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Small-molecule 5-alpha-reductase type II inhibitor, supplied as oral tablets

Finasteride — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

1 record in this file

  • REGULATORY1

Research areas. Approved hair-loss treatment.

Publication span. 2022.

What we know

    Editorial reading of the records below, labelled as Therapept analysis. How records are built

    What remains uncertain

      Regulatory notes

      FDA-approved drug substance

      • PROPECIA, NDA 020788, approved 19 December 1997 for androgenetic alopecia in men.
      • The approved label limits the indication to men, and states that efficacy in bitemporal recession has not been established.
      • Finasteride 5 mg (PROSCAR) is a different approved product, indicated for benign prostatic hyperplasia.
      • The label carries warnings and precautions, including effects on prostate-specific antigen interpretation and reports of sexual adverse experiences. Regulatory status is not a safety assessment.

      Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

      Studies and documents

      1. REGULATORY2022Approved product labelling

        PROPECIA (finasteride) tablets — prescribing information

        U.S. Food and Drug AdministrationFDA approved labelling

        Objective
        To record the approved indication, population and stated limits of the finasteride 1 mg hair-loss product.
        Endpoint investigated
        Approved indication and labelling

        The label indicates finasteride 1 mg for male pattern hair loss in men only, states that efficacy in bitemporal recession has not been established, and states that the product is not indicated for women. It also carries warnings and precautions.

        Limitations. Labelling summarises the development programme; it is not a new trial and not a complete safety review. It does not support use in women or in bitemporal recession.

        FDA — PROPECIA prescribing information (2022)Reviewed 13 November 2026

      Last reviewed 13 November 2026 · Compiled by Therapept Editorial · How these records are built