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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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/15
Not Applicable
Recruiting
2025/04/08
Phase 3
Not yet recruiting
2023/01/31
Phase 2
Withdrawn
2022/10/31
Phase 2
Active, not recruiting
2022/08/24
Phase 2
Recruiting
2021/07/01
Phase 3
Completed
2021/04/01
Phase 3
Completed
2021/02/16
Phase 2
Completed
2021/01/28
Phase 2
Completed
2020/12/21
Phase 1
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Strides Pharma Science Limited
64380-763
ORAL
0.5 mg in 1 1
12/28/2021
Zydus Pharmaceuticals USA Inc.
68382-640
ORAL
0.5 mg in 1 1
10/6/2022
AvKARE
42291-031
ORAL
0.5 mg in 1 1
11/15/2023
Intergel Pharmaceuticals Inc
62112-8068
ORAL
0.5 mg in 1 1
3/30/2016
NuCare Pharmaceuticals,Inc.
68071-2610
ORAL
0.5 mg in 1 1
1/4/2022
Physicians Total Care, Inc.
54868-5114
ORAL
0.5 mg in 1 1
12/20/2011
Camber Pharmaceuticals, Inc.
31722-131
ORAL
0.5 mg in 1 1
9/20/2021
Viona Pharmaceuticals Inc
72578-019
ORAL
0.5 mg in 1 1
11/20/2022
PuraCap Pharmaceutical LLC
51013-190
ORAL
0.5 mg in 1 1
5/29/2018
Bryant Ranch Prepack
63629-1222
ORAL
0.5 mg in 1 1
5/19/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DUTABIT PLUS 0.5/0.4 CAPSULES 0.5MG/0.4MG
SIN16633P
CAPSULE
0.5mg
11/1/2022
DUTABIT 0.5 SOFT CAPSULES 0.5MG
SIN16448P
CAPSULE, LIQUID FILLED
0.5mg
3/22/2022
AVODART SOFT CAPSULE 0.5 mg
SIN12434P
CAPSULE, LIQUID FILLED
0.5 mg
10/4/2003
DUOFLOW CAPSULE 0.5mg/0.4mg
SIN16558P
CAPSULE
0.5mg
7/20/2022
DUTASVITAE SOFT CAPSULE 0.5MG
SIN15590P
CAPSULE, LIQUID FILLED
0.5mg
12/4/2018
Duodart Capsules 0.5mg/0.4mg
SIN14181P
CAPSULE
0.5 mg
7/2/2012
ARIPSA SOFT CAPSULES 0.5MG
SIN16476P
CAPSULE, LIQUID FILLED
0.5 mg
4/13/2022
LOTUFLO-D CAPSULES 0.5 MG/0.4 MG
SIN16678P
CAPSULE
0.5 mg
1/17/2023
INTASTERIDE SOFT CAPSULE 0.5MG
SIN15563P
CAPSULE, LIQUID FILLED
0.5 mg
10/18/2018
RAFUSTER SOFT CAPSULES 0.5 MG
SIN15882P
CAPSULE, LIQUID FILLED
0.5 mg
1/31/2020

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
AVODART dutasteride 500 microgram soft capsule blister pack
90434
Medicine
A
11/14/2002
DUTATAM 500/400 dutasteride 500 microgram/tamsulosin hydrochloride 400 microgram modified release capsule bottle
414643
Medicine
A
6/24/2024
GenRx Dutasteride dutasteride 500 microgram soft capsule blister pack
212045
Medicine
A
2/28/2014
DUTASTERIDE/TAMSULOSIN ALIDAC 500/400 dutasteride 500 microgram/tamsulosin hydrochloride 400 microgram modified release capsule bottle
414645
Medicine
A
6/24/2024
DUTASTERIDE/TAMSULOSIN LUPIN 500/400 dutasteride 500 microgram/tamsulosin hydrochloride 400 microgram modified release capsule bottle
414647
Medicine
A
6/24/2024
APO-Dutasteride dutasteride 500 microgram soft capsule blister pack
212047
Medicine
A
2/28/2014
DOUBLUTS dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule bottle
326621
Medicine
A
3/4/2020
DUTASTERIDE/TAMSULOSIN SANDOZ 500/400 dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule blister pack
362953
Medicine
A
6/19/2024
DUTASTERIDE/TAMSULOSIN SANDOZ 500/400 dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule bottle
362954
Medicine
A
6/19/2024
DUTASTERIDE/TAMSULOSIN ZYDUS 500/400 dutasteride 500 microgram/ tamsulosin hydrochloride 400 microgram modified release capsule bottle
411272
Medicine
A
6/24/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACT DUTASTERIDE
teva canada limited
02412691
Capsule - Oral
0.5 MG
9/5/2014
SANDOZ DUTASTERIDE
02424444
Capsule - Oral
0.5 MG
7/22/2014
DUTASTERIDE
sivem pharmaceuticals ulc
02429012
Capsule - Oral
0.5 MG
10/8/2014
APO-DUTASTERIDE
02404206
Capsule - Oral
0.5 MG
7/18/2014
AVODART
02247813
Capsule - Oral
0.5 MG
11/14/2003
SANDOZ DUTASTERIDE
02434369
Capsule - Oral
0.5 MG
N/A
AG-DUTASTERIDE
angita pharma inc.
02485672
Capsule - Oral
0.5 MG
N/A
DUTASTERIDE
sanis health inc
02443058
Capsule - Oral
0.5 MG
7/21/2015
RIVA-DUTASTERIDE
laboratoire riva inc.
02427753
Capsule - Oral
0.5 MG
9/18/2014
JAMP DUTASTERIDE
02484870
Capsule - Oral
0.5 MG
11/7/2019

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DUTASTERIDA CINFA 0,5 MG CAPSULAS BLANDAS EFG
Laboratorios Cinfa S.A.
80595
CÁPSULA BLANDA
Medicamento Sujeto A Prescripción Médica
Commercialized
DUTASTERIDA STADA 0,5 MG CAPSULAS BLANDAS EFG
Laboratorio Stada S.L.
80581
CÁPSULA BLANDA
Medicamento Sujeto A Prescripción Médica
Commercialized
DUTASTERIDA/TAMSULOSINA TEVA 0,5 MG/0,4 MG CAPSULAS DURAS
83557
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DUTASTERIDA/TAMSULOSINA NORMOGEN 0,5 MG/0,4 MG CAPSULAS DURAS EFG
Laboratorios Normon S.A.
85505
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized
DUTAMSIN 0,5 MG/0,4 MG CAPSULAS DURAS
Exeltis Healthcare S.L.
83630
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized
DUTASTERIDA VIATRIS 0,5 MG CAPSULAS BLANDAS EFG
Viatris Pharmaceuticals S.L.U.
81781
CÁPSULA BLANDA
Medicamento Sujeto A Prescripción Médica
Commercialized
DUTASTERIDA/TAMSULOSINA NORMON 0,5 MG/0,4 MG CAPSULAS DURAS
Laboratorios Normon S.A.
83699
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DUTASTERIDA APOTEX 0,5 MG CAPSULAS BLANDAS EFG
Apotex Europe B.V.
79630
CÁPSULA BLANDA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DUTASTERIDA PENSA 0,5 MG CAPSULAS BLANDAS EFG
Towa Pharmaceutical S.A.
81153
CÁPSULA BLANDA
Medicamento Sujeto A Prescripción Médica
Commercialized
DUTASTERIDA/TAMSULOSINA RATIO 0,5 MG/0,4 MG CAPSULAS DURAS EFG
Teva Pharma S.L.U.
84670
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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