Drugs / Finasteride
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Finasteride

Small molecule targets SRD5A2 via inhibition

Developed for
androgenetic alopecia · benign prostatic hyperplasia · prostate cancer · retinal disorder · hypogonadism · male reproductive system disorder · baldness, male pattern · non-small cell lung carcinoma
+7 more · prostate adenocarcinoma · prostatic adenoma · sleep apnea syndrome · spinal cord injury · acne · alopecia · polycythemia
Investigated by
National Cancer Institute (NCI) · National Eye Institute (NEI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · VA Office of Research and Development · Actavis Inc.
+44 more · Beijing Dayspring Pharmaceutical Technology Co., Ltd · Beth Israel Deaconess Medical Center · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Merck Sharp & Dohme LLC · Mylan Pharmaceuticals Inc · Organon and Co · Teva Pharmaceuticals USA · University of Washington · Alliance for Clinical Trials in Oncology · Beni-Suef University · CancerCare Manitoba · Cliniche Humanitas Gavazzeni · Cutia Therapeutics (Wuxi) Co., Ltd · Dong-A ST Co., Ltd. · Endo USA Inc., a Keenova Therapeutics Company · Ente Ospedaliero Ospedali Galliera · European Institute of Oncology · Firuzgar hospital affiliated to Iran University of Medical Sciences · George Washington University · HairDx, LLC · Health Canada · Hospices Civils de Lyon · Il-Yang Pharm. Co., Ltd. · Indonesia University · Iran University of Medical Sciences · Kasiak Research Pvt. Ltd. · M.D. Anderson Cancer Center · Marche Polytechnic University · Merck Frosst Canada Ltd. · Polichem S.A. · Roswell Park Cancer Institute · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · The Emmes Company, LLC · The University of Texas Health Science Center at San Antonio · Triple Hair Inc · Turku University Hospital · University of Arizona · University of Birmingham · University of British Columbia · University of Chicago · University of Florida · University of Genoa · University of Kansas · University of Rochester

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed androgenetic alopecia 3 milestones
Filed China (NMPA) — androgenetic alopecia 2025-11-18

“Abbreviated New Drug Application (ANDA) for CU-40105 (self-developed topical finasteride spray) has been accepted by the NMPA.” cutiatx.com ↗

Filed Other — androgenetic alopecia 2024-04-29

“for CU-40102 (topical finasteride spray) of the Group was submitted to the Department of Health” cutiatx.com ↗

Filed China (NMPA) — androgenetic alopecia 2024-01-30

“for CU-40102 (topical finasteride spray) was accepted by the National Medical Products Administration (the “NMPA”) of the PRC” cutiatx.com ↗

Filed benign prostatic hyperplasia 1 milestone
Filed US (FDA) TADFIN benign prostatic hyperplasia 2021-02-23

“An NDA was submitted in February 2021 for TADFIN ™ (tadalafil 5mg and finasteride 5mg) capsule” verupharma.com ↗

Approved Indication not stated 3 milestones
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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 112 trials · 2 met primary
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 NCT00870480 Nov 2004 — Actavis Inc. Completed No outcome recorded
Phase 1 NCT00871247 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 1/23 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 · 1 met primary · 1 missed
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 Stop: Enrollment
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 Stop: Enrollment
Phase 2 NCT02146937 Mar 2014 → Mar 2015 prostatic adenoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Withdrawn No outcome recorded Stop: Enrollment
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 Stop: Enrollment
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 Missed primary
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 · 2 met primary
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 Met primary
Phase 3 NCT01534351 Aug → Nov 2013 benign prostatic hyperplasia Merck Sharp & Dohme LLC Terminated No outcome recorded Stop: Business
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 Met primary
Phase 45 trials · 1 missed
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 Missed primary
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
Comparator or background therapy21 trials
Phase 0 NCT04848181 Comparator Jul 2019 → Jul 2020 benign prostatic hyperplasia Benha University Completed No outcome recorded
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 1/2 NCT04945226 Comparator Sep 2021 → Feb 2022 androgenetic alopecia Inventage Lab., Inc. Completed No outcome recorded
Phase 2 NCT06826001 Comparator Feb → Jul 2025 overdue androgenetic alopecia Sheikh Zayed Medical College Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 22

