TheraRadar
Data updated: May 26, 2026

FINASTERIDE AND TADALAFIL (finasteride)

Urology Approved 2024-03-15
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-03-15
Routes
ORAL
Dosage Forms
CAPSULE

Companies

NOVITIUM PHARMA ZYDUS LIFESCIENCES
Active Ingredient: FINASTERIDE , TADALAFIL

FINASTERIDE AND TADALAFIL Approval History

2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2025
Mar 2025 ORIGINAL
Update
Mar 2024 ORIGINAL
Update
FDA Letter

What FINASTERIDE AND TADALAFIL Treats

2 FDA approvals

Originally approved for its first indication in 2024 . Covers 2 distinct patient populations.

  • Other (2)
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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NCT02548117 03-15-40-10 Ph 3 withdrawn H-36731: Finasteride in Management of Elevated Red Blood Cells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NCT00564460 E-2007 Ph 3 withdrawn On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)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
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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 AND TADALAFIL FDA Label Details

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Data Sources

FDA Approval: ANDA218499 → Trials: ClinicalTrials.gov →

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