Clinical Trials

Anastrozole has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4 protocols. The majority of these studies focus on early, advanced, invasive, and metastatic breast cancer, alongside non-oncological conditions including metabolic syndrome and inguinal hernia. Led by academic research centers, hospital health networks, and pharmaceutical organizations, these initiatives encompass completed, active not recruiting, recruiting, enrolling by invitation, and terminated protocols.

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
NCT05512364 RECRUITING
ER-positive Breast Cancer; HER2-negative Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2023-12-15 PHASE3
NCT06223698 NOT_YET_RECRUITING
Breast Cancer
Region Örebro County
2025-05-02 PHASE3
NCT07729046 NOT_YET_RECRUITING
Metastatic Invasive Breast Cancer; Resistant Breast Cancer; ER+, HER2-, Metastatic Breast Cancer
University of California, San Diego
2027-07 PHASE2
NCT07581834 RECRUITING
Breast Diseases; Breast Neoplasms; Dalpiciclib; Endocrine Breast Diseases; CDK4/6 Inhibitor; HR+/HER2- Breast Cancer
Fujian Cancer Hospital
2026-01-21 PHASE2
NCT07179939 NOT_YET_RECRUITING
HER2-positive Breast Cancer
Fudan University
2025-09-10 PHASE2
NCT07349069 RECRUITING
Breast Cancer
Shandong Suncadia Medicine Co., Ltd.
2026-03-04 PHASE3
NCT06671912 SUSPENDED
Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage 1 Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Estrogen Receptor-Positive Breast Carcinoma; HER2-Negative Breast Carcinoma; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ
Alliance for Clinical Trials in Oncology
2025-02-19 PHASE3
NCT04584853 ACTIVE_NOT_RECRUITING
Breast Cancer Female
Institute of Cancer Research, United Kingdom
2020-12-23 PHASE3
NCT07716046 NOT_YET_RECRUITING
Breast Cancer; HER2-positive Breast Cancer; Hormone Receptor-positive Breast Cancer; HR+/HER2+ Breast Cancer
Fudan University
2026-10-01 PHASE2
NCT05768139 RECRUITING
Breast Cancer; Solid Tumors, Adult
Eli Lilly and Company
2023-04-17 PHASE1; PHASE2
NCT05161195 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Novartis Pharmaceuticals
2022-07-07 PHASE4
NCT04134598 ACTIVE_NOT_RECRUITING
Breast Cancer
Azienda Ospedaliero-Universitaria Careggi
2021-02-08 PHASE3
NCT05952557 ACTIVE_NOT_RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
2023-10-05 PHASE3
NCT05645536 ENROLLING_BY_INVITATION
Breast Cancer
Tolmar Inc.
2022-12-28 PHASE3
NCT06380751 RECRUITING
Advanced Breast Cancer
AstraZeneca
2024-08-01 PHASE3
NCT07164976 RECRUITING
Breast Cancer
Nagoya City University
2025-10-01 PHASE1; PHASE2
NCT06492616 RECRUITING
Breast Cancer
Stemline Therapeutics, Inc.
2024-09-27 PHASE3
NCT07391774 RECRUITING
Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Estrogen Receptor-Positive Breast Carcinoma; HER2-Negative Breast Carcinoma
National Cancer Institute (NCI)
2026-08-10 PHASE3
NCT07061717 NOT_YET_RECRUITING
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2025-07-01 PHASE3
NCT06507618 RECRUITING
Breast Cancer Female
University of Virginia
2024-07-19 PHASE3
NCT07174336 RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2025-12-22 PHASE3
NCT05524584 RECRUITING
Breast Cancer; Metastatic Breast Cancer; Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer
University of California, Irvine
2022-08-31 PHASE2
NCT06072781 RECRUITING
Low Grade Serous Ovarian Cancer
Verastem, Inc.
