Clinical Trials

Raloxifene's therapeutic efficacy and safety have been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 for indications including postmenopausal osteoporosis, breast cancer, rheumatoid arthritis, postmenopausal schizophrenia, and perimenopausal depression. Sponsored by major pharmaceutical corporations, academic medical centers, and independent research foundations, these studies focused on outcomes such as bone mineral density, skeletal health, and neurogenic symptoms. Across these investigations, trial statuses encompass completed, active, recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07470606 NOT_YET_RECRUITING
Brain Tumor
The University of Texas Health Science Center at San Antonio
 2026-03 PHASE2
NCT06944145 RECRUITING
BPH (Benign Prostatic Hyperplasia); Lower Urinary Track Symptoms
Beth Israel Deaconess Medical Center
 2025-12-03 PHASE2
NCT06062810 ACTIVE_NOT_RECRUITING
Breast Cancer
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
 2025-06-21 PHASE2; PHASE3
NCT06055179 RECRUITING
Xiao Chai Hu Tang; Irinotecan-induced Diarrhea
Guangzhou University of Traditional Chinese Medicine
 2024-03-08
NCT04926545 COMPLETED
Malignant Tumor; Diarrhea
Guangzhou University of Traditional Chinese Medicine
 2021-07-16
NCT03623633 ACTIVE_NOT_RECRUITING
Osteoporosis, Postmenopausal; Osteoporosis
Massachusetts General Hospital
 2018-11-30 PHASE4
NCT05386784 COMPLETED
Postemenopusal Women With Osteopenia
Yonsei University
 2020-12-16 PHASE4
NCT03147196 WITHDRAWN
Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma
Mayo Clinic
 2017-06-27 PHASE2
NCT03006003 UNKNOWN
Depressive Syndrome
Taichung Veterans General Hospital
 2017-01-01 PHASE4
NCT03043820 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychosis NOS
Iris Sommer
 2016-08 PHASE3
NCT05172050 COMPLETED
SARS CoV 2 Infection
Dompé Farmaceutici S.p.A
 2021-01-22 PHASE2; PHASE3
NCT02517593 COMPLETED
Breast Cancer
Mayo Clinic
 2016-03 PHASE1; PHASE2
NCT02982083 COMPLETED
Rheumatoid Arthritis
Sara Saeidi Shahri
 2015-09
NCT03418831 COMPLETED
Schizophrenia
Shanghai Mental Health Center
 2018-07-17 PHASE4
NCT03824171 COMPLETED
Osteoporosis
Addpharma Inc.
 2019-02-28 PHASE1
NCT03764462 COMPLETED
Osteoporosis
Addpharma Inc.
 2018-12-14 PHASE1
NCT02354001 COMPLETED
Schizophrenia; Schizoaffective Disorder
The Alfred
 2011-04 PHASE4
NCT01481883 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
The Alfred
 2012-01 PHASE4
NCT03010267 COMPLETED
Healthy
Alvogen Korea
 2017-01-03 PHASE1
NCT02762643 COMPLETED
Healthy
Alvogen Korea
 2016-05 PHASE1
NCT02654093 COMPLETED
Healthy
Alvogen Korea
 2016-01 PHASE1
NCT00030147 COMPLETED
Perimenopausal Depression; Depression
National Institute of Mental Health (NIMH)
 2002-02 PHASE4
NCT00723398 COMPLETED
Breast Cancer
Milton S. Hershey Medical Center
 2009-03
NCT00361543 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
The Alfred
 2006-08 PHASE4
NCT01573637 COMPLETED
Schizophrenia in Post Menopausal Women
Fundació Sant Joan de Déu
 2011-07 PHASE3
NCT01607320 TERMINATED
Polycystic Ovarian Syndrome
Bruce Lessey
 2012-06
NCT01280305 UNKNOWN
Schizophrenia; Schizoaffective Disorder
Sheba Medical Center
 2011-03 PHASE3
NCT01535027 COMPLETED
Osteoporosis
Medical University of Vienna
 2006-03 PHASE4
NCT01166958 COMPLETED
Osteoporosis
University of Wisconsin, Madison
 2010-09 PHASE4
NCT01050842 COMPLETED
Prostate Cancer; Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Stage IV Prostate Cancer
Mayo Clinic
 2010-02 EARLY_PHASE1
NCT01973738 Unknown status
Selective Estrogen Receptor Modulator
Toshihiko Kono|Tomidahama Hospital
 2012-01 --
NCT02977949 Unknown status
Selective Estrogen Receptor Modulator (SERM)
Toshihiko Kono|Tomidahama Hospital
 2012-01 --
NCT01544894 COMPLETED
Postmenopausal Osteoporosis; Compliance
University of Valencia
 2009-09 PHASE4
NCT01573637 Completed
Schizophrenia in Post Menopausal Women
