NDAORALCAPSULE
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
AVODART (dutasteride) by Viatris (2) is 5-alpha reductase inhibitors [moa]. Approved for benign prostatic hyperplasia. First approved in 2001.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVODART (dutasteride) is a 5-alpha reductase inhibitor that reduces conversion of testosterone to dihydrotestosterone, the hormone driving benign prostatic hyperplasia and androgenetic alopecia. It is an oral capsule approved for BPH and lower urinary tract symptoms, with off-label use in prostate cancer prevention and androgenetic alopecia. The drug works by inhibiting both Type I and Type II 5-alpha reductase isoenzymes.
$0.227MPart D
LOE ApproachingDeclining
This product is in late-stage lifecycle with modest Part D spending; commercial teams should expect declining sales and resource rationalization.
Mechanism of Action
5-alpha Reductase Inhibitors
Pharmacologic Class:
5-alpha Reductase Inhibitor
Indications (1)
Clinical Trials (20)
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
Started Sep 2024
28 enrolled
Healthy Subjects
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
Started Mar 2017
36 enrolled
Benign Prostatic Hyperplasia
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
Started May 2016
28 enrolled
Benign Prostate Hyperplasia
Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
Started Sep 2015
36 enrolled
Prostatic Hyperplasia
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
Started Jul 2015
56 enrolled
Prostatic Hyperplasia
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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.