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BG-68501
- Development stage
- Phase 1
- Lead developer
- BeiGene
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
**BG-68501** is an investigational, orally administered small-molecule inhibitor of cyclin-dependent kinase 2. Originally developed by Ensem Therapeutics as **ETX-197**, it was licensed globally to BeiGene, now BeOne Medicines, in November 2023. The agent is designed to selectively suppress CDK2-mediated cell-cycle progression, a pathway implicated in cyclin E-driven tumors and acquired resistance to CDK4/6 inhibitors. BG-68501 is being evaluated in a first-in-human Phase 1a/1b study as monotherapy and in combinations including fulvestrant for advanced solid tumors, particularly hormone receptor-positive, HER2-negative breast cancer. ([ir.beonemedicines.com](https://ir.beonemedicines.com/news/beigene-and-ensem-therapeutics-announce-partnership-to-advance-differentiated-cdk2-inhibitor/e0be1502-68e8-459e-bc65-47258050bb01))
- Other names
- ETX-197/BG-68501
02
Targets
CDK2 (Cyclin-dependent kinase 2)
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