Asset profile
Culmerciclib
Small molecule
Evidence outlook · lead readout
NCT05375461 · HR-positive,HER2-negative in Advanced Breast Cancer
The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.
NCT05375461: The study randomized 293 participants to TQB3616 plus fulvestrant or placebo plus fulvestrant and used quadruple blinding, with progression-free survival as the primary clinical endpoint. Because the primary comparison has not yet been reported, the trial provides a well-controlled but currently incomplete evidence record.
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
62 competitors in this universe: 2 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 |
|---|---|---|---|---|---|
| Culmerciclib: this drug | Phase 3 | Small molecule | CDK2/4/6/CDK4, CDK2/CDK4/CDK6 | ||
| SPH4336 | Phase 2/3 | Small molecule | CDK2/4/6/CDK4 | ||
| RGT-419B | Phase 1/2 | Small molecule | CDK2/CDK4/CDK6 | ||
| Abemaciclib (Verzenio) | Approved | 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) | ||
| Exemestane | Approved | Small molecule | Aromatase | ||
| Fulvestrant (Faslodex) | Approved | Small molecule | Estrogen receptor |
…and 47 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
(8 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (2)
2027 (1)
December 2027 (1)
What to watch
2028 (5)
March 2028 (1)
What to watch
May 2028 (1)
What to watch
June 2028 (1)
What to watch
September 2028 (1)
What to watch
December 2028 (1)
What to watch
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.