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
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. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE SANDOZ CAPSULES 0.5MG/0.4MG | N/A | N/A | N/A | 7/11/2024 | |
DUTASTERIDE SANDOZ CAPSULES 0.5MG | N/A | N/A | N/A | 2/11/2025 | |
DUTABIT PLUS 0.5/0.4 CAPSULES 0.5MG/0.4MG | N/A | N/A | N/A | 9/13/2024 | |
DUODART CAPSULE 0.5MG/0.4MG | N/A | N/A | N/A | 3/22/2012 | |
AVODART CAPSULES 0.5MG | N/A | N/A | N/A | 11/27/2012 |
TGA Drug Approvals
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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