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 69 indications[4].[1]

Verzenio is one of 1110 small molecule programs targeting Glioma. It is currently in Approved.

Indications

211

Total Trials

109

Active Trials

1,109

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Hepatic FailureApproved

Colorectal CarcinomaApproved

MetastasisApproved

Esophageal Squamous Cell CarcinomaActive, not recruiting

Prostate AdenocarcinomaApproved

NeurofibromatosisActive, not recruiting

Lung CancerActive, not recruiting

Malignant Rhabdoid TumourApproved

LymphomaApproved

GliomaPhase 1

Active, not recruiting

Hepatic FailureApproved

Approved

Colorectal CarcinomaApproved

Approved

MetastasisApproved

Approved

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

NeurofibromatosisPhase 1/Phase 2

Active, not recruiting

Lung CancerPhase 1

Active, not recruiting

Malignant Rhabdoid TumourApproved

Approved

LymphomaApproved

Approved

Showing 10 of 69 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Verzenio

Eli Lilly

Approved

76 2

Avastin

BBio-Thera Solutions

Preclinical

153 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Lexiscan

Astellas

Preclinical

1 5

Adenocard

Astellas

Preclinical

1 6

Blenoxane

Bristol-Myers Squibb

Preclinical

1 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Breast Cancer

NCT03939897

Phase 2Recruiting

Breast Cancer

NCT04305834

Phase 1/2Active, not recruiting

Breast Cancer

NCT05548127

Phase 2Recruiting

Abemaciclib

NCT05766410

Phase 2Recruiting

CDK4/6 Inhibitor

NCT03310879

Q4 2026

Phase 1Recruiting

Recurrent Ovarian High Grade Serous Adenocarcinoma

NCT04633239

Clinical

Trials by Indication[1]

Breast Cancer75 trials

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT02107703·669 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

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

Show 72 more trials

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

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

Withdrawn·AAlison Stopeck·Phase 1·NCT04088032

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

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

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT02747004·234 enrolled

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

Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT04923542·31 enrolled

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

Recruiting·—·Phase 2·NCT04523857·66 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

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

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06760637·1,020 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

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

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

Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial

Not yet recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07191717·42 enrolled

Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer

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

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

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Recruiting· Roche logo

Roche·Phase 1/2·NCT03424005·792 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

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05169567·368 enrolled

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04975308·874 enrolled

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

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

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

Completed·TTechnical University of Munich··NCT04681768·95 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

Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer

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

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT05307705·193 enrolled

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)

Active, not recruiting· Pfizer logo

Pfizer·Phase 1/2·NCT05548127·37 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

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

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

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT02792725

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

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

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

Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

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

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 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

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

Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.

Recruiting·—·Phase 2·NCT04305834·43 enrolled

Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05386108·73 enrolled

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

Recruiting·—·Phase 2·NCT05933395·135 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

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

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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

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

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

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 in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer

Terminated·MMayo Clinic·Phase 2·NCT03979508·26 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

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

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

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

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT04316169

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

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

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

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Recruiting· Eli Lilly logo

Eli Lilly·Preclinical·NCT05768139·880 enrolled

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Recruiting·UUniversity of Illinois at Chicago·Approved·NCT06169371·50 enrolled

The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT06001762·90 enrolled

Abemaciclib15 trials

A Study of Abemaciclib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02672423·127 enrolled

CDK4/6 Tumor, Abemaciclib, Paclitaxel

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

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Withdrawn·—·Phase 1·NCT03846583

Show 12 more trials

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

Completed·MMedSIR·Phase 2·NCT04603183·162 enrolled

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

Terminated·AAnita Turk·Phase 2·NCT04534283·16 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

ALPINE: Maintenance Letrozole/Abemaciclib

Recruiting·—·Phase 2·NCT06366347·32 enrolled

Abemaciclib With or Without Atezolizumab for mCRPC

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

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

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

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 the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02884089·40 enrolled

A Study of Abemaciclib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02677844·35 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

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

Prostate Cancer6 trials

Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

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

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

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

Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Recruiting·VVadim S Koshkin·Phase 1/2·NCT05113537·30 enrolled

Show 3 more trials

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT03706365·393 enrolled

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

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT04408924·44 enrolled

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Active, not recruiting·PPraful Ravi, MB BCHir, MRCP·Phase 1·NCT05617885·9 enrolled

