NDAORALTABLETPriority Review
Approved
Jun 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
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 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROSCAR (finasteride) is an oral small-molecule 5-alpha reductase inhibitor approved in 1992 for benign prostatic hyperplasia (BPH). It works by blocking the conversion of testosterone to dihydrotestosterone, reducing prostate size and urinary symptoms. The drug is also used off-label for male pattern baldness under the brand name Propecia.
$0.459MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with modest Medicare spending, suggesting a contracting brand team focused on transition and generic management strategies.
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 (13)
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
A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy
Started Feb 2008
19 enrolled
Enlarged Prostate
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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.