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Drugs in development · updated 30 October 2026

Ribociclib: clinical trials and development status

Other names and codes: LEE011, Kisqali

NLM verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 22 August 2017

As of 30 October 2026 Ribociclib is in 73 active clinical trials (recruiting or ongoing, phases I–III) for 32 diseases. The most advanced phase is III.

73Active trials
IIIMost advanced phase
32Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Ribociclib and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov. Showing 30 of 32 diseases.

DiseaseMost advanced phaseActive trialsReference trial
Breast neoplasmIII46NCT05827081
MetastasisIII7NCT07647328
NeoplasmIII5NCT07647328
Breast diseaseIII3NCT07647328
Male breast neoplasmIII1NCT05827081
Unilateral breast neoplasmIII1NCT06760637
Endometrial neoplasmII3NCT03008408
GlioblastomaII2NCT05843253
Ovarian epithelial carcinomaI–II2NCT05867251
Triple-negative breast neoplasmI–II2NCT05867251
AstrocytomaII1NCT05843253
Brain NeoplasmsII1NCT05843253
Diffuse Intrinsic Pontine GliomaII1NCT05843253
Fallopian tube neoplasmI–II1NCT05867251
GliomaII1NCT05843253
Head and neck neoplasmsI–II1NCT05768139
Head and neck squamous cell carcinomaI–II1NCT05768139
LeiomyosarcomaII1NCT03114527
LiposarcomaII1NCT03114527
Lung small cell carcinomaI–II1NCT06726148
MelanomaII1NCT04417621
Ovarian neoplasmI–II1NCT05768139
SarcomaII1NCT03114527
Serous cystadenocarcinomaII1NCT03673124
Uterine cervix neoplasmI–II1NCT05768139
Colorectal neoplasmI1NCT06625775
Digestive system neoplasmI1NCT05238922
Lung neoplasmI1NCT06625775
Non-small-cell lung carcinomaI1NCT06625775
Precursor lymphoblastic lymphoma/leukemiaI1NCT03740334

Everything on Ribociclib

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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