Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate Abemaciclib mesylate across diverse oncological indications, predominantly hormone receptor-positive, HER2-negative breast cancers, pediatric malignancies such as diffuse intrinsic pontine glioma and refractory solid tumors, hepatocellular carcinoma, and head and neck cancer. Sponsored by academic institutions including Rutgers University, Emory University, Moffitt Cancer Center, and Penn Medicine, these studies encompass active, recruiting, completed, and terminated statuses, featuring various Phase 1 combination and pediatric evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07190443 RECRUITING
Breast Cancer; Locoregional Recurrence; Abemaciclib; Endocrine Therapy
Japanese Foundation for Cancer Research
2025-02-07 PHASE3
NCT07340541 RECRUITING
Breast Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer; Estrogen-receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma
UNC Lineberger Comprehensive Cancer Center
2026-02-16 PHASE2
NCT01042379 RECRUITING
Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer
QuantumLeap Healthcare Collaborative
2010-03-01 PHASE2
NCT06169371 RECRUITING
Breast Cancer
University of Illinois at Chicago
2023-12-28 PHASE4
NCT04584853 ACTIVE_NOT_RECRUITING
Breast Cancer Female
Institute of Cancer Research, United Kingdom
2020-12-23 PHASE3
NCT05933395 RECRUITING
Advanced Breast Cancer
Dartmouth-Hitchcock Medical Center
2024-09-23 PHASE2
NCT03424005 RECRUITING
Metastatic Breast Cancer
Hoffmann-La Roche
2018-03-30 PHASE1; PHASE2
NCT05768139 RECRUITING
Breast Cancer; Solid Tumors, Adult
Eli Lilly and Company
2023-04-17 PHASE1; PHASE2
NCT07553234 NOT_YET_RECRUITING
Breast Cancer
University of Chicago
2026-12-27
NCT07191717 RECRUITING
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Invasive Breast Carcinoma; Localized Estrogen Receptor-Positive Breast Carcinoma; Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma
Jonsson Comprehensive Cancer Center
2026-05-18 PHASE2
NCT05952557 ACTIVE_NOT_RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
2023-10-05 PHASE3
NCT06380751 RECRUITING
Advanced Breast Cancer
AstraZeneca
2024-08-01 PHASE3
NCT07490509 NOT_YET_RECRUITING
Abemaciclib; Abemaciclib-related Diarrhea; Breast Cancer
Poitiers University Hospital
2026-09 PHASE4
NCT07605728 RECRUITING
Breast Cancer; Chemotherapy-induced Diarrhea
Leeuwenhoek Laboratories Co. Ltd.
2026-05-15 PHASE2
NCT07521202 NOT_YET_RECRUITING
HR+/HER2- Early Breast Cancer
Institut fuer Frauengesundheit
2026-06
NCT04802759 RECRUITING
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Hoffmann-La Roche
2021-06-22 PHASE1; PHASE2
NCT07174336 RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2025-12-22 PHASE3
NCT07428018 NOT_YET_RECRUITING
Breast Cancer; HER2 + Breast Cancer; HR Positive; Neoadjuvant Therapy
Mario Negri Institute for Pharmacological Research
2026-04-30 PHASE2
NCT07410559 NOT_YET_RECRUITING
Breast Cancer
Fudan University
2026-07-01 PHASE2
NCT07492641 RECRUITING
HR+/HER2- Breast Cancer
BeOne Medicines
2026-05-22 PHASE3
NCT05362760 RECRUITING
Hormone Receptor-positive Metastatic Breast Cancer; HER2-negative Metastatic Breast Cancer
Prof. Wolfgang Janni
2022-04-27 PHASE4
NCT06760637 ACTIVE_NOT_RECRUITING
Breast Cancer
Pfizer
2025-01-06 PHASE3
NCT04616183 ACTIVE_NOT_RECRUITING
Metastatic Colon Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Recurrent Colorectal Carcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Colon Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Colon Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Colorectal Carcinoma; Unresectable Rectal Adenocarcinoma
M.D. Anderson Cancer Center
2020-12-02 PHASE1; PHASE2
NCT05524584 RECRUITING
Breast Cancer; Metastatic Breast Cancer; Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer
University of California, Irvine
2022-08-31 PHASE2
NCT04750928 RECRUITING
Neurofibromatosis 1
National Cancer Institute (NCI)
2021-11-29 PHASE1; PHASE2
NCT07292207 NOT_YET_RECRUITING
ctDNA Monitoring; Breast Cancer
Nagoya City University
2026-01-10 PHASE2
NCT06678269 RECRUITING
Metastatic Breast Cancer; Stage IV Breast Cancer; Breast Cancer; Breast Cancer Stage IV; Breast Cancer Metastatic; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; Hormone-receptor-positive Breast Cancer
Memorial Sloan Kettering Cancer Center
2024-11-15 PHASE1
NCT07209449 RECRUITING
Endometrial Cancer
Memorial Sloan Kettering Cancer Center
2025-10-01 PHASE2
NCT05940493 RECRUITING
Meningioma
Nader Sanai
2025-03-24 PHASE2
NCT07100106 RECRUITING
Breast Cancer
Genentech, Inc.
