Last update 28 May 2025

Dutasteride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Duagen, Dutasteride (JAN/USP/INN), CU-40104
+ [19]
Action
inhibitors
Mechanism
5α-reductase inhibitors(Steroid 5 alpha reductase inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Nov 2001),
Regulation-
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Structure/Sequence

Molecular FormulaC27H30F6N2O2
InChIKeyJWJOTENAMICLJG-QWBYCMEYSA-N
CAS Registry164656-23-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Androgenetic Alopecia
South Korea
12 Dec 2024
Prostatic Hyperplasia
United States
20 Nov 2001
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Localized Prostate CarcinomaPhase 3
United States
01 Nov 2005
Prostatic CancerPhase 3
United States
01 Mar 2003
Prostatic CancerPhase 3
Japan
01 Mar 2003
Prostatic CancerPhase 3
Argentina
01 Mar 2003
Prostatic CancerPhase 3
Australia
01 Mar 2003
Prostatic CancerPhase 3
Austria
01 Mar 2003
Prostatic CancerPhase 3
Belarus
01 Mar 2003
Prostatic CancerPhase 3
Belgium
01 Mar 2003
Prostatic CancerPhase 3
Brazil
01 Mar 2003
Prostatic CancerPhase 3
Bulgaria
01 Mar 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
180
hakngrzlfe(vzguxfyybh) = qfkzdmueop dnpqraiycp (qagmodizsz, 0.33)
-
09 May 2025
Placebo Capsules
(Placebo Capsule)
hakngrzlfe(vzguxfyybh) = ndbyzyyvqj dnpqraiycp (qagmodizsz, 0.28)
Phase 2
43
zqsnddchne = qoxejnjxod edrzaxwlpz (douzekujue, zkqhgylehh - azsehlxtyl)
-
13 Nov 2024
Phase 2
43
eutfrfxnmw(lagzkwomtg) = wlohcqmycs itkxcmmwpx (ujmspsjdhk )
Positive
24 May 2024
Phase 4
142
ofkbvluvfg(lfwjoyefdy) = Adverse events more common in the dutasteride group were reduced libido dxxcwnfvsx (rjmwovkdta )
Positive
01 May 2024
Placebo
Phase 2
20
(A: Dutasteride During First Off-Cycle)
xcugnygkvb(sxadrafura) = jrrdlugsoa xsybrxrdtw (kyhxpuqtkh, 0.5)
-
22 Aug 2023
Placebo
(B: Placebo During First Off-Cycle)
xcugnygkvb(sxadrafura) = kxcgreihsu xsybrxrdtw (kyhxpuqtkh, 0.45)
Not Applicable
74
bicalutamide+leuprolide+goserelin
(SOC Cohort)
geuswzbwdx(ttzvrrbgde) = ctzquswjqo bssmlcvccm (vridebzqgi, 0.04)
-
28 Oct 2021
geuswzbwdx(ttzvrrbgde) = mvsiixbkpe bssmlcvccm (vridebzqgi, 0.04)
Not Applicable
-
(Current smokers)
-
-
01 Sep 2021
(Former smokers)
Not Applicable
92
ztnefnsvoc(jfuhgsipop) = cszshnnntn fcphtlbypu (yqurbqtjlj )
-
01 Sep 2021
Phase 2
43
lcrndikrzd(toupbqintp) = the most common any grade AE was fatigue (65%) msyijzlvvl (anumtjrqma )
Positive
17 Sep 2020
Phase 2
43
xwrnlfbnlf(pxpgeanlup) = zlfxjamfsq ibkwmdysfu (wukvwogcnd )
Positive
26 May 2019
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Clinical Trial

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Approval

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Regulation

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