Clinical Trials

Finasteride has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 and non-interventional designs, primarily targeting urological and dermatological conditions such as benign prostatic hyperplasia, lower urinary tract symptoms, prostate disease, and androgenetic alopecia. Academic, government, and commercial sponsors—including the National Institute of Diabetes and Digestive and Kidney Diseases, Beth Israel Deaconess Medical Center, Dong-A ST, and Allergan—have supported protocols with varied recruitment statuses, including completed, actively recruiting, and withdrawn studies. This extensive research highlights finasteride’s therapeutic utility in managing prostate hypertrophy and androgen-mediated hair loss.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07742553 NOT_YET_RECRUITING
Spinal Cord Injury; Spinal Cord Injuries; Injuries, Spinal Cord; Spinal Cord Contusion; Spinal Cord Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Compression; Nervous System Diseases; Spinal Cord Diseases; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Genital Diseases, Male
VA Office of Research and Development
 2027-10-01 PHASE2; PHASE3
NCT06944145 RECRUITING
BPH (Benign Prostatic Hyperplasia); Lower Urinary Track Symptoms
Beth Israel Deaconess Medical Center
 2025-12-03 PHASE2
NCT02703220 RECRUITING
Sleep Apnea; Elderly Adults
VA Office of Research and Development
 2015-07-03 PHASE4
NCT07731802 NOT_YET_RECRUITING
Dihydrotestosterone; Periprosthetic Joint Infection (PJI); Cutibacterium Acnes
University of Washington
 2026-08-31 PHASE4
NCT04288427 RECRUITING
Benign Prostatic Hyperplasia; Prostate Hyperplasia; Prostate Disease; Prostate Hypertrophy; Prostate Pain; Lower Urinary Tract Symptoms; Urinary Obstruction; Urinary Tract Disease
Beth Israel Deaconess Medical Center
 2020-09-25
NCT04594018 RECRUITING
Androgenetic Alopecia
EMS
 2023-02-02 PHASE3
NCT06590779 UNKNOWN
Androgenetic Alopecia
Cosmetique Active International
 2024-11-02
NCT07322991 COMPLETED
Healthy Adult Male
Il-Yang Pharm. Co., Ltd.
 2025-10-14 PHASE1
NCT07076706 COMPLETED
Male Pattern of Hair Loss, Androgenic Alopecia; Androgenetic Alopecia (AGA)
Beijing Dayspring Pharmaceutical Technology Co., Ltd
 2024-12-05 PHASE2
NCT06826001 NOT_YET_RECRUITING
Androgenetic Alopecia
Sheikh Zayed Medical College
 2025-02 PHASE2
NCT05611593 UNKNOWN
Androgenic Alopecia
Follicle Pharma Ltd
 2022-10-20 PHASE1
NCT02213107 COMPLETED
Prostate Cancer
University of Rochester
 2014-09 PHASE2
NCT05990400 UNKNOWN
Androgenetic Alopecia
Indonesia University
 2023-05-01 PHASE2; PHASE3
NCT04049747 COMPLETED
Prostate Cancer; Non-metastatic Prostate Cancer; Prostate Adenocarcinoma
Imperial College London
 2019-12-11
NCT05135468 COMPLETED
AGA
Cutia Therapeutics（Wuxi）Co.,Ltd
 2021-12-06 PHASE3
NCT04945226 COMPLETED
Androgenetic Alopecia
Inventage Lab., Inc.
 2021-09-21 PHASE1; PHASE2
NCT02248701 TERMINATED
Spinal Cord Injury; Spinal Cord Injuries; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Genital Diseases, Male
VA Office of Research and Development
 2017-04-27 PHASE2
NCT04288427 Recruiting
Benign Prostatic Hyperplasia|Prostate Hyperplasia|Prostate Disease|Prostate Hypertrophy|Prostate Pain|Lower Urinary Tract Symptoms|Urinary Obstruction|Urinary Tract Disease
Beth Israel Deaconess Medical Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2020-09-25 Not Applicable
NCT04848181 COMPLETED
Prostate Hyperplasia
Benha University
 2019-07-01 EARLY_PHASE1
NCT01342367 ACTIVE_NOT_RECRUITING
Prostate Cancer
University of Chicago
 2010-12-17
NCT02483195 WITHDRAWN
Female Androgenetic Alopecia
University of Florida
 2016-08 PHASE4
NCT03669692 Withdrawn
Prostatic Hyperplasia Benign|Metabolic Syndrome
Complexo Hospitalario Universitario de A Coruña
 2018-07-10 Not Applicable
NCT02055170 TERMINATED
Non-small Cell Lung Cancer
CancerCare Manitoba
 2014-06 PHASE2
NCT02781311 COMPLETED
Alopecia
Allergan
 2016-07-14 PHASE2
NCT03004469 COMPLETED
Alopecia, Androgenetic
Polichem S.A.
 2016-08-02 PHASE3
NCT02502669 COMPLETED
NODULOCYSTIC ACNE
Elorac, Inc.
 2015-07 PHASE2
NCT01736033 UNKNOWN
Benign Prostate Hyperplasia
Seoul National University Hospital
 2012-02 PHASE4
NCT01296672 COMPLETED
Prostate Cancer
The University of Texas Health Science Center at San Antonio
 2011-02 PHASE4
NCT02824380 Completed
Androgenic Alopecia
Dong-A ST Co. Ltd.
 2016-07 Phase 1
NCT02791243 COMPLETED
Androgenetic Alopecia
Polichem S.A.