2025-10-07 PHASE1; PHASE2
NCT03675893 RECRUITING
Endometrial Cancer
Dana-Farber Cancer Institute
2018-12-24 PHASE2
NCT07112053 RECRUITING
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma
University of Washington
2025-11-17 PHASE2
NCT06062498 RECRUITING
Estrogen-receptor-positive Breast Cancer; HER2/Neu-Negative Breast Cancer; Advanced Breast Cancerv; Metastatic Breast Cancer
Northwestern University
2023-09-29 PHASE2
NCT05708235 RECRUITING
Breast Cancer
MedSIR
2024-04-01 PHASE2
NCT07706933 NOT_YET_RECRUITING
Breast Cancer
Henan Cancer Hospital
2026-08-01
NCT04565054 ACTIVE_NOT_RECRUITING
Breast Cancer Female
Women's Cancer Study Group GmbH
2020-09-02 PHASE3
NCT05891093 RECRUITING
Breast Cancer
Fudan University
2023-06-01 PHASE3
NCT07002177 RECRUITING
Metastatic Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Locally Advanced Breast Cancer (LABC); ER+ Breast Cancer
Forward Pharmaceuticals Co., Ltd.
2025-06-01 PHASE1; PHASE2
NCT04941274 RECRUITING
Kaposi Sarcoma
National Cancer Institute (NCI)
2021-09-29 PHASE1; PHASE2
NCT04931342 ACTIVE_NOT_RECRUITING
Ovarian Cancer
Hoffmann-La Roche
2021-10-07 PHASE2
NCT06813079 RECRUITING
Pancreatic Ductal Carcinoma; Advanced Cancer; Epithelial Tumor
University Health Network, Toronto
2025-04-07 PHASE2
NCT02977780 RECRUITING
Glioblastoma
David Reardon, MD
2017-02-09 PHASE2
NCT05573126 RECRUITING
Hormone Receptor-positive Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer; Metastatic Breast Cancer
Ellipses Pharma
2023-01-11 PHASE1; PHASE2
NCT05867251 RECRUITING
Advanced Solid Tumor; HR+/HER2- Breast Cancer; HR+, HER2-, Advanced Breast Cancer; CCNE1 Amplification; Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer; Endometrial Cancer; TNBC - Triple-Negative Breast Cancer
Avenzo Therapeutics, Inc.
2023-08-30 PHASE1; PHASE2
NCT05872204 RECRUITING
Low Grade Serous Ovarian Carcinoma; Adult Type Granulosa Cell Tumor
Universitaire Ziekenhuizen KU Leuven
2023-11-30 PHASE2
NCT05608252 RECRUITING
Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer
Adrienne G. Waks
2023-02-23 PHASE1; PHASE2
NCT02693535 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
American Society of Clinical Oncology
2016-03-14 PHASE2
NCT07599137 NOT_YET_RECRUITING
HR+/HER2- Breast Cancer
Peking University Cancer Hospital & Institute
2026-05-30 PHASE4
NCT04523857 RECRUITING
Breast Cancer
Abramson Cancer Center at Penn Medicine
2021-11-01 PHASE2
NCT06365788 RECRUITING
Triple Negative Breast Neoplasms
Universitaire Ziekenhuizen KU Leuven
2024-04-08 PHASE2
NCT04862663 ACTIVE_NOT_RECRUITING
Locally Advanced (Inoperable) or Metastatic Breast Cancer
AstraZeneca
2021-05-10 PHASE3
NCT03531645 ACTIVE_NOT_RECRUITING
Malignant Neoplasms of Female Genital Organs
M.D. Anderson Cancer Center
2019-08-13 PHASE2
NCT06366347 RECRUITING
Endometrial Cancer; Recurrent Endometrial Cancer; TP53
Dana-Farber Cancer Institute
2024-09-25 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
2016-08 PHASE2
NCT06188520 RECRUITING
ER+ HER2- Advanced Breast Cancer; High-grade Serous Ovarian Cancer (HGSOC)
AstraZeneca
2023-12-05 PHASE1; PHASE2
NCT04469764 RECRUITING
Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
Jonsson Comprehensive Cancer Center
2020-10-16 PHASE2
NCT03220646 ACTIVE_NOT_RECRUITING
Brain Tumor
Memorial Sloan Kettering Cancer Center
2017-07-13 PHASE2
NCT05735080 RECRUITING
Breast Cancer; Breast Cancer Metastatic; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Ovarian Cancer; CCNE1 Amplification; Solid Tumor; Advanced Cancer; Metastatic Cancer
Incyclix Bio
2023-03-28 PHASE1; PHASE2
NCT02846987 ACTIVE_NOT_RECRUITING
Sarcoma; Dedifferentiated Liposarcoma
Memorial Sloan Kettering Cancer Center
2016-07 PHASE2
NCT05372640 RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic NUT Carcinoma; Unresectable Breast Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable NUT Carcinoma
