Drugs / Dutasteride
last change Jun 2026 re-read 2 minutes ago

Dutasteride

Small molecule targets AR via inhibition

Developed for
benign prostatic hyperplasia · prostate cancer · alcohol abuse · alcohol dependence · alopecia · androgenetic alopecia · erectile dysfunction · hypogonadism, male
+15 more · acne · benign neoplasm · chronic prostatitis · obesity disorder · premenstrual tension · prostate adenocarcinoma · prostate neoplasm · salivary duct carcinoma · urinary bladder cancer · urinary tract obstruction · alcohol-related disorders · bulbospinal muscular atrophy · COVID-19 · hypogonadism · Kennedy disease
Investigated by
GlaxoSmithKline · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · UConn Health · Addpharma Inc. · CHU de Quebec-Universite Laval · Dongkook Pharmaceutical Co., Ltd.
+58 more · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · National Institutes of Health (NIH) · Northwestern University · Siami, Paul F., M.D. · University of Chicago · University of Washington · Assistance Publique - Hôpitaux de Paris · Assiut University · Beni-Suef University · Beth Israel Deaconess Medical Center · Bio-innova Co., Ltd · Case Comprehensive Cancer Center · Dana-Farber Cancer Institute · Dr. J. Curtis Nickel · Endeavor Health · Franklin D. Gaylis, MD Inc. · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Gangnam Severance Hospital · Kaunas University of Medicine · Kenneth Pienta, MD · M.D. Anderson Cancer Center · Mary-Ellen Taplin, MD · Masonic Cancer Center, University of Minnesota · Massachusetts General Hospital · Mayo Clinic · Ministry of Health, France · National Cancer Institute (NCI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Mental Health (NIMH) · North Florida/South Georgia Veterans Health System · Oregon Health and Science University · Paul Toren · Pfizer · Prostate Cancer Canada · Prostate Cancer Foundation Norway · Radboud University Medical Center · Roswell Park Cancer Institute · Samsung Medical Center · Schering-Plough · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Stiefel, a GSK Company · Sunnybrook Health Sciences Centre · The Cleveland Clinic · Toni Choueiri, MD · Turku University Hospital · Unita Complessa di Ostetricia e Ginecologia · University College London Hospitals · University of Birmingham · University of California, Los Angeles · University of California, San Diego · University of California, San Francisco · University of Colorado, Denver · University of Rochester · Urologic Consultants of Southeastern PA · Urology of Virginia · Yuyu Pharma, Inc. · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (4) US (FDA) AVODART 2002-10-09 – 2011-06-09 fda.gov
Approved US (FDA) AVODART 2001-11-20 fda.gov

