Minoxidil (topical)
Minoxidil (topical) is approved in at least one market for androgenetic alopecia.
Approved in the United States in 1988 and over the counter there since 1996, and the benchmark every new topical is measured against.
- Developed by
- Not recorded
- Current phase
- Approved
- Mechanism
- Potassium channel opener
- Indications
- Androgenetic alopecia, Female pattern hair loss
- Also known as
- Regaine, minoxidil topical solution, minoxidil foam, topical minoxidil
- Last public activity
- September 2026
- Copy last reviewed
- September 2026
- Record confidence
- High
Cleared for sale for a hair-loss indication in at least one market.
Opens potassium channels in the follicle - minoxidil's mechanism, thought to improve blood flow and prolong the growth phase.
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
Minoxidil is a potassium channel opener that was developed as an oral antihypertensive; hair growth was an observed side effect, and the topical formulation followed from it. It prolongs the growth phase of follicles that are still working. It does not create new follicles, which is the ceiling on what it can do and the gap most of the programmes in this register are aiming at.
Why it matters
Read the rest of the pipeline against this row. The US label for the men's 5% solution is unusually frank about the limits: some men need at least four months before seeing results, it is not intended for frontal baldness or a receding hairline, regrowth has not been shown to last beyond 48 weeks in the large trials, and the 2015 leaflet says stopping means losing the regrown hair within three to four months. Any new programme claiming to matter has to beat that, in public, on measured density.
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.
- FranceANSMApprovedAlostil· over the counter
Alopécie androgénétique de l'adulte
National procedure, held by Kenvue France. Sold without prescription.
Regulator filing ↗ - United StatesFDAApprovedRogaine· over the counter
Androgenetic alopecia; sold over the counter
Approval date not yet sourced to a primary document.
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.
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Eurofarma Laboratorios S.A. · n=372 · January 2027
Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia
Sheikh Zayed Federal Postgraduate Medical Institute · n=200 · December 2025
Efficacy & Safety of Minoxidil SL Tablets in Men With AGA
Samson Clinical Operations Pty Ltd · n=142 · July 2025
Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia
Cairo University · n=25 · July 2025
Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia
Shanghai Zhongshan Hospital · n=30 · June 2025
Efficacy and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · n=294 · February 2025
Clinical Trial to Evaluate CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
Beijing Dayspring Pharmaceutical Technology Co., Ltd · n=110 · December 2024
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Industrial Farmacéutica Cantabria, S.A. · n=520 · October 2024
Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia
Universitas Indonesia · n=36 · June 2023
Treatment of Androgenetic Alopecia in Men for 24 Weeks
Eurofarma Laboratorios S.A. · n=336 · March 2023
Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia
Dr. dr. Lili Legiawati, SpKK(K) · n=37 · October 2021
Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil
Maja Kovacevic, MD · June 2016
Comparison of Topical Minoxidil 5% in Ethanol Plus Propylene Glycol Versus Minoxidil 5% in Ethanol Alone in Treatment of Women With Female Pattern Hair Loss
Sohag University · n=60 · May 2015
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
Galderma R&D · n=61 · May 2015
Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia
Galderma R&D · n=63 · May 2015
Minoxidil Response Testing in Males With Androgenetic Alopecia
Applied Biology, Inc. · n=300 · July 2014
Minoxidil Response Testing in Females With Female Pattern Hair Loss
Applied Biology, Inc. · n=300 · July 2014
Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia
Vancouver General Hospital · n=20 · April 2014
Efficacy and Safety Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Androgenetic Alopecia
Siriraj Hospital · n=20 · June 2012
Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
Brasilia University Hospital · n=60 · March 2012
Microarray Analysis of Scalp Biopsies After Minoxidil Treatment
University Hospitals Cleveland Medical Center · n=14 · April 2011
Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss
Mae Fah Luang University Hospital · n=40 · March 2011
Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia
Natalie GARCIA BARTELS · n=70 · November 2010
Clinical Trial in Females With Female Pattern Hair Loss
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. · n=322 · June 2010
Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia
Charite University, Berlin, Germany · n=113 · June 2008
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
- MINOXIDIL TOPICAL SOLUTION, 5% — current label — Regulator filing
- Drugs@FDA: ROGAINE (minoxidil) NDA 019501, approval history — Regulator filing
- Minoxidil topical solution 5% — FDA-approved labeling, NDA 020834 — Regulator filing, January 2015
- Pharmacology review, NDA 21-812 (minoxidil 5% foam): history of Rogaine's 1988 approval and 1996 and 1997 switches to over-the-counter status — Regulator filing, January 2006
Related programmes
Other programmes in the register with the same mechanism: Potassium channel opener.
Cite this page
Hair Pipeline, "Minoxidil (topical) — development record", hairpipeline.com/pipeline/minoxidil-topical