 2016-05-09 PHASE1
NCT02548117 WITHDRAWN
ERYTHROCYTOSIS
Baylor College of Medicine
 2016-02 PHASE3
NCT02146937 WITHDRAWN
Detectable Prostate Nodules
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2014-03 PHASE2
NCT02146937 Withdrawn
Detectable Prostate Nodules
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2014-03 Phase 2
NCT01585441 TERMINATED
Retinal Disease
National Eye Institute (NEI)
 2012-04 PHASE2
NCT01534351 TERMINATED
Benign Prostatic Hyperplasia
Merck Sharp & Dohme LLC
 2013-08-01 PHASE3
NCT01923090 UNKNOWN
Healthy Volunteers
University of Birmingham
 2012-08 PHASE2
NCT01174953 COMPLETED
Prostate Cancer
University of Kansas
 2010-07
NCT01227993 COMPLETED
Retinal Disease
National Eye Institute (NEI)
 2010-10 PHASE1; PHASE2
NCT00736645 COMPLETED
Prostate Cancer
Roswell Park Cancer Institute
 2008-08 PHASE2
NCT00542243 COMPLETED
Enlarged Prostate
University Health Network, Toronto
 2008-02 PHASE3
NCT01643629 UNKNOWN
Androgenetic Alopecia
Kasiak Research Pvt. Ltd.
 2012-01 PHASE1; PHASE2
NCT00438464 COMPLETED
Adenocarcinoma of the Prostate; Stage II Prostate Cancer
National Cancer Institute (NCI)
 2007-02 PHASE2
NCT01391156 COMPLETED
Androgenetic Alopecia
Mae Fah Luang University Hospital
 2011-03 PHASE3
NCT00475501 COMPLETED
Male Hypogonadism; Muscle Atrophy; Sarcopenia; Benign Prostate Hypertrophy
VA Office of Research and Development
 2007-01 PHASE2
NCT01231607 COMPLETED
Androgenetic Alopecia
GlaxoSmithKline
 2010-10-28 PHASE3
NCT01829893 COMPLETED
Benign Prostatic Hyperplasia (BPH)
Korea University Anam Hospital
 2012-01 PHASE1
NCT01139762 COMPLETED
Benign Prostatic Hyperplasia; Enlarged Prostate
Eli Lilly and Company
 2010-09 PHASE3
NCT00600691 TERMINATED
Hematuria; Hematospermia
University of British Columbia
 2008-03 PHASE2
NCT01703520 Completed
Male Breast Cancer
Organon and Co|Institute for Applied Economics and Health Research Aps
 2011-05-01 --
NCT00564460 WITHDRAWN
Benign Prostatic Hyperplasia
University of Alberta
 2008-02 PHASE3
NCT00837252 COMPLETED
Retinal Disease
National Eye Institute (NEI)
 2009-02 PHASE1; PHASE2
NCT01052870 COMPLETED
Androgenetic Alopecia
HairDx, LLC
 2008-12 PHASE1
NCT00842751 COMPLETED
Healthy Males; Male Contraceptive
University of Washington
 2009-07 PHASE2
NCT00690950 UNKNOWN
Benign Prostatic Hyperplasia
Urologic Consultants of Southeastern PA
 2008-05 PHASE4
NCT00382356 COMPLETED
Benign Prostatic Hypertrophy
North Florida/South Georgia Veterans Health System
 2004-11
NCT00663793 COMPLETED
Contraception; Hypogonadism
University of Washington
 2008-10 PHASE1
NCT06601205 COMPLETED
Prostate Cancer; Prostatic Intraepithelial Neoplasia
Ente Ospedaliero Ospedali Galliera
 2004-01-01 PHASE2; PHASE3
NCT00759135 COMPLETED
Benign Prostatic Hyperplasia (BPH); Enlarged Prostate
Nymox Corporation
 2007-05 PHASE2
NCT01264289 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2006-11 PHASE1
NCT01264302 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2006-11 PHASE1
NCT00127179 COMPLETED
Benign Prostatic Hyperplasia
Organon and Co
 2004-01-01 PHASE3
NCT00870480 COMPLETED
Healthy
Actavis Inc.
 2004-11 PHASE1
NCT00871247 COMPLETED
Healthy
Actavis Inc.
 2004-11 PHASE1
NCT00648791 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-09 PHASE1
NCT00650377 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2004-10 PHASE1
NCT00835796 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-06 PHASE1
NCT00835666 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-06 PHASE1
NCT00003323 COMPLETED
Prostate Cancer; Sexual Dysfunction and Infertility
Alliance for Clinical Trials in Oncology
 1998-05 PHASE2
NCT01133457 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-04 PHASE1
NCT01133444 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-04 PHASE1
NCT00021814 COMPLETED
Prostatic Hyperplasia; Prostatic Hypertrophy, Benign
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1995-12 PHASE3
NCT02244229 COMPLETED
Prostatic Hyperplasia
Boehringer Ingelheim
 1998-04 PHASE4
NCT00396175 COMPLETED
Androgenetic Alopecia
Organon and Co
 1998-03 PHASE3
NCT00064649 TERMINATED
Benign Prostatic Hyperplasia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2004-04 PHASE3
NCT00564252 COMPLETED
Idiopathic Hirsutism
Iran University of Medical Sciences
 2006-02
NCT00130767 UNKNOWN
Benign Prostatic Hyperplasia
Hospices Civils de Lyon
 2004-12 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Finasteride functions as a specific intracellular inhibitor of steroid Type II 5α-reductase, blocking the enzymatic conversion of testosterone into 5α-dihydrotestosterone (DHT) and thereby suppressing androgen receptor pathway activation in target tissues. This reduction in local DHT concentration prevents prostate cellular hypertrophy and hair follicle miniaturization, demonstrating clinical therapeutic utility in the management of benign prostatic hyperplasia and androgenetic alopecia.

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.