Finasteride (Propecia)
Finasteride (Propecia) is approved in at least one market for androgenetic alopecia, developed by Organon.
Approved for male pattern hair loss in the United States in 1997 and in France in 1998, and still the only oral drug approved for it in the US and Europe.
- Developed by
- Organon
- Current phase
- Approved
- Mechanism
- 5α-reductase inhibitor
- Indications
- Androgenetic alopecia
- Also known as
- Propecia, MK-906, finasteride 1 mg
- Last public activity
- December 2025
- Copy last reviewed
- September 2026
- Record confidence
- High
Cleared for sale for a hair-loss indication in at least one market.
Stops testosterone being converted into DHT, the hormone that drives pattern hair loss.
A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.
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 US label says stopping reverses the effect within twelve months, and the French summary of product characteristics that the benefit starts to fade at six months and is gone by nine to twelve.
Why it matters
Nearly thirty years on, this is still the entire approved oral standard of care for androgenetic alopecia in the US and Europe, which is the clearest single measure of how little has reached the market; Japan and South Korea also approve dutasteride, as its own entry records. The caveats come from the labels rather than from us. In the US it is indicated in men only and contraindicated in women who are or may become pregnant, because it can cause abnormalities of the external genitalia of a male fetus; in France it is contraindicated in all women and indicated in men aged 18 to 41 with early-stage loss. Both labels record reports of sexual dysfunction that continued after treatment stopped, and of depression and suicidal ideation; in September 2025 the ANSM announced new measures on the risk of suicidal ideation, and from April 2026 a co-signed information form is required for dispensing. It is prescription-only in France, where the Propecia brand's authorisation was archived in April 2026 and generics remain on the market.
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.
Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia
Universitas Indonesia · n=40 · May 2023
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
EMS · n=190 · February 2023
Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
HairDx, LLC · n=12 · December 2008
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
- PROPECIA (finasteride) tablet, film coated — current label, Organon LLC — Regulator filing
- PROPECIA 1 mg, comprimé pelliculé — fiche AMM — Regulator filing
- Information pour les professionnels de santé à propos du finastéride 1 mg — Regulator filing
- FINASTERIDE BIOGARAN 1 mg, comprimé pelliculé, fiche AMM (générique commercialisé) — Regulator filing
- Drugs@FDA: PROPECIA (finasteride) NDA 020788, approval history — Regulator filing
- PROPECIA (finasteride) tablets — FDA-approved prescribing information — Regulator filing, January 2022
Related programmes
Other programmes in the register with the same mechanism: 5α-reductase inhibitor.
Cite this page
Hair Pipeline, "Finasteride (Propecia) — development record", hairpipeline.com/pipeline/finasteride