Verzenio

(Abemaciclib)

ApprovedSmall molecule

Abemaciclib is used to treat certain types of breast cancer, either alone or combined with other medications. It works by slowing down the growth of cancer cells.[2] Verzenio is currently approved and in use across 73 indications[4].[1]

Verzenio is one of 898 small molecule programs targeting Glioblastoma. It is currently in Approved.

Indications

215

Total Trials

106

Active Trials

897

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GlioblastomaWithdrawn

Endometrial CancerRecruiting

RhabdomyosarcomaApproved

Kaposi's SarcomaApproved

LymphomaApproved

MetastasisApproved

Prostate AdenocarcinomaApproved

Upper Aerodigestive Tract NeoplasmApproved

Genital Neoplasm, FemaleApproved

Glioblastoma MultiformeApproved

GlioblastomaPhase 2

Withdrawn

Endometrial CancerPhase 2

Recruiting

RhabdomyosarcomaApproved

Approved

Kaposi's SarcomaApproved

Approved

LymphomaApproved

Approved

MetastasisApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Upper Aerodigestive Tract NeoplasmApproved

Approved

Genital Neoplasm, FemaleApproved

Approved

Glioblastoma MultiformeApproved

Approved

Showing 10 of 73 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Verzenio

Eli Lilly

Approved

65 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Lexiscan

Astellas

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Duragesic

CCephalon

Preclinical

1 6

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 7

Ablavar

LLantheus Medical Imaging

Preclinical

2 8

Bisphosphonate

Amgen

Preclinical

2 9

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

2 10

Naltrexone/bupropion

Novo Nordisk

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Cancer

NCT05159245

Phase 3Active, not recruiting

Breast Cancer

NCT02246621

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT02779751

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT04545710

Phase 3Active, not recruiting

Lung Cancer

NCT02152631

Phase 1Active, not recruiting

Breast Cancer

NCT05307705

Clinical

Trials by Indication[1]

Breast Cancer61 trials

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT06678269·28 enrolled

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02102490·132 enrolled

Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)

Terminated·UUniversity of Milano Bicocca·Phase 2·NCT04227327·31 enrolled

Show 58 more trials

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Completed· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05759949·41 enrolled

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Terminated· Eli Lilly logo

Eli Lilly·Phase 4·NCT04031885·4 enrolled

Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors

Completed· Novartis logo

Novartis··NCT05153135·4,320 enrolled

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 1/2·NCT03280563·144 enrolled

A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT04707196·200 enrolled

Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer

Completed·—·Phase 2·NCT04352777·18 enrolled

Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer

Not yet recruiting·NNagoya City University·Phase 2·NCT07292207·30 enrolled

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT02246621·493 enrolled

Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT02792725

A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT03703466·72 enrolled

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06409390·15 enrolled

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02441946·224 enrolled

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03284957·136 enrolled

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting·—·Phase 2·NCT05933395·135 enrolled

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03099174·133 enrolled

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT04752332·111 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

Not yet recruiting·FFudan University·Phase 2·NCT06561022·260 enrolled

T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

Withdrawn·—·Phase 2·NCT04351230

Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT04481113·8 enrolled

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

Recruiting·FFudan University·Phase 3·NCT05891093·766 enrolled

Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT04316169

Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT02831530·101 enrolled

Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT03763604

Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

Not yet recruiting· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT07428018·150 enrolled

NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer

Recruiting·FFondazione Oncotech·Phase 2·NCT06259929·51 enrolled

Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients

Recruiting·AAzienda Ospedaliero-Universitaria di Modena··NCT07151911·100 enrolled

A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

Not yet recruiting·TThe Affiliated Hospital of Qingdao University··NCT06341283·200 enrolled

Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management

Recruiting·PProf. Wolfgang Janni·Phase 4·NCT05362760·300 enrolled

Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer

Withdrawn·AAlison Stopeck·Phase 1·NCT04088032

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

Withdrawn·DDanish Breast Cancer Cooperative Group·Phase 3·NCT06585969

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

Recruiting·—·Phase 2·NCT04523857·66 enrolled

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano··NCT06805812·3,500 enrolled

Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt

Completed·—·Phase 4·NCT07487129·206 enrolled

Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.

