{"entity":{"id":"bgb-43395","kind":"drug","name":"BGB-43395","aka":[],"tldr":"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.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of BGB-43395","url":"https://clinicaltrials.gov/search?intr=BGB-43395"},{"label":"Sponsor pipeline page","url":"https://www.beonemedicines.com/pipeline/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07492641"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/bgb-43395/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"company":[{"id":"beone","kind":"company","name":"BeOne Medicines (formerly BeiGene)","route":"/companies/beone/"}],"trial":[{"id":"nct07492641","kind":"trial","name":"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","route":"/trials/nct07492641/"}]}}