2024-03-18 PHASE3
NCT06086704 RECRUITING
Breast Cancer
University of Wisconsin, Madison
2024-09-25 PHASE2
NCT05467891 RECRUITING
Locoregional Recurrence; Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer
Oana Danciu
2022-09-13 PHASE2
NCT07604272 RECRUITING
Inguinal Hernia Unilateral; Inguinal Hernia Bilateral; Inguinal Hernia Without Obstruction or Gangrene; Inguinal Hernia, Without Mention of Obstruction or Gangrene
Northwestern University
2026-07-31 PHASE1
NCT02942355 ACTIVE_NOT_RECRUITING
Female Breast Carcinoma; Breast Cancer
Wake Forest University Health Sciences
2016-12-07 PHASE2
NCT02918084 ACTIVE_NOT_RECRUITING
Breast Cancer
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
2013-06 PHASE3
NCT05891093 RECRUITING
Breast Cancer
Fudan University
2023-06-01 PHASE3
NCT07568574 ENROLLING_BY_INVITATION
Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
Enhanced Emirates Limited
2026-03-12
NCT05837455 RECRUITING
Breast Cancer; Cancer of the Breast
Washington University School of Medicine
2024-05-30 PHASE2
NCT05514054 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2022-10-04 PHASE3
NCT04985266 RECRUITING
ER+ Breast Cancer; HER2-negative Breast Cancer
Royal Marsden NHS Foundation Trust
2022-03-30 PHASE2
NCT03304080 ACTIVE_NOT_RECRUITING
Breast Neoplasms; Breast Diseases
Icahn School of Medicine at Mount Sinai
2017-12-20 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
NCT05586802 RECRUITING
Klinefelter Syndrome
Georgios Papadakis
2023-03-21 PHASE3
NCT05774951 RECRUITING
Breast Cancer, Early Breast Cancer
AstraZeneca
2023-03-31 PHASE3
NCT05472792 RECRUITING
Breast Cancer; Quality of Life
UNC Lineberger Comprehensive Cancer Center
2022-05-17 PHASE2
NCT01953588 ACTIVE_NOT_RECRUITING
Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Carcinoma; Recurrent Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
Alliance for Clinical Trials in Oncology
2014-02-27 PHASE3
NCT05501704 RECRUITING
Male Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma
Jose Pablo Leone
2023-10-11 PHASE2
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
NCT02476786 RECRUITING
Breast Cancer; Cancer of Breast; Breast Neoplasms; Cancer of the Breast
Washington University School of Medicine
2017-01-17 PHASE2
NCT07212712 NOT_YET_RECRUITING
Cerebral Blood Flow; Cerebral Blood Flow Regulation; Sex Differences; Exercise; Vascular
University of British Columbia
2026-04-01
NCT04553770 RECRUITING
Early-stage Breast Cancer; Hormone Receptor Positive Breast Carcinoma; Invasive Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer
Jonsson Comprehensive Cancer Center
2020-10-09 PHASE2
NCT04886531 RECRUITING
Breast Cancer; HER2-positive Breast Cancer; ER Positive Breast Cancer; PR-Positive Breast Cancer
Ruth O'Regan
2022-07-21 PHASE2
NCT07024173 RECRUITING
Locally Advanced Breast Cancer; Metastatic Breast Cancer
Shandong Suncadia Medicine Co., Ltd.
2025-07-23 PHASE3
NCT05307705 RECRUITING
Breast Cancer
Eli Lilly and Company
2022-05-11 PHASE1
NCT07163481 NOT_YET_RECRUITING
Stage IV (Metastatic) Breast Cancer
Hunan Cancer Hospital
2025-10 PHASE1
NCT05780567 ACTIVE_NOT_RECRUITING
Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
2023-03-30 PHASE3
NCT06016738 ACTIVE_NOT_RECRUITING
Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma
Olema Pharmaceuticals, Inc.
2023-11-16 PHASE3
NCT04711252 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
2021-01-28 PHASE3
NCT05238831 WITHDRAWN
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; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
OHSU Knight Cancer Institute
2023-01-30 EARLY_PHASE1
NCT04906395 ACTIVE_NOT_RECRUITING
Breast Cancer
Tolmar Inc.
2021-07-01 PHASE3
NCT05150652 COMPLETED
Breast Cancer; HER2-negative Breast Cancer; Node-negative Breast Cancer; Breast Carcinoma
Irada Ibrahim-zada
2022-02-18 PHASE2
NCT05257395 ACTIVE_NOT_RECRUITING
Advanced Breast Cancer
Xuanzhu Biopharmaceutical Co., Ltd.
2022-03-14 PHASE3
NCT06235931 RECRUITING
Breast Neoplasms
Second Affiliated Hospital of Soochow University
2024-02-01
NCT05190094 RECRUITING
Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer
International Cancer Research Group, United Arab Emirates
2022-12-20 PHASE2
NCT05896566 COMPLETED
Breast Cancer
ETOP IBCSG Partners Foundation
2024-01-23 PHASE2
NCT04964934 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
2021-06-30 PHASE3
NCT06957379 ACTIVE_NOT_RECRUITING
HR+/HER2- Advanced/Metastatic Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2024-02-29 PHASE2
NCT03490513 COMPLETED
Hypogonadism, Hypogonadotropic; Obesity
Baylor College of Medicine
2018-04-15 PHASE4
NCT06253702 COMPLETED
Cerebrovascular Disorders
University of Wisconsin, Madison
2024-07-24 PHASE4
NCT04158362 ACTIVE_NOT_RECRUITING
Cancer Metastatic
UNICANCER
2020-06-11 PHASE3
NCT04719273 COMPLETED
Refractory Endometrial Adenocarcinoma; Refractory Endometrial Carcinoma; Refractory Endometrial Clear Cell Adenocarcinoma; Refractory Endometrial Endometrioid Adenocarcinoma; Refractory Endometrial Mixed Cell Adenocarcinoma; Refractory Endometrial Serous Adenocarcinoma; Refractory Endometrial Undifferentiated Carcinoma
Thomas Jefferson University
2021-01-28 PHASE2
NCT02344472 UNKNOWN
Metastatic Breast Cancer
Prof. Wolfgang Janni
2015-09 PHASE3
NCT04113863 TERMINATED
Breast Neoplasm Female
Mario Negri Institute for Pharmacological Research
2019-06-18 PHASE2
NCT06001762 ACTIVE_NOT_RECRUITING
Breast Cancer; Early-stage Breast Cancer; High Risk Breast Carcinoma
Dana-Farber Cancer Institute
2023-10-05 PHASE2
NCT00887380 UNKNOWN
Breast Cancer
Trans Tasman Radiation Oncology Group
2009-09-16 PHASE3
NCT02947685 ACTIVE_NOT_RECRUITING
HER-2 Positive Breast Cancer; Estrogen Receptor Positive Breast Cancer
Alliance Foundation Trials, LLC.