National Cancer Institute (NCI)
2023-08-10 PHASE1
NCT04040205 RECRUITING
Chondrosarcoma; Osteosarcoma; Soft Tissue Sarcoma
Medical College of Wisconsin
2019-10-07 PHASE2
NCT05774899 RECRUITING
Adenoid Cystic Carcinoma; Metastatic Adenoid Cystic Carcinoma; Recurrent Adenoid Cystic Carcinoma
Glenn J. Hanna
2023-06-01 PHASE1; PHASE2
NCT05095207 RECRUITING
Breast Cancer; Metastasis
Icahn School of Medicine at Mount Sinai
2021-09-20 PHASE1; PHASE2
NCT05113537 RECRUITING
Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Metastatic Castration-resistant Prostate Carcinoma; Metastatic Castration-resistant Prostate Cancer
Vadim S Koshkin
2022-07-08 PHASE1; PHASE2
NCT05999994 RECRUITING
Neoplasms; Child; Adolescent
Eli Lilly and Company
2020-01-22 PHASE2
NCT07441369 ENROLLING_BY_INVITATION
Liver Metastases From Colorectal Cancer (mCRC)
Fudan University
2026-07-30 PHASE2
NCT04614194 RECRUITING
Breast Cancer
University of Texas Southwestern Medical Center
2021-04-15 PHASE2
NCT06654037 RECRUITING
Metastatic Microsatellite Stable Colorectal Carcinoma; Refractory Microsatellite Stable Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8
National Cancer Institute (NCI)
2025-04-18 PHASE1
NCT05501704 RECRUITING
Male Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma
Jose Pablo Leone
2023-10-11 PHASE2
NCT06409390 RECRUITING
Metastatic Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
2024-08-14 PHASE2
NCT05696626 RECRUITING
Metastatic Breast Cancer
LeonaBio
2023-10-31 PHASE3
NCT06810544 RECRUITING
Non Small Cell Lung Cancer; Glioma Glioblastoma Multiforme; Glioma, Malignant; Solid Tumor; Non-Small Cell Adenocarcinoma; Lung Cancer; Brain Tumor
Tango Therapeutics, Inc.
2025-03-24 PHASE1; PHASE2
NCT05548127 ACTIVE_NOT_RECRUITING
Breast Cancer
Pfizer
2023-02-23 PHASE1; PHASE2
NCT06594679 RECRUITING
Ovarian Cancer
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2024-09-26 PHASE1; PHASE2
NCT06025747 RECRUITING
Retroperitoneal Sarcoma; Liposarcoma; Dedifferentiated Liposarcoma
University of Washington
2025-03-19 PHASE1
NCT06179303 RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Unresectable HER2-Negative Breast Carcinoma; Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma
University of Washington
2024-07-22 PHASE2
NCT05691400 WITHDRAWN
CYP3A4*22
University of Michigan Rogel Cancer Center
2024-03 PHASE4
NCT06341621 RECRUITING
Breast Cancer
Fudan University
2024-04-02 PHASE3
NCT06065748 RECRUITING
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Hoffmann-La Roche
2023-12-11 PHASE3
NCT06835972 RECRUITING
Metastatic Renal Cell Carcinoma; Translocation Renal Cell Carcinoma
Memorial Sloan Kettering Cancer Center
2025-02-14 PHASE1; PHASE2
NCT06413706 ACTIVE_NOT_RECRUITING
Glioma
Eli Lilly and Company
2024-10-25 PHASE2
NCT06498648 RECRUITING
Advanced Dedifferentiated Liposarcoma; Advanced Leiomyosarcoma; Advanced Soft Tissue Sarcoma; Metastatic Dedifferentiated Liposarcoma; Metastatic Leiomyosarcoma; Metastatic Soft Tissue Sarcoma; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
National Cancer Institute (NCI)
2026-03-18 PHASE1; PHASE2
NCT06207734 RECRUITING
Breast Cancer
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2024-01-17 PHASE2
NCT03310879 RECRUITING
Cancer
Dana-Farber Cancer Institute
2017-11-21 PHASE2
NCT02523014 RECRUITING
Intracranial Meningioma; Recurrent Meningioma; NF2 Gene Mutation
Alliance for Clinical Trials in Oncology
2015-09-28 PHASE2
NCT05714072 RECRUITING
Myelofibrosis Due to and Following Polycythemia Vera
Memorial Sloan Kettering Cancer Center
2023-01-25 PHASE1
NCT04316169 WITHDRAWN
Solid Tumor; Advanced Breast Cancer
Medical College of Wisconsin
2021-10-21 PHASE1
NCT05563220 ACTIVE_NOT_RECRUITING
Breast Cancer; Metastatic Breast Cancer
Stemline Therapeutics, Inc.
