Abemaciclib

Generic Name: Abemaciclib

Brand Names: Verzenio, Verzenios

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₃₂F_₂N_₈

CAS Number: 1231929-97-7

Unique Ingredient Identifier: 60UAB198HK

Background: Abemaciclib is an antitumor agent and dual inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6) that are involved in the cell cycle and promotion of cancer cell growth in case of unregulated activity. On September 28, 2017, FDA granted approval of abemaciclib treatment under the market name Verzenio for the treatment of HR-positive and HER2-negative advanced or metastatic breast cancer that has progressed after unsuccessful endocrine therapy. It is either given alone in patients who has undergone endocrine therapy and chemotherapy after the metastasis of cancer, or in combination with Fulvestrant. Following oral treatment in patients with HR-positive, HER2-negative breast cancer, abemaciclib demonstrated increased progression-free survival rates and objective response rates. Abemaciclib has been used in trials studying the treatment of melanoma, lymphoma, neoplasm, solid tumor, and glioblastoma.

Indication: 适应症为:⑴单药治疗接受过内分泌疗法和化疗后疾病进展的 ER+/HER2-晚期或转移性乳腺癌；⑵或联合氟维司群，二线治疗接受过内分泌疗法后疾病进展的 ER+/HER2-晚期或转移性乳腺癌；⑶联合芳香酶抑制剂作为 ER+/HER2-绝经后女性晚期或转移性乳腺癌的初始内分泌疗法。

Associated Conditions: HR+, HER2-, Advanced Breast Cancer, Early Hormone Receptor Positive, HER2/Neu Negative Node Positive Breast Cancer, Metastatic HR + HER2 - breast cancer

Clinical Trials

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

Phase 2

Recruiting

Conditions: Metastatic Breast Cancer
Hormone Receptor-positive Breast Cancer
Breast Cancer
HER2-negative Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Anastrozole
Drug: Abemaciclib

First Posted Date: 2022-09-01

Last Posted Date: 2024-06-07

Lead Sponsor: University of California, Irvine

Target Recruit Count: 20

Registration Number: NCT05524584

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

ETHAN - ET for Male BC

Phase 2

Recruiting

Conditions: Hormone Receptor Negative Breast Carcinoma
Hormone Receptor-positive Breast Cancer
Male Breast Cancer

Interventions: Drug: Tamoxifen
Drug: Anastrozole
Drug: Degarelix
Drug: Abemaciclib

First Posted Date: 2022-08-15

Last Posted Date: 2025-04-10

Lead Sponsor: Jose Pablo Leone

Target Recruit Count: 60

Registration Number: NCT05501704

Locations: 🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

and more 4 locations

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

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Chidamide
Drug: Abemaciclib
Drug: endocrinotherapy（doctor's choice）

First Posted Date: 2022-07-19

Last Posted Date: 2024-01-22

Lead Sponsor: Biyun Wang, MD

Target Recruit Count: 44

Registration Number: NCT05464173

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

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

Phase 2

Active, not recruiting

Conditions: Neoplasm Metastasis
Sarcoma, Ewing

Interventions: Drug: Abemaciclib
Drug: Irinotecan
Drug: Temozolomide

First Posted Date: 2022-07-01

Last Posted Date: 2025-04-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 45

Registration Number: NCT05440786

Locations: 🇺🇸
Lifespan Cancer Institute, Providence, Rhode Island, United States
🇦🇺
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

and more 24 locations

Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

Phase 1

Recruiting

Conditions: Glioma

Interventions: Drug: pre-operative abemaciclib
Device: Device for Cerebral Fluid Dialysate Collection
Device: Ashion Analytics GEM ExTra
Drug: abemaciclib + temozolomide

First Posted Date: 2022-06-10

Last Posted Date: 2025-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT05413304

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Phase 1

Recruiting

Conditions: Neoplasms by Site
Neoplasms
Brain Diseases
Brain Neoplasms
Central Nervous System Neoplasms
Central Nervous System Diseases
Breast Neoplasms
Breast Diseases

Interventions: Drug: Elacestrant
Drug: Abemaciclib

First Posted Date: 2022-05-23

Last Posted Date: 2025-05-07

Lead Sponsor: Stemline Therapeutics, Inc.

Target Recruit Count: 68

Registration Number: NCT05386108

Locations: 🇺🇸
Providence Medical Foundation, Fullerton, California, United States
🇺🇸
California Research Institute, Los Angeles, California, United States
🇺🇸
Carle Cancer Center, Urbana, Illinois, United States

and more 76 locations

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

Phase 1

Recruiting

Conditions: Breast Carcinoma
Malignant Solid Neoplasm

Interventions: Drug: Abemaciclib
Drug: BET Bromodomain Inhibitor ZEN-3694
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Diagnostic Imaging Testing

First Posted Date: 2022-05-13

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT05372640

Locations: 🇺🇸
Keck Medicine of USC Koreatown, Los Angeles, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 4 locations

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

Phase 4

Recruiting

Conditions: HER2-negative Metastatic Breast Cancer
Hormone Receptor-positive Metastatic Breast Cancer

Interventions: Drug: Abemaciclib + Fulvestrant
Drug: Abemaciclib + Aromatase Inhibitor

First Posted Date: 2022-05-05

Last Posted Date: 2025-05-16

Lead Sponsor: Prof. Wolfgang Janni

Target Recruit Count: 300

Registration Number: NCT05362760

Locations: 🇩🇪
St. Elisabeth-Krankenhaus GmbH, Köln, Germany
🇩🇪
Krankenhausgesellschaft St. Vincenz mbH, Limburg, Germany
🇨🇭
Spital Wallis, Brig, Switzerland

and more 51 locations

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

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: LOXO-783
Drug: Fulvestrant
Drug: Paclitaxel
Drug: Imlunestrant
Drug: Anastrozole, Exemestane, or Letrozole
Drug: Abemaciclib

First Posted Date: 2022-04-01

Last Posted Date: 2025-04-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 400

Registration Number: NCT05307705

Locations: 🇫🇷
Gustave Roussy, Villejuif, France
🇩🇪
Universitätsklinikum Erlangen, Erlangen, Bayern, Germany
🇺🇸
Mayo Clinic of Scottsdale, Scottsdale, Arizona, United States

and more 51 locations

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

Phase 3

Active, not recruiting

Conditions: Antineoplastic Agents
Steroid Synthesis Inhibitors
Cytochrome P-450
Prednisolone
Neoplasm Metastasis
Urogenital Neoplasms
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclin-Dependent Kinase 4
Hormones

Interventions: Drug: Abemaciclib
Drug: Prednisone or Prednisolone
Drug: Abiraterone
Drug: Placebo for Abemaciclib

First Posted Date: 2022-03-21

Last Posted Date: 2024-07-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 900

Registration Number: NCT05288166

Locations: 🇺🇸
AHN Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States
🇲🇽
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, Mexico

and more 260 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy