# BGB-43395

Source: https://onco.cc/drugs/bgb-43395/  
OnCo record `bgb-43395` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

BGB-43395 is an experimental small-molecule drug from BeOne Medicines in phase 3 trials for HR-positive / HER2-negative breast cancer, with its target not yet stated publicly.

## Summary

BGB-43395 is a small-molecule drug developed by BeOne Medicines. The sponsor describes its target as CDK4, which OnCo does not yet have a target page for. The sponsor states: A CDK4-selective inhibitor designed to spare CDK6, intended to drive down cancer cell growth signalling while reducing the blood-cell toxicities associated with CDK6 inhibition. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT07492641 (BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease), in HR-positive / HER2-negative breast cancer. The largest, NCT07492641, plans to enrol 1056 participants with primary completion expected 2029-04. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Modality: small molecule (structure undisclosed or not yet in PubChem)
- Mechanism: A CDK4-selective inhibitor designed to spare CDK6, intended to drive down cancer cell growth signalling while reducing the blood-cell toxicities associated with CDK6 inhibition.

## Sources

- ClinicalTrials.gov: trials of BGB-43395: https://clinicaltrials.gov/search?intr=BGB-43395
- Sponsor pipeline page: https://www.beonemedicines.com/pipeline/

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- companies: [BeOne Medicines (formerly BeiGene)](https://onco.cc/companies/beone/)
- trials: [BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease](https://onco.cc/trials/nct07492641/)

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