RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union)

Structure/Sequence

Molecular FormulaC17H12F3NO4S

InChIKeyLOMMPXLFBTZENJ-ZACQAIPSSA-N

CAS Registry1672668-24-4

Clinical Trials associated with Belzutifan

NCT07593040

/ Not yet recruitingPhase 2IIT

A Randomized Phase 2 Trial of Neoadjuvant Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Patients With Localized Renal Cell Carcinoma

This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).

Start Date01 Jun 2026

Sponsor / Collaborator

Vall d'Hebron Institut d'Oncologia

NCT07489495

/ RecruitingPhase 3

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).
A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone.
The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.

Start Date09 Apr 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT07405164

/ RecruitingPhase 3

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:
* Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery
* Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids
* VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer
Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.

Start Date23 Mar 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Belzutifan

100 Translational Medicine associated with Belzutifan

100 Patents (Medical) associated with Belzutifan

214

Literatures (Medical) associated with Belzutifan

01 Jun 2026·American journal of ophthalmology case reports

Very rapid response to belzutifan of VHL-related intracranial and retinal hemangioblastomas

Article

Author: Hadjistilianou, Doris ; Verrico, Antonio ; Piatelli, Gianluca ; Borzì, Leonardo ; Mercuri, Claudia ; Milanaccio, Claudia ; Gaggero, Gabriele ; Ramaglia, Antonia ; Molteni, Marta ; Piccolo, Gianluca ; Pagliara, Alessandra ; Di Profio, Sonia ; De Giuseppe, Sara ; Serafino, Massimiliano

Background:

Belzutifan, a hypoxia-inducible factor-2α (HIF-2α) inhibitor approved for von Hippel-Lindau (VHL) disease-related tumors, induces radiological responses in hemangioblastomas, but the timing and extent of early changes are not well defined.

Case presentation:

A 9-year-old girl was admitted with nausea, vomiting, and ataxia. Brain MRI showed a cystic cerebellar mass, which was fully resected; histology and genetic testing confirmed VHL. Follow-up revealed a small stable cerebellar residual. Two years later, she developed multiple retinal hemangioblastomas (RH) with major visual decline and new cerebellar nodules. Argon laser photocoagulation provided no lasting benefit, prompting initiation of belzutifan. The drug was well tolerated over the first six months, with only grade 1 anemia. Psychological assessments documented excellent adaptation, preserved quality of life, stable daily routines, and regular school attendance. MRI demonstrated a marked reduction in two of the three cerebellar nodules as early as day 15 of cycle 1, followed by progressive shrinkage and stabilization by cycle 4. No new RH emerged, and visual acuity improved within eight weeks of treatment and then remained stable.

Conclusions:

This case highlights an unusually rapid radiological response of VHL-associated cerebellar and retinal hemangioblastomas shortly after belzutifan initiation, suggesting that imaging performed soon after treatment onset may detect changes earlier than commonly reported. A slight but measurable improvement in visual acuity was also observed, despite the overall structural stability of the RH. These findings support the potential value of early radiological and functional assessment in selected patients receiving HIF-2α inhibitors.

15 May 2026·JOURNAL OF CLINICAL INVESTIGATION

Genome-wide CRISPR screen identifies a cytokine-enhancer circuit driving HIF-2α activation in renal cancer

Article

Author: Mani, Ram ; Brugarolas, James ; Zhou, Jin ; Bi, Xianju ; Liu, Hongyi ; Zhang, Cheng ; Simon, Jeremy M. ; Wang, Tao ; Nathan, James A. ; Gao, Yunpeng ; Fang, Jun ; Adachi, Yayoi ; Hu, Lianxin ; Liang, Qian ; Liao, Chengheng ; Zhang, Qing

Resistance to HIF-2α inhibitors such as belzutifan underscores the need to better understand how HIF-2α is transcriptionally regulated in clear cell renal cell carcinoma (ccRCC). Here, we uncover a cytokine-driven enhancer mechanism that sustains HIF-2α expression through the JAK1/STAT3 signaling pathway. Using a genome-wide CRISPR screen in von Hippel–Lindau–deficient (VHL-deficient) ccRCC cells, we identified SOCS3 as a key negative regulator of HIF-2α. Mechanistically, loss of SOCS3 activates JAK1/STAT3 signaling, leading to the recruitment of STAT3 to distal enhancers upstream of endothelial PAS domain-containing protein ( EPAS1 ) that physically loop to its promoter to drive HIF-2α transcription. This cytokine-enhancer circuit was recapitulated in samples from patients with ccRCC and functionally validated using CRISPR interference (CRISPRi), which disrupted enhancer-promoter looping and reduced tumor growth in HIF-2α–dependent models. SOCS3 overexpression or pharmacologic inhibition of JAK1/STAT3 markedly suppressed HIF-2α expression and tumor progression both in vitro and in vivo. Unlike prior studies focusing on VHL/HIF occupancy–driven enhancer activation, this work defines a trans -acting cytokine–JAK1/STAT3 pathway that transcriptionally controls EPAS1 . Together, these findings reveal a targetable enhancer mechanism that sustains HIF-2α expression and suggest that combined inhibition of JAK1/STAT3 and HIF-2α may overcome therapeutic resistance in kidney cancer. We discovered that cytokine signaling drives kidney cancer by activating a genetic circuit that boosts HIF-2α expression, offering new targets to overcome treatment resistance.

