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Topical finasteride

Finasteride as a scalp spray rather than a tablet — approved in several European markets and in China, and almost unknown in the United States.

ApprovedTopical5α-reductase inhibitor

No public activity in over 18 months

Developed by
Almirall
Current phase
Approved

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

Partners
cutia, bailleul
Indications
Androgenetic alopecia
Also known as
P-3074, ALM12845, CU-40102, Finjuve, Fincrezo, finasteride spray, topical finasteride
Last public activity
February 2025
Record confidence
High

How it is meant to work

The same 5-alpha-reductase inhibition as oral finasteride, delivered from a 0.25% cutaneous spray. The formulation is designed to keep the drug in the follicle rather than the bloodstream: in the phase III trial, peak plasma finasteride was more than a hundred times lower than with the tablet, and the fall in serum DHT was 34.5% against 55.6%.

Why it matters

It answers the question most readers of this register actually have — whether the systemic exposure can be avoided — and it answers it with an approval rather than a hypothesis. The phase III compared it against oral finasteride, not only placebo. The catch is geography: it is authorised and sold in France, Italy, Germany, Portugal and China, and is not FDA-approved, so the American discussion of "topical finasteride" is mostly about compounded preparations that have been through none of this.

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.

  • FranceANSMApprovedFincrezo· prescription only

    Alopécie androgénétique de l'homme adulte

    Authorised by mutual recognition and actually marketed in France, dispensed on liste I. Marketing authorisation held by Laboratoires Bailleul.

    Regulator filing ↗
  • United StatesFDANot approved

    No FDA-approved topical finasteride exists. Products sold under that name in the United States are compounded preparations, which are not reviewed for efficacy.

Development history

  1. Phase 3

    First Phase 3 trial on record: NCT03004469 — Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

    ClinicalTrials.gov ↗

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.

  • NCT06826001Phase 2NOT YET RECRUITING

    Various Procedural Treatment Options for Androgenetic Alopecia

    Sheikh Zayed Medical College · n=190 · February 2025

  • NCT05135468Phase 3COMPLETED

    A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)

    Cutia Therapeutics（Wuxi）Co.,Ltd · n=270 · December 2021

  • NCT03004469Phase 3COMPLETED

    Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

    Polichem S.A. · n=458 · August 2016

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