Overview
Dutasteride is an oral synthetic 4-azasteroid commonly marketed under the trade name Avodart. It is a novel dual 5α-reductase inhibitor that works by blocking both isoforms of 5α-reductase enzymes in a potent, selective, and irreversible manner. Type I and II 5α-reductase enzymes convert testosterone into dihydrotestosterone (DHT), a primary hormonal mediator that plays a role in the development and enlargement of the prostate gland. Dutasteride was approved by the FDA in 2001 for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men as monotherapy or in combination with the α-adrenergic antagonist tamsulosin to enhance the therapeutic response. Its clinical efficacy against benign prostate hyperplasia in male patients is comparable to that of finasteride, a specific type II 5α-reductase inhibitor. However, unlike finasteride, dutasteride is not yet indicated for the treatment of androgenic alopecia although it was demonstrated to be effective in several randomized, double-blind, placebo-controlled trials in androgenetic alopecia.
Background
Dutasteride is an oral synthetic 4-azasteroid commonly marketed under the trade name Avodart. It is a novel dual 5α-reductase inhibitor that works by blocking both isoforms of 5α-reductase enzymes in a potent, selective, and irreversible manner. Type I and II 5α-reductase enzymes convert testosterone into dihydrotestosterone (DHT), a primary hormonal mediator that plays a role in the development and enlargement of the prostate gland. Dutasteride was approved by the FDA in 2001 for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men as monotherapy or in combination with the α-adrenergic antagonist tamsulosin to enhance the therapeutic response. Its clinical efficacy against benign prostate hyperplasia in male patients is comparable to that of finasteride, a specific type II 5α-reductase inhibitor. However, unlike finasteride, dutasteride is not yet indicated for the treatment of androgenic alopecia although it was demonstrated to be effective in several randomized, double-blind, placebo-controlled trials in androgenetic alopecia.
Indication
Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with tamsulosin.
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
- Symptomatic benign prostatic hyperplasia (BPH)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/09/16 | Phase 4 | Completed | |||
2008/08/14 | Not Applicable | Completed | UConn Health | ||
2008/06/30 | Not Applicable | Completed | |||
2008/06/05 | Phase 4 | UNKNOWN | Urologic Consultants of Southeastern PA | ||
2008/05/20 | Not Applicable | Completed | Franklin D. Gaylis, MD Inc. | ||
2008/04/29 | Phase 2 | Completed | |||
2008/02/07 | Phase 1 | Completed | |||
2007/11/14 | Phase 2 | Completed | |||
2007/11/06 | Phase 2 | Completed | Canadian Urology Research Consortium | ||
2007/09/11 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||