Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from ClinicalTrials.gov registry records · Last verified 25 Sep 2026 · Editorial standards

At a glance

Abemaciclib is named as an intervention in 44 current clinical trials in our USA, China, UK, India and Ireland registers. 18 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.

Abemaciclib also has an approved-drug profile on this site (FDA label data): Verzenio (Abemaciclib) →

Trials by status

Recruiting1841%
Not yet open12%
Active, closed2455%
By invitation12%

Trials by phase

Phase 31841%
Phase 1/21330%
Phase 2716%
Phase 149%
Observational12%
Phase 2/312%

Clinical trials of Abemaciclib

44 trials

Study	Phase	Status	Lead sponsor	Registers
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation NCT05696626 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer	Phase 3	Recruiting	LeonaBio	UK, USA, China
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01) NCT05891093 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 3	Recruiting	Fudan University	China
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer NCT06380751 · ClinicalTrials.gov ↗ · Advanced Breast Cancer	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) NCT07174336 · Breast Neoplasms, Neoplasm Metastasis	Phase 3	Recruiting	Eli Lilly and Company	Ireland, UK, USA, China
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease NCT07492641 · ClinicalTrials.gov ↗ · HR+/HER2- Breast Cancer	Phase 3	Recruiting	BeOne Medicines	UK, USA, China
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer NCT05999994 · ClinicalTrials.gov ↗ · Neoplasms, Child, Adolescent	Phase 2	Recruiting	Eli Lilly and Company	UK, USA
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer NCT03424005 · Metastatic Breast Cancer	Phase 1/2	Recruiting	Hoffmann-La Roche	UK, USA
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer NCT04802759 · ClinicalTrials.gov ↗ · Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	Phase 1/2	Recruiting	Hoffmann-La Roche	USA
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer NCT05386108 · ClinicalTrials.gov ↗ · Breast Neoplasms, Brain Neoplasms, Neoplasms by Site	Phase 1/2	Recruiting	Stemline Therapeutics, Inc.	UK, USA
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer NCT05573126 · Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer	Phase 1/2	Recruiting	Ellipses Pharma	UK, USA
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer NCT05735080 · ClinicalTrials.gov ↗ · Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor	Phase 1/2	Recruiting	Incyclix Bio	USA
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors NCT05768139 · ClinicalTrials.gov ↗ · Breast Cancer, Solid Tumors, Adult	Phase 1/2	Recruiting	Eli Lilly and Company	Ireland, USA
Study of AVZO-021 in Patients With Advanced Solid Tumors NCT05867251 · Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer	Phase 1/2	Recruiting	Avenzo Therapeutics, Inc.	USA
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors NCT06188520 · ClinicalTrials.gov ↗ · ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)	Phase 1/2	Recruiting	AstraZeneca	UK, USA
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss NCT06810544 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme, Glioma, Malignant	Phase 1/2	Recruiting	Tango Therapeutics, Inc.	USA
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC NCT07002177 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II	Phase 1/2	Recruiting	Forward Pharmaceuticals Co., Ltd.	China
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer NCT07100106 · Breast Cancer	Phase 1/2	Recruiting	Genentech, Inc.	USA, China
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors NCT05307705 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 1	Recruiting	Eli Lilly and Company	UK, USA, China
Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer NCT07410559 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 2	Not yet open	Fudan University	China
Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer NCT07441369 · ClinicalTrials.gov ↗ · Liver Metastases From Colorectal Cancer (mCRC)	Phase 2	By invitation	Fudan University	China
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer NCT02107703 · ClinicalTrials.gov ↗ · Breast Neoplasms	Phase 3	Active, closed	Eli Lilly and Company	USA, China
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer NCT02152631 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer	Phase 3	Active, closed	Eli Lilly and Company	USA, China
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer NCT02246621 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 3	Active, closed	Eli Lilly and Company	UK, USA
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer NCT02763566 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 3	Active, closed	Eli Lilly and Company	India, China
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer NCT03155997 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 3	Active, closed	Eli Lilly and Company	UK, USA, India, China
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) NCT04862663 · ClinicalTrials.gov ↗ · Locally Advanced (Inoperable) or Metastatic Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) NCT04964934 · ClinicalTrials.gov ↗ · ER-Positive HER2-Negative Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer NCT04975308 · ClinicalTrials.gov ↗ · Breast Neoplasms, Neoplasm Metastasis	Phase 3	Active, closed	Eli Lilly and Company	USA, India, China
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer NCT05169567 · ClinicalTrials.gov ↗ · Breast Neoplasm, Neoplasm Metastasis	Phase 3	Active, closed	Eli Lilly and Company	USA
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) NCT05288166 · ClinicalTrials.gov ↗ · Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms	Phase 3	Active, closed	Eli Lilly and Company	UK, USA, China
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) NCT05952557 · Breast Cancer, Early Breast Cancer	Phase 3	Active, closed	AstraZeneca	Ireland, UK, USA, India, China
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) NCT06065748 · ClinicalTrials.gov ↗ · Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer	Phase 3	Active, closed	Hoffmann-La Roche	USA, India, China
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease NCT06760637 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 3	Active, closed	Pfizer	Ireland, UK, USA, India, China
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer NCT03706365 · ClinicalTrials.gov ↗ · Prostate Cancer	Phase 2/3	Active, closed	Eli Lilly and Company	USA, China
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer NCT02747004 · ClinicalTrials.gov ↗ · Metastatic Breast Cancer	Phase 2	Active, closed	Eli Lilly and Company	USA, China
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors NCT04931342 · ClinicalTrials.gov ↗ · Ovarian Cancer	Phase 2	Active, closed	Hoffmann-La Roche	UK, USA
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma NCT05440786 · ClinicalTrials.gov ↗ · Sarcoma, Ewing, Neoplasm Metastasis	Phase 2	Active, closed	Eli Lilly and Company	USA
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy NCT06413706 · ClinicalTrials.gov ↗ · Glioma	Phase 2	Active, closed	Eli Lilly and Company	USA
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) NCT05548127 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 1/2	Active, closed	Pfizer	USA
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer NCT05563220 · ClinicalTrials.gov ↗ · Breast Cancer, Metastatic Breast Cancer	Phase 1/2	Active, closed	Stemline Therapeutics, Inc.	UK, USA
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread NCT02057133 · ClinicalTrials.gov ↗ · Breast Neoplasms	Phase 1	Active, closed	Eli Lilly and Company	USA
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer NCT02779751 · ClinicalTrials.gov ↗ · Non Small Cell Lung Cancer, Breast Cancer	Phase 1	Active, closed	Eli Lilly and Company	USA
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer NCT04188548 · Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer	Phase 1	Active, closed	Eli Lilly and Company	USA, China
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer NCT06495164 · ClinicalTrials.gov ↗ · Breast Cancer, Malignant Neoplasm of Breast	Observational	Active, closed	Pfizer	USA

