Drugs / Finasteride
Finasteride
also known as
Proscar · Propecia · Aindeem · CU-40102 · FIN · Finasterida · Finasteride component of entadfi · IY001 · +5 more
Small molecule targets SRD5A2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PROSCAR | — | 1998-03-20 – 2004-04-12 | fda.gov ↗ |
| Label expansion | US (FDA) | PROPECIA | — | 2002-04-10 | fda.gov ↗ |
| Approved | US (FDA) | PROSCAR | — | 1992-06-19 | fda.gov ↗ |
Trials 46 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT07322991 | Oct → Dec 2025 | — | Il-Yang Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT07038941 | Mar → Jun 2024 | androgenetic alopecia | Beijing Dayspring Pharmaceutical Technology Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02824380 | Jul → Oct 2016 | androgenetic alopecia | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02791243 | May → Jun 2016 | androgenetic alopecia | Polichem S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01052870 | Dec 2008 → Dec 2009 | androgenetic alopecia | HairDx, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00663793 | Oct 2008 → May 2009 | hypogonadism | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT00871247 | Nov 2004 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00870480 | Nov 2004 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00650377 | Oct 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648791 | Sep → Oct 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00835666 | Jun 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00835796 | Jun → Jul 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT01643629 | Jan → Oct 2012 | androgenetic alopecia | Kasiak Research Pvt. Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT01227993 | Oct 2010 → Dec 2012 | retinal disorder | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1/2 | NCT00837252 | Feb 2009 → Apr 2010 | retinal disorder | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06944145 | Dec 2025 → Jun 2029 expected | benign prostatic hyperplasia | Beth Israel Deaconess Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07076706 | Dec 2024 → Aug 2025 | baldness, male pattern | Beijing Dayspring Pharmaceutical Technology Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT02248701 | Apr 2017 → Aug 2021 | hypogonadism, male reproductive system disorder, spinal cord injury | VA Office of Research and Development | Terminated | No outcome recorded |
| Phase 2 | NCT02213107 | Sep 2014 → Oct 2023 | prostate cancer | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT02055170 | Jun 2014 → Mar 2018 | non-small cell lung carcinoma | CancerCare Manitoba | Terminated | No outcome recorded |
| Phase 2 | NCT02146937 | Mar 2014 → Mar 2015 | prostatic adenoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 2 | NCT01923090 | Aug 2012 → Oct 2013 | — | University of Birmingham | Unknown | No outcome recorded |
| Phase 2 | NCT01585441 | Apr 2012 → Dec 2013 | retinal disorder | National Eye Institute (NEI) | Terminated | No outcome recorded |
| Phase 2 | NCT00842751 | Jul → Nov 2009 | — | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00736645 | Aug 2008 → Dec 2012 | prostate cancer | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00600691 | Mar 2008 → Dec 2011 | male reproductive system disorder | University of British Columbia | Terminated | No outcome recorded |
| Phase 2 | NCT00438464 | Feb 2007 → Apr 2012 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00475501 | Jan 2007 → Mar 2012 | benign prostatic hyperplasia, hypogonadism, male, muscular atrophy | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT00003323 | May 1998 → May 2002 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05990400 | May → Oct 2023 | androgenetic alopecia | Indonesia University | Unknown | No outcome recorded |
| Phase 2/3 | NCT06601205 | Jan 2004 → Mar 2008 | prostate cancer, prostate intraepithelial neoplasia | Ente Ospedaliero Ospedali Galliera | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07435012 | Apr 2026 → Dec 2027 expected | androgenetic alopecia | Triple Hair Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT05135468 | Dec 2021 → Mar 2023 | androgenetic alopecia | Cutia Therapeutics (Wuxi) Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01534351 | Aug → Nov 2013 | benign prostatic hyperplasia | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT00127179 | Jan 2004 → Jul 2005 | benign prostatic hyperplasia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00396175 | Mar 1998 → Jan 2000 | androgenetic alopecia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00021814 | Dec 1995 → Nov 2001 | benign prostatic hyperplasia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06001619 | Dec 2022 → Oct 2024 overdue | benign prostatic hyperplasia, prostate cancer | Turku University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT02703220 | Jul 2015 → Jul 2026 overdue | sleep apnea syndrome | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 4 | NCT01296672 | Feb 2011 → Nov 2016 | prostate cancer | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 4 | NCT00130767 | Dec 2004 → ? | benign prostatic hyperplasia | Hospices Civils de Lyon | Unknown | No outcome recorded |
| Phase 4 | NCT07715448 | ? → Jan 2026 | benign prostatic hyperplasia, erectile dysfunction | Beni-Suef University | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT04288427 | Sep 2020 → Jun 2026 overdue | benign prostatic hyperplasia, urinary tract obstruction | Beth Israel Deaconess Medical Center | Recruiting | No outcome recorded |
| — | NCT01342367 | Dec 2010 → May 2020 overdue | prostate cancer | University of Chicago | Active not recruiting | No outcome recorded |
| — | NCT01174953 | Jul 2010 → Mar 2013 | prostate cancer | University of Kansas | Completed | No outcome recorded |
| — | NCT00564252 | Feb → Oct 2006 | — | Iran University of Medical Sciences | Completed | No outcome recorded |
