BGB-43395

Phase 3Small molecule

BeiGene

BGB-43395 is one of 71 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Solid TumorRecruiting

HR+/HER2- Breast CancerRecruiting

Hormone-Receptor-Positive Breast CancerRecruiting

Breast CancerPhase 3

Active, not recruiting

Solid TumorPhase 1

Recruiting

HR+/HER2- Breast CancerPhase 3

Recruiting

Hormone-Receptor-Positive Breast CancerPhase 1

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

BGB-43395

BeiGene

Phase 3

1 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

Lexiscan

Astellas

Preclinical

1 4

Adenocard

Astellas

Preclinical

1 5

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Acupan

YYonsei University

Preclinical

1 7

Nubain

AAultman Health Foundation

Preclinical

1 8

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 9

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 10

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Breast Cancer

NCT06253195

Q3 2027

Phase 1Recruiting

Hormone-Receptor-Positive Breast Cancer

NCT06756932

Q3 2028

Phase 1Recruiting

Advanced

NCT06257264

Q4 2028

Phase 1Recruiting

Solid Tumor

NCT06120283

Phase 1Recruiting

Solid Tumor

NCT07226349

Clinical

Trials by Indication[1]

Solid Tumor2 trials

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Recruiting· BeiGene logo

BeiGene·Phase 1·NCT06120283·399 enrolled

A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Recruiting·BBeOne Medicines·Phase 1·NCT07226349·105 enrolled

Breast Cancer1 trial

BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Active, not recruiting· BeiGene logo

BeiGene·Phase 1·NCT06253195·33 enrolled

ART1 trial

A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants

Completed· BeiGene logo

BeiGene·Phase 1·NCT06761898·51 enrolled

Advanced1 trial

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

Recruiting· BeiGene logo

BeiGene·Phase 1·NCT06257264·258 enrolled

HR+/HER2- Breast Cancer1 trial

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Recruiting·BBeOne Medicines·Phase 3·NCT07492641·1,056 enrolled

1 more indication

Hormone-receptor-positive Breast Cancer1 trial

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer

Recruiting·BBeOne Medicines·Phase 1·NCT06756932·120 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for BGB-43395. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BGB-43395 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BGB-43395. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — BeiGene company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BeiGene

BGB-43395

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q3 2028

Q4 2028

Trials by Indication[1]

Solid Tumor2 trials

Breast Cancer1 trial

ART1 trial

Advanced1 trial

HR+/HER2- Breast Cancer1 trial

Hormone-receptor-positive Breast Cancer1 trial

References

Drug Info

Quick Facts

Related News