DUTASTERIDE
Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. BPH-related surgery. BPH in men with an enlarged prostate. Dutasteride is not approved for the prevention of prostate cancer.
Details
- Status
- Prescription
- First Approved
- 2010-12-21
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
DUTASTERIDE Approval History
What DUTASTERIDE Treats
12 FDA approvalsOriginally approved for its first indication in 2010 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Dec 2010)Letter
- • Approved indication (Nov 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Mar 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Apr 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Jun 2018)
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
20 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| NCT05705700 | 2019LS229 | Ph 2 | withdrawn | Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP) |
| NCT02147964 ITT-5 | STUDY00001449 | Ph 2 | withdrawn | ITT-5 Mechanisms of Spermatogenesis in Man |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 |
| 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.
DUTASTERIDE FDA Label Details
Indications & Usage
Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. 1.1 Monotherapy Dutasteride capsules are indicated for the treatment of s...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.