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Avodart (dutasteride)
Dual 5-alpha-reductase inhibitor (types I and II) that more completely suppresses DHT than finasteride for BPH treatment.
Dutasteride (Avodart) is a dual 5-alpha-reductase inhibitor developed by GSK, approved in 2001. More complete DHT suppression than finasteride. Available generically.
At a glance
| Generic name | dutasteride |
|---|---|
| Also known as | Avodart |
| Sponsor | GSK (GlaxoSmithKline) |
| Drug class | 5-alpha-reductase inhibitor (dual) |
| Target | 3-oxo-5-alpha-steroid 4-dehydrogenase 1, 3-oxo-5-alpha-steroid 4-dehydrogenase 2, Glycine receptor subunit alpha-1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2001-11-20 (United States) |
Mechanism of action
Dutasteride inhibits both type I and type II 5-alpha-reductase, suppressing serum DHT by >90% compared to ~70% with finasteride. This more complete DHT suppression may provide greater prostate volume reduction in BPH. Very long half-life (5 weeks) means effects persist long after discontinuation.
Approved indications
- Benign prostatic hyperplasia
Common side effects
- Ejaculation disorders
- Impotence
- Decreased libido
- Dizziness
- Breast disorders
Serious adverse events
- High-grade prostate cancer (Gleason score 8-10)
- Cardiac failure
Key clinical trials
- Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate (Phase 3)
- The Efficacy of Nano-water in Combination With Tamsulosin-Dutasteride for Alleviating Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia (NA)
- Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue (N/A)
- A Prospective Study of Sexual Function in Men Taking Dutasteride for the Treatment of Androgenetic Alopecia (Phase 3)
- Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3 (Phase 2)
- Prostate Medication, Metabolism and Gut Microbiota (Phase 4)
- An Open-label, Randomized, Single Dose, Three-way Crossover Study to Determine the Bioavailability of Two Fixed Dose Combination Capsule Formulations of Dutasteride and Tamsulosin Hydrochloride (0.5mg (Phase 1)
- A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Avodart CI brief — competitive landscape report
- Avodart updates RSS · CI watch RSS
- GSK (GlaxoSmithKline) portfolio CI