Belzutifan

also known as MK-6482 · PT-2977 · WELIREG

Small molecule targets EPAS1 via inhibition

Developed for: clear cell renal carcinoma · renal cell carcinoma · von Hippel-Lindau disease · cancer · pheochromocytoma-paraganglioma · adult glioblastoma · breast cancer · castration-resistant prostate carcinoma
+14 more
· cervical cancer · endolymphatic sac tumor · endometrial cancer · gastrointestinal stromal tumor · hemangioblastoma · hereditary clear cell renal cell carcinoma · ovarian carcinoma · pancreatic neuroendocrine tumor · perifoveal exudative vascular anomalous complex · pheochromocytoma · primitive neuroectodermal tumor · prostate cancer · vaginal cancer · vulva cancer
Investigated by: Merck Sharp & Dohme LLC · Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Eisai Inc. · Exelixis · Dana-Farber Cancer Institute · M.D. Anderson Cancer Center
+11 more
· National Cancer Institute (NCI) · AC Camargo Cancer Center · Cambridge University Hospitals NHS Foundation Trust · Eli Lilly and Company · HiberCell, Inc. · José Claudio Casali da Rocha · NYU Langone Health · Peter MacCallum Cancer Centre, Australia · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Cambridge · Vall d'Hebron Institute of Oncology

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed renal cell adenocarcinoma 2 milestones
Filed	US (FDA)	WELIREG	renal cell adenocarcinoma	2026-02-28	“FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC” merck.com ↗ “FDA accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX” merck.com ↗ “FDA has accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA” merck.com ↗
Filed	US (FDA)	WELIREG	renal cell adenocarcinoma	2023-09-19	“FDA has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG” merck.com ↗
Approved Indication not stated 3 milestones
Label expansions (3)	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 39

today

US approved 2021

EU approved 2025

NCT07840001 · Ph 2 NCT07700758 · Ph 2 NCT07593040 · Ph 2 NCT07680205 · Ph 2 NCT07489495 · Ph 3 NCT07405164 · Ph 3 NCT07187778 · Ph 2 NCT07227402 · Ph 3 NCT07023432 · Ph 2 NCT07179770 · Ph 1 NCT07121959 · Ph 1 NCT07049926 · Ph 1/2 NCT06903715 · Ph 1 NCT06677190 · Ph 2 NCT06428396 · Ph 2 NCT06234605 · Ph 1 NCT05574712 · Ph 2 NCT07167329 · Ph 2 NCT05468697 · Ph 1/2 NCT05899049 · Ph 3 NCT04994522 · Ph 1 NCT04995484 · Ph 1 NCT05239728 · Ph 3 NCT05030506 · Ph 1 NCT04976634 · Ph 2 NCT04924075 · Ph 2 NCT04846920 · Ph 1 NCT04736706 · Ph 3 NCT04586231 · Ph 3 NCT04627064 · Ph 1 NCT04626518 · Ph 1/2 NCT04626479 · Ph 1/2 NCT04489771 · Ph 2 NCT04195750 · Ph 3 NCT03634540 · Ph 2 NCT03401788 · Ph 2 NCT03445169 · Ph 1 NCT02974738 · Ph 1 NCT02861573 · Ph 1/2

201720182019202020212022202320242025202620272028202920302031203220332034

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
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	NCT02974738	Dec 2016 → Jan 2018 overdue	adult glioblastoma, clear cell renal carcinoma	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Active not recruiting	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	clear cell renal carcinoma	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1/2	NCT04626479	Dec 2020 → Aug 2026	renal cell carcinoma	Merck Sharp & Dohme LLC	Completed	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 215 trials · 1 missed
Phase 2	NCT07840001	Dec 2026 → Apr 2029 expected	clear cell renal carcinoma	Peter MacCallum Cancer Centre, Australia	Not yet recruiting	No outcome recorded
Phase 2	NCT07700758	Nov 2026 → Jan 2034 expected	cancer	Merck Sharp & Dohme LLC	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 2	NCT04924075	Aug 2021 → Nov 2032 expected	gastrointestinal stromal tumor, pancreatic neuroendocrine tumor, pheochromocytoma-paraganglioma, von Hippel-Lindau disease	Merck Sharp & Dohme LLC	Recruiting	No outcome recorded
Phase 2	NCT04489771	Sep 2020 → Feb 2023	renal cell carcinoma	Merck Sharp & Dohme LLC	Completed	Missed primary
Phase 2	NCT03634540	Sep 2018 → Feb 2027 expected	clear cell renal carcinoma	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Active not recruiting	No outcome recorded
Phase 2	NCT03401788	May 2018 → Apr 2027 expected	hereditary clear cell renal cell carcinoma, von Hippel-Lindau disease	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Active not recruiting	No outcome recorded

