NDAORALTABLETPriority Review
Approved
Jun 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
Priority Review
PROSCAR (finasteride) by Merck & Co. is 5-alpha reductase inhibitors [moa]. First approved in 1992.
Drug data last refreshed 12h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROSCAR (finasteride) is an oral small-molecule 5-alpha reductase inhibitor approved by the FDA in 1992 for benign prostatic hyperplasia (BPH) in men. It works by blocking the enzyme that converts testosterone to dihydrotestosterone, reducing prostate size and improving urinary symptoms. This is an established therapy with decades of clinical use and market presence.
$0.459MPart D
LOE ApproachingDeclining
With loss of exclusivity approaching, the brand team is likely contracting or shifting focus to life-cycle extensions; commercial roles may consolidate.
Mechanism of Action
5-alpha Reductase Inhibitors
Pharmacologic Class:
5-alpha Reductase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial
Started Oct 2027
300 enrolled
Spinal Cord InjurySpinal Cord InjuriesInjuries, Spinal Cord+11 more
Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
Started Aug 2013
1 enrolled
Benign Prostatic Hyperplasia
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Started Oct 2010
917 enrolled
Androgenetic Alopecia
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Started Sep 2010
696 enrolled
Benign Prostatic HyperplasiaEnlarged Prostate
The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy
Started Mar 2008
29 enrolled
HematuriaHematospermia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.