Also used as a comparator or background therapy in 21 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04848181 Comparator | Jul 2019 → Jul 2020 | benign prostatic hyperplasia | Benha University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05611593 Comparator | Oct 2022 → Dec 2024 | androgenetic alopecia | Follicle Pharma Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT01829893 Comparator | Jan → Feb 2012 | benign prostatic hyperplasia | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04945226 Comparator | Sep 2021 → Feb 2022 | androgenetic alopecia | Inventage Lab., Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06826001 Comparator | Feb → Jul 2025 overdue | androgenetic alopecia | Sheikh Zayed Medical College | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02781311 Comparator | Jul 2016 → Mar 2018 | alopecia | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT02502669 Comparator | Jul 2015 → Jun 2017 | acne | Elorac, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00759135 Comparator | May 2007 → Jan 2008 | benign prostatic hyperplasia | Nymox Corporation | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT04594018 Comparator | Feb 2023 → May 2026 overdue | androgenetic alopecia | EMS | Recruiting | No outcome recorded |
| Phase 3 | NCT05023824 Comparator | Dec 2020 → Dec 2023 | benign prostatic hyperplasia | Gangnam Severance Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03004469 Comparator | Aug 2016 → Mar 2018 | androgenetic alopecia | Polichem S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02548117 Comparator | Feb 2016 | polycythemia | Baylor College of Medicine | Withdrawn | No outcome recorded |
| Phase 3 | NCT01391156 Comparator | Mar 2011 → Mar 2012 | androgenetic alopecia | Mae Fah Luang University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01231607 Comparator | Oct 2010 → Feb 2012 | androgenetic alopecia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01139762 Background | Sep 2010 → Feb 2012 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00564460 Comparator | Feb 2008 → Feb 2011 | benign prostatic hyperplasia | University of Alberta | Withdrawn | No outcome recorded |
| Phase 3 | NCT00542243 Comparator | Feb 2008 → Dec 2012 | benign prostatic hyperplasia | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 3 | NCT00064649 Comparator | Apr 2004 → Jun 2006 | benign prostatic hyperplasia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02483195 Comparator | Aug 2016 → Aug 2018 | androgenetic alopecia | University of Florida | Withdrawn | No outcome recorded |
| Phase 4 | NCT01736033 Comparator | Feb 2012 → Feb 2017 | benign prostatic hyperplasia | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02244229 Comparator | Apr 1998 → Nov 2000 | benign prostatic hyperplasia | Boehringer Ingelheim | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2006-06-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives First FDA Approval for Generic Proscar® Tablets tevapharm.com ↗ |
| 2004-10-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Finasteride Tablets Usp, 5 Mg tevapharm.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Finasteride | “A 5-alpha reductase inhibitor (finasteride 5 mg or dutasteride 0.5 mg according to routine clinical practice) administered either once daily or every other day according to the...” NCT07715448 ↗66“A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male...” NCT05135468 ↗ “TH07 is a combined topical spray solution containing three active ingredients commonly used to treat hair loss: Minoxidil (5%) Finasteride (0.1%) and Latanoprost (0.03%).” NCT07435012 ↗ “The dosages prostatic hyperplasia medication: dutasteride 0,5 MG x1 or finasteride 5 MG x1 or combination of dutasteride and tamsulosin 0,5/0,4 MG x1.” NCT06001619 ↗ “Subjects were treated with a combination of finasteride and an alpha-blocker” PMID 18542722 ↗ Feb 2008 “finasteride 0.5mg twice daily, orally for 7 days” NCT00842751 ↗ “commercially available Finasteride 1mg Propecia” NCT05611593 ↗ “combination of minoxidil and finasteride” NCT07038941 ↗ “5% minoxidil / high dose of finasteride” NCT02824380 ↗ “2 % Minoxidil and /or Finasteride” NCT01643629 ↗ |
| Known as | Aindeem | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Known as | CU-40102 | “A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male...” NCT05135468 ↗ |
| Known as | FIN | “INTRODUCTION: Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic...” PMID 25353053 ↗ Oct 2014 |
| Known as | Finasterida | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Known as | Finasteride component of entadfi | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Known as | IY001 | “Drug: IY001(Finasteride)” NCT07322991 ↗ |
| Known as | MK-906 | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Known as | MK0906 | “MK0906, finasteride / Duration of Treatment : 48 Weeks” NCT00396175 ↗ |
| Known as | NSC-741485 | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Known as | NSC-759318 | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Known as | Propecia | “Whether this recommendation should apply to men taking 1 mg/day finasteride (Propecia) for the treatment of androgenic alopecia is unknown.” PMID 17196507 ↗ Jan 20071“commercially available Finasteride 1mg Propecia” NCT05611593 ↗ |
| Known as | Proscar | “BACKGROUND: Use of 5 mg/day finasteride (Proscar) for benign prostatic hyperplasia is known to affect serum concentrations of prostate-specific antigen (PSA).” PMID 17196507 ↗ Jan 20074“bioequivalence of Mylan's finasteride 5 mg tablets to Merck's Proscar® 5 mg tablets” NCT00648791 ↗ “oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together” NCT00021814 ↗ “Proscar® Tablets 5 mg” NCT00650377 ↗ “proscar” NCT02248701 ↗ |
| Known as | Prostide | ChEMBL registry synonym — accepted as the source's own label CHEMBL710 ↗ |
| Action | Inhibit | “Hormone therapy using flutamide and finasteride may fight prostate cancer by reducing the production of male hormones.” NCT00003323 ↗ |
| Modality | Small molecule | — CHEMBL710 ↗ |
| Route | Oral | “The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together” NCT00021814 ↗ |
| Target | SRD5A2 | “is an inhibitor of SRD5A2” NCT04288427 ↗ |