finasteride

Trade name: Proscar

Small moleculeapproved

Approved

Jun 19, 1992

Finasteride is a synthetic 4-azasteroid compound. This drug is a competitive and specific inhibitor of Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5a-reductase is predominant in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5a-reductase is responsible for approximately one-third of circulating DHT. The Type II 5a-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT. Although finasteride is 100-fold more selective for type II 5a-reductase than for the type I isoenzyme, chronic treatment with this drug may have some effect on type I 5a-reductase. Finasteride is used for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms, reduce the risk of acute urinary retention, reduce the risk of the need for surgery including transurethral resection of the prostate. Also used for the stimulation of regrowth of hair in men with mild to moderate androgenetic alopecia (male pattern alopecia, hereditary alopecia, common male baldness). Finasteride is sold under the brand names Proscar and Propecia among others. — NCATS

Clinical trial activity

72 trials · 92 clinical orgs · 18 marketing orgs

Phase 1
24
Phase 2
36
Phase 3
15
Phase 4
8

Earliest trial started Dec 1, 1995 (NCT00021814)

Timeline

1990s

  1. Jun 19, 1992

    Merck — Earliest FDA Approval

  2. Jun 19, 1992

    Organon — Marketing Organization

  3. Jun 19, 1992

    Merck — NDA Organization

  4. Jun 19, 1992

    Organon — NDA Secondary Org

  5. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  6. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)

  2. Jun 19, 2006

    Teva — Marketing Organization

  3. Jul 28, 2006

    Dr. Reddy's Laboratories — Marketing Organization

  4. Dec 18, 2006

    Mylan — Marketing Organization

  5. Dec 22, 2006

    Gedeon Richter Ltd. — Marketing Organization

  6. Oct 30, 2007

    Aurobindo Pharma — Marketing Organization

  7. Dec 28, 2009

    Zydus Discovery DMCC — Marketing Organization

2010s

  1. Feb 23, 2010

    Accord Research — Marketing Organization

  2. Jun 7, 2010

    Hetero Labs Ltd — Marketing Organization

  3. Aug 16, 2011

    Sun Pharmaceuticals — Marketing Organization

  4. Nov 5, 2013

    Actavis — Marketing Organization

  5. Nov 5, 2013

    Natco Pharma — Marketing Organization

  6. Nov 20, 2014

    Cipla — Marketing Organization

  7. Jan 5, 2017

    Alkem Labs Ltd — Marketing Organization

2020s

  1. Dec 9, 2021

    Veru Inc. — NDA Secondary Org

  2. Dec 9, 2021

    BLUE WATER BIOTECH — NDA Secondary Org

  3. Mar 19, 2025

    Novitium Pharma — Marketing Organization

Indications

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewJun 19, 1992

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)NC(=O)[C@H]1CC[C@H]2[C@@H]3CC[C@H]4NC(=O)C=C[C@]4(C)[C@H]3CC[C@]12C
Mol. weight
372.5441 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (5alpha,17beta)-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
  • (5alpha,17beta)-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
  • 5 ari
  • aindeem
  • cg 428
  • da-4001
  • finasterida
  • finasterida
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteride
  • finasteridum
  • finasteridum
  • finastid
  • mk-906
  • mk-906
  • propecia
  • propecia
  • propecia
  • proscar
  • proscar
  • proscar
  • proscar
  • prosteride
  • prostide
  • prostide
  • prostide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06944145Phase 2Nov 30, 2025Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT06826001Phase 2Feb 28, 2025Sheikh Zayed Medical College
NCT07076706Phase 2Dec 5, 2024Government of China, Peking University
NCT06590779N/ANov 2, 2024Cosmetique Active International, University of Nice Sophia Antipolis, University of Paris
NCT05990400Phase 2/Phase 3 (Phase 3)May 1, 2023University of Indonesia
NCT05611593Phase 1Oct 20, 2022Follicle Pharma Ltd
NCT04594018Phase 3Oct 31, 2021EMS S/A
NCT04945226Phase 1/Phase 2 (Phase 2)Aug 30, 2021Inventage Lab., Inc.
NCT04288427N/AApr 30, 2020Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT04848181Early Phase 1 (Phase 1)Jul 1, 2019Benha University
NCT02248701Phase 2Jan 16, 2017Department of Veteran Affairs, University of Florida
NCT02919735Phase 2Oct 1, 2016ViraCyte
NCT02483195Phase 4Aug 1, 2016University of Florida
NCT02605629N/AJul 13, 2016Legacy Healthcare Services, Sungkyunkwan University
NCT03004469Phase 3Jul 1, 2016Polichem S.A.
NCT02824380Phase 1Jul 1, 2016Dong-A Pharmaceutical
NCT02791243Phase 1May 9, 2016Polichem S.A., Princeton Consumer Research Inc.
NCT02548117Phase 3Feb 1, 2016Baylor University
NCT02986412N/AJan 15, 2016Legacy Healthcare Services, Sungkyunkwan University
NCT02703220Phase 4Jul 3, 2015Department of Veteran Affairs
Showing 20 of 72 trials
Page 1 / 4

Organizations

Research & Development (92)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit8321998
Dr. Reddy's LaboratoriesFor profit4412002
GlaxoSmithKlineFor profit4432003
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government4231995
Novum Pharmaceutical Research ServicesFor profit4012002
Department of Veteran AffairsGovernment3322007
National Cancer Institute (NCI)Government3221998
National Eye Institute (NEI)Government3312009
National Institutes of Health (NIH)Government3032008
Sungkyunkwan UniversityAcademic/Hospital3322011
ActavisFor profit2212004
Baylor UniversityAcademic/Hospital2111995
Dong-A PharmaceuticalFor profit2222014
Harvard UniversityAcademic/Hospital2222020
Kendle International Inc.For profit2012004
Legacy Healthcare ServicesAcademic/Hospital2012016
MDS PharmaFor profit2012002
MylanFor profit2212004
Polichem S.A.For profit2222016
SFBC AnapharmFor profit2012004
92 organizations
Page 1 / 5

Marketing (26)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGFeb 23, 2010
ActavisFor profitMKTGNov 5, 2013
ActavisFor profitSYNMar 28, 2007
Alkem Labs LtdFor profitMKTGJan 5, 2017
Aurobindo PharmaFor profitMKTGOct 30, 2007
Aurobindo PharmaFor profitSYNNov 5, 2013
BLUE WATER BIOTECHFor profitNDA2Dec 9, 2021
CiplaFor profitMKTGNov 20, 2014
Dr. Reddy's LaboratoriesFor profitMKTGJul 28, 2006
Dr. Reddy's LaboratoriesFor profitSYNFeb 28, 2007
Gedeon Richter Ltd.For profitMKTGDec 22, 2006
Hetero Labs LtdFor profitMKTGJun 7, 2010
MerckFor profitNDAJun 19, 1992
MylanFor profitMKTGDec 18, 2006
MylanFor profitSYNNov 5, 2013
Natco PharmaFor profitMKTGNov 5, 2013
Novitium PharmaFor profitMKTGMar 19, 2025
OrganonFor profitMKTGJun 19, 1992
OrganonFor profitNDA2Jun 19, 1992
Sun PharmaceuticalsFor profitMKTGAug 16, 2011
Sun PharmaceuticalsFor profitSYNAug 16, 2011
TevaFor profitSYNDec 15, 2006
TevaFor profitMKTGJun 19, 2006
Veru Inc.For profitNDA2Dec 9, 2021
Zydus Discovery DMCCFor profitMKTGDec 28, 2009
Zydus Discovery DMCCFor profitSYNMar 15, 2024