Abemaciclib clinical trials
Abemaciclib is named as an intervention in 69 current clinical trials in our USA, Spain, France, Italy, Australia, Germany, South Korea, Belgium, China, Japan, UK, Turkey, Taiwan, Canada, Israel, Brazil, Poland, Netherlands, Mexico, Austria, India, Czechia, Denmark, Singapore, Switzerland, Sweden, Portugal, Ireland, Egypt and Norway registers. 32 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Eli Lilly and Company (19). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 7 authorised or ongoing trials.
Where Abemaciclib is approved
All regulators →Of the three regulators tracked here, the first to approve Abemaciclib was the US, on 28 Sep 2017. It is approved in 3 of the 3 regulators tracked here.
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.
Abemaciclib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Abemaciclib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 28 Sep 2031 (US 7855211).
- Latest patent on the drug substance itself: 28 Sep 2031 (US 7855211).
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 Abemaciclib
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 Abemaciclib 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 6✓ In ChEMBL and the Guide to Pharmacology
- LiposarcomaPhase 3
- Lung cancerPhase 3
- Non-small cell lung carcinomaPhase 3
- Prostate cancerPhase 3
- Prostate adenocarcinomaPhase 2/3
- Ewing sarcomaPhase 2
- AdenocarcinomaPhase 2
- Biliary tract cancerPhase 2
- Brain neoplasmPhase 2
- CancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3301610, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7382, 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 Abemaciclib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Abemaciclib. 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 |
|---|---|---|---|
| Abemaciclib with endocrine therapy for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence NICE TA810 | Recommended | 20 Jul 2022 | Current |
| Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy NICE TA725 | Recommended | 15 Sep 2021 | Current |
| Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer NICE TA563 | Recommended | 27 Feb 2019 | 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 Abemaciclib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: VerzeniosEMA 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 Abemaciclib
- ATC code
- L01XE50
- ChEMBL
- CHEMBL3301610
- DrugBank
- DB12001
- PubChem CID
- 46220502
- CAS number
- 1231929-97-7
- FDA UNII
- 60UAB198HK
- Wikidata
- Q23901483
- Wikipedia
- Abemaciclib
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 Abemaciclib
69 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.
Abemaciclib in the EU trials register (CTIS)
7 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Abemaciclib. 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.
Abemaciclib 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)
3 single-substance products containing Abemaciclib on the HPRA medicines list.
- Verzenios 100 mg Film-coated tabletEli Lilly Nederland B.V. · EU/1/18/1307/004-006
- Verzenios 150 mg Film-coated tabletEli Lilly Nederland B.V. · EU/1/18/1307/007-009
- Verzenios 50 mg Film-coated tabletEli Lilly Nederland B.V. · EU/1/18/1307/001-003
Supply shortages
No entry for Abemaciclib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- VerzenioFDA · 28 Sep 2017 · New Drug (NDA) · Eli Lilly And Co
Conditions studied with Abemaciclib
88 conditionsAll 88 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 23 |
| Breast Neoplasms | 6 |
| Metastatic Breast Cancer | 6 |
| Neoplasm Metastasis | 5 |
| Non Small Cell Lung Cancer | 3 |
| Endometrial Cancer | 3 |
| Neoplasms | 2 |
| Advanced Breast Cancer | 2 |
| Ovarian Cancer | 2 |
| HR+/HER2- Breast Cancer | 2 |
| Solid Tumors, Adult | 1 |
| Breast Cancer, Early Breast Cancer | 1 |
| Prostatic Neoplasms | 1 |
| Urogenital Neoplasms | 1 |
| Physiological Effects of Drugs | 1 |
| ER+ HER2- Advanced Breast Cancer | 1 |
| High-grade Serous Ovarian Cancer (HGSOC) | 1 |
| Child | 1 |
| Adolescent | 1 |
| Brain Neoplasms | 1 |
| Neoplasms by Site | 1 |
| Locally Advanced (Inoperable) or Metastatic Breast Cancer | 1 |
