Drugs / Dutasteride
Dutasteride
also known as
Avodart · Dutasteride=Avodart · GI198745 · Avolve · Duastride · Dut · Dutasterida · Dutasteride component of jalyn · +3 more
Small molecule targets AR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn prostate cancer, hereditary, X-linked 3 4 milestones | |||||
| Rejected (CRL) | US (FDA) | Avodart | prostate cancer, hereditary, X-linked 3 | 2011-01-26 | “received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing...” gsk.com ↗ |
| Filed | US (FDA) | Avodart | prostate cancer, hereditary, X-linked 3 | 2010-03-28 | “it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction” gsk.com ↗ |
| Withdrawn | US (FDA) | Avodart | prostate cancer, hereditary, X-linked 3 | 2009-11-22 | “the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction” gsk.com ↗ |
| Filed | US (FDA) | Avodart | prostate cancer, hereditary, X-linked 3 | 2009-10-01 | “it has filed a supplemental New Drug Application (sNDA) for Avodart® (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction” gsk.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| 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
5
4
8
7
8
1
3
4
6
2
6
5
2
2
1
2
3
1
1
4
200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 | Mixed |
| 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 | NCT01577693 | May → Aug 2011 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01254071 | Sep → Dec 2010 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00537654 | Oct 2007 → Feb 2008 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00400335 | Oct 2006 → ? | hypogonadism, male | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00309855 | Dec 2005 → Aug 2008 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00082043 | Mar 2004 → Mar 2014 | depressive disorder, premenstrual tension | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT01215292 | Jan 2011 → Mar 2012 | — | University of Washington | Completed | Met primary |
| Phase 219 trials · 1 met primary | ||||||
| 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 Stop: Business |
| Phase 2 | NCT02159690 | Sep 2014 → Jan 2015 | prostate cancer | Kenneth Pienta, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02213107 | Sep 2014 → Oct 2023 | prostate cancer | University of Rochester | Completed | 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 Stop: Business |
| Phase 2 | NCT01193855 | Jun 2010 → Jan 2012 | prostate cancer | University College London Hospitals | Unknown | No outcome recorded |
| Phase 2 | NCT00985738 | Sep 2009 → Jan 2013 | prostate cancer | University of Colorado, Denver | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00866554 | Mar 2009 → Mar 2019 | erectile dysfunction, prostate cancer | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 2 | NCT00558363 | Nov 2007 → Dec 2010 | prostate cancer | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00668642 | Mar 2007 → May 2013 | prostate cancer | Endeavor Health | Completed | No outcome recorded |
| Phase 2 | NCT00398580 | Oct 2006 → Oct 2007 | hypogonadism, male | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00673127 | Feb 2005 → Feb 2012 | prostate cancer | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00403000 | Dec 2004 → Mar 2007 | prostate cancer | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00969072 | Aug 2003 → Feb 2005 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 315 trials · 5 met primary · 1 missed | ||||||
| Phase 3 | NCT05023824 | Dec 2020 → Dec 2023 | benign prostatic hyperplasia | Gangnam Severance Hospital | Unknown | Met primary |
| Phase 3 | NCT02869971 | Aug 2016 → Dec 2020 | benign prostatic hyperplasia | Assistance Publique - Hôpitaux de Paris | Completed | Met primary |
| 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 | Met primary |
| 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 Stop: Enrollment |
| Phase 3 | NCT00527605 | Oct 2007 → Mar 2009 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT00431626 | Oct 2006 → Apr 2009 | benign prostatic hyperplasia | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00244309 | Nov 2005 → Jun 2006 | prostate cancer | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00146146 | May 2005 → May 2006 | — | Unita Complessa di Ostetricia e Ginecologia | Completed | No outcome recorded |
| Phase 3 | NCT00090103 | Nov 2003 → Apr 2009 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT00070733 | Aug 2003 → Jun 2005 | sexual disorder | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Unknown | No outcome recorded |
| Phase 3 | NCT00056407 | Mar 2003 → Jan 2009 | prostate cancer | GlaxoSmithKline | Completed | Met primary |
| Phase 414 trials · 3 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT01758523 | Jan 2013 → Feb 2018 | alcohol abuse, alcohol dependence | UConn Health | Completed | Mixed |
| 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 | Missed primary |
| 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 | Missed primary |
| 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 4 | NCT00701779 | Sep 2005 → Jul 2009 | benign prostatic hyperplasia | Siami, Paul F., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00375765 | Apr 2005 → Jul 2007 | benign prostatic hyperplasia, prostate cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00062790 | Oct 2003 → Jul 2005 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT07715448 | ? → Jan 2026 | benign prostatic hyperplasia, erectile dysfunction | Beni-Suef University | 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 | Mixed |
