Kisqali
An oral targeted therapy used to treat hormone receptor-positive advanced breast cancer.
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 5 Oct 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), 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.
What Kisqali is used for
KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. ( 1 ) 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. 1.2 Advanced or Metastatic Breast Cancer …
How it works
12.1 Mechanism of Action Ribociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. These kinases are activated upon binding to D-cyclins and are downstream of signaling pathways which lead to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb). In vitro , ribociclib decreased pRb phosphorylation, resulting in arrest in the G1 phase of the cell cycle and reduced proliferation in breast cancer-derived models. In vivo , treatment with single agent ribociclib in a rat xenograft model with human tumor cells led to decreased tumor volumes, which correlated with inhibi…
Related clinical trials recruiting now
Compare Kisqali with
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.