Completed·—··NCT05789771·136 enrolled

Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

Unknown status·CCriterium, Inc.·Phase 1/2·NCT04791384·44 enrolled

A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors

Completed· Novartis logo

Novartis··NCT05141240·4,650 enrolled

A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer

Completed·ZZeno Alpha Inc.·Phase 1·NCT04514159·14 enrolled

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT03155997·5,637 enrolled

A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 4·NCT03988114

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06570031·46 enrolled

Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients

Completed·TTechnical University of Munich··NCT04681768·95 enrolled

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT05095207·42 enrolled

A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Active, not recruiting· Pfizer logo

Pfizer··NCT06495164·1 enrolled

Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

Withdrawn·EEmory University·Phase 1·NCT04585724

Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients

Active, not recruiting·SSpanish Breast Cancer Research Group·Phase 2·NCT04293393·200 enrolled

Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib

Unknown status·—·Phase 1/2·NCT05464173·44 enrolled

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02675231·237 enrolled

Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer

Terminated·UUniversity of California, Irvine·Phase 2·NCT04305236·1 enrolled

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05563220·435 enrolled

A Phase 1/1b, First-in-Human, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PRT13722, a KAT6A Protein Degrader, as Monotherapy and in Combination With Endocrine and Targeted Therapy in Adults With Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer

Not yet recruiting·PPrelude Therapeutics Incorporated·Phase 1·NCT07905001·242 enrolled

Tolerability of Dalpiciclib Versus Abemaciclib/Ribociclib in Combination With Standard Endocrine Therapy for HR-Positive/HER2-Negative Early Breast Cancer: A Prospective, Multicenter, Randomized Controlled Trial

Not yet recruiting·HHenan Cancer Hospital·Preclinical·NCT07706933·456 enrolled

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor

Recruiting· Roche logo

Roche·Preclinical·NCT07100106·285 enrolled

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT06760637·1,035 enrolled

Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer

Recruiting·UUniversity of California, Irvine·Phase 2·NCT05524584·20 enrolled

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05307705·260 enrolled

A Proof of Concept Study to Evaluate Treatments' Efficacy by Monitoring Minimal Residual Disease Using ctDNA in HR-positive/HER2-negative Early Breast Cancer Population

Active, not recruiting·MMedSIR·Phase 2·NCT05708235·976 enrolled

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY A (ARV-471 IN COMBINATION WITH ABEMACICLIB)

Active, not recruiting· Pfizer logo

Pfizer·Preclinical·NCT05548127·37 enrolled

Abemaciclib14 trials

A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02387814·35 enrolled

A Study of Abemaciclib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02672423·127 enrolled

A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02884089·40 enrolled

Show 11 more trials

A Study of Abemaciclib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02677844·35 enrolled

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Withdrawn·—·Phase 1·NCT03846583

ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

Completed·MMedSIR·Phase 2·NCT04603183·162 enrolled

A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02482935·30 enrolled

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Completed·JJules Bordet Institute·Phase 2·NCT03339843·85 enrolled

A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02688088·48 enrolled

Abemaciclib With or Without Atezolizumab for mCRPC

Active, not recruiting·—·Phase 2·NCT04751929·19 enrolled

CDK4/6 Tumor, Abemaciclib, Paclitaxel

Completed·YYonsei University·Phase 1/2·NCT04594005·30 enrolled

A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.

