sharp & Dohme LLC |
2022-08-10 | PHASE1; PHASE2 |
| NCT04626518 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2020-12-17 | PHASE1; PHASE2 |
| NCT04626479 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2020-12-16 | PHASE1; PHASE2 |
| NCT04846920 | COMPLETED | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2021-06-14 | PHASE1 |
| NCT05899049 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2022-07-27 | PHASE3 |
| NCT04736706 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2021-04-14 | PHASE3 |
| NCT04586231 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2021-02-25 | PHASE3 |
| NCT07167329 | RECRUITING | Von Hippel Lindau; Von Hippel Lindau Disease; Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma; Hemangioblastoma (HB) of the Central Nervous System (CNS); PNET; Retinal Angiomatous Proliferation; Pheochromocytoma/Paraganglioma; Endolymphatic Sac Tumor |
José Claudio Casali da Rocha |
2024-01-01 | PHASE2 |
| NCT07121959 | COMPLETED | Healthy |
Merck Sharp & Dohme LLC |
2025-08-18 | PHASE1 |
| NCT06903715 | COMPLETED | Healthy |
Merck Sharp & Dohme LLC |
2025-03-28 | PHASE1 |
| NCT05574712 | WITHDRAWN | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2024-01-01 | PHASE2 |
| NCT04195750 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2020-02-27 | PHASE3 |
| NCT04994522 | COMPLETED | End Stage Renal Disease; Renal Impairment |
Merck Sharp & Dohme LLC |
2022-07-12 | PHASE1 |
| NCT04995484 | COMPLETED | Moderate Hepatic Impairment |
Merck Sharp & Dohme LLC |
2022-06-24 | PHASE1 |
| NCT04489771 | ACTIVE_NOT_RECRUITING | Carcinoma, Renal Cell |
Merck Sharp & Dohme LLC |
2020-09-13 | PHASE2 |
| NCT04994522 | Completed | End Stage Renal Disease|Renal Impairment |
Merck Sharp & Dohme LLC |
2022-07-12 | Phase 1 |
| NCT04846920 | Active not recruiting | Carcinoma Renal Cell |
Merck Sharp & Dohme LLC |
2021-06-14 | Phase 1 |
| NCT04627064 | Active not recruiting | Clear Cell Renal Cell Carcinoma |
Dana-Farber Cancer Institute|Eli Lilly and Company |
2020-12-31 | Phase 1 |
| NCT04489771 | Active not recruiting | Carcinoma Renal Cell |
Merck Sharp & Dohme LLC |
2020-09-13 | Phase 2 |
| NCT03634540 | Active not recruiting | Renal Cell Carcinoma (RCC)|Clear Cell Renal Cell Carcinoma (ccRCC)|Kidney Cancer|Renal Cancer|Renal Cell Carcinoma|Renal Cell Cancer Metastatic|Renal Cell Carcinoma Recurrent|Renal Cell Cancer Recurrent|Kidney |
Peloton Therapeutics Inc. a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA) |
2018-09-27 | Phase 2 |
| NCT03445169 | COMPLETED | Healthy |
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2018-02-23 | PHASE1 |
| NCT03401788 | Active not recruiting | VHL - Von Hippel-Lindau Syndrome|VHL Gene Mutation|VHL Syndrome|VHL Gene Inactivation|VHL-Associated Renal Cell Carcinoma|VHL-Associated Clear Cell Renal Cell Carcinoma |
Peloton Therapeutics Inc. a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA) |
2018-05-02 | Phase 2 |
| NCT02974738 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumors; Solid Tumor; Solid Carcinoma; Solid Tumor, Adult; ccRCC; RCC, Clear Cell Adenocarcinoma; RCC; Kidney Cancer; Clear Cell Renal Cell Carcinoma; Renal Cell Carcinoma, Metastatic; Renal Cell Carcinoma Recurrent; Renal Cell Carcinoma, Clear Cell Adenocarcinoma; Glioblastoma; Glioblastoma, Adult; GBM; Glioblastoma Multiforme |
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2016-12-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-03)
Check the
PT2977 (Belzutifan)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- PT2977 (Belzutifan) Mechanism of Action: HIF-2α Inhibition in Tumor Cells Research
- PT2977 (Belzutifan) Working Concentration | Cell Culture | Treatment
- PT2977 (Belzutifan) Solubility in DMSO
- PT2977 (Belzutifan) Stock Solution
- PT2977 (Belzutifan) Storage
- PT2977 (Belzutifan) Stability
- PT2977 (Belzutifan) Combination Database
- PT2977 (Belzutifan) Molecular Weight
- PT2977 (Belzutifan) SMILES
- PT2977 (Belzutifan) CAS Number
- PT2977 (Belzutifan) Chemical Structure (2D and 3D)
- PT2977 (Belzutifan) IC50 for Cell-based and Cell-free Assays
- PT2977 (Belzutifan) Sigma (AMBH990F6293)? Try a better option.
- PT2977 (Belzutifan) MedChemExpress (HY-125840)? Try a better option.
- PT2977 (Belzutifan) Cayman (39652)? Try a better option.
- PT2977 (Belzutifan) Axonmedchem (Axon 3760)? Try a better option.
- PT2977 (Belzutifan) AbMole (M10436)? Try a better option.
- PT2977 (Belzutifan) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.