2023-01-24 PHASE1; PHASE2
NCT05305924 RECRUITING
ER-Positive Breast Cancer; HER2-negative Breast Cancer
The Methodist Hospital Research Institute
2021-02-25 PHASE2
NCT04393285 ACTIVE_NOT_RECRUITING
Endometrial Cancer
Gynecologic Oncology Group
2020-10-10 PHASE2
NCT05307705 RECRUITING
Breast Cancer
Eli Lilly and Company
2022-05-11 PHASE1
NCT05386108 RECRUITING
Breast Neoplasms; Brain Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Central Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases
Stemline Therapeutics, Inc.
2022-08-31 PHASE1; PHASE2
NCT05159245 RECRUITING
Advanced Cancer; Solid Tumor; Haematological Malignancy
Helsinki University Central Hospital
2021-12-10 PHASE2
NCT04923542 RECRUITING
Brain Metastases; HR+ Metastatic Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
2021-11-30 PHASE1; PHASE2
NCT04633239 RECRUITING
Recurrent Ovarian High Grade Serous Adenocarcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma
National Cancer Institute (NCI)
2021-07-02 PHASE1
NCT04486352 RECRUITING
Endometrial Cancer
Alliance Foundation Trials, LLC.
2021-10-20 PHASE1; PHASE2
NCT03994796 ACTIVE_NOT_RECRUITING
CDK Gene Mutation; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm; NTRK Family Gene Mutation; PI3K Gene Mutation; ROS1 Gene Mutation; KRAS G12C Mutation
Alliance for Clinical Trials in Oncology
2019-10-17 PHASE2
NCT06139107 RECRUITING
Breast Cancer
Mridula George, MD
2024-08-22 PHASE1
NCT06959979 RECRUITING
Medulloblastoma, Childhood
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2024-11-25 EARLY_PHASE1
NCT04305834 RECRUITING
Anatomic Stage IV Breast Cancer AJCC v8; Hormone Receptor Positive Breast Carcinoma; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8
City of Hope Medical Center
2020-03-25 PHASE2
NCT06570031 COMPLETED
Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer
Ono Pharmaceutical Co., Ltd.
2021-11-09 PHASE1
NCT04010357 COMPLETED
Small-cell Lung Cancer; Large Cell Neuroendocrine Carcinoma of the Lung; Extrapulmonary Small Cell Carcinoma
Case Comprehensive Cancer Center
2020-01-13 PHASE2
NCT06259929 RECRUITING
Breast Cancer
Fondazione Oncotech
2025-01-27 PHASE2
NCT03643510 COMPLETED
Adenocarcinoma of Endometrium
Memorial Sloan Kettering Cancer Center
2018-08-21 PHASE2
NCT06630325 TERMINATED
Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8
OHSU Knight Cancer Institute
2025-06-24 PHASE2
NCT06585969 WITHDRAWN
Metastatic Breast Cancer; ER-positive Breast Cancer; Luminal B; Her2 Enriched; Basal Like
Danish Breast Cancer Cooperative Group
2026-01-01 PHASE3
NCT06561022 UNKNOWN
Breast Cancer
Fudan University
2024-08-21 PHASE2
NCT06810492 NOT_YET_RECRUITING
Breast Cancer Stage III; Breast Cancer Stage II
Hongmei Zheng, PhD
2025-04-01
NCT04545710 ACTIVE_NOT_RECRUITING
Lung Cancer
University of California, San Diego
2020-11-21 PHASE2
NCT04967521 ACTIVE_NOT_RECRUITING
Advanced Dedifferentiated Liposarcoma
Sarcoma Alliance for Research through Collaboration
2021-11-11 PHASE3
NCT03891784 ACTIVE_NOT_RECRUITING