Terminated·AAnita Turk·Phase 2·NCT04534283·16 enrolled

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05766410·60 enrolled

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Recruiting·MMridula George, MD·Phase 1·NCT06139107·15 enrolled

Non-Small Cell Lung Cancer6 trials

A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC)

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02411591·66 enrolled

A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT02779751·100 enrolled

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02450539·159 enrolled

Show 3 more trials

Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance

Active, not recruiting·UUniversity of California, San Diego·Phase 2·NCT04545710·18 enrolled

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02308020·162 enrolled

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Recruiting·TTango Therapeutics, Inc.·Preclinical·NCT06810544·191 enrolled

Endometrial Cancer4 trials

Abemaciclib and Letrozole to Treat Endometrial Cancer

Active, not recruiting·GGynecologic Oncology Group·Phase 2·NCT04393285·53 enrolled

Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer

Completed·NNorthwestern University·Phase 1·NCT04049227·27 enrolled

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Recruiting·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT04486352·148 enrolled

Show 1 more trial

A Phase 2 Trial of Maintenance Abemaciclib/Letrozole After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wildtype Endometrial Cancer

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT06366347·32 enrolled

Advanced Cancer4 trials

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01394016·225 enrolled

A Study of LY3023414 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01655225·156 enrolled

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04071262·6 enrolled

Show 1 more trial

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Recruiting·IIncyclix Bio·Phase 1/2·NCT05735080·150 enrolled

86 more indications

Prostate Cancer4 trials

Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT04272645

Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT04408924·44 enrolled

Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer

Terminated·UUniversity of Alabama at Birmingham·Phase 2·NCT04298983·9 enrolled

Show 1 more trial

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Preclinical·NCT03706365·393 enrolled

Glioblastoma4 trials

LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients

Completed·NNader Sanai·Phase 1·NCT04391595·42 enrolled

Abemaciclib + Pembrolizumab In Glioblastoma

Withdrawn·—·Phase 2·NCT04118036

A Phase 0/2 Study of Abemaciclib in Recurrent Glioblastoma

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02981940·45 enrolled

Show 1 more trial

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

Recruiting·PPatrick Wen, MD·Phase 2·NCT02977780·460 enrolled

Breast Neoplasms4 trials

MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT02107703·669 enrolled

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Preclinical·NCT05386108·73 enrolled

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07174336·800 enrolled

Show 1 more trial

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life

Recruiting· Novartis logo

Novartis··NCT06830720·3,250 enrolled

Head and Neck Squamous Cell Carcinoma3 trials

A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy

Unknown status·SSeoul National University Hospital·Phase 2·NCT03356587·32 enrolled

Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy

Terminated·WWashington University School of Medicine·Phase 1/2·NCT03655444·6 enrolled

Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)

Terminated·UUniversity of Arizona·Phase 2·NCT04169074·7 enrolled

Anatomic Stage IV Breast Cancer AJCC v83 trials

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer

Recruiting·UUniversity of Washington·Phase 2·NCT07112053·40 enrolled

A Phase IIA Trial Assessing the Tolerability of Abemaciclib in Combination With Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed on or After Prior CDK 4/6 Inhibition

Recruiting·CCity of Hope Medical Center·Phase 2·NCT04305834·43 enrolled

A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination With Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03939897·24 enrolled

Cancer2 trials

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

A Study of LY2835219 in Participants With Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02117648·26 enrolled

CDK4/6 Inhibitor2 trials

Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC

Active, not recruiting·—·Phase 2·NCT04010357·14 enrolled

Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6

Recruiting·—·Phase 2·NCT03310879·38 enrolled

Trial2 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Lung Cancer2 trials

A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT02152631·453 enrolled

A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02079636·142 enrolled

Ovarian Cancer2 trials

Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT05872204·100 enrolled

A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

Glioma2 trials

Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for High Grade Glioma

Withdrawn·JJose Carrillo·Phase 1·NCT04220892

Feasibility of Evaluating Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05413304·5 enrolled

Anatomic Stage I Breast Cancer AJCC v82 trials

Window Trial of Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer (a BEAUTY Study*)

Terminated·MMayo Clinic·Phase 2·NCT03979508·26 enrolled

Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07191717·42 enrolled

Advanced Breast Cancer2 trials

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06380751·788 enrolled

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06065748·1,050 enrolled

Advanced Dedifferentiated Liposarcoma2 trials

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06498648·74 enrolled

SARC041: Phase 3 Randomized Double-Blind Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma

