Ribociclib clinical trials
Ribociclib is named as an intervention in 65 current clinical trials in our USA, Spain, France, Italy, Germany, South Korea, Australia, UK, China, Taiwan, Canada, Israel, Poland, Brazil, Turkey, Belgium, Japan, Netherlands, Portugal, Mexico, India, Switzerland, Czechia, Singapore, Austria, Denmark, Egypt, Ireland, Sweden and Norway registers. 33 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (10). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 10 authorised or ongoing trials, 1 with a site in Ireland.
Where Ribociclib is approved
All regulators →Of the three regulators tracked here, the first to approve Ribociclib was the US, on 13 Mar 2017. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: post-authorisation measure for Kisqali, 19 Feb 2025
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Ribociclib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ribociclib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 12 listed patents; the last listed expires 14 Oct 2036 (US 12064434, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 9 May 2032 (US 9193732, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 1 Jan 2030.
- Exclusivity M-14: Other exclusivity: additional clinical trial information added to pediatric use subsection, until 1 Jul 2029.
- Exclusivity PED: Pediatric exclusivity, until 17 Mar 2028.
- Exclusivity I-950: New indication: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (hr)-positive, human …, until 17 Sep 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Ribociclib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ribociclib works
All drug targets →- Cyclin-dependent kinase 4 inhibitor InhibitorTarget: CDK4 cyclin dependent kinase 4✓ In ChEMBL and the Guide to Pharmacology
- Cyclin-dependent kinase 6 inhibitor InhibitorTarget: CDK6 cyclin dependent kinase 6ChEMBL only
- Breast cancerPhase 3
- CancerPhase 2
- Dedifferentiated liposarcomaPhase 2
- Diffuse intrinsic pontine gliomaPhase 2
- Disease recurrencePhase 2
- Endometrial cancerPhase 2
- Endometrial carcinomaPhase 2
- Fallopian tube cancerPhase 2
- Hematopoietic and lymphoid cell neoplasmPhase 2
- Hepatocellular carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3545110, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7383, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Ribociclib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Ribociclib. 3 are current, and 3 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ribociclib with an aromatase inhibitor for adjuvant treatment of hormone receptor-positive HER2-negative early breast cancer at high risk of recurrence NICE TA1086 | Recommended | 6 Aug 2025 | Current |
| Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy NICE TA687 | Optimised | 31 Mar 2021 | Current |
| Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer NICE TA496 | Recommended | 20 Dec 2017 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Ribociclib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: KisqaliEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Ribociclib
- ATC code
- L01XE42
- ChEMBL
- CHEMBL3545110
- DrugBank
- DB11730
- PubChem CID
- 44631912
- CAS number
- 1211441-98-3
- FDA UNII
- TK8ERE8P56
- Wikidata
- Q27088552
- Wikipedia
- Ribociclib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Ribociclib
65 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ribociclib in the EU trials register (CTIS)
10 trials · 1 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ribociclib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Ribociclib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Ribociclib on the HPRA medicines list.