Trials 75 · started per year

today
US approved 2001
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200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 116 trials
Phase 1 NCT07444385 Feb → Apr 2026 overdue benign prostatic hyperplasia Addpharma Inc. Recruiting No outcome recorded
Phase 1 NCT06233227 Sep → Nov 2024 Bio-innova Co., Ltd Unknown No outcome recorded
Phase 1 NCT04214808 Jan → Feb 2020 androgenetic alopecia Addpharma Inc. Completed No outcome recorded
Phase 1 NCT02839122 May → Sep 2016 benign prostatic hyperplasia Yuyu Pharma, Inc. Completed No outcome recorded
Phase 1 NCT02509104 Jul → Oct 2015 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02352311 Jan → Jun 2015 benign prostatic hyperplasia Dongkook Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT02184585 Jul 2014 → Feb 2015 prostate disorder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01957189 Oct 2013 → Jan 2014 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01942551 Sep → Dec 2013 benign prostatic hyperplasia Dongkook Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT01471678 Jun → Sep 2011 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01215292 Jan 2011 → Mar 2012 University of Washington Completed No outcome recorded
Phase 219 trials
Phase 2 NCT07420517 Mar 2026 → Apr 2030 expected urinary bladder cancer Paul Toren Recruiting No outcome recorded
Phase 2 NCT05705700 Feb 2023 → Jan 2030 prostate cancer Masonic Cancer Center, University of Minnesota Withdrawn No outcome recorded
Phase 2 NCT05599243 Sep 2022 → Aug 2023 androgenetic alopecia Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Completed No outcome recorded
Phase 2 NCT05513365 Sep 2022 → Sep 2025 overdue salivary duct carcinoma Radboud University Medical Center Recruiting No outcome recorded
Phase 2 NCT02147964 Jun 2019 → Dec 2021 hypogonadotropic hypogonadism University of Washington Withdrawn No outcome recorded
Phase 2 NCT02213107 Sep 2014 → Oct 2023 prostate cancer University of Rochester Completed No outcome recorded
Phase 2 NCT02159690 Sep 2014 → Jan 2015 prostate cancer Kenneth Pienta, MD Withdrawn No outcome recorded
Phase 2 NCT01923090 Aug 2012 → Oct 2013 University of Birmingham Unknown No outcome recorded
Phase 2 NCT01393730 Sep 2011 → Jan 2016 prostate cancer Mary-Ellen Taplin, MD Completed No outcome recorded
Phase 2 NCT01368003 Apr 2011 → Nov 2012 prostate adenocarcinoma Toni Choueiri, MD Withdrawn No outcome recorded
Phase 315 trials
Phase 3 NCT05023824 Dec 2020 → Dec 2023 benign prostatic hyperplasia Gangnam Severance Hospital Unknown No outcome recorded
Phase 3 NCT02869971 Aug 2016 → Dec 2020 benign prostatic hyperplasia Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 3 NCT02014584 Jul 2014 → Mar 2016 alopecia Stiefel, a GSK Company Completed No outcome recorded
Phase 3 NCT02058368 Feb 2014 → Mar 2017 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01831791 Apr 2013 → Jul 2014 alopecia GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01830829 Apr 2013 → Oct 2014 benign prostatic hyperplasia, chronic prostatitis Dr. J. Curtis Nickel Terminated No outcome recorded
Phase 3 NCT00527605 Oct 2007 → Mar 2009 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00780754 Apr 2007 → Dec 2010 prostate cancer Kaunas University of Medicine Completed No outcome recorded
Phase 3 NCT00398281 Nov 2006 → Jul 2010 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 3 NCT00431626 Oct 2006 → Apr 2009 benign prostatic hyperplasia Northwestern University Terminated No outcome recorded
Phase 414 trials
Phase 4 NCT06001619 Dec 2022 → Oct 2024 overdue benign prostatic hyperplasia, prostate cancer Turku University Hospital Recruiting No outcome recorded
Phase 4 NCT01777269 Feb 2013 → Apr 2016 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01758523 Jan 2013 → Feb 2018 alcohol abuse, alcohol dependence UConn Health Completed No outcome recorded
Phase 4 NCT01673490 Jun 2012 → Mar 2015 benign prostatic hyperplasia GlaxoSmithKline Terminated No outcome recorded
Phase 4 NCT01262287 Jan 2011 → Dec 2012 alcohol abuse, alcohol dependence UConn Health Completed No outcome recorded
Phase 4 NCT00939120 Jul 2009 → Sep 2014 benign prostatic hyperplasia Siami, Paul F., M.D. Completed No outcome recorded
Phase 4 NCT00690950 May 2008 → Jul 2009 benign prostatic hyperplasia Urologic Consultants of Southeastern PA Unknown No outcome recorded
Phase 4 NCT00470834 May 2007 → Feb 2013 prostate cancer GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT00421421 Mar 2007 → ? benign prostatic hyperplasia GlaxoSmithKline Terminated No outcome recorded
Phase 4 NCT00827814 Jun 2006 → Apr 2009 benign prostatic hyperplasia Samsung Medical Center Completed No outcome recorded
Phase not applicable10 trials
NCT07421804 Apr 2026 → Apr 2027 expected acne Assiut University Not yet recruiting No outcome recorded