Active, not recruiting·SSarcoma Alliance for Research through Collaboration·Phase 3·NCT04967521·108 enrolled

Metastatic Breast Cancer2 trials

A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02747004·234 enrolled

A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)

Recruiting· Roche logo

Roche·Preclinical·NCT03424005·1,132 enrolled

Anatomic Stage III Breast Cancer AJCC v82 trials

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Recruiting·UUniversity of Washington·Phase 2·NCT06179303·60 enrolled

A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05372640·45 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02981342·106 enrolled

Solid Tumor Malignancies1 trial

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Recruiting·EEffector Therapeutics·Phase 1/2·NCT04092673·30 enrolled

Triple-Negative Breast Cancer1 trial

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT06365788·53 enrolled

Refractory Solid Tumors1 trial

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

Completed·EEmory University·Phase 1·NCT02644460·53 enrolled

Dedifferentiated Liposarcoma1 trial

Study of Abemaciclib in Dedifferentiated Liposarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02846987·33 enrolled

Advanced Refractory Solid Tumors1 trial

A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02791334·164 enrolled

Metastatic Cancer1 trial

A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02919696·26 enrolled

Tics1 trial

Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 4·NCT05691400

Phase IB1 trial

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

Recruiting·FForward Pharmaceuticals Co., Ltd.·Phase 1/2·NCT07002177·196 enrolled

Hepatocellular Carcinoma1 trial

Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

Terminated·—·Phase 2·NCT03781960·7 enrolled

Neuroendocrine Tumors1 trial

Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors

Active, not recruiting·UUniversity of Washington·Phase 2·NCT03891784·20 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT02784795·94 enrolled

Renal Cell Carcinoma1 trial

A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma

Terminated·—·Phase 1·NCT03905889·3 enrolled

Pancreatic Cancer1 trial

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06630325·30 enrolled

Thyroid Cancer1 trial

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

Completed·SStanford University·Phase 2·NCT04552769·9 enrolled

Advanced Solid Tumors1 trial

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Terminated· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT04165031·5 enrolled

Neoadjuvant1 trial

Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT04614194·60 enrolled

Esophageal Squamous Cell Carcinoma1 trial

Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

Completed·SSeoul National University Hospital·Phase 2·NCT03292250·180 enrolled

Mantle Cell Lymphoma1 trial

Study of LY2835219 for Mantle Cell Lymphoma

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01739309·28 enrolled

Bevacizumab1 trial

Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT04074785·10 enrolled

Advanced Biliary Tract Carcinoma1 trial

A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma

Terminated·MMilton S. Hershey Medical Center·Phase 2·NCT04003896·4 enrolled

Adjuvant Therapy1 trial

Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC

Active, not recruiting·WWest German Study Group·Phase 3·NCT04565054·1,260 enrolled

Myeloma1 trial

Myeloma-Developing Regimens Using Genomics (MyDRUG)

Completed·MMultiple Myeloma Research Consortium·Phase 1/2·NCT03732703·103 enrolled

Meningioma1 trial

Abemaciclib in Newly Diagnosed Meningioma Patients

Recruiting·NNader Sanai·Phase 2·NCT05940493·72 enrolled

Advanced/Metastatic Cancer1 trial

A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02857270·210 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Esophageal Adenocarcinoma1 trial

Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149

Terminated·NNataliya Uboha·Phase 2·NCT03997448·3 enrolled

Metastatic Head and Neck Cancer1 trial

Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6

Completed·CCentre Leon Berard·Phase 2·NCT03356223·25 enrolled

Neuroblastoma1 trial

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

Completed· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT04238819·47 enrolled

Endocrine Therapy1 trial

PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

Active, not recruiting·IInstitute of Cancer Research, United Kingdom·Phase 3·NCT04584853·123 enrolled