- Kisqali 200 mg film-coated tabletsNovartis Europharm Limited · EU/1/17/1221/001-012
Supply shortages
No entry for Ribociclib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ribociclib
69 conditionsAll 69 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 22 |
| Metastatic Breast Cancer | 9 |
| Breast Neoplasms | 3 |
| HER2-negative Breast Cancer | 3 |
| Early Breast Cancer | 2 |
| HR+/HER2- Breast Cancer | 2 |
| Solid Tumors | 2 |
| ER-Positive HER2-Negative Breast Cancer | 2 |
| Advanced Breast Cancer | 2 |
| Solid Tumor, Adult | 2 |
| Breast Cancer Stage II | 2 |
| Solid Tumors, Adult | 1 |
| Neoplasm Metastasis | 1 |
| Melanoma | 1 |
| ER+ HER2- Advanced Breast Cancer | 1 |
| High-grade Serous Ovarian Cancer (HGSOC) | 1 |
| Locally Advanced Breast Cancer | 1 |
| ER Positive Breast Cancer | 1 |
| Locally Advanced (Inoperable) or Metastatic Breast Cancer | 1 |
| Advanced HR+/HER2- Breast Cancer | 1 |
| Advanced CCNE1-amplified Solid Tumors | 1 |
| Extensive-stage Small Cell Lung Cancer | 1 |
| ER-positive Breast Cancer | 1 |
| Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer | 1 |
| Advanced Cancer | 1 |
| Advanced Solid Tumors | 1 |
| PI3K Gene Mutation | 1 |
| Advanced Solid Tumor | 1 |
| HR+, HER2-, Advanced Breast Cancer | 1 |
| CCNE1 Amplification | 1 |
| Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer | 1 |
| Malignant Neoplasm of Breast | 1 |
| PIK3CA Mutation | 1 |
| HER2 Mutation-Related Tumors | 1 |
| HR+/HER2-negative Breast Cancer | 1 |
| Breast Cancer Stage I | 1 |
| Locally Advanced Breast Cancer (LABC) | 1 |
| HER2-positive Advanced Breast Cancer | 1 |
| Hormon Receptor Positive Breast Cancer | 1 |
| High Grade Glioma | 1 |
| Diffuse Intrinsic Pontine Glioma | 1 |
| Anaplastic Astrocytoma | 1 |
| Glioblastoma | 1 |
| EGFR-mutant Non-small Cell Lung Cancer | 1 |
| Breast Cancer Female | 1 |
| Pediatric Cancer | 1 |
| Malignant Solid Tumor | 1 |
| Breast Adenocarcinoma | 1 |
| Breast Cancer Stage IV | 1 |
| Breast Cancer, Metastatic | 1 |
| Breast Carcinoma | 1 |
| Breast Neoplasm Female | 1 |
| Cancer | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Locoregional Recurrence | 1 |
| Hormone Receptor-positive Breast Cancer | 1 |
| Low Grade Serous Carcinoma | 1 |
| Anatomic Stage II Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IIIC Breast Cancer AJCC v8 | 1 |
| Estrogen Receptor-Positive Breast Carcinoma | 1 |
| Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies | 1 |
| Lung Neoplasm Malignant | 1 |
| Head and Neck Squamous Cell Carcinomas | 1 |
| Hepatocellular Carcinoma | 1 |
| Alzheimer Disease, Early Onset | 1 |
| Mild Cognitive Impairment | 1 |
Sponsors
lead sponsor per trial+ 27 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Ribociclib trials
How many clinical trials are testing Ribociclib?
65 current trials in our USA, Spain, France, Italy, Germany, South Korea, Australia, UK, China, Taiwan, Canada, Israel, Poland, Brazil, Turkey, Belgium, Japan, Netherlands, Portugal, Mexico, India, Switzerland, Czechia, Singapore, Austria, Denmark, Egypt, Ireland, Sweden and Norway registers name Ribociclib (also registered as LEE011) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Ribociclib trials recruiting patients?
Yes. 33 of the 65 trials are recruiting: 17 with sites in USA, 18 with sites in Spain, 15 with sites in France, 13 with sites in Italy, 15 with sites in Germany, 14 with sites in South Korea, 13 with sites in Australia, 9 with sites in UK, 8 with sites in China, 7 with sites in Taiwan, 8 with sites in Canada, 8 with sites in Israel, 6 with sites in Poland, 7 with sites in Brazil, 5 with sites in Turkey, 4 with sites in Belgium, 6 with sites in Japan, 5 with sites in Netherlands, 4 with sites in Portugal, 5 with sites in Mexico, 1 with sites in India, 1 with sites in Switzerland, 5 with sites in Czechia, 2 with sites in Singapore, 3 with sites in Austria, 3 with sites in Denmark, 2 with sites in Egypt, 2 with sites in Ireland and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ribociclib clinical trials?
Novartis Pharmaceuticals (10), AstraZeneca (5), Hoffmann-La Roche (5) and Pfizer (3), among 42 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Ribociclib clinical trials in Ireland?
Yes. 4 trials in our Ireland register (ClinicalTrials.gov), and 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Ribociclib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Ribociclib, for example Kisqali 200 mg film-coated tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ribociclib shortage?
Not in the lists we track: Ribociclib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ribociclib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ribociclib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ribociclib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.