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Dutasteride

Generic Name
Dutasteride
Brand Names
Avodart, Jalyn
Drug Type
Small Molecule
Chemical Formula
C27H30F6N2O2
CAS Number
164656-23-9
Unique Ingredient Identifier
O0J6XJN02I

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

Published: Aug 3, 2025

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

Continue reading the full research report

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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