Advanced Digestive System Neuroendocrine Neoplasm; Digestive System Neuroendocrine Tumor; Foregut Neuroendocrine Tumor; Hindgut Neuroendocrine Tumor; Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm; Metastatic Digestive System Neuroendocrine Neoplasm; Midgut Neuroendocrine Tumor; Pancreatic Neuroendocrine Tumor; Refractory Digestive System Neuroendocrine Neoplasm
University of Washington
2019-10-31 PHASE2
NCT05413304 ACTIVE_NOT_RECRUITING
Glioma
National Cancer Institute (NCI)
2023-04-07 PHASE1
NCT07487129 COMPLETED
Breast Cancer
Beni-Suef University
2024-08-25 PHASE4
NCT05766410 RECRUITING
Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Therapy
National Taiwan University Hospital
2022-09-16 PHASE2
NCT05617885 COMPLETED
Metastatic Prostate Cancer; Non-metastatic Prostate Cancer; Prostate Cancer
Praful Ravi, MB BCHir, MRCP
2023-08-09 PHASE1
NCT04964934 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
2021-06-30 PHASE3
NCT04352777 COMPLETED
Metastatic Breast Cancer; Locally Advanced Breast Cancer; Hormone Receptor Positive Tumor
Duke University
2020-09-14 PHASE2
NCT03969706 ACTIVE_NOT_RECRUITING
Oligodendroglioma, Adult
Stephen Bagley, MD, MSCE
2019-05-15 PHASE2
NCT04158362 ACTIVE_NOT_RECRUITING
Cancer Metastatic
UNICANCER
2020-06-11 PHASE3
NCT05759949 COMPLETED
PIK3CA Mutation; Solid Tumor, Adult; HER2-negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Solid Tumor; Hormone Receptor Positive Tumor
Relay Therapeutics, Inc.
2023-03-29 PHASE1
NCT05464173 UNKNOWN
Breast Cancer
Biyun Wang, MD
2022-07-01 PHASE1; PHASE2
NCT04432454 COMPLETED
Metastatic Breast Cancer
Sermonix Pharmaceuticals Inc.
2020-09-29 PHASE2
NCT06001762 ACTIVE_NOT_RECRUITING
Breast Cancer; Early-stage Breast Cancer; High Risk Breast Carcinoma
Dana-Farber Cancer Institute
2023-10-05 PHASE2
NCT05440786 ACTIVE_NOT_RECRUITING
Sarcoma, Ewing; Neoplasm Metastasis
Eli Lilly and Company
2022-09-20 PHASE2
NCT04092673 UNKNOWN
Solid Tumor, Adult
Effector Therapeutics
2019-10-25 PHASE1; PHASE2
NCT03732703 COMPLETED
Relapsed Refractory Multiple Myeloma
Multiple Myeloma Research Consortium
2019-04-01 PHASE1; PHASE2
NCT04921904 ACTIVE_NOT_RECRUITING
Metastatic Esophageal Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma
Baylor Research Institute
2021-06-11 PHASE1; PHASE2
NCT03979508 TERMINATED
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Ductal Carcinoma In Situ; Breast Fibrocystic Change; Breast Lobular Carcinoma In Situ; Invasive Breast Carcinoma; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma
Mayo Clinic
2020-01-10 PHASE2
NCT04169074 TERMINATED
HNSCC
University of Arizona
2021-07-07 PHASE2
NCT03284957 TERMINATED
Breast Cancer
Sanofi
2017-09-20 PHASE1; PHASE2
NCT05189717 UNKNOWN
Metastatic or Local Advanced Breast Cancer of Patients
Shandong Suncadia Medicine Co., Ltd.
2022-02-17 PHASE1
NCT06152471 UNKNOWN
Early-stage Breast Cancer; Diarrhea; Adverse Drug Event
Henrik Lindman
2023-06-07 PHASE3
NCT03280563 COMPLETED
Breast Neoplasms
Hoffmann-La Roche
2017-12-22 PHASE1; PHASE2
NCT03616587 ACTIVE_NOT_RECRUITING
ER+ HER2- Advanced Breast Cancer
AstraZeneca
2018-10-11 PHASE1
NCT04791384 TERMINATED
Breast Cancer
Criterium, Inc.