04 May 2026·JOURNAL OF EXPERIMENTAL MEDICINE

Targeting conserved domains of hypoxia-inducible factors for cancer therapy

Article

Author: Drehmer, Daiana ; Yang, Yongkang ; Wicks, Elizabeth E. ; Chen, Chelsey ; Jackson, Walter ; Lee, Sophia N. ; Salman, Shaima ; Semenza, Gregg L. ; Lyu, Yajing ; Huang, Tina Y. ; Datan, Emmanuel ; Dordai, Dominic ; Hwang, Yousang ; Prabhakar, Nanduri R. ; Li, Oscar ; Peng, Ying-Jie ; Kumar, Anmol ; Cho, Ellen ; MacKerell, Alexander D.

Hypoxia-inducible factors 1 and 2 (HIF-1/2) function as master regulators of cancer progression by regulating angiogenesis, cancer stem cell specification, epithelial–mesenchymal transition, immune evasion, tissue invasion, and metastasis. We utilized computer-aided drug discovery and cell-based reporter assays to identify dual HIF-1/2 inhibitors, which bind directly to highly conserved domains of HIF-1α and HIF-2α, disrupt dimerization with HIF-1β, and trigger proteasomal degradation, thereby inhibiting HIF-1/2 transcriptional activity. These inhibitors and derivative compounds block growth and vascularization of breast, colorectal, head/neck, melanoma, and prostate tumors as monotherapy, and overcome resistance to anti-CTLA-4 or anti-PD-1 immunotherapy, with an aggregate complete response rate of over 50%, through reprogramming of the tumor immune cell microenvironment. Compared with the HIF-2–selective inhibitors belzutifan and PT2385, dual HIF-1/2 inhibitor 1.21S9N showed superior activity against breast and colorectal cancer models, respectively. PT2385 caused breathing abnormalities, whereas 1.21S9N did not. The drugs are orally bioavailable, and no safety concerns were identified even after extended or supratherapeutic dosing.

149

News (Medical) associated with Belzutifan

12 Jun 2026

·firstwordpharma.com

FDA clears Merck & Co.'s Welireg, Keytruda combo in adjuvant kidney cancer

The FDA has approved a combination of Merck & Co.'s Keytruda (pembrolizumab) with the company's HIF-2α inhibitor Welireg (belzutifan) as an adjuvant treatment for adults with clear cell renal cell carcinoma (ccRCC) at risk of recurrence after surgery. The approval also applied to Keytruda's subcutaneous formulation, Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph).The decision, which follows a priority review, is based on the Phase III LITESPARK-022 trial, which enrolled 1841 patients with prior nephrectomy who were at intermediate-high or high risk of recurrence, or who had resected metastases with no evidence of disease. Patients were randomised to receive Welireg plus Keytruda as adjuvant therapy or Keytruda plus placebo.At a prespecified interim analysis, Welireg plus Keytruda was associated with a 28% benefit on the primary endpoint of disease-free survival (DFS), defined as time to recurrence, metastasis or death, with 186 events and 246 events in the Welireg and comparator arms, respectively. Median DFS wasn't reached in either arm, while overall survival (OS) data weren't mature at the interim analysis.Welireg already has a kidney cancer indication, having been approved in late 2023 for advanced RCC patients previously treated with PD-1/L1 and VEGF-targeted therapies (see – KOL Views Q&A: Welireg's safety will aid Merck & Co.'s upstream ambitions in RCC).Meanwhile, Friday's approval gives Keytruda it's fourth kidney cancer indication following two in the first-line advanced setting with Pfizer's Inlyta (axitinib) or Eisai's Lenvima (lenvatinib), and another in the post-nephrectomy setting based on results from the KEYNOTE-564 trial, where it showed a significant 38% improvement in OS in patients with high-risk disease.However, several experts interviewed by FirstWord for a Therapy Trends report last year indicated they planned to stick with Bristol Myers Squibb's Opdivo (nivolumab) for immuno-oncology combinations in RCC given the uncertainty around treatment sequencing (see – Spotlight On: Opdivo combos hold firm in RCC, despite growing pressure from Keytruda).

