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Drug

Finasteride

Approved · FDA
Emerging researchLate-stage development
Also known as Entadfi, Propecia, Proscar, Finasterida+2 more

Entadfi, Propecia, Proscar, Finasterida, (5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide, Finasteridum.

RxNorm25025ChEMBLCHEMBL710UNII57GNO57U7G
1
Research papers
4
Active clinical trials
49
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Label change: FINASTERIDE (ANDA076511)

Regulatory2026-07-02FDA

Label change: FINASTERIDE (ANDA090121)

Regulatory2026-07-02FDA

Label change: FINASTERIDE (ANDA076437)

Regulatory2026-07-01FDA

Label change: FINASTERIDE (ANDA078341)

Regulatory2026-07-01FDA

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

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Phase 2b Randomized, Single-Center, Double Blind, Placebo Controlled, 2-Arm Study to Investigate Orally Administered Combination Therapies (5-alpha Reductase Inhibitor + Raloxifene) Compared With Monotherapy (5-alpha Reductase Inhibitor + Placebo) in Adult Patients With Benign Prostatic Hyperplasia (BPH)

Clinical trial2026-03-23Results expected Q2 2029 · ClinicalTrials.gov

Label change: FINASTERIDE (ANDA076511)

Regulatory2026-01-26FDA

Label change: FINASTERIDE (ANDA076437)

Regulatory2025-06-17FDA

Label change: FINASTERIDE (ANDA090121)

Regulatory2025-06-17FDA

A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities

Clinical trial2025-06-10Results posted · ClinicalTrials.gov

Finasteride for chronic central serous chorioretinopathy.

Research2011-04-01Retina (Philadelphia, Pa.)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Finasteride
Aliases & brands
EntadfiPropeciaProscarFinasterida(5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamideFinasteridum
RxNorm CUI
25025
ChEMBL ID
CHEMBL710
UNII
57GNO57U7G
Regulatory jurisdictions
mhrafda

Regulatory timeline

49 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2006-12-15
Latest approval
2010-02-23
Authorities
FDA · MHRA
Total events
49
fdaU.S. Food and Drug Administration· 46 events
2026-07-02Label change
Label change: FINASTERIDE (ANDA076511)
Evidence ↗
2026-07-02Label change
Label change: FINASTERIDE (ANDA090121)
Evidence ↗
2026-07-01Label change
Label change: FINASTERIDE (ANDA076437)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 3 events
2024-04-29Safety communicationSafety
Drug Safety Update: Finasteride: reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)
Evidence ↗
2017-05-24Safety communicationSafety
Drug Safety Update: Finasteride: rare reports of depression and suicidal thoughts
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Finasteride: potential risk of male breast cancer
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

46 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
46
registered trials across all phases
LATEST COMPLETION 2022
4
Active studies
3
Recruiting
18
Late-stage (III+)
29
Completed
13
Discontinued
PHASE DISTRIBUTIONn = 46
Early Phase 11Phase 111Phase 1 / 23Phase 213Phase 2 / 32Phase 37Phase 46Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly

RecruitingPH IVVA Office of Research and Developmentn=1002026

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

WithdrawnPH IVUniversity of Florida2018

A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH

Unknown statusPH IVSeoul National University Hospitaln=5452017

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

CompletedPH IVThe University of Texas Health Science Center at San Antonion=3832017

Kinetics of the Finasteride Prostate Induced Apoptosis

Unknown statusPH IVHospices Civils de Lyonn=902007

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending Dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants

CompletedPH I/IIInventage Lab., Inc.n=402022

The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate

CompletedPH IBenha Universityn=602020

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males

CompletedPH IIAllergann=1692018

A Multicentre, Randomized, Double-blind, Parallel-group, Controlled Study, to Assess the Efficacy and Safety of P-3074 Cutaneous Spray, Solution, in the Treatment of Male Pattern Baldness

CompletedPH IIIPolichem S.A.n=4582018

A Randomized, Phase IIB, Double Blind, Placebo Controlled, Multicenter, Pre-surgical, Window-of-opportunity Trial of Finasteride Vs. Low-dose Flutamide Vs. Placebo in Prostate Cancer (2F Trial)

CompletedPH II/IIIEnte Ospedaliero Ospedali Gallieran=1252017

A Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study Evaluating the Efficacy and Safety of Once Weekly High Dose Oral Finasteride in the Treatment of Severe Nodulocystic Acne

CompletedPH IIElorac, Inc.n=1062017

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Finasteride for chronic central serous chorioretinopathy.

Retina (Philadelphia, Pa.) · 2011 · 50 cites
Recent papers

Finasteride for chronic central serous chorioretinopathy.

Retina (Philadelphia, Pa.) · 2011 · 50 cites
Journals, researchers & institutions
Top journals
  • Retina (Philadelphia, Pa.)1
Leading researchers
  • Chew EY1
  • Cukras C1
  • Forooghian F1
  • Meleth AD1
  • Meyerle CB1
  • Wong WT1
Leading institutions
free-text, unnormalised
  • Division of Epidemiology and Clinical Applications1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.