Last update 23 Jan 2025

Finasteride

Overview

Basic Info

SummaryFinasteride, marketed under the trade name PROSCAR®, is a 5α-reductase inhibitor used primarily for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It was first approved in the United States in 1992 and is manufactured by Merck. Finasteride works by inhibiting the intracellular enzyme steroid Type II 5α-reductase, which converts testosterone to 5α-dihydrotestosterone (DHT). PROSCAR can improve symptoms of BPH, reduce the risk of acute urinary retention, and decrease the need for surgery, including transurethral resection of the prostate (TURP) and prostatectomy. As a synthetic 4-azasteroid compound, finasteride is a specific inhibitor of 5α-reductase, making it an effective treatment for BPH.
Drug Type
Small molecule drug
Synonyms
(5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide, Finasteride (JAN/USP/INN), 非那雄胺(奎安)
+ [47]
Mechanism
5α-reductase inhibitors(Steroid 5 alpha reductase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (19 Jun 1992),
Regulation-
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Structure/Sequence

Molecular FormulaC23H36N2O2
InChIKeyDBEPLOCGEIEOCV-WSBQPABSSA-N
CAS Registry98319-26-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Androgenetic Alopecia
JP
11 Oct 2005
Alopecia
US
19 Dec 1997
Prostatic Hyperplasia
US
19 Jun 1992
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Androgenetic AlopeciaNDA/BLA
CN
31 Jan 2024
Androgenetic AlopeciaNDA/BLA
CN
31 Jan 2024
Alopecia, Male PatternPreclinical
DE
02 Aug 2016
Alopecia, Male PatternPreclinical
HU
02 Aug 2016
Alopecia, Male PatternPreclinical
RU
02 Aug 2016
Alopecia, Male PatternPreclinical
BE
02 Aug 2016
Alopecia, Male PatternPreclinical
ES
02 Aug 2016
HematuriaPreclinical
CA
01 Mar 2008
Prostatic HyperplasiaPreclinical
CA
01 Feb 2008
Prostatic HyperplasiaPreclinical
CA
01 Feb 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Spinal Cord Injuries
testosterone | estradiol | dihydrotestosterone
12
High-dose Testosterone + Finasteride
(klbltxebhw) = reduced more than vehicle+placebo at 12 months kpdfqvuwku (ylficuxpnn )
Positive
11 Dec 2024
FDA_CDER
ManualManual
Not Applicable
696
Placebo and finasteride 5 mg
(sdimixxpbj) = lktnksqory dnwxqdhqke (lfetqdsgrc )
Positive
28 Jun 2024
Tadalafil 5 mg and finasteride 5 mg
(sdimixxpbj) = beyusrijcq dnwxqdhqke (lfetqdsgrc )
Not Applicable
-
(thwrfhpjuy) = catcuflnsf bzakibxmzs (tcfrhdkbkm )
Negative
05 Oct 2023
Phase 2
33
(Testosterone Enanthate, Finasteride)
onwlorvetq(cajpfdhuck) = nrldbyalqi umwfmmpibj (rowdmslfgp, nkhpsfxaph - tbqxvdseug)
-
29 Sep 2023
Placebo pill
(Placebo Treatment)
onwlorvetq(cajpfdhuck) = kzvxzbpuaj umwfmmpibj (rowdmslfgp, sjvodgomnd - gmfylkwbbt)
Not Applicable
28
mbpvtztnxd(gjusycwvrq) = phbijgbyig pfqasnhhzs (bmsicjbxah )
-
03 Jul 2023
mbpvtztnxd(gjusycwvrq) = ivlarivasm pfqasnhhzs (bmsicjbxah )
Not Applicable
-
(fkmcgximim) = lxiyulfpqr mhawvvrikc (aclfpxxquu )
-
01 Sep 2022
Not Applicable
116
ppngsyslal(ewnfmgnnag) = gwzkpgiifx jcdbbacywr (hlmibiiakv )
-
01 May 2022
ppngsyslal(ewnfmgnnag) = rjusmlqlnk jcdbbacywr (hlmibiiakv )
Not Applicable
Sexual Dysfunction
DHT | testosterone | calculated free T
91
(jevliipcml) = bikfusorwl fxksezxbrg (frnkwvqtbu )
-
01 May 2022
Not Applicable
74
bicalutamide+goserelin+leuprolide
(SOC Cohort)
dumdnsmgcg(ukfksdfmzi) = usevnxkcpc qassdejzhn (yznhpsfdzf, zdrqwbaizv - ubpzididby)
-
28 Oct 2021
dumdnsmgcg(ukfksdfmzi) = qitqezlwfx qassdejzhn (yznhpsfdzf, umtybosgdx - hluwnbwzki)
Phase 3
458
P-3074+Finasteride Placebo
(P-3074 + Finasteride Placebo)
iprobpzbty(khsmcyjjqt) = ovtkbaktdl bwqpnyqezh (cvphijzvdr, aiyxvesutc - tnukgfnpln)
-
19 Apr 2019
Finasteride Placebo+P-3074 Vehicle
(P-3074 Vehicle + Finasteride Placebo)
iprobpzbty(khsmcyjjqt) = kvqepaingm bwqpnyqezh (cvphijzvdr, alqfucrpgj - pzgjfwigik)
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