Wednesday, July 8, 2026

Drug profile · INN

finasteride

finasteride (APO-FINASTERIDE) is a steroid 5-alpha-reductase 2 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 1
Pipeline programs 2
News articles 0
Drug details — finasteride
US status
approved
Class
Route
ORAL
Patents
1
Programs
2
Data quality
0.89

Quick answer

finasteride (APO-FINASTERIDE) is a steroid 5-alpha-reductase 2 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN finasteride
Brand APO-FINASTERIDE
Mechanism Steroid 5-alpha-reductase 2 inhibitor
Target 3-oxo-5-alpha-steroid 4-dehydrogenase 2
Route ORAL
Formulation CAPSULE

Mechanism of action

Steroid 5-alpha-reductase 2 inhibitor

Primary target: 3-oxo-5-alpha-steroid 4-dehydrogenase 2

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. A randomized for healthy male subjects Phase 1 · Anaxis Pharma · healthy male subjects
  2. Finasteride 5 mg tablets Phase 1 · Teva Pharma · Healthy
  1. US 11357783

    Conjugate of finasteride with peptide

    Expires Mon Jun 09 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is finasteride?

finasteride (APO-FINASTERIDE) is a steroid 5-alpha-reductase 2 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for finasteride?

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

What is the US approval status of finasteride?

finasteride 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.