Phase 38 trials · 1 met primary · 1 missed
Phase 3	NCT07489495	Apr 2026 → Nov 2030 expected	renal cell carcinoma	Merck Sharp & Dohme LLC	Recruiting	No outcome recorded
Phase 3	NCT07405164	Mar 2026 → Apr 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	Met primary
Phase 3	NCT04736706	Apr 2021 → Feb 2026 overdue	clear cell renal carcinoma	Merck Sharp & Dohme LLC	Active not recruiting	Missed primary
Phase 3	NCT04586231	Feb 2021 → Feb 2026 overdue	renal cell carcinoma	Merck Sharp & Dohme LLC	Active not recruiting	Mixed
Phase 3	NCT04195750	Feb 2020 → Apr 2024 overdue	renal cell carcinoma	Merck Sharp & Dohme LLC	Active not recruiting	Mixed
Comparator or background therapy1 trial
Phase 2	NCT07793942 Background	Oct 2026 → Sep 2028 expected	cancer	Merck Sharp & Dohme LLC	Not yet recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 32

Date	Issuer	Release
2026-09-28	Eisai Inc.	Regulatory U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Approval based on results from the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC following treatment with a PD-1/PD-L1 inhibitor WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients eisai.com ↗
2026-07-24	MSD R&D (China) Co., Ltd.	Regulatory KEYTRUDA®（ペムブロリズマブ）およびKEYTRUDA QLEX™（ペムブロリズマブ＋ベラヒアルロニダーゼアルファ-pmph）、それぞれWELIREG®（ベルズチファン）との併用療法として特定の淡明細胞型腎細胞がん（ccRCC）患者さんに対する術後補助療法でFDAの承認を取得 msd.co.jp ↗
2026-06-12	Merck Sharp & Dohme LLC	Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC) merck.com ↗ These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2α inhibitor combination regimens.
2026-05-21	HiberCell, Inc.	Results HiberCell to Present Preliminary Results from the Phase 1b Trial of GCN2 Activator HC-7366 When Combined with WELIREG® (belzutifan) for the Treatment of Late-Line Clear Cell Renal Cell Carcinoma (ccRCC) at the Upcoming 2026 ASCO Annual Meeting hibercell.com ↗ Encouraging preliminary signals of efficacy for the higher dose combination cohorts of HC-7366 with belzutifan were observed.
2026-04-21	Merck Sharp & Dohme LLC	Results Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗ At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA.
2026-04-21	Eisai Inc.	Results Merck & Co., Inc., Rahway, NJ, USA and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) eisai.com ↗ At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA.
2026-03-02	Eisai Inc.	Results WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) This is the first positive Phase 3 trial of a multi-targeted tyrosine kinase inhibitor in combination with a HIF-2 alpha inhibitor, the first for patients with RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy, and the first to improve PFS compared to a modern tyrosine kinase inhibitor Based on these data, the U.S. FDA accepts for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC eisai.com ↗
2026-02-28	Merck Sharp & Dohme LLC	Results WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2026-02-28	Merck Sharp & Dohme LLC	Results KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Given as Adjuvant Therapy Reduced the Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage Renal Cell Carcinoma (RCC) merck.com ↗
2026-02-12	Merck Sharp & Dohme LLC	Results Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium merck.com ↗ New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG ® (belzutifan) plus KEYTRUDA and progression-free survival benefit of WELIREG in combination with LENVIMA ® (lenvatinib), respectively
2025-10-28	Merck Sharp & Dohme LLC	Results Merck Announces KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Clear Cell Renal Cell Carcinoma (RCC) Following Nephrectomy merck.com ↗ Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy.
2025-10-28	Merck Sharp & Dohme LLC	Results Merck and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma merck.com ↗ At a pre-specified interim analysis, WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in PFS compared to cabozantinib in these patients.
2025-10-28	Eisai Inc.	Results Merck & Co., Inc., Rahway, NJ, USA and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma First treatment regimen to demonstrate a statistically significant improvement in PFS for patients whose disease progressed following anti-PD-1/L1 therapy, compared with cabozantinib in Phase 3 study LITESPARK-011 marks the first positive Phase 3 study of a HIF-2 alpha inhibitor in combination with a multi-targeted VEGF tyrosine kinase inhibitor eisai.com ↗ At a pre-specified interim analysis, WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in PFS compared to cabozantinib in these patients.