2017-06-21 PHASE3
NCT05439499 UNKNOWN
Advanced Breast Cancer; Female Breast Cancer
Ahon Pharmaceutical Co., Ltd.
2022-03-02 PHASE3
NCT03616587 ACTIVE_NOT_RECRUITING
ER+ HER2- Advanced Breast Cancer
AstraZeneca
2018-10-11 PHASE1
NCT03909152 COMPLETED
Granulosa Cell Ovarian Cancer; Low Grade Serous Ovarian/ Primary Peritoneal Cancer; Endometrioid Endometrial Cancer
Memorial Sloan Kettering Cancer Center
2019-05-02 PHASE2
NCT04666961 RECRUITING
Ductal Carcinoma in Situ; Extensive Disease; Mastectomy
Institut Cancerologie de l'Ouest
2021-02-03 PHASE2
NCT03179904 COMPLETED
Advanced Breast Carcinoma; HER2-Positive Breast Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; HER2-positive Breast Cancer
Mayo Clinic
2017-08-03 PHASE2
NCT02095184 TERMINATED
Breast Cancer
University of Maryland, Baltimore
2015-05-25
NCT02206984 COMPLETED
Breast Cancer
Priscilla McAuliffe
2015-09-30 PHASE2
NCT05549505 COMPLETED
Breast Cancer
Arvinas Inc.
2023-02-15 PHASE2
NCT06154590 Not yet recruiting
Metastatic Breast Cancer|Tumor|Muscle Neoplasms|Chronic Pain
DR. DIANE CHISESI NFS. MD. PHD.|IRB|Paradyne Networks A Foundation
2024-07 --
NCT04272801 ACTIVE_NOT_RECRUITING
Breast Cancer Female
Shayna Showalter, MD
2020-04-07 PHASE2
NCT02097459 UNKNOWN
Breast Cancer
Peking Union Medical College Hospital
2014-03 PHASE3
NCT05792410 UNKNOWN
HER2 Low Advanced or Metastatic Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.
2023-04 PHASE1; PHASE2
NCT02188745 COMPLETED
Metastatic Breast Cancer
Dartmouth-Hitchcock Medical Center
2016-03-11 PHASE2
NCT03554044 COMPLETED
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Positive; HER2/Neu Negative; Invasive Breast Carcinoma; 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; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Breast Carcinoma
University of California, San Francisco
2020-02-05 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
NCT04556773 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
AstraZeneca
2020-12-17 PHASE1
NCT04539496 ACTIVE_NOT_RECRUITING
Metastasis Solid Tumors; Advanced Breast Cancer
Sihuan Pharmaceutical Holdings Group Ltd.
2018-05-22 PHASE1; PHASE2
NCT03099174 COMPLETED
Neoplasms; Breast Neoplasms
Boehringer Ingelheim
2017-05-04 PHASE1
NCT03238703 WITHDRAWN
HER2/Neu Negative; Invasive Breast Carcinoma; Postmenopausal; Stage 0 Breast Cancer; Stage IA Breast Cancer
Fred Hutchinson Cancer Center
2018-09-01 PHASE4
NCT04836520 COMPLETED
Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
2021-08-02 PHASE2
NCT02894398 COMPLETED
Breast Cancer; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
iOMEDICO AG
2016-09-06 PHASE2
NCT01272037 ACTIVE_NOT_RECRUITING
Breast Ductal Carcinoma In Situ; Invasive Breast Carcinoma; Multicentric Breast Carcinoma; Multifocal Breast Carcinoma; Synchronous Bilateral Breast Carcinoma
National Cancer Institute (NCI)
2011-02-28 PHASE3
NCT04707196 COMPLETED
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2021-02-22 PHASE4
NCT04236310 UNKNOWN
Breast Cancer; HER2-positive Breast Cancer; ER-positive Breast Cancer
Ruijin Hospital
2020-01-15 PHASE2
NCT03966898 UNKNOWN
Advanced Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.