Endometrial Cancer6 trials

Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT04469764·32 enrolled

Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03643510·28 enrolled

Abemaciclib and Letrozole to Treat Endometrial Cancer

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

Show 3 more trials

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

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

A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07209449·75 enrolled

Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer

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

Non-Small Cell Lung Cancer5 trials

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

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

Show 2 more trials

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 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

72 more indications

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 Study of Abemaciclib in Recurrent Glioblastoma

Active, not recruiting·—·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

Advanced Cancer4 trials

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

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01394016·225 enrolled

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

Show 1 more trial

A Study of LY3023414 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01655225·156 enrolled

Glioma3 trials

Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

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

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

Withdrawn·JJose Carrillo·Phase 1·NCT04220892

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT06413706·45 enrolled

CDK4/6 Inhibitor3 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

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04964934·315 enrolled

Head and Neck Squamous Cell Carcinoma3 trials

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

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

Dedifferentiated Liposarcoma2 trials

SARC041: 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

Study of Abemaciclib in Dedifferentiated Liposarcoma

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

Lung Cancer2 trials

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

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

Soft Tissue Sarcoma2 trials

Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma

Recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT06498648·74 enrolled

Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration

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

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

Breast Neoplasms2 trials

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

A 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·NCT07174336·920 enrolled

Advanced Breast Cancer2 trials

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

Recruiting· Roche logo

Roche·Phase 3·NCT06065748·1,050 enrolled

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant 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·NCT06380751·500 enrolled

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

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

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

Retroperitoneal Sarcoma1 trial

Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma

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

Malignant Mesothelioma1 trial

Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma

Unknown status·UUniversity of Leicester·Phase 2·NCT03654833·186 enrolled

Thyroid Cancer1 trial

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

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

Oligodendroglioma1 trial

Abemaciclib in Patients with Oligodendroglioma

Active, not recruiting·SStephen Bagley, MD, MSCE·Phase 2·NCT03969706·10 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

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

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

Meningioma1 trial

Abemaciclib in Newly Diagnosed Meningioma Patients

Recruiting·NNader Sanai·Phase 2·NCT05940493·72 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

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

Clinical Trial1 trial

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT05999994·105 enrolled

Advanced Stage Cancer1 trial

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

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

Gastroesophageal Junction1 trial

Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca

Active, not recruiting·—·Phase 1/2·NCT04921904·8 enrolled

Kaposi Sarcoma1 trial

Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma

Recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT04941274·86 enrolled

Myelofibrosis1 trial

A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis

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

Colorectal Cancer1 trial

Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer

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

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

Liver Metastases1 trial

Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer

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

Patients With Advanced Solid Tumors1 trial

Study of AVZO-021 in Patients With Advanced Solid Tumors

Recruiting·AAvenzo Therapeutics, Inc.·Phase 1/2·NCT05867251·430 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

Hepatocellular Carcinoma1 trial

Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

Terminated·—·Phase 2·NCT03781960·7 enrolled

Low Grade Serous Carcinoma1 trial

Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

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

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

HER2-Negative1 trial

A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

Recruiting·MMedSIR·Phase 2·NCT05708235·976 enrolled

Refractory Solid Tumors1 trial

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

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

Metastatic Colorectal Cancer1 trial

LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04616183·46 enrolled

Mantle Cell Lymphoma1 trial

Study of LY2835219 for Mantle Cell Lymphoma

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01739309·28 enrolled

Efficacy and Safety1 trial

A 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

Brain Metastases1 trial

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Suspended·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03994796·186 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

Patients With Solid Tumors1 trial

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Recruiting·TTango Therapeutics, Inc.·Phase 1/2·NCT06810544·191 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

Ewing's Sarcoma1 trial

CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT05440786·46 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

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

Urothelial Cancer1 trial

(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer

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

Ovarian Cancer1 trial

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

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

Retinoblastoma1 trial

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

Terminated·—·Phase 2·NCT03130439·27 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

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

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

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

Brain Tumor1 trial

A Phase 2 Study of Abemaciclib in Patients With Recurrent Primary Brain Tumors

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03220646·64 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

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

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

Prostatic Neoplasms1 trial

CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05288166·925 enrolled

Unspecified3 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

ETHAN - ET for Male BC

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

Regulatory

FDA Approval Timeline[5]

Sep 28, 2017

VERZENIO

NDA NDA208716

Sources

References

[1]
ClinicalTrials.gov — 211 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