2025-05-27	HiberCell, Inc.	Results HiberCell Announces Successful Completion of Dose Escalation and Enrollment Update for Ph1b Study Evaluating HC-7366 in Combination with WELIREG® (belzutifan) in Advanced ccRCC hibercell.com ↗ All three dose levels tested cleared the respective dose-limiting toxicity (DLT) evaluations.
2025-05-14	Merck Sharp & Dohme LLC	Regulatory FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL) merck.com ↗ Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
2025-02-18	Merck Sharp & Dohme LLC	Regulatory WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications merck.com ↗ Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has conditionally approved WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for:
2025-01-27	Merck Sharp & Dohme LLC	Regulatory FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL) merck.com ↗ Today’s U.S. filing acceptance demonstrates our commitment to advancing novel therapies, such as WELIREG, to help treat patients with certain rare oncologic diseases.
2024-12-13	Merck Sharp & Dohme LLC	Regulatory Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma merck.com ↗
2024-11-22	Merck Sharp & Dohme LLC	Regulatory Merck’s WELIREG® (belzutifan) Approved in China for the Treatment of Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors merck.com ↗ WELIREG is the first and only systemic therapy approved in China for adult patients with certain VHL disease-associated tumors
2024-01-19	MSD R&D (China) Co., Ltd.	Regulatory WELIREG®（belzutifan）、PD-1またはPD-L1阻害剤とVEGF-TKIによる治療後に進行した腎細胞がん（RCC）の治療薬としてFDAの承認を取得 msd.co.jp ↗ Merck & Co., Inc., Rahway, N.J., U.S.A.（米国とカナダ以外ではMSD）は本日、経口低酸素誘導因子2アルファ（HIF-2α）阻害剤のWELIREGが、PD-1（プログラム細胞死受容体1）またはPD-L1（プログラム細胞死リガンド1）阻害剤と血管内皮細胞増殖因子チロシンキナーゼ阻害剤（VEGF-TKI）による治療後に進行した成人の腎細胞がん（RCC）の治療薬として、米国食品医薬品局（FDA）の承認を取得したことを発表しました。
2023-12-14	Merck Sharp & Dohme LLC	Regulatory FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI merck.com ↗ Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
2023-11-17	MSD R&D (China) Co., Ltd.	Results WELIREG®（belzutifan）、前治療歴のある進行腎細胞がん（RCC）に対し、エベロリムスと比較して無増悪生存期間と客観的奏効率を有意に改善 msd.co.jp ↗ WELIREGは、2つの主要評価項目の1つである無増悪生存期間（PFS）と主な副次評価項目である客観的奏効率（ORR）について、エベロリムスと比較して統計学的に有意な改善が認められました。
2023-10-21	Merck Sharp & Dohme LLC	Results Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗ In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key secondary endpoint of objective response rate (ORR) compared to everolimus.
2023-10-10	Merck Sharp & Dohme LLC	Results Merck Highlights Innovative Oncology Portfolio and Pipeline at ESMO Congress 2023 Underscoring Commitment to Advancing Cancer Research and Improving Patient Outcomes Across Multiple Stages of Disease merck.com ↗
2023-09-19	Merck Sharp & Dohme LLC	Regulatory FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2023-09-08	MSD R&D (China) Co., Ltd.	Results WELIREG®（belzutifan）、前治療歴のある進行腎細胞がんを対象とした第3相LITESPARK-005試験で、無増悪生存期間の主要評価項目を達成 WELIREGがエベロリムスと比較して有意にPFSを延長LITESPARK-005試験はWELIREGの良好な結果を示した最初の第3相無作為化比較試験となる msd.co.jp ↗ 本試験の独立データモニタリング委員会による事前に規定された中間解析の結果、WELIREGは、エベロリムスと比較して無増悪生存期間（PFS）について統計学的に有意かつ臨床的に意味のある延長が認められました。
2023-08-18	Merck Sharp & Dohme LLC	Results Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma merck.com ↗ In the trial, WELIREG showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee.
2021-08-13	Merck Sharp & Dohme LLC	Regulatory FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors merck.com ↗ Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
2021-03-16	Merck Sharp & Dohme LLC	Regulatory Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482) merck.com ↗ The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 15, 2021.
2020-09-20	Merck Sharp & Dohme LLC	Results Merck Presents Promising New Data for Three Investigational Medicines From Diverse and Expansive Oncology Pipeline at ESMO Virtual Congress 2020 merck.com ↗ Additionally, late-breaking Phase 2 data for MK-6482 showed anti-tumor responses in von Hippel-Lindau (VHL) disease patients with clear cell renal cell carcinoma (RCC) and other tumors (Abstract #LBA26).
2020-07-29	Merck Sharp & Dohme LLC	Regulatory FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma merck.com ↗
2020-05-13	Merck Sharp & Dohme LLC	Results Merck’s Novel HIF-2α Inhibitor Showed an Objective Response Rate of Nearly 30% in Patients with von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinoma merck.com ↗

