Asset profile
BPI-16350
Small molecule
Evidence outlook · lead readout
NCT05433480 · Breast Cancer
The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.
NCT05433480: This randomised, quadruple-blind, placebo-controlled trial in 274 women with HR-positive, HER2-negative advanced breast cancer reported median progression-free survival of 16.5 months with tibremciclib plus fulvestrant against 5.6 months with placebo plus fulvestrant, a hard clinical endpoint.
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
65 competitors in this universe: 5 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 29 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| BPI-16350: this drug | Phase 3 | Small molecule | CDK4 and CDK6 | ||
| Abemaciclib (Verzenio) | Approved | Small molecule | CDK4 and CDK6 | ||
| Palbociclib (Ibrance) | Approved | Small molecule | CDK4 and CDK6 | ||
| Ribociclib | Approved | Small molecule | CDK4 and CDK6 | ||
| Dalpiciclib | Phase 3 | Small molecule | CDK4 and CDK6 | ||
| BPI-1178 | Phase 1/2 | Small molecule | CDK4 and CDK6 | ||
| Alpelisib (BYL719) | Approved | Small molecule | PI3K-alpha | ||
| Anastrozole | Approved | Small molecule | Aromatase | ||
| Capecitabine | Approved | Small molecule | Fluoropyrimidine (antimetabolite) | ||
| Capivasertib | Approved | Small molecule | AKT (inhibitor) | ||
| Datopotamab Deruxtecan | Approved | Antibody–drug conjugate | TROP2 | ||
| Denosumab | Approved | Monoclonal antibody | RANKL | ||
| Docetaxel | Approved | Small molecule | Microtubules (tubulin) | ||
| Elacestrant | Approved | Small molecule | Estrogen receptor | ||
| Eribulin Mesylate | Approved | Small molecule | Tubulin / microtubules | ||
| Everolimus | Approved | Small molecule | mTOR kinase, mTOR (mTORC1) (inhibitor) |
…and 50 more. Research shows the complete landscape.
Unlock the full comparison
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
No upcoming readouts on record for this asset.
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.