Registers 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 across our data

Ireland · EU · US

The 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

All 3 Irish products →

Supply shortages

No entry for Abemaciclib in the EMA, FDA or German BfArM shortage lists we track.

EU shortages US shortages German shortages

Recent approvals

VerzenioFDA · 28 Sep 2017 · New Drug (NDA) · Eli Lilly And Co

EMA approvals tracker FDA approvals tracker

Conditions studied with Abemaciclib

45 conditions

Breast Cancer15 Metastatic Breast Cancer7 Breast Neoplasms5 Neoplasm Metastasis5 Non Small Cell Lung Cancer3 HR+/HER2- Breast Cancer2 Advanced Breast Cancer2 Neoplasms2Breast Cancer, Early Breast Cancer1Solid Tumors, Adult1 Hormone Receptor-positive Breast Cancer1Hormone Receptor Positive HER-2 Negative Breast Cancer1

All 45 conditions

Condition (as registered)	Trials
Breast Cancer	15
Metastatic Breast Cancer	7
Breast Neoplasms	5
Neoplasm Metastasis	5
Non Small Cell Lung Cancer	3
HR+/HER2- Breast Cancer	2
Advanced Breast Cancer	2
Neoplasms	2
Breast Cancer, Early Breast Cancer	1
Solid Tumors, Adult	1
Hormone Receptor-positive Breast Cancer	1
Hormone Receptor Positive HER-2 Negative Breast Cancer	1
ER-Positive HER2-Negative Breast Cancer	1
Ovarian Cancer	1
Locally Advanced (Inoperable) or Metastatic Breast Cancer	1
ER+ HER2- Advanced Breast Cancer	1
High-grade Serous Ovarian Cancer (HGSOC)	1
Prostatic Neoplasms	1
Urogenital Neoplasms	1
Physiological Effects of Drugs	1
Brain Neoplasms	1
Neoplasms by Site	1
Child	1
Adolescent	1
Advanced Solid Tumor	1
HR+, HER2-, Advanced Breast Cancer	1
CCNE1 Amplification	1
Endometrial Cancer	1
Glioma	1
Glioma Glioblastoma Multiforme	1
Glioma, Malignant	1
Solid Tumor	1
Sarcoma, Ewing	1
Malignant Neoplasm of Breast	1
Breast Cancer Metastatic	1
Hormone Receptor Positive Tumor	1
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast	1
Prostate Cancer	1
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer	1
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	1
Breast Neoplasm	1
Breast Cancer Stage I	1
Breast Cancer Stage II	1
Locally Advanced Breast Cancer (LABC)	1
Liver Metastases From Colorectal Cancer (mCRC)	1

By country register

Register	Trials	Recruiting
Clinical trials in USA	39	16
Clinical trials in China	23	8
Clinical trials in UK	19	10
Clinical trials in India	8	1
Clinical trials in Ireland	4	2

A trial with sites in more than one country appears in each of those registers.

Related compounds

Questions about Abemaciclib trials

How many clinical trials are testing Abemaciclib?

44 current trials in our USA, China, UK, India and Ireland registers name Abemaciclib (also registered as LY2835219) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Abemaciclib trials recruiting patients?

Yes. 18 of the 44 trials are recruiting: 16 with sites in USA, 8 with sites in China, 10 with sites in UK, 1 with sites in India and 2 with sites in Ireland. 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 14 lead sponsors in total. The number in brackets is how many trials each organisation leads.

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 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.

Abemaciclib clinical trials