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] |
Target |
Mechanism 5α-reductase inhibitors(Steroid 5 alpha reductase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (19 Jun 1992), |
Regulation- |
Molecular FormulaC23H36N2O2 |
InChIKeyDBEPLOCGEIEOCV-WSBQPABSSA-N |
CAS Registry98319-26-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D00321 | Finasteride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Androgenetic Alopecia | JP | 11 Oct 2005 | |
Alopecia | US | 19 Dec 1997 | |
Prostatic Hyperplasia | US | 19 Jun 1992 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Androgenetic Alopecia | NDA/BLA | CN | 31 Jan 2024 | |
Androgenetic Alopecia | NDA/BLA | CN | 31 Jan 2024 | |
Alopecia, Male Pattern | Preclinical | DE | 02 Aug 2016 | |
Alopecia, Male Pattern | Preclinical | HU | 02 Aug 2016 | |
Alopecia, Male Pattern | Preclinical | RU | 02 Aug 2016 | |
Alopecia, Male Pattern | Preclinical | BE | 02 Aug 2016 | |
Alopecia, Male Pattern | Preclinical | ES | 02 Aug 2016 | |
Hematuria | Preclinical | CA | 01 Mar 2008 | |
Prostatic Hyperplasia | Preclinical | CA | 01 Feb 2008 | |
Prostatic Hyperplasia | Preclinical | CA | 01 Feb 2008 |
Phase 2 | Spinal Cord Injuries testosterone | estradiol | dihydrotestosterone | 12 | High-dose Testosterone + Finasteride | (klbltxebhw) = reduced more than vehicle+placebo at 12 months kpdfqvuwku (ylficuxpnn ) View more | Positive | 11 Dec 2024 | |
FDA_CDER Manual | Not Applicable | 696 | (sdimixxpbj) = lktnksqory dnwxqdhqke (lfetqdsgrc ) View more | Positive | 28 Jun 2024 | ||
(sdimixxpbj) = beyusrijcq dnwxqdhqke (lfetqdsgrc ) View more | |||||||
Not Applicable | - | (thwrfhpjuy) = catcuflnsf bzakibxmzs (tcfrhdkbkm ) | Negative | 05 Oct 2023 | |||
Phase 2 | 33 | (Testosterone Enanthate, Finasteride) | onwlorvetq(cajpfdhuck) = nrldbyalqi umwfmmpibj (rowdmslfgp, nkhpsfxaph - tbqxvdseug) View more | - | 29 Sep 2023 | ||
Placebo pill (Placebo Treatment) | onwlorvetq(cajpfdhuck) = kzvxzbpuaj umwfmmpibj (rowdmslfgp, sjvodgomnd - gmfylkwbbt) View more | ||||||
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 | Finasteride 1 mg or 2.5 mg | ppngsyslal(ewnfmgnnag) = gwzkpgiifx jcdbbacywr (hlmibiiakv ) View more | - | 01 May 2022 | ||
ppngsyslal(ewnfmgnnag) = rjusmlqlnk jcdbbacywr (hlmibiiakv ) View more | |||||||
Not Applicable | Sexual Dysfunction DHT | testosterone | calculated free T | 91 | (jevliipcml) = bikfusorwl fxksezxbrg (frnkwvqtbu ) View more | - | 01 May 2022 | ||
Not Applicable | 74 | bicalutamide+goserelin+leuprolide (SOC Cohort) | dumdnsmgcg(ukfksdfmzi) = usevnxkcpc qassdejzhn (yznhpsfdzf, zdrqwbaizv - ubpzididby) View more | - | 28 Oct 2021 | ||
(Oral ADT Group) | dumdnsmgcg(ukfksdfmzi) = qitqezlwfx qassdejzhn (yznhpsfdzf, umtybosgdx - hluwnbwzki) View more | ||||||
Phase 3 | 458 | P-3074+Finasteride Placebo (P-3074 + Finasteride Placebo) | iprobpzbty(khsmcyjjqt) = ovtkbaktdl bwqpnyqezh (cvphijzvdr, aiyxvesutc - tnukgfnpln) View more | - | 19 Apr 2019 | ||
Finasteride Placebo+P-3074 Vehicle (P-3074 Vehicle + Finasteride Placebo) | iprobpzbty(khsmcyjjqt) = kvqepaingm bwqpnyqezh (cvphijzvdr, alqfucrpgj - pzgjfwigik) View more |