Retinoblastoma1 trial

Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

Terminated·—·Phase 2·NCT03130439·27 enrolled

Advanced Cancers1 trial

A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02745769·23 enrolled

Recurrent Ovarian High Grade Serous Adenocarcinoma1 trial

A Phase 1/1b Dose Escalation Study of Abemaciclib and Olaparib for Recurrent Platinum-Resistant Ovarian Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04633239·42 enrolled

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Recruiting· Roche logo

Roche·Preclinical·NCT04802759·316 enrolled

Intracranial Meningioma1 trial

Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT02523014·124 enrolled

CDK Gene Mutation1 trial

Genomically-Guided Treatment Trial in Brain Metastases

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03994796·50 enrolled

ER+ HER2- Advanced Breast Cancer1 trial

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT06188520·55 enrolled

HR+/HER2- Breast Cancer1 trial

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Recruiting·BBeOne Medicines·Phase 3·NCT07492641·1,056 enrolled

Bladder Cancer1 trial

A Window-of-opportunity Trial of Abemaciclib Followed by Radical Cystectomy in Patients With Platinum-ineligible Urothelial Carcinoma to Evaluate CDK4/6-dependent Phosphorylation of Pocket Proteins and Clonal Evolution Dynamics

Active, not recruiting·WWeill Medical College of Cornell University·Phase 1·NCT03837821·20 enrolled

Metastatic Renal Cell Carcinoma1 trial

A Phase 1b/2 Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT06835972·43 enrolled

Sarcoma, Ewing1 trial

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Irinotecan and Temozolomide in Participants With Relapsed or Refractory Ewing's Sarcoma

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT05440786·46 enrolled

Neurofibromatosis 11 trial

A Phase 0/I/II Study of the Cyclin-Dependent Kinase(CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type 1 (NF1) Related Atypical Neurofibromas

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04750928·55 enrolled

Kaposi Sarcoma1 trial

A Phase I/II Study of Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04941274·111 enrolled

Metastatic Prostate Cancer1 trial

A Phase 1/2 Study of Darolutamide and Abemaciclib in High-Risk Prostate Cancer

Terminated·PPraful Ravi, MB BCHir, MRCP·Phase 1·NCT05617885·9 enrolled

Metastatic Microsatellite Stable Colorectal Carcinoma1 trial

A Phase 1 Study of 5-Fluorouracil in Combination With Abemaciclib in Metastatic, Refractory CRC

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT06654037·39 enrolled

Breast Neoplasm1 trial

postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05169567·368 enrolled

Metastatic Colon Adenocarcinoma1 trial

Open-Label Phase 1b/2 Study of Cetuximab Administered in Combination With LY3214996 (ERK 1/2 Inhibitor) or Cetuximab in Combination With LY3214996 and Abemaciclib in Patients With Metastatic, Anti-EGFR-Refractory Colorectal Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT04616183·46 enrolled

Brain Metastases1 trial

Phase I/II Study of Stereotactic Radiation and Abemaciclib With or Without Imlunestrant in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases (STRONG Trial)

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Preclinical·NCT04923542·31 enrolled

Solid Tumor1 trial

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

Recruiting·AAvenzo Therapeutics, Inc.·Preclinical·NCT05867251·430 enrolled

Adenocarcinoma1 trial

Phase II Study of Fulvestrant in Combination With Abemaciclib in Hormone Receptor Positive Adenocarcinoma of Endometrium

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03643510·27 enrolled

Oligodendroglioma, Adult1 trial

A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients With Recurrent Oligodendroglioma

Completed·SStephen Bagley, MD, MSCE·Phase 2·NCT03969706·10 enrolled

HER2-negative Breast Cancer1 trial

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04964934·315 enrolled

Lymphoma, Non-Hodgkin1 trial

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Recruiting·AAmerican Society of Clinical Oncology·Phase 2·NCT02693535·4,200 enrolled

