Asset profile
Dalpiciclib
Small molecule
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 2026-10-31.
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.
Unlock with Research ↗
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Dalpiciclib: 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 | ||
| BPI-16350 | 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.
Research
Unlock with Research ↗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
(33 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (8)
October 2026 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-10-31 · NCT04842617 · CT.gov ↗
What to watch
December 2026 (7)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12-01 · NCT06107673 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-01 · NCT04486911 · CT.gov ↗
What to watch
Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-30 · NCT04993430 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12-31 · NCT07492394 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2026-12-31 · NCT06556862 · CT.gov ↗
What to watch
Phase 2Head and Neck Squamous Cell CarcinomaNot yet recruiting
Est. primary completion 2026-12-31 · NCT06199271 · CT.gov ↗
What to watch
Phase 2Hepatocellulcar CarcinomaRecruiting
Est. primary completion 2026-12-31 · NCT07238881 · CT.gov ↗
What to watch
2027 (10)
February 2027 (1)
Phase 1/2Advanced Solid TumorsRecruiting
Est. primary completion 2027-02-26 · NCT06208410 · CT.gov ↗
What to watch
June 2027 (2)
October 2027 (2)
December 2027 (5)
Early phase / not applicableHR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2027-12-30 · NCT06711094 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12-31 · NCT05582499 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12-31 · NCT07014410 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12-31 · NCT07285382 · CT.gov ↗
What to watch
Phase 2/3Esophageal Squamous Cell CarcinomaNot yet recruiting
Est. primary completion 2027-12-31 · NCT07653451 · CT.gov ↗
What to watch
2028 (7)
June 2028 (3)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-06 · NCT07618923 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-06-28 · NCT07810088 · CT.gov ↗
What to watch
Early phase / not applicableHR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-06-30 · NCT07706933 · CT.gov ↗
What to watch
August 2028 (1)
Phase 1Meningioma, CDK4/6 InhibitorRecruiting
Est. primary completion 2028-08 · NCT07652762 · CT.gov ↗
What to watch
November 2028 (1)
Phase 2Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast CancerRecruiting
Est. primary completion 2028-11-01 · NCT07610720 · CT.gov ↗
What to watch
2029 (3)
May 2029 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05-31 · NCT07207070 · CT.gov ↗
What to watch
August 2029 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2029-08-01 · NCT07539753 · CT.gov ↗
What to watch
December 2029 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-12-31 · NCT06970912 · CT.gov ↗
What to watch
2030 (1)
December 2030 (1)
Phase 2HER2-positive Breast CancerNot yet recruiting
Est. primary completion 2030-12-30 · NCT07179939 · CT.gov ↗
What to watch
2031 (4)
March 2031 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2031-03-31 · NCT07432178 · CT.gov ↗
What to watch
December 2031 (3)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2031-12 · NCT07101159 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2031-12-31 · NCT07581834 · CT.gov ↗
What to watch
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2031-12-31 · NCT07467330 · CT.gov ↗
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.