Propecia

(Finasteride)

ApprovedSmall molecule

Finasteride is used to treat male pattern baldness (hair loss) and to reduce symptoms of an enlarged prostate gland in men, such as difficulty urinating.[2] Propecia is currently approved and in use across 14 indications[4].[1]

Propecia is one of 236 small molecule programs targeting Acne. It is currently in Approved.

Indications

Total Trials

Active Trials

235

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AcneApproved

Prostate CarcinomaActive, not recruiting

HypotrichosisActive, not recruiting

Prostate AdenocarcinomaApproved

HyperplasiaApproved

HirsutismActive, not recruiting

DihydrotestosteroneNot yet recruiting

ResistanceRecruiting

Androgenetic AlopeciaUnknown status

Benign Prostatic HyperplasiaTerminated

AcneApproved

Approved

Prostate CarcinomaApproved

Active, not recruiting

HypotrichosisApproved

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

HyperplasiaApproved

Approved

HirsutismPreclinical

Active, not recruiting

DihydrotestosteroneApproved

Not yet recruiting

ResistancePreclinical

Recruiting

Androgenetic AlopeciaApproved

Unknown status

Benign Prostatic HyperplasiaApproved

Terminated

Showing 10 of 14 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Propecia

OOrganon and Co

Approved

7 2

Zoladex

TTerSera Therapeutics LLC

Phase 3

35 3

AAA617

Novartis

Phase 3

2 4

Triptorelin Embonate

Ipsen

Phase 3

3 5

Lhrha

Johnson & Johnson

Phase 3

2 6

Gnrh Agonist/antagonist

NNorthwestern University

Phase 3

2 7

Luteinizing Hormone Releasing Hormone

UUS Department of Veterans Affairs

Phase 3

2 8

Trexall

Duragesic

1 10

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Resistance

NCT04288427

Q3 2027

ApprovedNot yet recruiting

Dihydrotestosterone

NCT07731802

Q4 2027

ApprovedRecruiting

Sleep Apnea

NCT02703220

Q3 2030

Phase 2Recruiting

Benign Prostatic Hyperplasia

NCT06944145

Clinical

Trials by Indication[1]

Prostate Cancer7 trials

Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00736645·55 enrolled

High Risk Prostate Cancer Prevention Study

Completed·UUniversity of Kansas·N/A·NCT01174953·18 enrolled

Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.

Completed·EEnte Ospedaliero Ospedali Galliera·Phase 2/3·NCT06601205·125 enrolled

Show 4 more trials

Hormone Therapy in Treating Patients With Prostate Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00003323·101 enrolled

Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00438464·204 enrolled

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT01296672·383 enrolled

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Active, not recruiting·UUniversity of Chicago·N/A·NCT01342367·74 enrolled

Androgenetic Alopecia7 trials

Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia

Completed·HHairDx, LLC·Phase 1·NCT01052870·12 enrolled

Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia

Unknown status·IIndonesia University·Phase 2/3·NCT05990400·40 enrolled

Various Procedural Treatment Options for Androgenetic Alopecia

Not yet recruiting·SSheikh Zayed Medical College·Phase 2·NCT06826001·190 enrolled

Show 4 more trials

The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

Withdrawn·UUniversity of Florida·Phase 4·NCT02483195

Photosensitization Study in Androgenetic Alopecia

Completed·PPolichem S.A.·Phase 1·NCT02791243·58 enrolled

A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Completed· AbbVie logo

AbbVie·Phase 2·NCT02781311·169 enrolled

Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

Completed·PPolichem S.A.·Phase 3·NCT03004469·458 enrolled

Benign Prostatic Hyperplasia4 trials

Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

Completed·NNymox Corporation·Phase 2·NCT00759135·85 enrolled

New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia

Recruiting·—·Phase 2·NCT06944145·242 enrolled

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01534351·1 enrolled

Show 1 more trial

Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02244229·403 enrolled

Retinopathy3 trials

Finasteride for Chronic Central Serous Chorioretinopathy

Terminated·NNational Eye Institute (NEI)·Phase 2·NCT01585441·6 enrolled

Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Completed·NNational Eye Institute (NEI)·Phase 1/2·NCT01227993·3 enrolled

Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Completed·NNational Eye Institute (NEI)·Phase 1/2·NCT00837252·5 enrolled

Prostate3 trials

The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

Terminated·UUniversity of British Columbia·Phase 2·NCT00600691·29 enrolled

A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy

Completed·UUniversity Health Network, Toronto·Phase 3·NCT00542243·19 enrolled

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01139762·696 enrolled

19 more indications

Fasting Conditions3 trials

Finasteride 5 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835666·32 enrolled

Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions

Completed·—·Phase 1·NCT01264302·26 enrolled

Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

Completed·—·Phase 1·NCT01264289·26 enrolled

Scar2 trials

Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650377·30 enrolled

Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648791·29 enrolled

Labor2 trials

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition

Completed·—·Phase 1·NCT01133444·24 enrolled

Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition

Completed·—·Phase 1·NCT01133457·24 enrolled

Spinal Cord Injury2 trials

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Terminated·VVA Office of Research and Development·Phase 2·NCT02248701·33 enrolled

A Multisite, Double-blind, Randomized Controlled Trial Comparing Body Composition, Muscle, and Bone Changes to TestosteRone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial

Not yet recruiting·VVA Office of Research and Development·Preclinical·NCT07742553·300 enrolled

Transurethral Resection1 trial

The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate

Completed·—·Phase 1·NCT04848181·60 enrolled

Age1 trial

H-36731: Finasteride in Management of Elevated Red Blood Cells

Withdrawn·—·Phase 3·NCT02548117

Oral1 trial

ORAL T-6: Oral Androgens in Man-6

Completed·UUniversity of Washington·Phase 1·NCT00663793·16 enrolled

Testosterone1 trial

5-Alpha Reductase and Anabolic Effects of Testosterone

Completed·VVA Office of Research and Development·Phase 2·NCT00475501·60 enrolled

Monotherapy1 trial

Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients

Unknown status·SSeoul National University Hospital·Phase 4·NCT01736033·545 enrolled

Non-Small Cell Lung Cancer1 trial

Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

Terminated·CCancerCare Manitoba·Phase 2·NCT02055170·4 enrolled

Hirsutism1 trial

Topical Finasteride in the Treatment of Idiopathic Hirsutism

Completed·IIran University of Medical Sciences·N/A·NCT00564252·56 enrolled

NODULOCYSTIC ACNE1 trial

Finasteride Treatment of Severe Nodulocystic Acne

Completed·EElorac, Inc.·Phase 2·NCT02502669·106 enrolled

Clinical Trial1 trial

A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

Completed·IInventage Lab., Inc.·Phase 1/2·NCT04945226·40 enrolled

Resistance1 trial

5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy

Recruiting·—·N/A·NCT04288427·120 enrolled

Ptosis1 trial

Kinetics of the Finasteride Prostate Induced Apoptosis

Unknown status·HHospices Civils de Lyon·Phase 4·NCT00130767·90 enrolled

Transurethral Resection of the Prostate1 trial

On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)

Withdrawn·UUniversity of Alberta·Phase 3·NCT00564460

Sleep Apnea1 trial

Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly

Recruiting·VVA Office of Research and Development·Approved·NCT02703220·100 enrolled

Dihydrotestosterone1 trial

Finasteride and Cutibacterium

Not yet recruiting·UUniversity of Washington·Approved·NCT07731802·40 enrolled

Unspecified3 trials

Finasteride, Dutasteride and Insulin Action

Unknown status·UUniversity of Birmingham·Phase 2·NCT01923090·12 enrolled

Finasteride 5 mg Tablets, Non-fasting

Completed· Teva logo

Teva·Phase 1·NCT00835796·20 enrolled

Medical Therapy of Prostatic Symptoms

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00021814·3,407 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 19, 1992

PROSCAR

NDA NDA020180

Dec 19, 1997

PROPECIA

NDA NDA020788

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Finasteride. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Propecia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Finasteride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Finasteride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020788). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Steroid 5-Alpha-Reductase 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Propecia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q3 2030

Trials by Indication[1]

Prostate Cancer7 trials

Androgenetic Alopecia7 trials

Benign Prostatic Hyperplasia4 trials

Retinopathy3 trials

Prostate3 trials

Fasting Conditions3 trials

Scar2 trials

Labor2 trials

Spinal Cord Injury2 trials

Transurethral Resection1 trial

Age1 trial

Oral1 trial

Testosterone1 trial

Monotherapy1 trial

Non-Small Cell Lung Cancer1 trial

Hirsutism1 trial

NODULOCYSTIC ACNE1 trial

Clinical Trial1 trial

Resistance1 trial

Ptosis1 trial

Transurethral Resection of the Prostate1 trial

Sleep Apnea1 trial

Dihydrotestosterone1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News