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Bremelanotide, sold in the United States as Vyleesi, is an injection given under the skin of the stomach or thigh about 45 minutes before sex. It has no marketing authorisation in the European Union, so no EU doctor — including a Hi-Doctor doctor — can prescribe it.
Bremelanotide has no EU marketing authorisation. It cannot legally be prescribed or dispensed by any doctor working in the EU, and Hi-Doctor does not offer it.

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What it is

Bremelanotide is for premenopausal women with persistently low sexual desire that causes them real distress — a diagnosis doctors call hypoactive sexual desire disorder (HSDD). It works on desire signals in the brain, so it is nothing like the tablets men take for erection problems, and it is not meant to improve sexual performance. It is a melanocortin receptor agonist that binds most potently to the MC4R and MC1R subtypes (US FDA-approved label). MC4R-expressing neurons are concentrated in hypothalamic and limbic circuits — the medial preoptic area, the paraventricular nucleus and the arcuate nucleus — where they modulate dopamine and serotonin signalling involved in sexual motivation. Because it works on central desire pathways rather than on genital blood flow, its mechanism is entirely distinct from that of PDE5 inhibitors such as sildenafil. Bremelanotide reaches peak plasma concentration about one hour after subcutaneous injection and has a half-life of approximately 2.7 hours, which supports the as-needed dosing schedule of 45 minutes before anticipated sexual activity (US FDA label, DailyMed).

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Regulatory status

Bremelanotide is approved in the United States but has no marketing authorisation in the European Union. As of a check of the EMA public medicines register on 27 July 2026, there is no entry for bremelanotide or Vyleesi as an authorised, refused or withdrawn application.
An EU authorisation gap is not the same as a safety concern. It means the medicine has not been through, or has not completed, the EU regulatory process — so it sits outside what any EU-licensed doctor is permitted to prescribe.

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What the studies reported

The RECONNECT phase 3 trials (Kingsberg et al., Obstetrics & Gynecology, 2019) enrolled 1,267 premenopausal women with acquired, generalised HSDD. Both trials were randomised, double-blind and placebo-controlled; the coprimary endpoints were the change from baseline in the Female Sexual Function Index (FSFI) desire domain score and the Patient Global Impression (PGI) of change at 24 weeks. The trials did not include a long-term open-label extension, so data on durability of effect beyond 24 weeks are limited. Two registry entries cover this programme: NCT02333071 and NCT02338960. A few things are worth knowing about who was studied: 96.6% of participants were recruited at US sites, and 85.6% were white. The differences from placebo were small movements on questionnaire scales whose day-to-day meaning is debated.
Every NCT identifier links to its ClinicalTrials.gov record. A trial readout is not the same as a peer-reviewed publication — the primary source here is Kingsberg et al., Obstet Gynecol 2019, alongside the US FDA prescribing information for VYLEESI (via DailyMed) and the 2019 FDA-approved label.

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If low desire is the concern

A GP or gynaecologist can look at hormones, mood, medication side effects and relationship factors together, which is the assessment low desire actually needs. Within Hi-Doctor’s sexual health consultation, doctors review the case that is actually submitted and consider the EU-authorised options that fit it — see low sexual desire for how that consultation works. Where a related PDE5-inhibitor question comes up in a sexual health case (for a different indication, such as erectile dysfunction), the options a Hi-Doctor doctor can assess include sildenafil and other authorised tablets in that class — none of which treat HSDD, and a doctor decides case by case whether any of them are relevant to what was actually reported in the questionnaire.

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Common questions

Bremelanotide is for premenopausal women with persistently low sexual desire that causes real distress — a diagnosis called hypoactive sexual desire disorder (HSDD). It is a melanocortin receptor agonist that binds MC4R and MC1R in the central nervous system and modulates dopamine and serotonin signalling in hypothalamic and limbic circuits involved in sexual motivation, rather than acting on blood flow to the genitals.
Bremelanotide has no EU marketing authorisation. It cannot legally be prescribed or dispensed by any doctor working in the EU, and Hi-Doctor does not offer it. An EU authorisation gap is not the same as a safety concern — it means the medicine has not been through the EU regulatory process.
A GP or gynaecologist can look at hormones, mood, medication side effects and relationship factors together, which is the assessment low desire actually needs. Within Hi-Doctor’s sexual health consultation, doctors review the case and consider EU-authorised options. See low sexual desire for how that consultation works.
The RECONNECT phase 3 trials enrolled 1,267 women. Of those, 96.6% were recruited at US sites and 85.6% were white. The differences from placebo were small movements on questionnaire scales whose day-to-day meaning is debated. Nausea was reported by 40.0% of women given bremelanotide versus 1.3% on placebo; flushing by 20.3% versus 0.3%.
It is an injection given under the skin of the stomach or thigh about 45 minutes before sex.
PDE5 inhibitors such as sildenafil treat erectile dysfunction, not HSDD. A doctor decides case by case whether any of them are relevant to what was reported in the questionnaire.

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How Hi-Doctor handles it

One consultation, one doctor, one decision. A licensed doctor reviews every sexual health case; nothing is prescribed automatically. See how it works and pricing for the consultation process and cost of the medical review — medication, where something is prescribed, is paid separately at the pharmacy.

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Start a consultation

Sexual health consultation

Answer the sexual health questionnaire and a registered doctor reviews it. They decide whether treatment is appropriate, which one, and at what dose — and declining is a normal outcome. See what it costs and how the review works.
This page is reference information, not medical advice and not a prescription. Whether a medicine is appropriate for you is decided by a registered doctor after reviewing your consultation.