Sexual Health

PT-141

Bremelanotide ยท Vyleesi

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Boosts sexual desire through the brain rather than blood flow, which sets it apart from typical erectile dysfunction drugs. It has one genuine approval: low desire in women who haven't reached menopause. Everything else, including its use in men, is off-label.

Central with phase 3 efficacy and safety evidence for a specific female indication; broader libido and male-ED use is extrapolation.

How well studied

Tier Guide: A = Well studied, B = Some good studies, C = Early evidence & D = Barely studied

AHow well studiedWell studied

Backed by large human trials, so we have solid data on how it works and what it does.

UK status

How you could legitimately come across it here, if at all

UK statusNo authorised UK product identified

No authorised UK medicine contains this, and we have no record of a routine UK clinic route. Material sold online is unregulated.

Evidence strength and UK regulatory status answer different questions.

Heightened caution: this compound carries unresolved regulatory, safety or supply-chain concerns in the UK. Nothing here is a recommendation to use it.

Overview

How it works

Acts in the brain, on the pathways behind desire and arousal, a different route entirely from drugs like Viagra, which work on blood flow.

Acts on in the brain to boost arousal and desire, a different pathway from blood-flow-based ED treatments like inhibitors.

Reported benefits

  • Phase 3 trials showed statistically significant improvements in sexual desire and related distress in premenopausal women with acquired, generalised HSDD
  • Evidence does not establish efficacy for men with erectile dysfunction or for general libido enhancement

Who it's typically used for

Evidence is strongest for premenopausal women with acquired, generalised HSDD. Male ED and general libido use are not established indications.

Timeline to results

Studied as an as-needed treatment before anticipated sexual activity in the approved US indication; this does not create a UK prescribing recommendation.

Safety & UK access

Dosage

Approved dose

US FDA Vyleesi label: 1.75 mg subcutaneously as needed, at most one dose in 24 hours and no more than eight doses a month, licensed only for acquired generalised hypoactive sexual desire disorder in premenopausal women. Not licensed in the UK. No licensed dose exists for men, for postmenopausal women, or for general libido.

Side effects

  • Nauseavery common in the phase 3 trials of 1.75 mg in premenopausal women with HSDD, mostly with the first doses
  • Flushingcommon in those same trials
  • Headachecommon in those same trials
  • Short-lived rise in blood pressurereported in those trials; small and transient, but relevant if your blood pressure is not controlled

Getting it in the UK

UK statusNo authorised UK product identified

No authorised UK medicine contains this, and we have no record of a routine UK clinic route. Material sold online is unregulated.

Where it turns up

  • Not routinely available in the UK

Bremelanotide is authorised in the US for a narrow HSDD indication, but no authorised UK medicinal product was identified. US approval does not imply UK authorisation.

Not MHRA-licensed for either population; the women's approved product (Vyleesi) has no UK licence

MHRA: the UK regulator that assesses whether a medicine is safe and works before it can be authorised for use here. Something not being MHRA-licensed does not automatically mean it is illegal, and it does not mean it is safe.

This is background information about UK regulation, not advice about what you can or should obtain.

Evidence & sources

Why this rating?

The A to D rating shown above comes from our earlier editorial review and is still waiting to be migrated into the structured review record below. That is a gap in our record-keeping, not a sign the rating is wrong.

Evidence fingerprint

No route and indication scope has been published for this profile yet, so no fingerprint is shown.

Sources

Structured source audit not yet published for this profile. The references behind this page are being catalogued one compound at a time, and this one has not been through that process yet.

Content freshness

Last reviewed
24 Sept 2026
Regulatory status last checked
21 Aug 2026