Ribociclib
Also known as Kisqali, Ribociclib succinate
NOVARTIS AG NVS NVSEF · Breast Cancer; Advanced Metastatic Breast Cancer; Early Breast Cancer; Advanced Breast Cancer; Advanced, Metastatic Breast Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
10
From ClinicalTrials.gov
Latest FDA action
Approved
NDA209092,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
- Indications
- Breast Cancer; Advanced Metastatic Breast Cancer; Early Breast Cancer; Advanced Breast Cancer; Advanced, Metastatic Breast Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 209092 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 209092 (opens in a new tab)
- NDA 209935 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 209935 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 17 Dec 201310 linked trials
- Filed Completed
- Approved Current stageFirst approval 13 Mar 2017
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Ribociclib. Editors add each one with its source.
Filed application
No filed application is on record for Ribociclib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Ribociclib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05827081ClinicalTrials.gov record for NCT05827081 (opens in a new tab)Adjuvant WIDER | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer | Phase 3 | Active, not recruiting | 1,464 (actual) | 7 Sep 2029 (estimated) | No |
| NCT03701334ClinicalTrials.gov record for NCT03701334 (opens in a new tab)NATALEE | A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer | Phase 3 | Active, not recruiting | 5,101 (actual) | 29 May 2030 (estimated) | No |
Publications listing NATALEE (5), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03081234ClinicalTrials.gov record for NCT03081234 (opens in a new tab)EarLEE-2 | Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer | Phase 3 | Withdrawn | 0 (actual) | 17 Nov 2025 (estimated) | No |
| NCT03439046ClinicalTrials.gov record for NCT03439046 (opens in a new tab)BioItaLEE | Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant | Phase 3 | Terminated | 287 (actual) | 11 Dec 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03439046 (opens in a new tab) |
Posted results on ClinicalTrials.gov for BioItaLEE Serious adverse events (Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 5.8 years in the core phase and 1.7 years in the extension phase.): Ribociclib+Letrozole (Core Phase) 79 of 287; Alpelisib+Fulvestrant (Extension Phase) 6 of 21 Source: ClinicalTrials.gov results for NCT03439046 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03050398ClinicalTrials.gov record for NCT03050398 (opens in a new tab) | A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib | Phase 3 | Terminated | 8 (actual) | 8 Mar 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03050398 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03050398 Serious adverse events (First biomarker sample collected up to approximately 21 months biomarker collection procedure SAEs were to have been collected in CORE study (CLEE011A2404)): Ribociclib + Letrozole 0 of 8 Source: ClinicalTrials.gov results for NCT03050398 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT02941926ClinicalTrials.gov record for NCT02941926 (opens in a new tab)COMPLEEMENT-1 | Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC | Phase 3 | Completed | 3,246 (actual) | 8 Nov 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02941926 (opens in a new tab) |
Posted results on ClinicalTrials.gov for COMPLEEMENT-1 Serious adverse events (On-treatment-Core phase: from first treatment to 30 days post-treatment or last treatment in the Core phase (for extension phase participants), up to 33 months; Extension phase: from first treatment in the Extension phase to 30 days post-treatment, up to approx. 37.6 months.Post-treatment survival-Core phase: from 31 days post-treatment in the Core phase to study end, up to 33 months; Extension phase: from 31 days post-treatment in the Extension phase up to study end, up to approx.. 37.6 months.): All Patients- On-treatment Core Phase 702 of 3246; All Patients- On-treatment Extension Phase 54 of 413; All-patients- Post-treatment Survival Follow-up Core Phase 0 of 0; All-patients- Post-treatment Survival Follow-up Extension Phase 0 of 0 Source: ClinicalTrials.gov results for NCT02941926 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing COMPLEEMENT-1 (5), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03096847ClinicalTrials.gov record for NCT03096847 (opens in a new tab) | Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer | Phase 3 | Completed | 502 (actual) | 11 Dec 2018 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03096847 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03096847 Serious adverse events (Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 1150 days (approx. 3.15 years).(Treatment duration ranged from 2 days to 1120 days.)): Ribociclib + Letrozole Cohort A 97 of 319; Ribociclib + Letrozole Cohort B 50 of 183; Ribociclib + Letrozole Cohort B1 5 of 26; Ribociclib + Letrozole Cohort B2 45 of 157; Total 147 of 502 Source: ClinicalTrials.gov results for NCT03096847 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03096847 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02422615ClinicalTrials.gov record for NCT02422615 (opens in a new tab)MONALEESA-3 | Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. | Phase 3 | Completed | 726 (actual) | 3 Nov 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02422615 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MONALEESA-3
