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Cyclic heptapeptide melanocortin receptor agonist

Bremelanotide — 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

2 records in this file

  • CLINICAL TRIAL1
  • REGULATORY1

Research areas. Approved-drug Phase 3; United States approval.

Publication span. 2019.

What we know

  • FDA-approved as Vyleesi (NDA 210557, 21 June 2019). RECONNECT Phase 3 trials are published.
  • Chemically the free-acid counterpart of melanotan II; the two are distinct substances with different regulatory status.

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

What remains uncertain

  • Nothing in this file extends the labelled indication. Approved-product evidence stays inside the labelled population and presentation.

Regulatory notes

FDA-approved drug substance

  • VYLEESI, NDA 210557, approved 21 June 2019. Active prescription product.
  • Not listed on FDA's Category 2 or withdrawn-nomination compounding tables.
  • Not named on the WADA 2026 Prohibited List.

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

Studies and documents

  1. CLINICAL TRIAL2019Two randomised, double-blind, placebo-controlled Phase 3 trials

    Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized Phase 3 trials (RECONNECT)

    Kingsberg SA, Clayton AH, Portman D, et al.Obstetrics & Gynecology

    Population
    Premenopausal women with hypoactive sexual desire disorder, as enrolled in RECONNECT
    Sample
    1,267 randomised across RECONNECT 301 and 302 (1,247 safety population; 1,202 modified intent-to-treat)
    Objective
    To test subcutaneous bremelanotide versus placebo on labelled endpoints in the RECONNECT programme.
    Endpoint investigated
    Co-primary endpoints of the approved-product Phase 3 programme

    Study design

    Phase
    Phase 3 — two identical trials, RECONNECT 301 (NCT02333071) and 302 (NCT02338960)
    Duration
    24 weeks
    Intervention, as the source describes it
    Bremelanotide
    Comparator
    Placebo, randomised 1:1, double-blind
    Primary endpoint
    Two co-primary efficacy endpoints: change in desire, and change in distress related to low sexual desire
    Registry
    NCT02333071

    This describes the published study design. It is not a usage or dosing recommendation.

    The two RECONNECT Phase 3 trials supporting the approved product Vyleesi. Population, dose form (autoinjector) and endpoints are those of the labelled programme.

    Limitations. Approved-product trials in a specific labelled population. Not evidence about melanotan II, despite near-identical mass.

    DOI 10.1097/AOG.0000000000003500Kingsberg et al., Obstet Gynecol (2019) — RECONNECTReviewed 12 September 2026

  2. REGULATORY2019Approved-drug labelling

    Drugs@FDA — VYLEESI (NDA 210557)

    U.S. Food and Drug AdministrationDrugs@FDA

    Objective
    To record United States approval.
    Endpoint investigated
    Marketing authorisation

    VYLEESI, NDA 210557, approved 21 June 2019. Active prescription product administered by subcutaneous autoinjector. Not listed on FDA compounding Category 2 or withdrawn-nomination tables.

    Limitations. Labelled product only.

    Drugs@FDA — approved drug productsReviewed 12 September 2026

Last reviewed 3 September 2026 · Compiled by Therapept Editorial · How these records are built