Low Grade Ovarian Serous Adenocarcinoma1 trial

A Phase II Trial of Imlunestrant/Abemaciclib/Selinexor in Low Grade Serous Ovarian Cancer and in Endometrioid Endometrial Cancer

Not yet recruiting·DDana-Farber Cancer Institute·Phase 2·NCT07832227·60 enrolled

Retroperitoneal Sarcoma1 trial

A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas

Recruiting·UUniversity of Washington·Phase 1·NCT06025747·18 enrolled

Metastatic Esophageal Adenocarcinoma1 trial

Phase I/II Study of Abemaciclib + Ramucirumab in Metastatic Esophageal/Gastroesophageal Junction Carcinomas

Completed·BBaylor Research Institute·Preclinical·NCT04921904·26 enrolled

Malignant Neoplasms of Female Genital Organs1 trial

A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03531645·18 enrolled

Adenoid Cystic Carcinoma1 trial

A Phase 1/2 Study of CB-103 (Oral Pan-NOTCH Inhibitor) With Abemaciclib or Lenvatinib in Combination in Patients With NOTCH Activated Adenoid Cystic Carcinoma (CALCulus)

Recruiting·GGlenn J. Hanna·Preclinical·NCT05774899·32 enrolled

Myelofibrosis Due to and Following Polycythemia Vera1 trial

A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients With Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05714072·18 enrolled

Male Breast Cancer1 trial

ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer

Recruiting·JJose Pablo Leone·Phase 2·NCT05501704·60 enrolled

Mesothelioma, Malignant1 trial

Mesothelioma Stratified Therapy (MiST): A Stratified Multi-arm Phase IIa Clinical Trial to Enable Accelerated Evaluation of Targeted Therapies for Relapsed Malignant Mesothelioma

Completed·UUniversity of Leicester·Phase 2·NCT03654833·186 enrolled

Locally Advanced (Inoperable) or Metastatic Breast Cancer1 trial

A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04862663·893 enrolled

Early Breast Cancer1 trial

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05952557·5,511 enrolled

Neoplasms1 trial

CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT05999994·105 enrolled

Chondrosarcoma1 trial

Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04040205·44 enrolled

Castration-Resistant Prostate Carcinoma1 trial

Phase I/II Study of CDK4/6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy

Recruiting·VVadim S Koshkin·Preclinical·NCT05113537·30 enrolled

Liver Metastases From Colorectal Cancer (mCRC)1 trial

Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy

Enrolling by invitation·FFudan University·Phase 2·NCT07441369·16 enrolled

Cancer Metastatic1 trial

Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Burden Disease

Active, not recruiting·UUNICANCER·Phase 3·NCT04158362·180 enrolled

Unspecified2 trials

ABEMA Alone or in COMBO With MK-6482

Completed·—·Phase 1·NCT04627064·11 enrolled

VS-6766+Abema+Fulv in Met HR+/HER- BC

Recruiting·—·Phase 1/2·NCT05608252·63 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 28, 2017

VERZENIO

NDA NDA208716

Sep 28, 2017

VERZENIO

NDA NDA208716

Sep 9, 2019

VERZENIO

NDA NDA208716

Mar 30, 2020

VERZENIO

NDA NDA208716

Oct 12, 2021

VERZENIO

NDA NDA208716

Oct 12, 2021

VERZENIO

NDA NDA208716

Oct 12, 2021

VERZENIO

NDA NDA208716

Mar 3, 2023

VERZENIO

NDA NDA208716

Mar 3, 2023

VERZENIO

NDA NDA208716

Nov 13, 2024

VERZENIO

NDA NDA208716

Feb 27, 2025

VERZENIO

NDA NDA208716

Jul 13, 2026

VERZENIO

NDA NDA208716

Sources

References

[1]
ClinicalTrials.gov — 215 trial records for Abemaciclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Verzenio drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Abemaciclib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Abemaciclib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208716). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Verzenio. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CDK4/6 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Patent Landscape[6]

Patent Cliff

Sep 28, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7855211Sep 28, 2031