Serious adverse events (On-treatment AEs: from 1st dose to 30 days post-treatment (or start of crossover treatment), up to 82 months. Post-treatment efficacy/survival follow-up deaths: from 31 days post-treatment to end of study, up to 82 months. Crossover on-treatment AEs: from 1st dose to 30 days post-crossover treatment, up to 3.5 months. Crossover post-treatment efficacy/survival follow-up deaths: from 31 days post-crossover treatment to end of study, up to 1 year): Ribociclib + Fulvestrant (On-treatment) 179 of 483; Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up) 0 of 0; Placebo + Fulvestrant (On-treatment) 51 of 241; Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up) 0 of 0; Crossover to Ribociclib + Fulvestrant (Crossover On-treatment) 1 of 3; Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival Follow-up) 0 of 0 Source: ClinicalTrials.gov results for NCT02422615 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing MONALEESA-3 (11), newest first
All 11 publications for NCT02422615 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02278120ClinicalTrials.gov record for NCT02278120 (opens in a new tab)MONALEESA-7 | Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer | Phase 3 | Completed | 672 (actual) | 21 Aug 2017 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02278120 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MONALEESA-7
Serious adverse events (On-treatment: from 1st dose to 30 days post-treatment or start of crossover treatment, up to 90 months Crossover on-treatment: from 1st dose of crossover treatment to 30 days post-crossover treatment, up to approximately 33 months. Post-treatment survival follow-up: from day 31 post-treatment to end of study or start of crossover treatment, up to 90 months. Crossover post-treatment survival follow-up period from day 31 post-crossover treatment to end of study, up to approximately 33 months.): Ribociclib + NSAI/Tamoxifen + Goserelin (On-treatment) 81 of 335; Placebo + NSAI/Tamoxifen+ Goserelin (On-treatment) 49 of 337; Placebo Crossover to Ribociclib (On-Treatment) 1 of 17; Ribociclib + NSAI/Tamoxifen + Goserelin (Post-treatment Survival Follow-up) 0 of 0; Placebo + NSAI/Tamoxifen+ Goserelin (Post-treatment Survival Follow-up) 0 of 0; Placebo Crossover to Ribociclib (Post-treatment Survival Follow-up) 0 of 0 Source: ClinicalTrials.gov results for NCT02278120 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing MONALEESA-7 (11), newest first
All 11 publications for NCT02278120 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT01958021ClinicalTrials.gov record for NCT01958021 (opens in a new tab)MONALEESA-2 | Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer | Phase 3 | Completed | 668 (actual) | 29 Jan 2016 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01958021 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MONALEESA-2
Serious adverse events (All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months): Ribociclib + Letrozole 108 of 334; Placebo + Letrozole 62 of 330; Crossover to Ribociclib + Letrozole 1 of 4; Ribociclib + Letrozole (Post-treatment Survival Follow-up) 0 of 0; Placebo + Letrozole (Post-treatment Survival Follow-up) 0 of 0; Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Survival Follow-up) 0 of 0 Source: ClinicalTrials.gov results for NCT01958021 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing MONALEESA-2 (13), newest first
All 13 publications for NCT01958021 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
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EU status (EMA)
Authorised
Kisqali (EMEA/H/C/004213)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Novartis Europharm Limited
- Active substance (INN)
- ribociclib
- ATC code
- L01EF02
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Kisqali (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
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Sources
- Drugs@FDA 209092 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05827081 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03701334 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03081234 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03439046 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03050398 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02941926 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03096847 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02422615 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02278120 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT01958021 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA209092 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA209935 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.