drug · small molecule
belzutifan
Marketedupdated 5mo agoby $MRK Merck & Co., Inc.🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 3 investigational indications.
targets
Endothelial PAS domain-containing protein 1
all catalysts(0)
nothing on the calendar yet
Trials studying belzutifan
- phase2Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
- phase3A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
- phase2A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
- phase3Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
- phase2Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
- phase2A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)
- phase3A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
- phase2A Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 14, 2026
71 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (3)
- Jun 30, 2042formulationUS 12358870
- Sep 5, 2034compositionUS 9908845
- Sep 5, 2034compositionUS RE49948
FDA exclusivities (4)
- Aug 13, 2028ODE-364Orphan Drug (7y)1.9y
- May 14, 2028I-968Indication (3y)1.6y
- Dec 14, 2026I-931Indication (3y)71d
- Aug 13, 2026NCENew Chemical Entity (5y)
News(7)
- Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADCMerck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Ca…biospace · 5d ago
- Novo pursues long-acting obesity drugs; Acadia slumps on Alzheimer’s dataNovo’s latest alliance involves injectables given every one to three months. Elsewhere, Nektar won a legal spat with Eli Lilly and the FDA issued two approvals.biopharma_dive · 8d ago
- Merck expands Welireg's use to broader set of kidney cancer patientsMerck’s Welireg won FDA approval on Friday for use in combination with Eisai’s Lenvima to treat certain kidney cancer patients. The combination will be available to patients with advanced renal cel…endpoints · 8d ago
- Earnings roundup: Gilead’s ‘uncertain’ future, Pfizer’s crossroads and Merck’s PCSK9 launchSome analysts see warning signs in crucial drug launches from Gilead and Merck, while an important trial readout could change Pfizer’s growth trajectory.biopharma_dive · 1mo ago
- Merck’s $10.8B Prometheus deal delivers another win—plus a Phase 2b missThe anti-TL1A antibody from Merck's 2023 Prometheus buy delivered positive mid-stage results in a skin condition but failed in a certain type of lung disease, the Big Pharma revealed alongside seco…biospace · 2mo ago
- Merck brings Welireg-Keytruda combo to treat kidney cancerMerck’s Welireg and Keytruda combination won approval as an adjuvant treatment for kidney cancer patients after surgery to remove all or part of the organ. The combination was approved Friday for ...endpoints · 3mo ago
- Merck still sees ‘compelling’ outlook for Terns leukemia drugDespite updated study data that suggest Terns’ treatment may be less differentiated, company executives claimed Thursday that it still could be an important step forward in care.biopharma_dive · 5mo ago
Data sources
last refreshed 23m ago
Found something off?
comments(0)
5-min edit window · permanent after that