TheraRadar
Data updated: May 26, 2026

ENTADFI (finasteride)

Trial Activity: Declining 2 active trials
Urology Approved 2021-12-09
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

National Eye Institute (NEI) conducting 3 trials (17%)
26 indications explored (Broad Platform)
→ retinal disease (3 trials)
→ benign prostatic hyperplasia (3 trials)
→ prostate cancer (2 trials)
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Discontinued
First Approved
2021-12-09
Routes
ORAL
Dosage Forms
CAPSULE

Companies

BLUE WATER BIOTECH
Active Ingredient: FINASTERIDE , TADALAFIL

ENTADFI Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Dec 2021 ORIGINAL
New Combo · Type 4 - New Combination
FDA Letter Label

What ENTADFI Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
📋

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NCT02548117 03-15-40-10 Ph 3 withdrawn H-36731: Finasteride in Management of Elevated Red Blood Cells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NCT00564460 E-2007 Ph 3 withdrawn On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)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

ENTADFI FDA Label Details

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Data Sources

FDA Approval: NDA215423 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment