AVODART (dutasteride)
AVODART is indicated for the treatment of Benign Prostatic Hyperplasia; Acute Urinary Retention.
How AVODART Works
Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes. It works by blocking the conversion of testosterone to dihydrotestosterone (DHT), the primary androgen responsible for the development and enlargement of the prostate gland. The drug forms a stable enzyme complex with slow dissociation and does not bind to the human androgen receptor. By significantly lowering circulating and intraprostatic DHT levels, the medication manages prostate enlargement.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2001-11-20
- Routes
- ORAL
- Dosage Forms
- CAPSULE
AVODART Approval History
What AVODART Treats
2 indicationsAVODART is approved for 2 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Benign Prostatic Hyperplasia
- Acute Urinary Retention
AVODART Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05599243 | ALOSTOP | Ph 2 | completed | Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia. |
| NCT04947631 | DKF-313-P3 | Ph 3 | completed | Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia |
| NCT05705700 | 2019LS229 | Ph 2 | withdrawn | Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP) |
| NCT02352311 | DK-DT-002 | Ph 1 | completed | Safety and Pharmacokinetic Characteristics of DKF-313 |
| NCT02147964 ITT-5 | STUDY00001449 | Ph 2 | withdrawn | ITT-5 Mechanisms of Spermatogenesis in Man |
| NCT01758523 results posted | 13-056-2 2P60AA003510 | Ph 4 | completed | Dutasteride Treatment for the Reduction of Heavy Drinking in Men |
| NCT01547299 results posted | MDV3100-07 C3431019 | Ph 2 | completed | Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer |
| NCT02014584 results posted | 200209 | Ph 3 | completed | Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia |
| NCT00953576 KHLAD results posted | 08-374 | Ph 1, Ph 2 | terminated | Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer |
| NCT01577693 ARI115148 | 115148 | Ph 1 | completed | Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects |
| NCT01393730 results posted | 10-448 | Ph 2 | completed | Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer |
| NCT01657851 | 116502 | Ph 1 | completed | Bioequivalence - Duodart Against Avodart & Omnic |
| NCT02839122 | YY_DUTA_2016 | Ph 1 | completed | A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects |
| NCT01262287 results posted | 11-036-2 P60AA003510 | Ph 4 | completed | Dutasteride for the Reduction of Alcohol Use in Male Drinkers |
| NCT00985738 results posted | 09-0247.cc | Ph 2 | terminated | Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer |
| NCT01942551 | DK-DT-001 | Ph 1 | completed | Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride |
| NCT02159690 | Neoadj enz/abi/dut/deg | Ph 2 | withdrawn | A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy |
| NCT00805701 | 047838 | Ph 4 | completed | Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation |
| NCT01215292 ITT4 results posted | 38692-K U54HD012629 | Ph 1, Ph 2 | completed | ITT4 Intratesticular Hormonal Milieu in Man (ITT4) |
| NCT00490555 PROS-1 results posted | 31434-A RFA-HD-06-014;, 06-4795-A 01 | Ph 2, Ph 3 | completed | PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue |
| NCT00880672 | JHKu1 | Ph 4 | completed | Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate |
| NCT00752869 DUT/T | GSK 111504 FDA IND # 101,619 | Ph 4 | completed | Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
AVODART FDA Label Details
Indications & Usage
FDA Label (PDF)AVODART is indicated for the treatment of Benign Prostatic Hyperplasia; Acute Urinary Retention.
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Data Sources
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