Minoxidil (low-dose oral)
The same molecule, swallowed at a fraction of the blood-pressure dose — widely prescribed, nowhere approved for hair.
- Developed by
- Unknown
- Current phase
- Marketed, off-label
- Indications
- Androgenetic alopecia, Female pattern hair loss
- Also known as
- oral minoxidil, low-dose oral minoxidil, LDOM, minoxidil oral
- Last public activity
- May 2026
- Record confidence
- High
Approved for something else and prescribed off-label for hair loss.
How it is meant to work
Oral minoxidil is approved as an antihypertensive, not for hair loss. Prescribing it at low doses for alopecia is off-label everywhere, and the practice grew out of dermatology case series rather than a registration programme. Reviews describe typical doses well below the cardiovascular ones, with hypertrichosis — unwanted hair elsewhere on the body — as the most common adverse effect.
Why it matters
It is in the register as an honest marker of where the field actually is. The most widely used systemic option for pattern hair loss in 2026 is a repurposed 1970s antihypertensive, prescribed off-label on the strength of dermatology case series rather than a registration programme, because the molecule is long off patent and for decades nobody could see how to recoup the cost. That is now changing: Industrial Farmacéutica Cantabria has been running a 520-participant Phase 3 of oral minoxidil 1 mg in female androgenetic alopecia in Germany since October 2024, with primary completion due in October 2026. If it reads out, the most-prescribed systemic treatment in the field would finally have an approval behind it somewhere.
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 StatesFDAOff-label· prescription only
Oral minoxidil is authorised as an antihypertensive. No authority has approved it for hair loss, so every prescription for alopecia is off-label.
Peer-reviewed ↗
Development history
- Phase 2Phase 3
First Phase 3 trial on record: NCT05888922 — Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
ClinicalTrials.gov ↗ - Phase 2
First Phase 2 trial on record: NCT05778825 — A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
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.
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Industrial Farmacéutica Cantabria, S.A. · n=520 · October 2024
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
Memorial Sloan Kettering Cancer Center · n=10 · March 2023
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
Ohio State University Comprehensive Cancer Center · n=50 · March 2023
Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
Northwestern University · n=14 · April 2019
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
- Low-dose oral minoxidil for alopecia: a comprehensive review — Peer-reviewed, February 2024
- Oral minoxidil treatment for hair loss: a review of efficacy and safety — Peer-reviewed, March 2021