2019-07-19 PHASE3
NCT04294225 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 III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Early-Stage Breast Carcinoma; 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
Mayo Clinic
2020-04-28 PHASE2
NCT01674140 ACTIVE_NOT_RECRUITING
Breast Cancer
SWOG Cancer Research Network
2013-09-12 PHASE3
NCT00253422 COMPLETED
Breast Cancer
Institute of Cancer Research, United Kingdom
2004-03-26 PHASE3
NCT05167643 UNKNOWN
Advanced HR+ HER2 Negative Breast Carcinoma
Tianjin Medical University Cancer Institute and Hospital
2022-01-23
NCT03691493 COMPLETED
Anatomic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Positive; HER2/Neu Negative; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Bone; Progesterone Receptor Positive; Prognostic Stage IV Breast Cancer AJCC v8
Emory University
2019-02-08 PHASE2
NCT03481998 COMPLETED
Advanced Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.
2018-03-22 PHASE1; PHASE2
NCT03229499 COMPLETED
Pulmonary Arterial Hypertension
University of Pennsylvania
2017-12-07 PHASE2
NCT03555877 COMPLETED
Breast Cancer Metastatic
GBG Forschungs GmbH
2018-03-15 PHASE2
NCT01824836 ACTIVE_NOT_RECRUITING
Estrogen Receptor-positive Breast Cancer; Musculoskeletal Complications; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
ECOG-ACRIN Cancer Research Group
2013-06-11
NCT00738777 SUSPENDED
Breast Cancer
The Netherlands Cancer Institute
2008-07 PHASE2
NCT03312738 COMPLETED
Advanced Breast Cancer
Novartis Pharmaceuticals
2017-09-15 PHASE2
NCT03839823 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2019-02-25 PHASE2
NCT02648477 COMPLETED
Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; Progesterone Receptor Negative; Progesterone Receptor Positive; Stage IV Breast Cancer; Triple-Negative Breast Carcinoma
City of Hope Medical Center
2016-03-28 PHASE2
NCT00301457 COMPLETED
Breast Cancer
Maastricht University Medical Center
2006-06 PHASE3
NCT03988114 WITHDRAWN
Metastatic Breast Cancer
Eli Lilly and Company
2019-09-16 PHASE4
NCT04059484 TERMINATED
Breast Cancer Metastatic
Sanofi
2019-10-22 PHASE2
NCT03220178 TERMINATED
Breast Neoplasm
Palleos Healthcare GmbH
2017-07-24 PHASE4
NCT02440230 COMPLETED
Breast Cancer
Shanghai Jiao Tong University School of Medicine
2015-05 PHASE2
NCT04075604 COMPLETED
Breast Cancer; Cancer
Bristol-Myers Squibb
2019-10-18 PHASE2
NCT04436744 COMPLETED
Early Breast Cancer
Hoffmann-La Roche
2020-09-04 PHASE2
NCT03822468 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2019-06-11 PHASE2
NCT04714619 Terminated
Advanced Breast Cancer
MedSIR|Cellestia Biotech AG
2021-05-06 Phase 2
NCT01723774 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Washington University School of Medicine
2013-04-10 PHASE2
NCT02057133 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Eli Lilly and Company
2014-03-10 PHASE1
NCT04757532 COMPLETED
Healthy Volunteers
Parc de Salut Mar
2020-12-03 PHASE1
NCT02269670 TERMINATED
Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
Emory University
2014-11-25 PHASE2
NCT01197170 COMPLETED
Solid Tumors; Advanced Cancer
M.D. Anderson Cancer Center
2010-09-07 PHASE1
NCT02109913 UNKNOWN
Hormone Receptor Positive Malignant Neoplasm of Breast; Metastatic Breast Cancer
Amsterdam UMC, location VUmc
2014-03
NCT03874325 TERMINATED
Breast Cancer; Hormone Receptor Positive Tumor
H. Lee Moffitt Cancer Center and Research Institute
2019-04-26 PHASE2
NCT04438733 UNKNOWN
Healthy Volunteers
The Affiliated Hospital of Qingdao University
2020-06-18 PHASE1
NCT04445922 UNKNOWN
Healthy Volunteers
The Affiliated Hospital of Qingdao University
2020-07-04 PHASE1
NCT03272477 COMPLETED
Breast Neoplasms
Palleos Healthcare GmbH
2017-10-05 PHASE2
NCT00541086 UNKNOWN
Breast Cancer
Gruppo Italiano Mammella (GIM)
2007-03 PHASE3