DateIssuerRelease
2026-09-20 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory VOLUNTARY ANNOUNCEMENT - CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE MACAO PHARMACEUTICAL ADMINISTRATION BUREAU cutiatx.com ↗
CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE MACAO PHARMACEUTICAL ADMINISTRATION BUREAU
2026-09-20 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory 自愿公告 - CU-40102(外用非那雄胺喷雾剂)获得澳门药物监督管理局上市批准 cutiatx.com ↗
2025-11-18 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory VOLUNTARY ANNOUNCEMENT - ABBREVIATED NEW DRUG APPLICATION FOR CU-40105 (SELF-DEVELOPED TOPICAL FINASTERIDE SPRAY) ACCEPTED BY THE NMPA cutiatx.com ↗
2025-08-01 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory VOLUNTARY ANNOUNCEMENT - CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE HONG KONG DEPARTMENT OF HEALTH cutiatx.com ↗
CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE HONG KONG DEPARTMENT OF HEALTH
2025-08-01 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory 自愿公告 - CU-40102(外用非那雄胺喷雾剂)获得香港卫生署上市批准 cutiatx.com ↗
2025-06-30 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory VOLUNTARY ANNOUNCEMENT - CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION cutiatx.com ↗
The board of directors (the “Board”) of the Company is pleased to announce that CU-40102 (topical finasteride spray) of the Group has obtained marketing approval by the National Medical Products Administration (the “NMPA ”) of the People ’s Republic of China (the “PRC ” or “China ”).
2024-11-28 Cutia Therapeutics(Wuxi)Co.,Ltd Results VOLUNTARY ANNOUNCEMENT - RESULTS OF PHASE III CLINICAL TRIAL OF CU-40102 (TOPICAL FINASTERIDE SPRAY) AND CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) IN CHINA WERE PRESENTED AT THE 19TH CDA ANNUAL MEETING cutiatx.com ↗
RESULTS OF PHASE III CLINICAL TRIAL OF CU-40102 (TOPICAL FINASTERIDE SPRAY) AND CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) IN CHINA WERE PRESENTED AT THE 19TH CDA ANNUAL MEETING
2024-11-28 Cutia Therapeutics(Wuxi)Co.,Ltd Results 自願公告 - CU-40102(外用非那雄胺噴霧劑)及CU-30101(局部外用利多卡因丁卡因乳膏劑)中國III期臨床試驗結果在第十九屆CDA年會發佈 cutiatx.com ↗
2024-08-29 Cutia Therapeutics(Wuxi)Co.,Ltd Results 自願公告 - CU-40102(外用非那雄胺噴霧劑)中國III期臨床試驗結果獲中華醫學會第八屆毛髮學術會議接受以電子壁報形式展示 cutiatx.com ↗
2024-04-29 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory VOLUNTARY ANNOUNCEMENT - SUBMISSION OF NEW DRUG APPLICATION FOR CU-40102 (TOPICAL FINASTERIDE SPRAY) IN HONG KONG, PRC cutiatx.com ↗
The board of directors (the “Board”) of the Company is pleased to announce that the New Drug Application (the “NDA”) for CU-40102 (topical finasteride spray) of the Group was submitted to the Department of Health of the Government of the Hong Kong Special Administrative Region (“Hong Kong ”) of the People ’s Republic of China (the “PRC”).
2024-01-30 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory VOLUNTARY ANNOUNCEMENT - NEW DRUG APPLICATION FOR CU-40102 (TOPICAL FINASTERIDE SPRAY) ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION cutiatx.com ↗
The board of directors (the “Board”) of the Company is pleased to announce that the New Drug Application (the “NDA”) for CU-40102 (topical finasteride spray) was accepted by the National Medical Products Administration (the “NMPA”) of the PRC.
2024-01-30 Cutia Therapeutics(Wuxi)Co.,Ltd Regulatory 自愿公告 - CU-40102(外用非那雄胺喷雾剂)新药上市申请获得国家药品监督管理局受理 cutiatx.com ↗

All press releases naming this drug 28 releases

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 70 sources stand behind the page.

FieldValueCited 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 ↗

NCT00564460 ↗

Show 56 more sources

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 2007
1

“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 2007
4

“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 ↗