Fundació Sant Joan de Déu|Hospital Sant Joan de Deu|Parc Sanitari Sant Joan de Déu|Stanley Medical Research Institute
 2011-07 Phase 3
NCT00368459 COMPLETED
Alzheimer Disease
Stanford University
 2006-08 PHASE2
NCT00205777 COMPLETED
Osteoporosis
Pfizer
 2001-12 PHASE3
NCT00371956 COMPLETED
Osteoporosis
Tuen Mun Hospital
 2006-09 PHASE4
NCT01041092 COMPLETED
Schizophrenia
Fundació Sant Joan de Déu
 2004-06 PHASE4
NCT00427700 COMPLETED
Polycystic Ovary Syndrome
Hospital de Clinicas de Porto Alegre
 2008-08 PHASE3
NCT00431444 COMPLETED
Osteoporosis
Novartis
 2007-01 PHASE4
NCT00383422 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2006-10 PHASE3
NCT00687102 COMPLETED
Cognition; Aging
Wake Forest University
 2001-10 PHASE3
NCT00149604 COMPLETED
Postmenopause
National Institute on Aging (NIA)
 2000-03 PHASE2
NCT00675688 COMPLETED
Endometrial Hyperplasia; Osteoporosis
Wyeth is now a wholly owned subsidiary of Pfizer
 2002-04 PHASE3
NCT00003906 COMPLETED
Breast Cancer
NSABP Foundation Inc
 1999-05 PHASE3
NCT00163137 COMPLETED
Osteoporosis
Ligand Pharmaceuticals
 2003-05 PHASE3
NCT00065767 COMPLETED
Alzheimer Disease
University of Wisconsin, Madison
 2001-09 PHASE2; PHASE3
NCT00431431 COMPLETED
Osteopenia
Organon and Co
 2000-07-31 PHASE4
NCT00481169 COMPLETED
Osteoporosis
Wyeth is now a wholly owned subsidiary of Pfizer
 2001-07 PHASE3
NCT00200174 COMPLETED
Breast Cancer
Memorial Sloan Kettering Cancer Center
 1999-07
NCT00031811 COMPLETED
Breast Cancer; Menopausal Symptoms; Osteoporosis
OHSU Knight Cancer Institute
 2001-03
NCT00389740 COMPLETED
Osteoporosis, Postmenopausal
Organon and Co
 2001-04-02 PHASE3
NCT00004915 COMPLETED
Endometrial Cancer
Northwestern University
 1998-11 PHASE2
NCT00670319 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 1994-11 PHASE3
NCT00532428 COMPLETED
Osteoporosis, Post-Menopausal
Eli Lilly and Company
 2003-04 PHASE4
NCT00026962 COMPLETED
Breast Cancer
National Cancer Institute (NCI)
 1999-09 PHASE2
NCT00019500 COMPLETED
Breast Cancer
National Cancer Institute (NCI)
 1998-12 PHASE2
NCT00310531 COMPLETED
Osteopenia
Bayer
 2004-02 PHASE3
NCT00079924 COMPLETED
Postmenopausal Osteoporosis
Eli Lilly and Company
 2004-11 PHASE4
NCT00206557 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
The Alfred
 2002-10 PHASE2
NCT00190593 COMPLETED
Cardiovascular Diseases; Breast Neoplasms
Eli Lilly and Company
 1998-06 PHASE3
NCT00790101 TERMINATED
Osteoporosis, Postmenopausal
Sanofi
 2004-06 PHASE4
NCT00046137 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 PHASE3
NCT00035971 COMPLETED
Osteoporosis
Eli Lilly and Company
 PHASE4
NCT00532246 COMPLETED
Osteoporosis, Post-Menopausal
Eli Lilly and Company
 2003-03 PHASE4
NCT00191425 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2002-08 PHASE4
NCT00332553 COMPLETED
Vasomotor Symptoms; Endometrial Safety
Eli Lilly and Company
 2002-02 PHASE2
NCT00035256 COMPLETED
Osteoporosis, Postmenopausal
Eli Lilly and Company
 2001-10 PHASE4
NCT00031850 COMPLETED
Breast Cancer
Institute of Cancer Research, United Kingdom
 2000-03
NCT00001848 COMPLETED
Endometriosis; Pelvic Pain
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 1998-11 PHASE2
NCT00108238 COMPLETED
Healthy
US Department of Veterans Affairs
 2003-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-03-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Raloxifene functions as a selective estrogen receptor modulator that binds competitively to estrogen receptors, altering receptor conformation and regulating estrogen-responsive gene transcription in a tissue-specific manner. This dual agonist and antagonist activity inhibits osteoclast-mediated bone resorption while suppressing estrogen-driven cell proliferation, providing clinical relevance in the management of postmenopausal osteoporosis and breast cancer.

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>).

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