Phase 3Clinical ResultDrug ApprovalPriority ReviewImmunotherapy

12 Jun 2026

·www.fda.gov

FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma

On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.Full prescribing information for Welireg, Keytruda, and Keytruda Qlex will be posted on Drugs@FDA.Efficacy and SafetyEfficacy was evaluated in LITESPARK-022 (NCT05239728), a multicenter, double-blind, randomized trial in 1,841 patients with prior nephrectomy for ccRCC who were at intermediate-high or high risk of recurrence, or who had resected metastases with no evidence of disease. Patients were randomized (1:1) to receive belzutifan in combination with pembrolizumab as adjuvant therapy or placebo in combination with pembrolizumab until disease recurrence or unacceptable toxicity or for up to 54 weeks of belzutifan or 12 months of pembrolizumab.The major efficacy outcome measure was investigator-assessed disease-free survival (DFS), defined as time to recurrence, metastasis, or death. A statistically significant improvement in DFS was demonstrated at a prespecified interim analysis with 186 events in the belzutifan with pembrolizumab arm and 246 events in the placebo with pembrolizumab arm (hazard ratio 0.72 [95% CI: 0.59, 0.87]; p-value 0.0003). Median DFS was not reached in either arm. Overall survival data were not mature at the protocol pre-specified interim analysis.The belzutifan prescribing information includes a boxed warning for embryo-fetal toxicity and warnings and precautions for anemia and hypoxia. The pembrolizumab prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. Recommended DosageThe recommended belzutifan dose is 120 mg orally once daily in combination with pembrolizumab or pembrolizumab and berahyaluronidase-pmph alfa until disease recurrence or unacceptable toxicity, or for up to 54 weeks. The recommended pembrolizumab dose is 200 mg intravenously every three weeks or 400 mg every six weeks in combination with belzutifan 120 mg orally once daily until disease recurrence, unacceptable toxicity, or for up to 12 months. The recommended pembrolizumab and berahyaluronidase alfa-pmph dose is 395 mg/4,800 units subcutaneously every three weeks or 790 mg/9,600 units every six weeks in combination with belzutifan 120 mg orally once daily until disease recurrence, unacceptable toxicity, or for up to 12 months.This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada. The application reviews are ongoing at the other regulatory agencies.This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology.