NCT02730091 TERMINATED
Breast Cancer
Centre Hospitalier Universitaire de Besancon
2016-02-24 PHASE3
NCT03024580 UNKNOWN
Breast Neoplasm
Instituto Nacional de Cancer, Brazil
2017-03-06 PHASE2
NCT03219476 COMPLETED
Breast Cancer; Invasive Breast Cancer
Medical College of Wisconsin
2017-02-05 PHASE2
NCT02779751 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; Breast Cancer
Eli Lilly and Company
2016-11-14 PHASE1
NCT04227327 Active not recruiting
Advanced Breast Cancer
University of Milano Bicocca
2020-01-07 Phase 2
NCT02137837 TERMINATED
Breast Cancer
SWOG Cancer Research Network
2014-05 PHASE3
NCT02730923 UNKNOWN
Endometrial Carcinoma; Metastatic Carcinoma; Hormone Receptor Positive Tumor
Centre Leon Berard
2016-04 PHASE1; PHASE2
NCT02476955 TERMINATED
Solid Tumors; Ovarian Cancer; Endometrial Cancer
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
2015-06-09 PHASE1
NCT02089854 UNKNOWN
Female Breast Cancer
Peking Union Medical College Hospital
2014-11 PHASE4
NCT02763566 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2016-12-05 PHASE3
NCT02291913 COMPLETED
Breast Cancer
SCRI Development Innovations, LLC
2014-12-18 PHASE2
NCT00256217 COMPLETED
DCIS
Rita Sanghvi, Mehta
2004-09-21 PHASE2
NCT02689921 UNKNOWN
Breast Neoplasms
Midwestern Regional Medical Center
2016-04 PHASE2
NCT01783444 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2013-02-26 PHASE2
NCT02137538 COMPLETED
Short Stature
Stanford University
2009-11-18 PHASE4
NCT01266213 UNKNOWN
Metastatic Breast Cancer; Estrogen Receptor Positive Tumor; Breast Cancer Nos Premenopausal
Samsung Medical Center
2010-12 PHASE2
NCT01989780 COMPLETED
Metastatic Breast Cancer
Japan Breast Cancer Research Group
2014-01 PHASE2
NCT03314298 COMPLETED
Mammographic Density
Havah Therapeutics Pty Ltd
2017-08-14 PHASE1
NCT03264651 COMPLETED
Mammographic Density
Havah Therapeutics Pty Ltd
2017-02-01 PHASE1
NCT00310180 ACTIVE_NOT_RECRUITING
Breast Adenocarcinoma; Hormone Receptor Positive; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIB Breast Cancer AJCC v7
National Cancer Institute (NCI)
2006-04-07 PHASE3
NCT01216176 COMPLETED
Breast Cancer
Joyce Marie Slingerland, MD
2008-10-21 PHASE1; PHASE2
NCT01127295 COMPLETED
Hormono-depending Adjuvant Breast Cancer
Institut Claudius Regaud
2010-06-17 PHASE4
NCT00077168 UNKNOWN
Breast Cancer
Institute of Cancer Research, United Kingdom
2004-04 PHASE2
NCT02278120 COMPLETED
Advanced Metastatic Breast Cancer
Novartis Pharmaceuticals
2014-11-20 PHASE3
NCT00295620 COMPLETED
Breast Cancer
AstraZeneca
2004-03-01 PHASE3
NCT02585388 TERMINATED
Breast Cancer
ARCAGY/ GINECO GROUP
2015-10-23 PHASE2
NCT01234532 TERMINATED
Estrogen Receptor-negative Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Triple-negative Breast Cancer
University of Maryland, Baltimore
2010-10 PHASE2
NCT00437359 TERMINATED
Breast Neoplasms
Japan Breast Cancer Research Network
2007-05 PHASE2
NCT03933618 COMPLETED
Hypogonadism, Male
Albany Medical College
2015-04-02 PHASE2
NCT02549430 COMPLETED
Breast Cancer
Fondazione Sandro Pitigliani
2012-10 PHASE2
NCT02246621 ACTIVE_NOT_RECRUITING
Breast Cancer
Eli Lilly and Company
2014-11-06 PHASE3
NCT01791985 COMPLETED
Breast Cancer
Imperial College London
2012-07 PHASE1; PHASE2
NCT02203331 COMPLETED
Endometriosis
Bayer
2014-10-16 PHASE2
NCT01862835 COMPLETED
Normal Healthy Volunteers
Mayo Clinic
2013-05 PHASE1
NCT02441946 COMPLETED
Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma
Eli Lilly and Company
2015-08 PHASE2
NCT01520467 UNKNOWN
Silver Russell Syndrome; Prader-Willi Syndrome
Assistance Publique - Hôpitaux de Paris
2012-04
NCT00543127 TERMINATED
Breast Cancer
Spanish Breast Cancer Research Group
2007-11 PHASE3
NCT01602380 COMPLETED
Hormone Receptor Positive Breast Cancer
AstraZeneca
2012-10-17 PHASE3
NCT02545452 COMPLETED