All press releases naming this drug 37 releases

Date	Issuer	Release
2026-09-28	Eisai Inc.	U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Approval based on results from the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC following treatment with a PD-1/PD-L1 inhibitor WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients eisai.com ↗
2026-07-24	MSD R&D (China) Co., Ltd.	KEYTRUDA®（ペムブロリズマブ）およびKEYTRUDA QLEX™（ペムブロリズマブ＋ベラヒアルロニダーゼアルファ-pmph）、それぞれWELIREG®（ベルズチファン）との併用療法として特定の淡明細胞型腎細胞がん（ccRCC）患者さんに対する術後補助療法でFDAの承認を取得 msd.co.jp ↗
2026-06-12	Merck Sharp & Dohme LLC	FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC) merck.com ↗
2026-05-21	HiberCell, Inc.	HiberCell to Present Preliminary Results from the Phase 1b Trial of GCN2 Activator HC-7366 When Combined with WELIREG® (belzutifan) for the Treatment of Late-Line Clear Cell Renal Cell Carcinoma (ccRCC) at the Upcoming 2026 ASCO Annual Meeting hibercell.com ↗
2026-04-21	Merck Sharp & Dohme LLC	Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2026-04-21	Eisai Inc.	Merck & Co., Inc., Rahway, NJ, USA and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) eisai.com ↗
2026-03-27	Eisai Inc.	Application Submitted for LENVIMA® (lenvatinib) in Japan Seeking Approval of Additional Dosage and Administration for Combination with WELIREG® (belzutifan) for Renal Cell Carcinoma that has Progressed After Chemotherapy eisai.com ↗
2026-03-02	Eisai Inc.	WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) This is the first positive Phase 3 trial of a multi-targeted tyrosine kinase inhibitor in combination with a HIF-2 alpha inhibitor, the first for patients with RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy, and the first to improve PFS compared to a modern tyrosine kinase inhibitor Based on these data, the U.S. FDA accepts for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC eisai.com ↗
2026-02-28	Merck Sharp & Dohme LLC	WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2026-02-28	Merck Sharp & Dohme LLC	KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Given as Adjuvant Therapy Reduced the Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage Renal Cell Carcinoma (RCC) merck.com ↗
2026-02-12	Merck Sharp & Dohme LLC	Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium merck.com ↗
2025-10-28	Merck Sharp & Dohme LLC	Merck Announces KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Clear Cell Renal Cell Carcinoma (RCC) Following Nephrectomy merck.com ↗
2025-10-28	Merck Sharp & Dohme LLC	Merck and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma merck.com ↗
2025-10-28	Eisai Inc.	Merck & Co., Inc., Rahway, NJ, USA and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma First treatment regimen to demonstrate a statistically significant improvement in PFS for patients whose disease progressed following anti-PD-1/L1 therapy, compared with cabozantinib in Phase 3 study LITESPARK-011 marks the first positive Phase 3 study of a HIF-2 alpha inhibitor in combination with a multi-targeted VEGF tyrosine kinase inhibitor eisai.com ↗
2025-05-27	HiberCell, Inc.	HiberCell Announces Successful Completion of Dose Escalation and Enrollment Update for Ph1b Study Evaluating HC-7366 in Combination with WELIREG® (belzutifan) in Advanced ccRCC hibercell.com ↗
2025-05-14	Merck Sharp & Dohme LLC	FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL) merck.com ↗
2025-02-18	Merck Sharp & Dohme LLC	WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications merck.com ↗
2025-01-27	Merck Sharp & Dohme LLC	FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL) merck.com ↗
2024-12-13	Merck Sharp & Dohme LLC	Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma merck.com ↗
