Minoxidil (topical)
The over-the-counter standard since 1988, and the benchmark every new topical is measured against.
- Developed by
- Unknown
- Current phase
- Approved
- Indications
- Androgenetic alopecia, Female pattern hair loss
- Also known as
- Regaine, minoxidil topical solution, minoxidil foam, topical minoxidil
- Last public activity
- August 2026
- Record confidence
- High
Cleared for sale for a hair-loss indication in at least one market.
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 label is unusually frank about the limits: results may take four months, it is not intended for a receding hairline, regrowth has not been shown to last beyond 48 weeks in the large trials, and 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
Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
Ohio State University Comprehensive Cancer Center · n=50 · July 2026
VENEZE Peptide Factor Hair Serum Compared With Topical 2% Minoxidil for Androgenetic Alopecia
Institute of Dermatology, Thailand · n=80 · May 2026
Topical Methotrexate vs Minoxidil for Localized Alopecia Areata
Jinnah Postgraduate Medical Centre · n=268 · March 2026
JAK2 Expression in Androgenetic Alopecia Before and After Topical Minoxidil
Kasr El Aini Hospital · n=25 · February 2026
Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution for Androgenetic Alopecia
Kasr El Aini Hospital · n=60 · January 2026
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 and Safety of 5% Minoxidil Foam in Female Androgenetic Alopecia
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · n=294 · February 2025
Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men
Indonesia University · n=36 · June 2023
Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination in Male Androgenetic Alopecia
Indonesia University · n=36 · June 2023
Exosome Injection Versus Topical Minoxidil for Androgenetic Alopecia
Tanta University · n=40 · April 2023
Treatment of Androgenetic Alopecia in Men for 24 Weeks
Eurofarma Laboratorios S.A. · n=336 · March 2023
Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
Assiut University · n=60 · January 2023
Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia
University of Minnesota · September 2022
Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia
Mohammed Abd El Mawgoud Amer · n=50 · March 2022
Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia
Assiut University · n=60 · June 2020
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
Farid Masoud · n=24 · November 2018
Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women
Mayo Clinic · n=20 · January 2017
Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil
Maja Kovacevic, MD · June 2016
Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata
Cairo University · n=40 · March 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
A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss
Merz Pharmaceuticals GmbH · n=74 · April 2012
Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
Brasilia University Hospital · n=60 · March 2012
The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement
Siriraj Hospital · n=20 · January 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
Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia
Charite University, Berlin, Germany · n=113 · June 2008
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss
University of British Columbia · n=40 · September 2005
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
Johnson & Johnson Consumer and Personal Products Worldwide · n=352 · October 2003
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
- Minoxidil topical solution 5% — FDA-approved labeling, NDA 020834 — Regulator filing, January 2015