NCT01342367 Dec 2010 → May 2020 overdue prostate cancer University of Chicago Active not recruiting No outcome recorded
NCT01653925 Oct 2010 → Dec 2016 overdue prostate neoplasm CHU de Quebec-Universite Laval Active not recruiting No outcome recorded
NCT00734656 Mar 2007 → Oct 2010 alcohol abuse, alcohol dependence UConn Health Completed No outcome recorded
NCT00802321 Apr → Nov 2006 alcohol abuse, alcohol dependence UConn Health Completed No outcome recorded
NCT00274417 Jan 2006 → May 2009 benign prostatic hyperplasia Urology of Virginia Unknown No outcome recorded
NCT00706966 Jun 2005 → Dec 2008 benign neoplasm, prostate cancer University of California, San Francisco Completed No outcome recorded
NCT00983554 Jun 2005 → May 2009 obesity disorder National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Unknown No outcome recorded
NCT00382356 Nov 2004 → Jul 2009 benign prostatic hyperplasia North Florida/South Georgia Veterans Health System Completed No outcome recorded
NCT00680680 May 2004 → Feb 2008 benign prostatic hyperplasia, urinary tract obstruction Franklin D. Gaylis, MD Inc. Completed No outcome recorded
Also used as a comparator or background therapy in 32 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07065682 Comparator Jul 2023 → Dec 2024 overdue benign prostatic hyperplasia Universitas Diponegoro Recruiting No outcome recorded
Phase 1 NCT04677855 Background Mar 2021 → Oct 2023 prostate cancer Pellficure Pharmaceuticals, Inc Terminated No outcome recorded
Phase 1 NCT03240939 Comparator Mar → Jul 2017 benign prostatic hyperplasia Yuyu Pharma, Inc. Completed No outcome recorded
Phase 1 NCT00609596 Background Feb → Apr 2008 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT00953576 Background Sep 2009 → Apr 2013 prostate cancer Dana-Farber Cancer Institute Terminated No outcome recorded
Phase 1/2 NCT00399165 Comparator Nov 2006 → May 2007 University of Washington Completed No outcome recorded
Phase 24 trials
Phase 2 NCT01547299 Background Mar 2012 → Nov 2013 prostate cancer Pfizer Completed No outcome recorded
Phase 2 NCT00298155 Comparator Jul 2006 → Jun 2010 cancer, prostate neoplasm University of Washington Completed No outcome recorded
Phase 2 NCT00303446 Comparator Mar 2006 → Dec 2009 Kennedy disease, bulbospinal muscular atrophy National Institute of Neurological Disorders and Stroke (NINDS) Completed No outcome recorded
Phase 2 NCT00161421 Background Mar 2005 → Jul 2006 hypogonadism, male University of Washington Completed No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT04729491 Comparator Jun → Sep 2020 COVID-19 Corpometria Institute Completed No outcome recorded
Phase 2/3 NCT04098302 Comparator Oct 2019 → Jun 2024 alcohol-related disorders UConn Health Completed No outcome recorded
Phase 2/3 NCT04756206 Comparator Jan 2019 → Jan 2020 chronic prostatitis, post 5-alpha-reductase inhibitors treatment syndrome Ain Shams University Completed No outcome recorded
Phase 2/3 NCT00490555 Comparator Jan 2009 → Jan 2012 University of Washington Completed No outcome recorded
Phase 2/3 NCT00553878 Comparator Mar 2007 → Sep 2009 prostate cancer Canadian Urology Research Consortium Completed No outcome recorded
Phase 39 trials
Phase 3 NCT06916793 Comparator Apr 2025 → Dec 2026 expected androgenetic alopecia Chong Kun Dang Pharmaceutical Not yet recruiting No outcome recorded
Phase 3 NCT06264414 Comparator Feb 2025 → Jun 2026 overdue benign prostatic hyperplasia, erectile dysfunction EMS Not yet recruiting No outcome recorded
Phase 3 NCT04245566 Comparator Sep 2021 → Dec 2022 benign prostatic hyperplasia Dominik Abt Unknown No outcome recorded
Phase 3 NCT04947631 Comparator Jul 2021 → Jun 2023 benign prostatic hyperplasia Dongkook Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT04825561 Comparator Jun 2021 → Jan 2023 androgenetic alopecia Addpharma Inc. Completed No outcome recorded
Phase 47 trials
Phase 4 NCT01294592 Comparator Dec 2010 → Oct 2013 benign prostatic hyperplasia GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT00805701 Comparator Jan 2009 → Apr 2014 prostate cancer Bay State Clinical Trials, Inc. Completed No outcome recorded
Phase 4 NCT00752869 Comparator Sep 2008 → Mar 2012 hypogonadism The Miriam Hospital Completed No outcome recorded
Phase 4 NCT00880672 Comparator Jan → Dec 2008 benign prostatic hyperplasia Seoul National University Hospital Completed No outcome recorded
Phase 4 NCT00363311 Comparator Jul 2006 → Mar 2010 prostate cancer GlaxoSmithKline Completed No outcome recorded
Phase not applicable1 trial
NCT06677177 Comparator Feb 2016 → Nov 2022 ALI KAMAL M. SAMI Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2015-10-12 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Exclusive Launch of Generic Avodart® Capsules in the United States tevapharm.com

