Wednesday, July 8, 2026

Drug profile · INN

dutasteride

dutasteride (APO-DUTASTERIDE) is a steroid 5-alpha-reductase inhibitor. Associated with GlaxoSmithKline. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved PMDA: approved
US status approved
Patents linked 1
Pipeline programs 3
News articles 0
Drug details — dutasteride
US status
approved
Class
Route
ORAL
Patents
1
Programs
3
Data quality
0.89

Quick answer

dutasteride (APO-DUTASTERIDE) is a steroid 5-alpha-reductase inhibitor. Associated with GlaxoSmithKline. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN dutasteride
Brand APO-DUTASTERIDE
Mechanism Steroid 5-alpha-reductase inhibitor
Target Steroid 5-alpha-reductase
Route ORAL
Formulation CAPSULE

Mechanism of action

Steroid 5-alpha-reductase inhibitor

Primary target: Steroid 5-alpha-reductase

Approval history

Authority Status Date
FDA approved
TGA approved
PMDA approved

Pipeline programs

  1. dutasteride 0.5mg once daily for 4 years Phase 3 · GSK Glaxo Smith · Prostatic Hyperplasia
  2. Tamsulosin Phase 1 · Teva Pharma · Healthy
  3. Dutasteride plus tamsulosin Approved · GSK Glaxo Smith · Prostatic Hyperplasia
  1. US 11324760

    Solid dispersion of dutasteride, method for preparing the solid dispersion, and pharmaceutical composition including the solid dispersion

    Expires Mon May 05 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is dutasteride?

dutasteride (APO-DUTASTERIDE) is a steroid 5-alpha-reductase inhibitor. Associated with GlaxoSmithKline. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for dutasteride?

APO-DUTASTERIDE is a marketed brand name for dutasteride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dutasteride?

dutasteride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.