Product Description
An orally bioavailable inhibitor of cyclin-dependent kinase 4 (CDK4), with potential antineoplastic activity. Upon oral administration, CDK4 inhibitor BGB-43395 selectively inhibits CDK4, which inhibits the phosphorylation of retinoblastoma protein (Rb) early in the G1 phase, prevents CDK-mediated G1-S-phase transition and leads to cell cycle arrest. This suppresses DNA replication and inhibits tumor cell proliferation. CDK4, a serine/threonine kinase, is upregulated in many tumor cell types and plays a key role in the regulation of both cell cycle progression from the G1-phase into the S-phase and tumor cell proliferation. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cdk4-inhibitor-bgb-43395)
Mechanisms of Action: CDK4 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: BeOne Medicines
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, China, France, Japan, Malaysia, Moldova, New Zealand, South Korea, Thailand, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
- Clinical Outcomes Reported - BeOne Medicines presented P1 Breast Cancer results on 2026-06-01 for BGB-43395
- Clinical Trial Start Expected - BeOne Medicines announced they will initiate a P3 Breast Cancer trial in 2Q26 for BGB-43395
- Clinical Outcomes Reported - BeiGene announced they will present P1 Breast Cancer results in 4Q24 for BGB-43395
Highest Development Phases
Phase 3: Breast Cancer
Phase 1: Healthy Volunteers|Non-Small-Cell Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06120283 |
BGB-43395-101 | P1 |
Recruiting |
Breast Cancer|Non-Small-Cell Lung Cancer |
2028-11-01 |
50% |
2026-04-16 |
|
NCT06253195 |
BGB-43395-102 | P1 |
Active, not recruiting |
Breast Cancer |
2026-02-28 |
12% |
2025-05-21 |
Primary Endpoints |
jRCT2031240404 |
jRCT2031240404 | P1 |
Not yet recruiting |
Breast Cancer |
2025-12-28 |
|||
NCT06761898 |
BGB-43395-103 | P1 |
Completed |
Healthy Volunteers |
2025-05-20 |
88% |
2025-09-05 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
CTR20243370 |
CTR20243370 | P1 |
Recruiting |
Breast Cancer |
None |
50% |
2025-07-27 |
Patient Enrollment|Treatments |
CTR20240674 |
CTR20240674 | P1 |
Active, not recruiting |
Breast Cancer |
None |
12% |
2025-06-22 |
Patient Enrollment|Treatments|Trial Status |
NCT07492641 |
KANDELA-302 | P3 |
Recruiting |
Breast Cancer |
2029-04-01 |
16% |
2026-05-23 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/21/2025 |
News Article |
Anticancer Drugs Market Set to Expand at 9.14% CAGR, Reaching USD 401.32 Billion by 2034 |
|
11/06/2025 |
News Article |
BeOne Medicines Announces Third Quarter 2025 Financial Results and Business Updates |
|
08/06/2025 |
News Article |
BeOne Medicines Announces Second Quarter 2025 Financial Results and Business Updates |
|
06/26/2025 |
News Article |
BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day |