Priority ReviewClinical ResultDrug ApprovalClinical Study

28 May 2026

·www.biospace.com

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

Data from Phase 1b dose escalation and expansion trial (n=69) shows a favorable safety profile, with manageable adverse events consistent with the known profiles of the respective drugs. Encouraging preliminary signals of efficacy for the higher dose combination cohorts of HC-7366 with belzutifan were observed. Additionally, several patients in the dose escalation and initial expansion (Expansion 1) remain on treatment. Translational analyses demonstrate clear evidence of HC-7366 pathway engagement and a pharmacodynamic pro the combination from the known effects of HC-7366 and belzutifan monotherapy. Second Dose Expansion Cohort (Expansion 2) fully enrolled, with updated results from both Expansion 1 and Expansion 2 expected in 2H 2026 and full results to be reported at a future date. ROSEVILLE, Minn., May 21, 2026 (GLOBE NEWSWIRE) -- HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics targeting the integrated stress response (ISR) to address cancer relapse, metastasis, and resistance, today announced that preliminary results from its ongoing Phase 1b study (NCT06234605) of HC-7366 in combination with WELIREG ® (belzutifan), Merck’s (known as MSD outside of the United States and Canada) oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, will be presented in two poster presentations at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The study is evaluating HC-7366, an activator of the ISR kinase GCN2, in patients with advanced clear cell renal cell carcinoma (ccRCC) whose disease progressed after prior PD-1/PD-L1 checkpoint inhibitor and VEGF-tyrosine kinase inhibitor (VEGF-TKI) therapy. "These preliminary results from the Phase 1b study are encouraging,” said Robert Motzer, M.D., lead principal investigator for the study. “In a patient population with limited treatment options following checkpoint inhibitor and VEGF-TKI therapy, the combination of HC-7366 and belzutifan demonstrated a manageable safety pro early signals of disease control that warrant further investigation.” “The data from our dose escalation and expansion cohorts suggest that HC-7366 in combination with belzutifan is generally well tolerated, with preliminary efficacy findings that are consistent with our preclinical hypotheses,” said Nandita Bose, Ph.D., Chief Development Officer of HiberCell. “While these are early results, the observed response rates and pharmacodynamic evidence of pathway engagement provide a reasonable basis for continuing evaluation in our Expansion 2 cohort." Abstract 4534 - A phase 1b, open-label, safety, tolerability, and efficacy study of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic renal cell carcinoma. The study enrolled patients with advanced ccRCC previously treated with ≥1 anti-PD-1/PD-L1 and ≥1 VEGF-TKI. As of the later data cutoff date for the poster presentation, April 23, 2026, 69 patients received study treatment: 16 monotherapy and 53 as part of dose escalation/Expansion 1 of HC-7366 in combination with belzutifan (7 at 20 mg, 22 at 40 mg, 24 at 60 mg with 120 mg belzutifan). Expansion 2 in ~20 patients is fully enrolled and follow-up is ongoing. The median number of prior therapies was 3 (range 1-5) in monotherapy and 2 (range 1-4) in combination. Most TEAEs were Grade 1-2. Grade 3 events were mainly hematological (anemia) and gastrointestinal (nausea and diarrhea), with one DLT (Grade 3 nausea, 40 mg combination). In efficacy-evaluable patients, the 40 mg combination (median follow-up of 13.3 months) demonstrated a best overall response rate (BORR) of 37%, including a confirmed ORR (cORR) of 26%, disease control rate (DCR) of 89%, and primary progressive disease (PD) rate of 11%. The 60 mg combination (median follow-up of 10.9 months) had a BORR and cORR of 37%, DCR of 84%, and primary PD rate of 16%. In monotherapy, BORR of 15% and DCR of 62% were observed. Early efficacy signals at 40–60 mg align with the preclinical projected optimal efficacious dose range. Overall, HC-7366, alone or in combination with belzutifan, was generally well tolerated. Preliminary efficacy analyses indicate favorable disease control, characterized by a high DCR and low primary PD for the combination. Abstract 4535 - Combining HC-7366 with belzutifan in patients with renal cell carcinoma to alter tumor and microenvironment: Pharmacokinetic and pharmacodynamic (PK/PD) analysis of a phase 1b study. Findings from a robust translational program, including pharmacokinetic and pharmacodynamic analyses from paired tumor biopsies and systemic biomarker assessments, demonstrated clear evidence of HC-7366 pathway engagement and a differential pharmacodynamic biomarker pro monotherapy from the combination. Notably, several favorable changes countering ccRCC biology were observed, including sustained inhibition of the HIF-2 target EPO, reduction of HIF-1α, cell cycle inhibition, and modulation of pro- and anti-tumor adipokines. Modulation of angiogenic and immune-related pathways further supports the scientific rationale for evaluating HC-7366/belzutifan in combination with immune checkpoint inhibitors and/or VEGF-TKIs. WELIREG ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About HC-7366 HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with various standard-of-care agents in preclinical models of both solid and liquid tumors. HC-7366 is currently under clinical development in Phase 1b studies in ccRCC and acute myeloid leukemia (AML). About HiberCell HiberCell is a clinical-stage oncology company, dedicated to the advancement of first-in-class agents with the novel mechanism of action of modulation of adaptive stress pathways. We believe that therapeutic modulation of these mechanisms allows us to address tumor metastasis, treatment resistance, and cancer relapse, all significant drivers of cancer-related deaths. Our GCN2 activator, HC-7366, is currently under investigation in Phase 1b trials in ccRCC and AML. Meanwhile, our PERK inhibitor, HC-5404, is advancing into Phase 1b development. For more information about HiberCell, please visit hibercell.com. Dr. Motzer has financial interests related to Merck. For Media/Investor Inquiries: IR@hibercell.com

