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Reference information only. Therapept does not sell peptides and does not provide medical advice.Research-use notice

Therapept

Small-molecule vasodilator and ATP-sensitive potassium-channel opener, supplied as a topical solution or foam and as oral tablets

Minoxidil — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

1 record in this file

  • REGULATORY1

Research areas. Approved hair-loss treatment.

Publication span. 2006.

What we know

    Editorial reading of the records below, labelled as Therapept analysis. How records are built

    What remains uncertain

      Regulatory notes

      FDA-approved drug substance

      • Topical minoxidil for androgenetic alopecia has been available over the counter in the United States since 1996, in 2% and 5% strengths.
      • Oral minoxidil is an FDA-approved prescription antihypertensive. Low-dose oral use for hair loss is off-label and is not an approved indication.
      • FDA-approved labelling for topical minoxidil is specific about the studied scalp area; it is not a general hair-growth licence.

      Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

      Studies and documents

      1. REGULATORY2006Regulatory review of an over-the-counter topical product

        NDA 021812 — topical minoxidil foam for male androgenetic alopecia: medical review

        U.S. Food and Drug AdministrationFDA new drug application review

        Objective
        To record the regulatory basis for a topical minoxidil foam product for male androgenetic alopecia.
        Endpoint investigated
        Approval basis and labelling for a topical hair-regrowth product

        The FDA review describes the topical minoxidil products already available over the counter at 2% and 5% for androgenetic alopecia and evaluates a foam formulation for the vertex scalp. It sets out the indication wording and the studied scalp area.

        Limitations. A regulatory document, not a new efficacy trial. It supports the approved topical indication; it does not support oral minoxidil for hair loss or use in unstudied hair-loss types.

        FDA — NDA 021812 medical reviewReviewed 13 November 2026

      Last reviewed 13 November 2026 · Compiled by Therapept Editorial · How these records are built