2022-04-21 PHASE1; PHASE2
NCT04227327 TERMINATED
Advanced Breast Cancer
University of Milano Bicocca
2020-01-07 PHASE2
NCT04298983 TERMINATED
Prostate Cancer
University of Alabama at Birmingham
2021-02-25 PHASE2
NCT04594005 COMPLETED
Tumors
Yonsei University
2021-02-25 PHASE1; PHASE2
NCT03837821 ACTIVE_NOT_RECRUITING
Bladder Cancer
Weill Medical College of Cornell University
2019-02-05 EARLY_PHASE1
NCT04603183 COMPLETED
Breast Cancer Metastatic
MedSIR
2021-06-02 PHASE2
NCT02981940 ACTIVE_NOT_RECRUITING
Glioblastoma
Dana-Farber Cancer Institute
2017-02-09 PHASE2
NCT04752332 TERMINATED
Breast Neoplasms
Eli Lilly and Company
2021-05-10 PHASE3
NCT04975308 ACTIVE_NOT_RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2021-10-04 PHASE3
NCT04751929 COMPLETED
Prostate Cancer; Metastatic Castration-resistant Prostate Cancer
Dana-Farber Cancer Institute
2021-08-20 PHASE2
NCT06139107 Recruiting
Breast Cancer
Mridula George MD|Rutgers The State University of New Jersey
2024-06-21 Phase 1
NCT06259929 Not yet recruiting
Breast Cancer
Fondazione Oncotech
2024-04-01 Phase 2
NCT04238819 COMPLETED
Relapsed Solid Tumor; Refractory Solid Tumor
Eli Lilly and Company
2020-11-09 PHASE1; PHASE2
NCT05999968 TERMINATED
Prostatic Neoplasms
Eli Lilly and Company
2024-01-12 PHASE1
NCT05288166 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms; Neoplasm Metastasis; Urogenital Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Abiraterone Acetate; Steroid Synthesis Inhibitors; Cytochrome P-450; Enzyme Inhibitors; Prednisone; Prednisolone; Cyclin-Dependent Kinase 4; Cyclin-Dependent Kinase 6
Eli Lilly and Company
2022-04-14 PHASE3
NCT04627064 COMPLETED
Clear Cell Renal Cell Carcinoma
Dana-Farber Cancer Institute
2020-12-31 PHASE1
NCT05169567 ACTIVE_NOT_RECRUITING
Breast Neoplasm; Neoplasm Metastasis
Eli Lilly and Company
2022-03-11 PHASE3
NCT03706365 ACTIVE_NOT_RECRUITING
Prostate Cancer
Eli Lilly and Company
2018-11-26 PHASE2; PHASE3
NCT04118036 WITHDRAWN
Glioblastoma
Dana-Farber Cancer Institute
2021-12-01 PHASE2
NCT05065411 TERMINATED
Metastatic Breast Cancer
Veru Inc.
2022-04-11 PHASE3
NCT04074785 TERMINATED
GBM; Glioblastoma; Brain Tumor; Brain Tumor, Recurrent
University of Texas Southwestern Medical Center
2019-12-13 EARLY_PHASE1
NCT04481113 COMPLETED
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; HER2 Negative Breast Adenocarcinoma; Hormone Receptor Positive Breast Adenocarcinoma; Invasive Breast Carcinoma; Multifocal Breast Carcinoma; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Unilateral Breast Carcinoma
OHSU Knight Cancer Institute
2021-06-07 PHASE1
NCT02644460 COMPLETED
Diffuse Intrinsic Pontine Glioma; Brain Tumor, Recurrent; Solid Tumor, Recurrent; Neuroblastoma, Recurrent, Refractory; Ewing Sarcoma, Recurrent, Refractory; Rhabdomyosarcoma, Recurrent, Refractory; Osteosarcoma, Recurrent, Refractory; Rhabdoid Tumor, Recurrent, Refractory
Emory University
2016-02 PHASE1
NCT04256941 TERMINATED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8
M.D. Anderson Cancer Center
2019-05-31 PHASE2
NCT04003896 TERMINATED
Biliary Tract Carcinoma
Milton S. Hershey Medical Center
2021-09-24 PHASE2
NCT04534283 TERMINATED
Cancer; Cancer Metastatic; BRAF V600E; MEK1 Gene Mutation; MEK2 Gene Mutation; ERK Mutation; RAF1 Gene Mutation
Anita Turk
2020-10-05 PHASE2
NCT04391595 COMPLETED
Glioblastoma; GBM; Glioma
Nader Sanai
2020-07-11 EARLY_PHASE1
NCT03939897 ACTIVE_NOT_RECRUITING
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma; Recurrent Breast Carcinoma
National Cancer Institute (NCI)
2020-06-17 PHASE1
NCT04293393 ACTIVE_NOT_RECRUITING
Early Breast Cancer
Spanish Breast Cancer Research Group
2020-10-02 PHASE2
NCT03099174 COMPLETED
Neoplasms; Breast Neoplasms
Boehringer Ingelheim
2017-05-04 PHASE1
NCT04552769 COMPLETED
Thyroid Cancer; Anaplastic Thyroid Cancer; Undifferentiated Thyroid Cancer
Stanford University
2020-09-10 PHASE2
NCT04049227 COMPLETED
Endometrial Endometrioid Adenocarcinoma
Northwestern University
2019-08-12 EARLY_PHASE1
NCT03654833 COMPLETED
Mesothelioma, Malignant
University of Leicester
2019-01-28 PHASE2
NCT04707196 COMPLETED
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2021-02-22 PHASE4
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
2021-09-23
NCT03356223 COMPLETED
Head and Neck Cancer; Advanced Cancer; Metastatic Cancer
Centre Leon Berard
2018-02-05 PHASE2
NCT04514159 COMPLETED
Breast Cancer
Zeno Alpha Inc.
