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 332 small molecule programs targeting Hyperplasia. It is currently in Approved.

Indications

Total Trials

Active Trials

331

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HyperplasiaApproved

Prostate AdenocarcinomaApproved

Prostate CarcinomaActive, not recruiting

RetinopathyActive, not recruiting

Benign Prostatic HyperplasiaActive, not recruiting

AcneApproved

Androgenetic AlopeciaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Prostate CancerApproved

Spinal Cord InjuryActive, not recruiting

HyperplasiaApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Prostate CarcinomaApproved

Active, not recruiting

RetinopathyPhase 2

Active, not recruiting

Benign Prostatic HyperplasiaApproved

Active, not recruiting

AcneApproved

Approved

Androgenetic AlopeciaApproved

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Prostate CancerApproved

Approved

Spinal Cord InjuryPhase 2

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Propecia

OOrganon and Co

Approved

1 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Lenvima

Eisai

Preclinical

6 4

Gilotrif

Boehringer Ingelheim

Preclinical

12 5

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 6

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 7

Treatment

GSK

Preclinical

1 8

REGN2810

Regeneron

Preclinical

1 9

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Preclinical

3 10

Immune Checkpoint Inhibitor

IImmuneSensor Therapeutics Inc.

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Sleep Apnea

NCT02703220

Q4 2026

N/ARecruiting

Resistance

NCT04288427

Q3 2030

Phase 2Recruiting

Benign Prostatic Hyperplasia

NCT06944145

Clinical

Trials by Indication[1]

Prostate Cancer7 trials

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

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

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

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

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

Show 4 more trials

High Risk Prostate Cancer Prevention Study

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

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

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

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

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

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

Benign Prostatic Hyperplasia4 trials

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

Recruiting·—·Phase 2·NCT06944145·242 enrolled

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

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

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

Show 1 more trial

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

Prostate3 trials

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

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

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

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

Fasting Conditions3 trials

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

Completed·—·Phase 1·NCT01264302·26 enrolled

Finasteride 5 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835666·32 enrolled

Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

Completed·—·Phase 1·NCT01264289·26 enrolled

18 more indications

Retinopathy3 trials

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

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

Finasteride for Chronic Central Serous Chorioretinopathy

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

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

Testosterone1 trial

5-Alpha Reductase and Anabolic Effects of Testosterone

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

Sleep Apnea1 trial

Sleep Apnea in Elderly

Recruiting·VVA Office of Research and Development·Phase 4·NCT02703220·100 enrolled

Ptosis1 trial

Kinetics of the Finasteride Prostate Induced Apoptosis

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

Spinal Cord Injury1 trial

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

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

Age1 trial

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

Withdrawn·—·Phase 3·NCT02548117

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

Oral1 trial

ORAL T-6: Oral Androgens in Man-6

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

Unspecified3 trials

Medical Therapy of Prostatic Symptoms

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

Finasteride 5 mg Tablets, Non-fasting

Completed· Teva logo

Teva·Phase 1·NCT00835796·20 enrolled

Finasteride, Dutasteride and Insulin Action

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

Regulatory

FDA Approval Timeline[5]

Jun 19, 1992

PROSCAR

NDA NDA020180

Dec 19, 1997

PROPECIA

NDA NDA020788

Sources

References

[1]
ClinicalTrials.gov — 48 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

Q3 2026

Q4 2026

Q3 2030

Trials by Indication[1]

Prostate Cancer7 trials

Androgenetic Alopecia7 trials

Benign Prostatic Hyperplasia4 trials

Prostate3 trials

Fasting Conditions3 trials

Retinopathy3 trials

Labor2 trials

Scar2 trials

Testosterone1 trial

Transurethral Resection1 trial

Sleep Apnea1 trial

Ptosis1 trial

Spinal Cord Injury1 trial

Transurethral Resection of the Prostate1 trial

Age1 trial

Monotherapy1 trial

Non-Small Cell Lung Cancer1 trial

Hirsutism1 trial

NODULOCYSTIC ACNE1 trial

Clinical Trial1 trial

Resistance1 trial

Oral1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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