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Finasteride (Propecia)

Approved in 1997 for male pattern hair loss, and still the only oral drug approved for it.

ApprovedOral5α-reductase inhibitor
Developed by
Organon
Current phase
Approved

Cleared for sale for a hair-loss indication in at least one market.

Indications
Androgenetic alopecia
Also known as
Propecia, MK-906, finasteride 1 mg
Last public activity
December 2025
Record confidence
High

How it is meant to work

Finasteride inhibits type II 5-alpha reductase, the enzyme that converts testosterone into dihydrotestosterone. DHT is what miniaturises genetically susceptible follicles, so lowering it slows the process. Like minoxidil it is a holding action on follicles that still exist: the label notes that stopping reverses the effect within twelve months.

Why it matters

Nearly thirty years on, this is still the entire approved oral standard of care for androgenetic alopecia — which is the clearest single measure of how little has reached the market. Two caveats belong with it, both from the label rather than from us: it is indicated in men only and is contraindicated in women who are or may become pregnant, because it can cause abnormalities of the external genitalia of a male fetus; and the postmarketing section records reports of sexual dysfunction that continued after treatment stopped. It is a prescription-only medicine in France.

Where it is approved

Marketing authorisation is granted country by country, for a specific indication. A drug approved for hair loss in one market may be approved only for something else — or not at all — in another.

  • United StatesFDAApprovedPropecia· prescription only

    Male pattern hair loss (androgenetic alopecia), men only

    Regulator filing ↗
  • FranceANSMAuthorised, not marketedPropecia· prescription only

    Alopécie androgénétique au stade précoce, homme de 18 à 41 ans

    Authorised since 1998, held by Organon France. The originator brand is no longer marketed in France; generics remain. Since February 2026 the ANSM requires a signed shared-information certificate, renewed annually, before finasteride 1 mg can be dispensed — from 16 April 2026 for new patients and 16 June 2026 for those already treated.

    Regulator filing ↗

Development history

No phase changes recorded yet.

Registered trials

Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.

  • NCT05990400Phase 2/3UNKNOWN

    Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia

    Indonesia University · n=40 · May 2023

  • NCT04594018Phase 3RECRUITING

    Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

    EMS · n=190 · February 2023

  • NCT02483195ApprovedWITHDRAWN

    The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

    University of Florida · August 2016

  • NCT01052870Phase 1COMPLETED

    Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia

    HairDx, LLC · n=12 · December 2008

  • NCT00396175Phase 3COMPLETED

    Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)

    Organon and Co · n=355 · March 1998

Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.

Sources