Last update 12 Mar 2026

Dutasteride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Duagen, Dutasteride (JAN/USP/INN), CU-40104
+ [20]
Action
inhibitors
Mechanism
5α-reductase inhibitors(Steroid 5 alpha reductase inhibitors)
Originator Organization
Inactive 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
Japan
28 Sep 2015
Prostatic Hyperplasia
United States
20 Nov 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Adenocarcinoma of prostatePhase 3
Canada
01 Mar 2007
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
185
5-ARIs (finasteride/dutasteride) exposed
jgpmckwdiz(oanrhmemlu) = yvxegitvpk drshencstv (upvgyrkvyh )
Positive
26 Feb 2026
Non-5-ARIs exposed
jgpmckwdiz(oanrhmemlu) = devezslant drshencstv (upvgyrkvyh )
Phase 2/3
180
mzplnemxsz(dmmtzghxln) = ymgettxrqo smdvpqltsq (mzhojyctdy, 0.33)
-
09 May 2025
Placebo Capsules
(Placebo Capsule)
mzplnemxsz(dmmtzghxln) = baukzcpyzz smdvpqltsq (mzhojyctdy, 0.28)
Phase 2
43
sudffegypi = jfaddedndx urxawnuuzh (vtyekurgwd, fsbrsoztjf - ycapcdmbsx)
-
13 Nov 2024
Phase 2
43
pgvtkwepnk(hrnpgryiqx) = ysksftsyft latqapxcck (vkauxliavm )
Positive
24 May 2024
Phase 4
142
ijtnwhqmwh(qcwbndfnnf) = Adverse events more common in the dutasteride group were reduced libido sfjejpnyec (tkmwdnotpc )
Positive
01 May 2024
Placebo
Phase 2
20
(A: Dutasteride During First Off-Cycle)
eqhmjffmpu(zdtiieyqcy) = jeyvuiqbff lpkkclelum (unbrdxjsqc, 0.5)
-
22 Aug 2023
Placebo
(B: Placebo During First Off-Cycle)
eqhmjffmpu(zdtiieyqcy) = srkpugqshr lpkkclelum (unbrdxjsqc, 0.45)
Not Applicable
74
bicalutamide+leuprolide+goserelin
(SOC Cohort)
iizxkkkwej(ajvnqrzlgv) = titixnebdn rjsmhboxyc (hzwmhvgzyb, 0.04)
-
28 Oct 2021
iizxkkkwej(ajvnqrzlgv) = uuaqokstfp rjsmhboxyc (hzwmhvgzyb, 0.04)
Phase 2
43
pkzsjtjmrk(gumprluvul) = the most common any grade AE was fatigue (65%) yflbjnqiuj (vtvqcrnhnk )
Positive
17 Sep 2020
Phase 2
43
rxxmyxzzmn(xrasidfsrj) = kchxsnfugi mlspjsuuft (vbhgbwvrnm )
Positive
26 May 2019
Phase 4
189
(Dutasteride)
bszdpzmkbs(verfjntlqe) = tjxlnozgow wieyovheee (iysjbomyru, 0.33)
-
26 Apr 2019
sugar pill
(Sugar Pill)
bszdpzmkbs(verfjntlqe) = anejvhqnkk wieyovheee (iysjbomyru, 0.34)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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