Asset profile

BGB-43395

Small molecule

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Phase 3underway

Evidence outlook · registrational

HR+/HER2- Metastatic Breast Cancer: registrational readout pending

Its supporting mid-stage evidence has not yet been graded on this platform. Registrational readout expected around 2029-04.

Also in development:Non-Small Cell Lung Cancer

How the evidence outlook works ↗

Competitive landscape

119 competitors in this universe: 4 direct rivals (same mechanism and indication), 0 same-class, 115 same-indication; 82 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
BGB-43395: this drugPhase 3Small moleculeCDK4
AtirmociclibPhase 3Small moleculeCDK4
HRS-6209Phase 2Small moleculeCDK4
SHR-6209Phase 2Small moleculeCDK4
AVZO-023Phase 1/2Small moleculeCDK4
Abemaciclib (Verzenio)ApprovedSmall moleculeCDK4 and CDK6
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alpelisib (BYL719)ApprovedSmall moleculePI3K-alpha
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AnastrozoleApprovedSmall moleculeAromatase
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor

…and 104 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(4 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
July 2027 (1)
Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-07-30 · NCT06756932 · CT.gov ↗
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2028 (1)
November 2028 (1)
Phase 1Advanced Solid TumorRecruiting
Est. primary completion 2028-11-01 · NCT07226349 · CT.gov ↗
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2029 (2)
April 2029 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-04 · NCT07492641 · CT.gov ↗
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December 2029 (1)
Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-12 · NCT06120283 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 1 (6)