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Vial - lyophilised powderSubcutaneous (SQ)10 mg
A melanocortin-4 receptor agonist approved in the United States for hypoactive sexual desire disorder in premenopausal women, making it one of the few compounds here with full trial evidence.
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Delivery and return
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Composition and care
We speak a lot about the importance of gut health—not only for beauty—but also in terms of our overall health, wellbeing and immunity. But before we can fully understand why the gut is so integral to our health, it’s first essential to learn more about the physiology of the gut itself—and how it works.
Research Handling Note
Allow sealed vials to equilibrate to ambient laboratory temperature before opening. This helps minimise the risk of condensation forming within the vial. Keep unopened vials stored at 2-8 C, protected from direct light and moisture. All handling, storage after opening, and laboratory procedures should be carried out according to the receiving laboratory’s established protocols and applicable requirements.
Bremelanotide is a cyclic heptapeptide melanocortin receptor agonist and one of only a small number of compounds in this portfolio to have completed full regulatory development. It was approved by the FDA in 2019, marketed as Vyleesi, for acquired generalised hypoactive sexual desire disorder in premenopausal women, on the strength of two identically designed Phase III trials. Its mechanism is centrally mediated rather than vascular, which distinguishes it from PDE5 inhibitors and explains why it acts on desire rather than on erectile mechanics. Use outside the approved indication and population – including use in men – is off-label and unsupported by the registration trials, though earlier development did examine erectile dysfunction. Practitioners should note that intranasal development was discontinued specifically because of blood pressure effects.
Active Compound: PT-141 / Bremelanotide
Permitted Claim GuidelinesA melanocortin receptor agonist approved in the United States for a specific licensed indication. Supplied on prescription for practitioner-directed use.
Mechanism of Action
Agonist at melanocortin receptors, principally MC4R, in the central nervous system. Acts on hypothalamic pathways governing sexual desire and arousal, upstream of the vascular mechanisms targeted by PDE5 inhibitors. The effect is on desire and central arousal rather than on peripheral blood flow.
Evidence Grade: A - FDA-approved with Phase III evidence for the licensed indication
Clinical Evidence BaseTwo Phase III randomised placebo-controlled trials in premenopausal women with HSDD demonstrated statistically significant improvements in desire and reduction in distress, supporting FDA approval. Earlier Phase II work examined erectile dysfunction. Evidence in men and in postmenopausal women is limited; use in those groups is off-label.
Literature & ReferencesKingsberg SA et al. Obstet Gynecol, 2019 - bremelanotide for HSDD, the RECONNECT trials. | Clayton AH et al. Womens Health (Lond), 2016 - bremelanotide Phase IIb in premenopausal women. | Diamond LE et al. Int J Impot Res, 2004 - intranasal bremelanotide in erectile dysfunction. | US FDA prescribing information, Vyleesi (bremelanotide) injection, 2019.
Safety & Precautions
The most common adverse effects in trials were nausea, affecting a substantial proportion of participants, flushing and headache. Transient increases in blood pressure with reductions in heart rate occur and are clinically relevant: it is contraindicated in uncontrolled hypertension and known cardiovascular disease. Focal hyperpigmentation may occur with repeated use, more commonly in patients with darker skin. Contraindicated in pregnancy. There is a limit on dosing frequency in the licensed product that should be observed.
ContraindicationsUncontrolled hypertension; known cardiovascular disease; pregnancy and breastfeeding; known hypersensitivity.
Storage & HandlingStore lyophilised vial at 2-8 C, protected from light.
Regulatory Status
Approved in the United States as Vyleesi for a specific indication and population. Not authorised in the UK or EU. The product supplied here is not the licensed presentation and its use is off-label. Prescription-medicine advertising restrictions apply.