Endometriosis
Bayer
2015-09-15 PHASE1
NCT02269072 WITHDRAWN
Hypertension
Massachusetts General Hospital
2015-02
NCT01763541 WITHDRAWN
Hypertension
Massachusetts General Hospital
2014-06 EARLY_PHASE1
NCT01612871 COMPLETED
Breast Cancer
Institut Claudius Regaud
2012-06-27 PHASE4
NCT01597193 COMPLETED
Breast Cancer
Pfizer
2012-04-30 PHASE1
NCT00072462 COMPLETED
Breast Cancer
Queen Mary University of London
2003-09 PHASE3
NCT02140437 WITHDRAWN
Carcinoma Breast Stage IV
Fudan University
2014-03 PHASE2
NCT02026973 COMPLETED
Normal Healthy Volunteers
Mayo Clinic
2014-03 PHASE1
NCT02000596 TERMINATED
Metastatic Breast Cancer
University of Maryland, Baltimore
2014-01 PHASE2
NCT02072512 UNKNOWN
Metastatic Breast Cancer
Hospital Affiliated to Military Medical Science, Beijing
2014-01 PHASE2
NCT00629616 COMPLETED
Breast Cancer
UNICANCER
2007-10 PHASE2
NCT01545336 COMPLETED
Pulmonary Arterial Hypertension
University of Pennsylvania
2012-10 PHASE2
NCT00661531 TERMINATED
Breast Cancer; Cancer of the Breast; Neoplasms, Breast
Georgetown University
2008-04 PHASE2
NCT01776008 TERMINATED
Estrogen Receptor Positive; HER2/Neu Negative; Recurrent Breast Carcinoma; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
National Cancer Institute (NCI)
2013-01 PHASE2
NCT02093351 COMPLETED
Solid Tumours
AstraZeneca
2014-09-01 PHASE1
NCT00921115 COMPLETED
Invasive Breast Cancer
University of Kansas Medical Center
2009-05 PHASE2
NCT01720602 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
University of Washington
2012-11
NCT00053898 COMPLETED
Breast Cancer
NSABP Foundation Inc
2003-01 PHASE3
NCT00863655 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2009-06-03 PHASE3
NCT00248170 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2005-12 PHASE3
NCT01972984 COMPLETED
Breast Cancer
Ottawa Hospital Research Institute
2012-10 PHASE2
NCT01381874 COMPLETED
Metastatic ER+ Her2- Breast Cancer; Postmenopausal
Janssen Research & Development, LLC
2011-08-24 PHASE2
NCT00440180 TERMINATED
Obesity; Oligospermia
University of Utah
2007-03 PHASE3
NCT00104572 COMPLETED
Hypogonadism; Diabetes; Sarcopenia; Osteoporosis; Depression
National Institute on Aging (NIA)
2004-03 PHASE2
NCT00078832 COMPLETED
Breast Cancer
Queen Mary University of London
2003-09 PHASE3
NCT00871858 COMPLETED
Breast Cancer
Institut Bergonié
2008-03-18 PHASE2
NCT01262274 TERMINATED
Breast Neoplasms
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
2010-12 PHASE2
NCT00077025 COMPLETED
Breast Cancer
AstraZeneca
2004-01 PHASE2
NCT01280045 TERMINATED
UTERINE LEIOMYOMA
University of Sao Paulo
2011-01
NCT01368263 TERMINATED
Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
Washington University School of Medicine
2011-09 PHASE2
NCT01553903 COMPLETED
Breast Cancer
Institut Claudius Regaud
2011-12 PHASE4
NCT00688194 UNKNOWN
Breast Cancer
Gruppo Italiano Mammella (GIM)
2008-05 PHASE3
NCT00186121 COMPLETED
Breast Cancer
Stanford University
2000-10 PHASE2
NCT00573755 TERMINATED
Breast Cancer
Mayo Clinic
2007-12 PHASE2
NCT00122356 COMPLETED
Breast Cancer
Barwon Health
2005-09 PHASE3
NCT00932152 TERMINATED
Non-small Cell Lung Cancer; Postmenopausal Women
University of Pittsburgh
2010-09 PHASE2
NCT01151215 TERMINATED
Neoplasms; Breast Neoplasms; Breast Cancer
AstraZeneca
2010-06 PHASE2
NCT00075764 COMPLETED
Breast Cancer
SWOG Cancer Research Network
2004-04 PHASE3
NCT01231659 COMPLETED
Postmenopausal Women; Locally Advanced Metastatic Breast Cancer; Metastatic Breast Cancer
Novartis Pharmaceuticals
2011-08-09 PHASE2
NCT00265759 COMPLETED
Breast Cancer
Alliance for Clinical Trials in Oncology
2006-01 PHASE3
NCT01153672 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
University of Washington
2010-11
NCT01568281 COMPLETED
Safety; Pharmacokinetics
AstraZeneca
2012-04 PHASE1
NCT00057941 COMPLETED