| Hormone Receptor-positive Breast Cancer | 1 |
| Hormone Receptor Positive HER-2 Negative Breast Cancer | 1 |
| ER-Positive HER2-Negative Breast Cancer | 1 |
| Malignant Neoplasm of Breast | 1 |
| Sarcoma, Ewing | 1 |
| Glioma Glioblastoma Multiforme | 1 |
| Glioma, Malignant | 1 |
| Solid Tumor | 1 |
| Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer | 1 |
| Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer | 1 |
| Glioma | 1 |
| Advanced Solid Tumor | 1 |
| HR+, HER2-, Advanced Breast Cancer | 1 |
| CCNE1 Amplification | 1 |
| Prostate Cancer | 1 |
| Breast Neoplasm | 1 |
| Breast Cancer Metastatic | 1 |
| Hormone Receptor Positive Tumor | 1 |
| Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | 1 |
| Liver Metastases From Colorectal Cancer (mCRC) | 1 |
| Breast Cancer Stage I | 1 |
| Breast Cancer Stage II | 1 |
| Locally Advanced Breast Cancer (LABC) | 1 |
| Breast Cancer Female | 1 |
| Hormone Receptor-positive Metastatic Breast Cancer | 1 |
| HER2-negative Metastatic Breast Cancer | 1 |
| Low Grade Serous Ovarian Carcinoma | 1 |
| Adult Type Granulosa Cell Tumor | 1 |
| Cancer Metastatic | 1 |
| Early Breast Cancer | 1 |
| HER2 + Breast Cancer | 1 |
| HR Positive | 1 |
| Neoadjuvant Therapy | 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 |
| Triple Negative Breast Neoplasms | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Multiple Myeloma | 1 |
| Advanced Solid Tumors | 1 |
| Pancreatic Ductal Carcinoma | 1 |
| Advanced Cancer | 1 |
| Epithelial Tumor | 1 |
| Intracranial Meningioma | 1 |
| Recurrent Meningioma | 1 |
| NF2 Gene Mutation | 1 |
| CDK Gene Mutation | 1 |
| Metastatic Malignant Neoplasm in the Brain | 1 |
| Metastatic Malignant Solid Neoplasm | 1 |
| NTRK Family Gene Mutation | 1 |
| Locoregional Recurrence | 1 |
| Abemaciclib | 1 |
| Endocrine Therapy | 1 |
| ctDNA Monitoring | 1 |
| Healthy Volunteers | 1 |
| Early-stage Breast Cancer | 1 |
| High Risk Breast Carcinoma | 1 |
| Recurrent Endometrial Cancer | 1 |
| TP53 | 1 |
| Metastasis | 1 |
Sponsors
lead sponsor per trial+ 19 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 Abemaciclib trials
How many clinical trials are testing Abemaciclib?
69 current trials in our USA, Spain, France, Italy, Australia, Germany, South Korea, Belgium, China, Japan, UK, Turkey, Taiwan, Canada, Israel, Brazil, Poland, Netherlands, Mexico, Austria, India, Czechia, Denmark, Singapore, Switzerland, Sweden, Portugal, Ireland, Egypt and Norway registers name Abemaciclib (also registered as LY2835219) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Abemaciclib trials recruiting patients?
Yes. 32 of the 69 trials are recruiting: 14 with sites in USA, 11 with sites in Spain, 10 with sites in France, 11 with sites in Italy, 10 with sites in Australia, 11 with sites in Germany, 8 with sites in South Korea, 7 with sites in Belgium, 7 with sites in China, 6 with sites in Japan, 8 with sites in UK, 5 with sites in Turkey, 5 with sites in Taiwan, 5 with sites in Canada, 7 with sites in Israel, 4 with sites in Brazil, 3 with sites in Poland, 4 with sites in Netherlands, 2 with sites in Mexico, 2 with sites in Austria, 1 with sites in India, 1 with sites in Czechia, 3 with sites in Singapore, 1 with sites in Switzerland, 1 with sites in Portugal, 2 with sites in Ireland, 1 with sites in Egypt and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Abemaciclib clinical trials?
Eli Lilly and Company (19), AstraZeneca (5), Hoffmann-La Roche (4) and Pfizer (3), among 34 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Abemaciclib clinical trials in Ireland?
Yes. 4 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Abemaciclib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Abemaciclib, for example Verzenios 100 mg Film-coated tablet (Eli Lilly Nederland B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Abemaciclib shortage?
Not in the lists we track: Abemaciclib 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 Abemaciclib 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 Abemaciclib 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 Abemaciclib (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.