Asset profile

Ribociclib

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: HR+/HER2- Metastatic Breast Cancer

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Reliable signal

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Competitive landscape

65 competitors in this universe: 5 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Ribociclib: this drugApprovedSmall moleculeCDK4 and CDK6
Abemaciclib (Verzenio)ApprovedSmall moleculeCDK4 and CDK6
Palbociclib (Ibrance)ApprovedSmall moleculeCDK4 and CDK6
BPI-16350Phase 3Small moleculeCDK4 and CDK6
DalpiciclibPhase 3Small moleculeCDK4 and CDK6
BPI-1178Phase 1/2Small moleculeCDK4 and CDK6
Alpelisib (BYL719)ApprovedSmall moleculePI3K-alpha
AnastrozoleApprovedSmall moleculeAromatase
CapecitabineApprovedSmall moleculeFluoropyrimidine (antimetabolite)
CapivasertibApprovedSmall moleculeAKT (inhibitor)
Datopotamab DeruxtecanApprovedAntibody–drug conjugateTROP2
DenosumabApprovedMonoclonal antibodyRANKL
DocetaxelApprovedSmall moleculeMicrotubules (tubulin)
ElacestrantApprovedSmall moleculeEstrogen receptor
Eribulin MesylateApprovedSmall moleculeTubulin / microtubules
EverolimusApprovedSmall moleculemTOR kinase, mTOR (mTORC1) (inhibitor)

…and 50 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

(61 total)

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

2026 (7)
October 2026 (1)
Phase 1EGFR-mutant Non-small Cell Lung CancerActive not recruiting
Est. primary completion 2026-10-05 · NCT03333343 · CT.gov ↗
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November 2026 (1)
Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-11 · NCT02608216 · CT.gov ↗
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December 2026 (5)
Phase 2Soft Tissue SarcomaActive not recruiting
Est. primary completion 2026-12 · NCT03114527 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-27 · NCT05563220 · CT.gov ↗
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Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-30 · NCT05870579 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-30 · NCT05573555 · CT.gov ↗
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Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-31 · NCT06239467 · CT.gov ↗
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2027 (16)
January 2027 (1)
Phase 2HER2-positive Advanced Breast CancerEnrolling by invitation
Est. primary completion 2027-01-10 · NCT06481956 · CT.gov ↗
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February 2027 (3)
Phase 2Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors …Active not recruiting
Est. primary completion 2027-02-01 · NCT02934568 · CT.gov ↗
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Phase 2MelanomaActive not recruiting
Est. primary completion 2027-02-02 · NCT04417621 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT01872260 · CT.gov ↗
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April 2027 (4)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-04 · NCT06409390 · CT.gov ↗
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Phase 1/2Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8 …Active not recruiting
Est. primary completion 2027-04-01 · NCT05319873 · CT.gov ↗
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Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-04-30 · NCT05216432 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-04-30 · NCT05900206 · CT.gov ↗
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July 2027 (3)
Phase 1Solid TumorsActive not recruiting
Est. primary completion 2027-07-27 · NCT05238922 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-07-31 · NCT07054190 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-07-31 · NCT04055493 · CT.gov ↗
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August 2027 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-08-04 · NCT06188520 · CT.gov ↗
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September 2027 (1)
Phase 2Cancer, Tumors, Neoplasm, NeoplasiaRecruiting
Est. primary completion 2027-09 · NCT02925234 · CT.gov ↗
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November 2027 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-11-01 · NCT04862663 · CT.gov ↗
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December 2027 (2)
Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-12 · NCT05683418 · CT.gov ↗
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Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-12-31 · NCT05508906 · CT.gov ↗
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2028 (16)
January 2028 (2)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-01-01 · NCT07380646 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-01-31 · NCT05867251 · CT.gov ↗
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February 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-02 · NCT07195227 · CT.gov ↗
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April 2028 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2028-04-20 · NCT06065748 · CT.gov ↗
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May 2028 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-05-01 · NCT07002177 · CT.gov ↗
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July 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-07-01 · NCT06062498 · CT.gov ↗
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August 2028 (3)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-08-15 · NCT05467891 · CT.gov ↗
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Phase 2Recurrent Endometrial Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Refractory Endometrial Carcinoma …Active not recruiting
Est. primary completion 2028-08-31 · NCT03008408 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-08-31 · NCT06377852 · CT.gov ↗
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September 2028 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-09-25 · NCT06726148 · CT.gov ↗
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October 2028 (1)
Phase 1/2Advanced Solid TumorsNot yet recruiting
Est. primary completion 2028-10-28 · NCT07767474 · CT.gov ↗
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November 2028 (1)
Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-11 · NCT06625775 · CT.gov ↗
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December 2028 (4)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-12 · NCT07618390 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-12 · NCT07085767 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-12-19 · NCT07405801 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-12-31 · NCT05816655 · CT.gov ↗
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2029 (12)
February 2029 (2)
Phase 3HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2029-02 · NCT07340658 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-02-28 · NCT07647328 · CT.gov ↗
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May 2029 (2)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05 · NCT07174336 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05-30 · NCT04802759 · CT.gov ↗
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July 2029 (2)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-07-31 · NCT07391774 · CT.gov ↗
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Phase 4Solid TumorsRecruiting
Est. primary completion 2029-07-31 · NCT05203172 · CT.gov ↗
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August 2029 (1)
Phase 2High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Glioblastoma, Glioblastoma Multiforme, Diffuse Midline Glioma …Recruiting
Est. primary completion 2029-08-31 · NCT05843253 · CT.gov ↗
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September 2029 (3)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-09-01 · NCT07164976 · CT.gov ↗
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Phase 4HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2029-09-01 · NCT07630948 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-09-07 · NCT05827081 · CT.gov ↗
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October 2029 (1)
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2029-10-01 · NCT05296746 · CT.gov ↗
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December 2029 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-12-18 · NCT06380751 · CT.gov ↗
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2030 (7)
February 2030 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-02-10 · NCT07400523 · CT.gov ↗
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May 2030 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2030-05-29 · NCT03701334 · CT.gov ↗
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June 2030 (1)
Phase 4HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2030-06-28 · NCT05161195 · CT.gov ↗
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July 2030 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-07 · NCT05768139 · CT.gov ↗
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September 2030 (2)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09 · NCT06953882 · CT.gov ↗
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Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09-30 · NCT03424005 · CT.gov ↗
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October 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2030-10-01 · NCT07423611 · CT.gov ↗
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2031 (2)
February 2031 (1)
Phase 1/2Pediatric CancerRecruiting
Est. primary completion 2031-02 · NCT02813135 · CT.gov ↗
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June 2031 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2031-06-30 · NCT06849947 · CT.gov ↗
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2033 (1)
November 2033 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2033-11-30 · NCT07237256 · 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 (27)
Phase 2 (51)
Phase 1/2 (27)
Phase 1 (53)
Phase 4 (7)
Early phase / not applicable (4)
Used as active comparator (7)
Appears in other studies (1)