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.
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)
Research Report
Dutasteride (DB01126): A Comprehensive Pharmacological and Clinical Monograph
Section 1: Chemical Identity and Physicochemical Properties
Introduction
Dutasteride is a synthetic small molecule drug classified as a 4-azasteroid compound. Its chemical architecture is specifically engineered to interact with and inhibit key enzymes in the androgen metabolic pathway. As a derivative of a natural steroid hormone structure, it leverages biological recognition, while its unique synthetic modifications confer potent and long-lasting pharmacological activity. This section provides a definitive overview of the chemical and physical data that underpin its function, formulation, and stability.
Nomenclature and Identifiers
The unambiguous identification of a pharmaceutical agent is paramount for research, clinical practice, and regulatory oversight. Dutasteride is cataloged under a variety of internationally recognized naming conventions and database identifiers.
- Generic Name: Dutasteride [1].
- DrugBank ID: DB01126 [2].
- CAS Number: 164656-23-9 [2, 3]. This unique numerical identifier is assigned by the Chemical Abstracts Service and is a universal standard for chemical substance identification.
- IUPAC Name: The systematic name assigned by the International Union of Pure and Applied Chemistry is (1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide [2].
- Synonyms and Alternate Names: In scientific literature and commercial contexts, Dutasteride is also known by several synonyms, including its chemical classification name (5α,17β)-N--3-oxo-4-azaandrost-1-ene-17-carboxamide, and various development codes and brand names such as Avodart, Avolve, GG 745, GI 198745, and Veltride [4, 5].
- Other Database Identifiers: To facilitate comprehensive cross-referencing, Dutasteride is indexed in numerous major biomedical an
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2008/10/28 | Phase 3 | Completed | |||
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 |
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CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DUTASTERIDA/TAMSULOSINA STADAGEN 0,5 MG/0,4 MG CAPSULAS DURAS | Laboratorio Stada S.L. | 83711 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ILMAGO 0,5 MG/0,4 MG CAPSULAS DURAS | Laboratorios Salvat S.A. | 83753 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
AVIDART 0,5 mg CAPSULAS BLANDAS | 65178 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
DUTACAP 0,5 MG CAPSULAS BLANDAS EFG | Galenicum Derma S.L.U. | 84497 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica | Commercialized |
DUTASTERIDA VIR 0,5 MG CAPSULAS BLANDAS EFG | Industria Quimica Y Farmaceutica Vir S.A. | 79750 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica | Commercialized |
DUTASTERIDA AUROVITAS SPAIN 0,5 mg CÁPSULAS BLANDAS EFG | Aurovitas Spain, S.A.U. | 81244 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
BIDUTAM 0,5 MG/0,4 MG CAPSULAS DURAS EFG | Laboratorios Q Pharma S.L. | 84976 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
DUTASTERIDA/TAMSULOSINA AUROVITAS SPAIN 0,5MG/0,4MG CAPSULAS DURAS. | Aurovitas Spain, S.A.U. | 83710 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
DUTASTERIDA/TAMSULOSINA TARBIS 0,5 MG/0,4 MG CAPSULAS DURAS | Tarbis Farma S.L. | 83700 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
DUTASTERIDA/TAMSULOSINA ACCORD 0,5 MG/0,4 MG CAPSULAS DURAS EFG | 84628 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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