TheraRadar
Data updated: Jul 17, 2026

FINASTERIDE · Sun Pharma

Generic · see PROSCAR
Urology Approved 1992-06-19

FINASTERIDE is FDA-approved to treat 2 conditions (same as PROSCAR).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
34
Years on Market

Details

Status
Prescription
First Approved
1992-06-19
Routes
ORAL
Dosage Forms
TABLET

Companies

Sun Pharma Dr. Reddy's IVAX SUB TEVA PHARMS Aurobindo Pharma GEDEON RICHTER USA NATCO PHARMA LTD ALKEM LABS LTD Teva HETERO LABS LTD III ACCORD HLTHCARE Cipla ZYDUS PHARMS USA Viatris
Active Ingredient: FINASTERIDE

FINASTERIDE Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
123 FDA actions from 2006 to 2026
Jul 2026 SUPPL
Label · Labeling
Jul 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling

What FINASTERIDE Treats

2 indications

FINASTERIDE is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as PROSCAR (same active ingredient).

Source: FDA Label

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
📋

Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT06944145 2025P000440 R01DK142211 Ph 2 recruiting New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
NCT02703220 PULM-008-14F Ph 4 recruiting Sleep Apnea in Elderly
NCT01227993 CSC-Ext results posted 110012 11-EI-0012 Ph 1, Ph 2 completed Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
NCT00736645 results posted CDR0000611962 RPCI I 104607 Ph 2 completed Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
NCT02248701 results posted B1449-R 1I01RX001449-01A1 Ph 2 terminated Testosterone Plus Finasteride Treatment After Spinal Cord Injury
NCT02548117 03-15-40-10 Ph 3 withdrawn H-36731: Finasteride in Management of Elevated Red Blood Cells
NCT03004469 results posted PM1541 Ph 3 completed Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
NCT02781311 results posted 1922-201-002 Ph 2 completed A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
NCT01534351 results posted 0906A-149 Ph 3 terminated Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
NCT00564460 E-2007 Ph 3 withdrawn On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
NCT01296672 results posted ROI 10-352H R01CA138627 Ph 4 completed 3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
NCT00837252 results posted 090075 09-EI-0075 Ph 1, Ph 2 completed Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
NCT00542243 Prostress 07-0499-B Ph 3 completed A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy
NCT01585441 results posted 120119 12-EI-0119 Ph 2 terminated Finasteride for Chronic Central Serous Chorioretinopathy
NCT00600691 H07-01188 Health Canada Control #118638, Merck Frosst #IISP #P2587 Ph 2 terminated The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy
NCT01139762 results posted 13529 H6D-CR-LVIW Ph 3 completed A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
NCT00663793 ORAL-T-6 results posted 33738-B U54HD42456-06, K23HD045386 Ph 1 completed ORAL T-6: Oral Androgens in Man-6
NCT01052870 HairDx2009 Ph 1 completed Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FINASTERIDE FDA Label Details

Indications & Usage

FINASTERIDE is FDA-approved to treat 2 conditions — same approved indications as PROSCAR.

Looking for the branded version?

PROSCAR

Full clinical data, patents, trials, and competitive landscape for finasteride.

See PROSCAR

Data Sources

FDA Approval: ANDA090507 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.