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

CGT4255

Small molecule · Inhibitor of HER2 (ERBB2) · developed by Cogent Biosciences

Phase 1 Most advanced trial
COGT Developer
1 Registered trials

What is CGT4255?

CGT4255 is an orally bioavailable, mutant-selective inhibitor of HER2 receptor tyrosine kinase. It targets HER2 mutations including L755S and YVMA exon 20 insertions, preventing HER2-mediated signaling and inducing cell death in HER2-expressing tumor cells. It is being studied in advanced solid tumors, HER2-altered breast cancer, and non-small cell lung cancer.

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

At a glance

Drug type
Small molecule
Targets
HER2 (ERBB2)
Mechanism
Inhibitor of HER2 (ERBB2)
Pathways
MAPK/ERK, PI3K/Akt
Therapy area
Oncology
Developer
Cogent Biosciences, Inc. (COGT)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 1

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07361562 Phase 1 Advanced Solid Tumor, Adult Recruiting COGT

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

Conditions studied

Advanced Solid Tumor, AdultERBB2 Altered Breast CancerERBB2 Gene AmplificationHER2HER2 OverexpressionNon-Small Cell Lung Cancer

Other drugs acting on ERBB2

Neratinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CUDC-101 Phase 1 ELVN-002 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1 TTX-MC138 Phase 1/2 Tuxobertinib Phase 1

More from Cogent Biosciences

ACTR087 Phase 1 ACTR707 Phase 1 Bezuclastinib Phase 3 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 CGT4255

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

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.