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 110 sources stand behind the page.

FieldValueCited text
Known as Dutasteride “This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg),...” NCT00701779
103

“patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin...” NCT04245566

“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

“Co-administration of dutasteride 0.5 mg capsule (Oblong, size 6, dull yellow capsules: Commercially available) and tamsulosin hydrochloride 0.2 mg tablet (White, round standard...” NCT02184585

“Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.” NCT07444385

“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

“Patients with male AGA were randomized to receive 0.2 mg dutasteride, placebo, or 0.5 mg dutasteride (2:2:1) once daily for 24 weeks.” PMID 40736519 Aug 2025

“Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state” NCT00537654

“Jalyn: dutasteride 0.5 mg/day and tamsulosin 0.4 mg/day combination tablet” NCT01830829

Dutasteride and tamsulosin are to treat benign prostatic hyperplasia.” NCT00609596

“testosterone and the 5-alpha reductase inhibitor dutasterideNCT00070733

“dual action 5alpha-reductase inhibitor (5ARI) dutasteridePMID 14499682 Oct 2003

“Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)” NCT02869971

Dutasteride 0.5 mg” NCT02352311

Dutasteride 0.2mg” NCT04214808

NCT00673127

NCT00690950

NCT00668642

NCT07421804

NCT01231607

NCT01777269

NCT00985738

NCT04098302

NCT00802321

NCT01262287

NCT00780754

NCT00493987

NCT00527605

NCT00403000

NCT01294592

NCT05513365

NCT02213107

NCT00244309

NCT00421421

NCT06264414

NCT00082043

NCT00939120

NCT02058368

NCT00866554

NCT00363311

NCT00274417

NCT02839122

NCT06677177

NCT00431626

NCT00553878

NCT01368003

NCT00303446

NCT01547299

NCT00470834

NCT00375765

NCT06916793

NCT00953576

NCT04947631

NCT01215292

NCT00398281

NCT00490555

NCT00161421

NCT02509104

NCT00706966

NCT00056407

NCT01673490

NCT01653925

NCT00399165

NCT05599243

NCT06233227

NCT00752869

NCT02159690

NCT01957189

NCT00194675

NCT07420517

NCT01758523

NCT00441116

NCT01393730

NCT03240939

NCT02014584

NCT04756206

NCT00680680

NCT04545450

NCT00090103

NCT00309855

NCT00398580

NCT02147964

NCT01942551

NCT01342367

NCT04677855

NCT01471678

NCT00827814

NCT01577693

NCT01923090

NCT07065682

NCT00400335

NCT00880672

NCT00298155

NCT01254071

NCT01831791

NCT00382356

NCT00734656

NCT00062790

NCT01193855

NCT00146146

NCT05705700

NCT00368979

NCT00983554

NCT04729491

Known as Avodart “Dutasteride (AVODART ™) is an approved potent 5-alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged...” NCT01254071
9

“Dutasteride (AVODART ™) is an approved potent 5-alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged...” NCT01471678

“The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is...” NCT00244309

“Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent urinary symptoms and reduce the risk of surgery.” NCT00752869

“1 dutasteride 0.5-mg capsule [Avodart® ] + 1 tamsulosin” PMID 28800206 Aug 2017

AVODART (dutasteride) soft gelatin capsule” NCT02352311

“Dutasteride (Avodart) 0.5mg” NCT01193855

“Dutasteride (Avodart)” NCT00431626

NCT00805701

NCT00558363

Known as Avolve ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Known as Duastride ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Known as Dut “At the first study period, the subjects will receive 0.5mg of dutasteride (Dut) as a single dose (SD) under fed conditions.” NCT01957189
Known as Dutasterida ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Known as Dutasteride (Avodart) Dutasteride (Avodart)NCT00866554
1

“Dutasteride=Avodart” NCT00673127

Known as Dutasteride component of jalyn ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Known as GG-745 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Known as GI198745 “Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects” NCT00368979
1

NCT00969072

Known as NSC-740477 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Known as NSC-759880 ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969
Action Inhibit “5-alpha reductase inhibitor dutasteride” NCT00070733
Modality Small molecule CHEMBL1200969
Route Oral “Administered Orally” NCT00056407
Target AR “dutasteride was a more potent direct antagonist of the T878A versus the wild-type ARPMID 25320358 Oct 2014