2020-11-12 PHASE1
NCT04272645 WITHDRAWN
Prostate Cancer
University of Michigan Rogel Cancer Center
2020-10 PHASE2
NCT03781960 TERMINATED
Hepatocellular Carcinoma
Abramson Cancer Center at Penn Medicine
2019-07-31 PHASE2
NCT04408924 COMPLETED
Metastatic Castration-Resistant Prostate Cancer
Eli Lilly and Company
2021-01-20 PHASE2
NCT03988114 WITHDRAWN
Metastatic Breast Cancer
Eli Lilly and Company
2019-09-16 PHASE4
NCT03905889 TERMINATED
Renal Cell Carcinoma Metastatic
Brown University
2019-06-05 PHASE1
NCT04305236 TERMINATED
Breast Neoplasm; Hormone Receptor Positive Breast Carcinoma
University of California, Irvine
2020-07-23 PHASE2
NCT04351230 WITHDRAWN
Anatomic Stage IV Breast Cancer AJCC v8; HER2 Positive Breast Carcinoma; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8
Academic and Community Cancer Research United
2020-11-11 PHASE2
NCT03339843 COMPLETED
Esophageal Adenocarcinoma; Esophagus SCC; Cholangiocarcinoma; Urothelial/Bladder Cancer, Nos; Endometrial Cancer
Jules Bordet Institute
2018-12-19 PHASE2
NCT04585724 WITHDRAWN
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain; Prognostic Stage IV Breast Cancer AJCC v8
Emory University
2020-06-12 PHASE1
NCT03130439 TERMINATED
Breast Cancer
Dana-Farber Cancer Institute
2017-05-26 PHASE2
NCT02057133 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2014-03-10 PHASE1
NCT04071262 COMPLETED
Advanced Cancer
Eli Lilly and Company
2019-12-20 PHASE1
NCT02857270 COMPLETED
Advanced Cancer; Metastatic Melanoma; Metastatic Non-small Cell Lung Cancer; Colorectal Cancer
Eli Lilly and Company
2016-09-29 PHASE1
NCT04088032 WITHDRAWN
Breast Cancer Female; Locally Advanced Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast
Alison Stopeck
2019-10-01 EARLY_PHASE1
NCT03878524 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma
OHSU Knight Cancer Institute
2020-04-01 PHASE1
NCT04165031 TERMINATED
Advanced Solid Tumor; Non-Small Cell Lung Cancer; Colorectal Cancer
Eli Lilly and Company
2019-11-28 PHASE1; PHASE2
NCT03846583 WITHDRAWN
Breast Cancer
Dana-Farber Cancer Institute
2020-06-28 PHASE1
NCT03655444 TERMINATED
Head and Neck Squamous Cell Carcinoma
Washington University School of Medicine
2019-05-29 PHASE1; PHASE2
NCT04031885 TERMINATED
Metastatic Breast Cancer
Eli Lilly and Company
2019-08-14 PHASE4
NCT04220892 WITHDRAWN
High Grade Glioma
Jose Carrillo
2020-07-08 EARLY_PHASE1
NCT04188548 ACTIVE_NOT_RECRUITING
Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Endometrial Cancer
Eli Lilly and Company
2019-12-10 PHASE1
NCT02791334 COMPLETED
Solid Tumor; Microsatellite Instability-High (MSI-H) Solid Tumors; Cutaneous Melanoma; Pancreatic Cancer; Breast Cancer (HR+HER2-)
Eli Lilly and Company
2016-06-29 PHASE1
NCT03938337 TERMINATED
Head and Neck Cancer
University of Alabama at Birmingham
2019-10-08 PHASE2
NCT03155997 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2017-07-12 PHASE3
NCT03292250 COMPLETED
HNSCC; Head and Neck Neoplasms
Seoul National University Hospital
2017-09-10 PHASE2
NCT02779751 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; Breast Cancer
Eli Lilly and Company
2016-11-14 PHASE1
NCT03997448 TERMINATED
Gastroesophageal Cancer; Adenocarcinoma
Nataliya Uboha
2019-08-26 PHASE2
NCT03356587 UNKNOWN
HNSCC; Head and Neck Neoplasms
Seoul National University Hospital
2017-10-16 PHASE2
NCT03703466 COMPLETED