Phase 1Clinical ResultASCO

100 Deals associated with Belzutifan

External Link

KEGG	Wiki	ATC	Drug Bank
D11954	-	-	DB15463

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic Renal Cell Carcinoma	Japan	MSD KK (Tokyo)	24 Jun 2025
Paraganglioma	United States	Merck & Co., Inc.	14 May 2025
Pheochromocytoma	United States	Merck & Co., Inc.	14 May 2025
Advanced Renal Cell Carcinoma	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	22 Dec 2022
Hemangioblastoma	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	22 Dec 2022
Neuroendocrine tumor of pancreas	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	22 Dec 2022
Renal Cell Carcinoma	Canada	Merck Canada, Inc.	11 Jul 2022
Von Hippel-Lindau Disease	United States	Merck Sharp & Dohme Corp.	13 Aug 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Clear Cell Renal Cell Carcinoma	NDA/BLA	European Union	Merck & Co., Inc.	12 Dec 2024
Unresectable Renal Cell Carcinoma	Phase 3	United States	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Argentina	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Australia	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Austria	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Belgium	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Brazil	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Croatia	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Czechia	Merck Sharp & Dohme LLC	26 Nov 2025
Unresectable Renal Cell Carcinoma	Phase 3	Denmark	Merck Sharp & Dohme LLC	26 Nov 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


LITESPARK-005 (ASCO2026)	Not Applicable	Advanced Renal Cell Carcinoma tobacco use \| sex \| BMI ... View more	2,844	Belzutifan	znjmeyozij(vceqkegxhq) = llnlefqxnf hhikxoryko (wvkyexlwpd ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Von Hippel-Lindau Disease	9	Belzutifan	bjqxjkmjlh(kayutfcqad) = ofnnukfopk snlweyxogp (znjazwjnxy, 42.1 - 99.6) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Renal Cell Carcinoma First line	190	Cabozantinib	ikogfncvvn(ovtngjypjc) = trolmhbwgs wtdbqgcigq (bjpvxpyfsn ) View more	Positive	29 May 2026
				Belzutifan	ikogfncvvn(ovtngjypjc) = jiclhcvuxw wtdbqgcigq (bjpvxpyfsn ) View more
ASCO2026	Not Applicable	Renal Cell Carcinoma	150	Belzutifan (Responder)	whmwsvdpuw(oraepuxlea) = ratvnooeeq uvhnikgjvh (hppwmaffpw ) View more	Positive	29 May 2026
				Belzutifan	whmwsvdpuw(oraepuxlea) = tfehejdlhk uvhnikgjvh (hppwmaffpw ) View more
NCT07227402 (LITESPARK-033, ASCO2026)	Phase 3	Renal Cell Carcinoma Adjuvant	904	Belzutifan plus zanzalintinib	bzcjdpxvmy(yjrebxvwtw) = oukjxsmobz rishqmtiry (yaerxrmrpf ) View more	Positive	29 May 2026
				Cabozantinib	bzcjdpxvmy(yjrebxvwtw) = eqoxymxcii rishqmtiry (yaerxrmrpf )
NCT02861573 (KEYNOTE-365, ASCO2026)	Phase 1/2	Metastatic castration-resistant prostate cancer Hypoxia-inducible factor 2α (HIF-2α)	21	Belzutifan 120 mg	gmmoirmnlz(rjlffutpaj) = qgbgnzdevd yyeaxghfbq (hrdvslcptr, 10.8 - NR) View more	Negative	29 May 2026
AACR2026	Not Applicable	Von Hippel-Lindau Disease	14	Belzutifan	udjimwzagl(vltmdxluzn) = The most common AEs were anemia (35%), dizziness (21%), and headache (21%). qniyngmjqe (rksekneslt ) View more	Positive	21 Apr 2026
NCT04586231 (LITESPARK-011, ASCO_GU2026) Manual	Phase 3	Advanced Renal Cell Carcinoma	747	Belzutifan 120 mg + Lenvatinib 20 mg (IA1)	uhwuqrqzjn(orfbmzjvrt) = ksaxqsuhlx luckiqbyxc (ugkuvodimz, 11.1–16.6) View more	Positive	26 Feb 2026
				Cabozantinib 60 mg (IA1)	uhwuqrqzjn(orfbmzjvrt) = soavrlnxtp luckiqbyxc (ugkuvodimz, 9.2–11.1) View more
NCT05239728 (LITESPARK-022, ASCO_GU2026) Manual	Phase 3	Renal Cell Carcinoma Adjuvant	1,841	Pembrolizumab + belzutifan	zchylnsjhr(vnndjhdpqb): HR = 0.72 (95% CI, 0.59 - 0.87), P-Value = 0.0003 View more	Positive	26 Feb 2026
				Pembrolizumab + placebo
ASCO_GU2026	Not Applicable	Renal Cell Carcinoma	240	Belzutifan responders	gyefnzvzna(oxdrpwkkhr) = xplvqkbduf aqibuecxxw (xvfkbatepz ) View more	Positive	26 Feb 2026
				Belzutifan non-responders	gyefnzvzna(oxdrpwkkhr) = vzmntheocv aqibuecxxw (xvfkbatepz ) View more

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