Dashboard PDUFA PDUFA History Dilution Watch Downside Radar Missed Milestones Earnings Big Movers Blog

🎤 Upcoming Biotech Conferences

Loading conferences...

Free to browse, no account needed Follow the companies behind these drugs with free AI briefings, catalyst countdowns and dilution alerts.

Start 7-day free trial → Log in

Bezuclastinib · CGT-9486, PLX-9486

Small molecule · Inhibitor of c-Kit (KIT) · developed by Cogent Biosciences

Phase 3 Most advanced trial

COGT Developer

3 Registered trials

What is Bezuclastinib?

Bezuclastinib is an orally bioavailable tyrosine kinase inhibitor that binds to and inhibits mutated forms of c-Kit. It is studied in systemic mastocytosis variants (advanced, aggressive, smoldering, indolent) and gastrointestinal stromal tumors.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: CGT-9486, PLX-9486
Drug type: Small molecule
Targets: c-Kit (KIT)
Mechanism: Inhibitor of c-Kit (KIT)
Pathways: cell proliferation, cell differentiation
Therapy area: Oncology
Developer: Cogent Biosciences, Inc. (COGT)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 3
UNII: 2ROQ545LAG

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05208047	Phase 3	Advanced Gastrointestinal Stromal Tumors	Recruiting	COGT
NCT05186753	Phase 2	SSM	Active not recruiting	COGT
NCT04996875	Phase 2	Advanced Systemic Mastocytosis (AdvSM)	Recruiting	COGT

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Advanced Gastrointestinal Stromal TumorsAdvanced Systemic Mastocytosis (AdvSM)Aggressive Systemic Mastocytosis (ASM)BMMBone Marrow MastocytosisISMMast Cell Leukemia (MCL)MastocytosisMastocytosis, IndolentMastocytosis, SystemicMetastatic CancerSM With an Associated Hematologic Neoplasm (SM-AHN)Smoldering Systemic MastocytosisSSM

Other drugs acting on KIT

Midostaurin FDA approved Pexidartinib FDA approved Regorafenib FDA approved Sunitinib FDA approved Barzolvolimab Phase 3 Briquilimab Phase 1/2 CDX 0158 Phase 1 Olverembatinib Phase 3 Sitravatinib Phase 3

More from Cogent Biosciences

ACTR087 Phase 1 ACTR707 Phase 1 CGT4255 Phase 1 CGT4859 Phase 1/2 CGT6297 Phase 1 SEA-BCMA Phase 1

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the COGT page.

Follow COGT, the company behind Bezuclastinib

See COGT's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

COGT catalysts and pipeline →

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z