Topical finasteride
Topical finasteride is approved in at least one market for androgenetic alopecia, developed by Almirall.
Finasteride as a scalp spray rather than a tablet — approved in several European markets and in China, and almost unknown in the United States.
- Developed by
- Almirall
- Current phase
- Approved
- Mechanism
- 5α-reductase inhibitor
- 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
- 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
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 European 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 European phase III compared it against oral finasteride, not only placebo. The catch is geography and the label: it is approved in Italy, Germany, Luxembourg and Portugal since 2021, in France since March 2024 with sales declared from March 2025, and in China since June 2025; the French authorisation is for men aged 18 to 41 with mild to moderate loss, on prescription. It 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
- 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.
Various Procedural Treatment Options for Androgenetic Alopecia
Sheikh Zayed Medical College · n=190 · February 2025
A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
Cutia Therapeutics（Wuxi）Co.,Ltd · n=270 · December 2021
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
Photosensitization Study in Androgenetic Alopecia
Polichem S.A. · n=58 · May 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
- A Phase 3 Clinical Study in Patients With Androgenetic Alopecia (CU-40102) — ClinicalTrials.gov
- Cutia Therapeutics voluntary announcement: NMPA marketing approval of CU-40102 topical finasteride spray — Regulator filing, June 2025
- FINCREZO 2,275 mg/mL, solution pour pulvérisation cutanée — fiche BDPM — Regulator filing, March 2024
- Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial — Peer-reviewed, February 2022
- Hikma and Almirall enter an exclusive licensing agreement to market Finjuve in the Middle East and North Africa (approved in Italy, Germany, Luxembourg and Portugal) — Company release, November 2021
Related programmes
Other programmes in the register with the same mechanism: 5α-reductase inhibitor.
Cite this page
Hair Pipeline, "Topical finasteride — development record", hairpipeline.com/pipeline/topical-finasteride