Metastatic Breast Cancer
Eli Lilly and Company
2018-11-28 PHASE2
NCT02675231 COMPLETED
Hormone Receptor Positive Breast Cancer; HER-2 Positive Breast Cancer
Eli Lilly and Company
2016-05-23 PHASE2
NCT01655225 COMPLETED
Advanced Cancer; Metastatic Cancer; Non-Hodgkin's Lymphoma; Metastatic Breast Cancer; Malignant Mesothelioma; Non-small Cell Lung Cancer
Eli Lilly and Company
2012-07-31 PHASE1
NCT02763566 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2016-12-05 PHASE3
NCT02919696 COMPLETED
Advanced Cancer; Metastatic Cancer
Eli Lilly and Company
2017-08-07 PHASE1
NCT02308020 COMPLETED
Breast Cancer; Non-small Cell Lung Cancer; Melanoma; Brain Metastases
Eli Lilly and Company
2015-04-20 PHASE2
NCT02745769 COMPLETED
Advanced Cancer; Colorectal Cancer; Mantle Cell Lymphoma
Eli Lilly and Company
2016-10-21 PHASE1
NCT02784795 TERMINATED
Solid Tumor; Breast Cancer; Colon Cancer; Cholangiocarcinoma; Soft Tissue Sarcoma
Eli Lilly and Company
2016-11-04 PHASE1
NCT02747004 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Eli Lilly and Company
2016-09-14 PHASE2
NCT02079636 COMPLETED
Carcinoma, Non-small Cell Lung
Eli Lilly and Company
2014-03-28 PHASE1
NCT02981342 COMPLETED
Pancreatic Ductal Adenocarcinoma
Eli Lilly and Company
2017-01-12 PHASE2
NCT02688088 COMPLETED
Neoplasm Metastasis
Eli Lilly and Company
2016-03-08 PHASE1
NCT02831530 COMPLETED
Breast Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2016-03-16 PHASE2
NCT02152631 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer
Eli Lilly and Company
2014-10-03 PHASE3
NCT02411591 COMPLETED
Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
Eli Lilly and Company
2015-06-04 PHASE1
NCT02450539 COMPLETED
Non-Small Cell Lung Cancer Stage IV
Eli Lilly and Company
2015-08-06 PHASE2
NCT02107703 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2014-07-22 PHASE3
NCT02246621 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2014-11-06 PHASE3
NCT02884089 COMPLETED
Healthy
Eli Lilly and Company
2016-08 PHASE1
NCT02672423 COMPLETED
Healthy
Eli Lilly and Company
2016-02 PHASE1
NCT02441946 COMPLETED
Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma
Eli Lilly and Company
2015-08 PHASE2
NCT02677844 COMPLETED
Healthy
Eli Lilly and Company
2016-02 PHASE1
NCT02102490 COMPLETED
Metastatic Breast Cancer
Eli Lilly and Company
2014-06-10 PHASE2
NCT01739309 COMPLETED
Mantle Cell Lymphoma
Eli Lilly and Company
2013-03-20 PHASE2
NCT02482935 COMPLETED
Healthy
Eli Lilly and Company
2015-06 PHASE1
NCT02387814 COMPLETED
Hepatic Insufficiency
Eli Lilly and Company
2015-03 PHASE1
NCT02117648 COMPLETED
Neoplasm; Neoplasm Metastasis
Eli Lilly and Company
2014-04 PHASE1
NCT01394016 COMPLETED
Advanced Cancer
Eli Lilly and Company
2009-12-07 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-09-29)

Check the LY2835219 (Abemaciclib) Mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abemaciclib mesylate selectively binds to and inhibits cyclin-dependent kinases 4 and 6, thereby blocking retinoblastoma protein phosphorylation and halting cell cycle progression from the G1 to the S phase. This sustained cell cycle arrest suppresses tumor cell proliferation, driving therapeutic efficacy in clinical trial settings for hormone receptor-positive, HER2-negative breast cancer and other solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.