Estrogen Receptor-positive Breast Cancer; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
2003-09 PHASE2
NCT00684216 TERMINATED
Breast Cancer
The Netherlands Cancer Institute
2008-04 PHASE2; PHASE3
NCT01394211 TERMINATED
Estrogen Receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Male Breast Cancer; Recurrent Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer
University of Arizona
2011-07-13 PHASE2
NCT00893061 COMPLETED
Breast Cancer
Centre Oscar Lambret
2009-03-16 PHASE3
NCT01215292 COMPLETED
Healthy Males
University of Washington
2011-01 PHASE1; PHASE2
NCT00728949 COMPLETED
Metastatic Breast Cancer
Eli Lilly and Company
2008-08 PHASE2
NCT00537771 COMPLETED
Breast Cancer
AstraZeneca
2007-09 PHASE4
NCT00555477 TERMINATED
Breast Cancer
University of Michigan Rogel Cancer Center
2007-08 PHASE2
NCT01344031 COMPLETED
Estrogen Receptor Positive; Invasive Breast Carcinoma; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
2011-04-21 PHASE1
NCT00944918 COMPLETED
Progression-free Survival
AstraZeneca
2008-12 PHASE3
NCT00354302 COMPLETED
Breast Cancer; Osteoporosis
NCIC Clinical Trials Group
2006-04-24 PHASE3
NCT00433173 SUSPENDED
Metabolic Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2006-05
NCT00612560 COMPLETED
Breast Cancer
Roswell Park Cancer Institute
2007-11
NCT00143390 COMPLETED
Breast Neoplasms
Pfizer
2005-04 PHASE3
NCT00066573 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
2003-06-06 PHASE3
NCT03118479 TERMINATED
Hypogonadotropic Hypogonadism; Kallmann Syndrome
Massachusetts General Hospital
2010-05 PHASE1
NCT00519883 UNKNOWN
Musculoskeletal Symptoms
British Columbia Cancer Agency
2007-12 PHASE3
NCT00405938 COMPLETED
Breast Cancer; Breast Neoplasms
SCRI Development Innovations, LLC
2006-11 PHASE2
NCT00902954 UNKNOWN
Breast Cancer
Fudan University
2008-03 PHASE3
NCT00729859 COMPLETED
Healthy
University of Washington
2008-12 PHASE2
NCT00687648 UNKNOWN
Breast Cancer
National Cancer Centre, Singapore
2008-05 PHASE2
NCT00438321 TERMINATED
Metabolic Syndrome
Massachusetts General Hospital
2006-09 PHASE1
NCT00481845 TERMINATED
Breast Cancer
Stanford University
2008-01 PHASE2
NCT00588003 COMPLETED
Breast Cancer
Memorial Sloan Kettering Cancer Center
2004-03 PHASE1
NCT00605267 COMPLETED
Breast Cancer
AstraZeneca
2007-10 PHASE3
NCT00263185 COMPLETED
Breast Neoplasms
Washington University School of Medicine
2005-11 EARLY_PHASE1
NCT01004744 COMPLETED
Invasive Breast Cancer
Columbia University
2007-07
NCT00217399 COMPLETED
Recurrent Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
2005-06 PHASE1; PHASE2
NCT00688909 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2008-03 PHASE4
NCT00291759 COMPLETED
Breast Cancer
AstraZeneca
1996-01 PHASE3
NCT00081510 COMPLETED
Breast Cancer
Merck Sharp & Dohme LLC
2003-12 PHASE2
NCT00256698 COMPLETED
Breast Cancer
AstraZeneca
2004-01 PHASE3
NCT00323479 COMPLETED
Early Breast Cancer
AstraZeneca
2006-06 PHASE4
NCT00354640 COMPLETED
Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2006-06 PHASE2
NCT00357110 COMPLETED
Breast Cancer
AstraZeneca
2006-04 PHASE2
NCT00259090 COMPLETED
Breast Cancer
AstraZeneca
2004-04 PHASE2
NCT00136695 COMPLETED
Hypogonadism
Massachusetts General Hospital
2004-10 PHASE2
NCT01105299 COMPLETED
Healthy
Asan Medical Center
2008-06
NCT01155960 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2008-05 PHASE1
NCT01155947 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2008-05 PHASE1
NCT00094328 COMPLETED
Puberty, Precocious
AstraZeneca
2004-11-22 PHASE2
NCT00179517 COMPLETED
Seizure Disorder; Hypogonadism; Erectile Dysfunction
Beth Israel Deaconess Medical Center
2001-06 PHASE2
NCT00295646 COMPLETED
Breast Cancer
Austrian Breast & Colorectal Cancer Study Group
1999-06 PHASE3
NCT00274469 COMPLETED
Metastatic Breast Cancer
AstraZeneca