2024-11-22	Merck Sharp & Dohme LLC	Merck’s WELIREG® (belzutifan) Approved in China for the Treatment of Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors merck.com ↗
2024-10-14	Merck Sharp & Dohme LLC	Exelixis and Merck Sign Clinical Development Collaboration to Evaluate Investigational Zanzalintinib in Combination With KEYTRUDA® (pembrolizumab) in Head and Neck Cancer and in Combination With WELIREG® (belzutifan) in Renal Cell Carcinoma merck.com ↗
2024-10-14	Exelixis	Exelixis and Merck Sign Clinical Development Collaboration to Evaluate Investigational Zanzalintinib in Combination with KEYTRUDA® (pembrolizumab) in Head and Neck Cancer and in Combination with WELIREG® (belzutifan) in Renal Cell Carcinoma exelixis.com ↗
2024-05-01	HiberCell, Inc.	HiberCell Announces First Patient Dosed in Clinical Collaboration with Merck, Evaluating HC-7366 in Combination with WELIREG® (belzutifan) in patients with advanced ccRCC hibercell.com ↗
2024-01-19	MSD R&D (China) Co., Ltd.	WELIREG®（belzutifan）、PD-1またはPD-L1阻害剤とVEGF-TKIによる治療後に進行した腎細胞がん（RCC）の治療薬としてFDAの承認を取得 msd.co.jp ↗
2023-12-14	Merck Sharp & Dohme LLC	FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI merck.com ↗
2023-12-05	HiberCell, Inc.	HiberCell, Inc. Announces Clinical Collaboration with Merck to Evaluate HC-7366, an Activator of ISR Kinase GCN2, in Combination with WELIREG® (belzutifan) in a Phase 1b Study of Patients with Clear Cell Renal Cell Carcinoma (ccRCC) hibercell.com ↗
2023-11-17	MSD R&D (China) Co., Ltd.	WELIREG®（belzutifan）、前治療歴のある進行腎細胞がん（RCC）に対し、エベロリムスと比較して無増悪生存期間と客観的奏効率を有意に改善 msd.co.jp ↗
2023-10-21	Merck Sharp & Dohme LLC	Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2023-10-10	Merck Sharp & Dohme LLC	Merck Highlights Innovative Oncology Portfolio and Pipeline at ESMO Congress 2023 Underscoring Commitment to Advancing Cancer Research and Improving Patient Outcomes Across Multiple Stages of Disease merck.com ↗
2023-09-19	Merck Sharp & Dohme LLC	FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2023-09-08	MSD R&D (China) Co., Ltd.	WELIREG®（belzutifan）、前治療歴のある進行腎細胞がんを対象とした第3相LITESPARK-005試験で、無増悪生存期間の主要評価項目を達成 WELIREGがエベロリムスと比較して有意にPFSを延長LITESPARK-005試験はWELIREGの良好な結果を示した最初の第3相無作為化比較試験となる msd.co.jp ↗
2023-08-18	Merck Sharp & Dohme LLC	Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma merck.com ↗
2021-08-13	Merck Sharp & Dohme LLC	FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors merck.com ↗
2021-03-16	Merck Sharp & Dohme LLC	Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482) merck.com ↗
2020-09-20	Merck Sharp & Dohme LLC	Merck Presents Promising New Data for Three Investigational Medicines From Diverse and Expansive Oncology Pipeline at ESMO Virtual Congress 2020 merck.com ↗
2020-07-29	Merck Sharp & Dohme LLC	FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma merck.com ↗
2020-05-13	Merck Sharp & Dohme LLC	Merck’s Novel HIF-2α Inhibitor Showed an Objective Response Rate of Nearly 30% in Patients with von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinoma merck.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

Field	Value	Cited 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 ↗ 38 NCT04626518 ↗ NCT05899049 ↗ NCT04976634 ↗ NCT03401788 ↗ NCT04626479 ↗ NCT07489495 ↗ NCT07227402 ↗ NCT07680205 ↗ NCT07840001 ↗ NCT04995484 ↗ Show 28 more sources
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 molecule” NCT02974738 ↗
Route	Oral	“Belzutifan was administered orally” PMID 33888901 ↗ Apr 2021
Target	HIF2A	“MK-6482 is an oral, first-in-class selective small-molecule inhibitor that targets hypoxia-inducible factor (HIF)-2a” NCT04627064 ↗