| — | 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 |
| — | NCT00983554 | Jun 2005 → May 2009 | obesity disorder | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Unknown | No outcome recorded |
| — | NCT00706966 | Jun 2005 → Dec 2008 | benign neoplasm, prostate cancer | University of California, San Francisco | Completed | 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 |
| Comparator or background therapy32 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 Stop: Enrollment |
| 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 1/2 | 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 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 2/3 | 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 3 | NCT06916793 Comparator | Apr 2025 → Sep 2027 expected | androgenetic alopecia | Chong Kun Dang Pharmaceutical | 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 3 | NCT01231607 Comparator | Oct 2010 → Feb 2012 | androgenetic alopecia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04545450 Comparator | Nov 2008 → Jul 2009 | hypogonadism | Unita Complessa di Ostetricia e Ginecologia | Completed | No outcome recorded |
| Phase 3 | NCT00441116 Comparator | Dec 2006 → Jan 2008 | alopecia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00368979 Comparator | Feb 2006 → Dec 2007 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01294592 Comparator | Dec 2010 → Oct 2013 | benign prostatic hyperplasia | GlaxoSmithKline | Completed | Met primary |
| 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 4 | NCT00194675 Comparator | Mar 2005 → Apr 2010 | benign prostatic hyperplasia, hypogonadism | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT00493987 Comparator | Nov 2002 → Dec 2009 | — | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| — | NCT06677177 Comparator | Feb 2016 → Nov 2022 | — | ALI KAMAL M. SAMI | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2015-11-24 | Impax Laboratories, LLC | Regulatory Impax Launches Generic Version of Avodart® (Dutasteride) Capsules, 0.5 mg amneal.com ↗ |
| 2011-03-23 | GlaxoSmithKline | Regulatory GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction gsk.com ↗ |
| 2011-01-26 | GlaxoSmithKline | Regulatory GSK receives FDA Complete Response letter for Avodart for prostate cancer risk reduction supplemental indication gsk.com ↗ |
| 2010-11-30 | GlaxoSmithKline | Regulatory Avodart reviewed by FDA advisory committee for prostate cancer risk reduction gsk.com ↗
When asked if the dutasteride risk/benefit profile is favorable for reduction in the risk of prostate cancer in this target population, the ODAC voted 14 against, 2 in favor, and 2 abstentions. |
| 2010-06-13 | GlaxoSmithKline | Regulatory FDA approves Jalyn™, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate gsk.com ↗
GlaxoSmithKline (NYSE: GSK) announced today the U.S. Food and Drug Administration (FDA) has approved Jalyn, a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. |
| 2010-03-30 | GlaxoSmithKline | Regulatory GSK receives European approval for Duodart® gsk.com ↗
GlaxoSmithKline (GSK) today announced that Duodart®, a fixed dose combination (FDC) of dutasteride (0.5mg), and tamsulosin (0.4mg) has received approval in Europe via the Decentralised Procedure with Germany acting as Reference Member State. |
| 2010-03-28 | GlaxoSmithKline | Regulatory GSK regulatory update – Avodart (dutasteride) gsk.com ↗
GlaxoSmithKline (GSK) announced today that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration (FDA). |
| 2010-03-21 | GlaxoSmithKline | Regulatory GlaxoSmithKline announces Swiss approval of Duodart® gsk.com ↗
GlaxoSmithKline (GSK) announced today that the Swiss regulatory authority, Swissmedic, has granted approval for Duodart®, a fixed dose combination (FDC) of dutasteride (0.5mg) and tamsulosin (0.4mg). |
| 2009-11-22 | GlaxoSmithKline | Regulatory GSK Regulatory Update: Avodart gsk.com ↗
the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease. |
| 2009-10-12 | GlaxoSmithKline | Results GSK’s Avodart® / tamsulosin combination showed benefits for men with prostate enlargement gsk.com ↗
GlaxoSmithKline (GSK) announced today that final results from a large, 4-year study showed that Avodart (dutasteride) and tamsulosin combination treatment reduced the risk of acute urinary retention (AUR) or Benign Prostatic Hyperplasia* (BPH)-related surgery and reduced the risk of BPH clinical progression more than tamsulosin alone**. |
| 2009-10-01 | GlaxoSmithKline | Regulatory Avodart (dutasteride) regulatory update gsk.com ↗
GlaxoSmithKline (GSK) announced today that it has filed a supplemental New Drug Application (sNDA) for Avodart® (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction among men at increased risk of developing the disease. |
| 2009-04-26 | GlaxoSmithKline | Results Large, long-term study shows dutasteride reduced prostate cancer risk in men at increased risk of the disease gsk.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 110 sources stand behind the page.
| Field | Value | Cited 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 dutasteride” NCT00070733 ↗ |
| 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 ↗ |
| 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 component of jalyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200969 ↗ |
| Known as | Dutasteride=Avodart | “Dutasteride (Avodart)” NCT00866554 ↗1“Dutasteride=Avodart” NCT00673127 ↗ |
| 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 ↗ |
| 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 AR” PMID 25320358 ↗ Oct 2014 |