2006-02-06 PHASE2
NCT00005908 COMPLETED
Breast Cancer; Breast Neoplasm
National Cancer Institute (NCI)
2000-06 PHASE2
NCT00329940 COMPLETED
Breast Cancer
Novartis Pharmaceuticals
2005-11 PHASE3
NCT00213148 COMPLETED
Anovulation
EMD Serono
2005-03-10 PHASE2
NCT00544986 COMPLETED
Breast Cancer
AstraZeneca
2005-06 PHASE4
NCT00049062 COMPLETED
Breast Cancer
The University of Texas Health Science Center at San Antonio
2002-09 PHASE2
NCT00082277 COMPLETED
Breast Cancer
AstraZeneca
2004-04 PHASE4
NCT00244959 COMPLETED
Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2004-01 PHASE2
NCT00467493 COMPLETED
Menstruation Disorders
Meditrina Pharmaceuticals
2007-03 PHASE2
NCT00066378 COMPLETED
Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2003-05 PHASE2
NCT01016665 COMPLETED
Breast Cancer
Federal University of São Paulo
2005-04
NCT00303615 TERMINATED
Metastatic Breast Cancer
Legacy Health System
2005-06 PHASE2
NCT00217659 WITHDRAWN
Breast Cancer
SWOG Cancer Research Network
2005-09 PHASE2
NCT00241436 COMPLETED
Gynecomastia
AstraZeneca
2005-06 PHASE2
NCT00133354 COMPLETED
Hypopituitarism
Nemours Children's Clinic
2001-11 PHASE2; PHASE3
NCT01155089 COMPLETED
Breast Cancer
Roxane Laboratories
2006-05
NCT01155102 COMPLETED
Breast Cancer
Roxane Laboratories
2006-04
NCT00181688 COMPLETED
Ovarian Cancer; Peritoneal Carcinoma; Tubal Carcinoma
Massachusetts General Hospital
2003-10 PHASE2
NCT00055302 COMPLETED
McCune-Albright Syndrome
AstraZeneca
2002-08 PHASE2
NCT01183390 COMPLETED
Healthy
Teva Pharmaceuticals USA
2005-09 PHASE1
NCT01182181 COMPLETED
Healthy
Teva Pharmaceuticals USA
2005-08 PHASE1
NCT00128843 COMPLETED
Breast Cancer
Spanish Breast Cancer Research Group
2001-08 PHASE2
NCT00784940 COMPLETED
Bone Density
AstraZeneca
1998-06 PHASE3
NCT00053911 TERMINATED
Breast Cancer
UNICANCER
2002-11 PHASE3
NCT00066339 COMPLETED
Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2003-05 PHASE2
NCT00637182 COMPLETED
Gynecomastia
AstraZeneca
2001-01 PHASE3
NCT00814125 COMPLETED
Breast Cancer
AstraZeneca
1997-06 PHASE3
NCT00004900 COMPLETED
Breast Cancer
Hackensack Meridian Health
1999-10 PHASE2
NCT00004906 COMPLETED
Breast Cancer
Hackensack Meridian Health
1999-10 PHASE2
NCT00382057 WITHDRAWN
Metabolic Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2006-05 PHASE2
NCT00437853 COMPLETED
Breast Cancer
Instituto Nacional de Cancerologia de Mexico
2003-06
NCT00327769 COMPLETED
Advanced Breast Cancer
AstraZeneca
2005-11 PHASE3
NCT00784862 COMPLETED
Breast Cancer
AstraZeneca
1998-06 PHASE3
NCT00126360 UNKNOWN
Breast Cancer
St George Hospital, Australia
2005-08 PHASE4
NCT00235937 COMPLETED
Breast Cancer
AstraZeneca
2001-12 PHASE2
NCT00255463 COMPLETED
Breast Cancer
AstraZeneca
2004-01 PHASE2
NCT00398489 UNKNOWN
Breast Cancer
Technical University of Munich
2006-10 PHASE2
NCT00300508 COMPLETED
Breast Neoplasms
AstraZeneca
1996-01 PHASE3
NCT00635713 COMPLETED
Advanced Breast Cancer
AstraZeneca
1997-05 PHASE3
NCT00287534 COMPLETED
Breast Cancer
AstraZeneca
1996-11 PHASE2
NCT00324714 WITHDRAWN
Breast Cancer; Osteoporosis
ETOP IBCSG Partners Foundation
2003-02 PHASE3
NCT00784680 COMPLETED
Quality of Life
AstraZeneca
1998-04 PHASE3
NCT00286117 COMPLETED
Breast Cancer
AstraZeneca
1998-03 PHASE3

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

Check the Anastrozole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anastrozole reversibly binds to aromatase via competitive inhibition, effectively blocking the peripheral conversion of circulating precursor androgens into estrogens. This targeted estrogen depletion suppresses estrogen receptor-mediated cell proliferation and hyperplastic signaling, thereby inhibiting hormone-driven tumor growth in clinical breast cancer indications.

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.