PT-141
Also known as Bremelanotide · developed by Palatin / AMAG
Licensed by at least one major regulator for a specific indication, on the strength of completed phase 3 trials. Approval is for that indication in that population — it is not a general endorsement of the compound.
What it is
The des-amide metabolite of Melanotan II, developed separately as a melanocortin agonist for sexual dysfunction. The two compounds differ by one functional group, and that difference produced one approved medicine and one regulators warn against.
How it is thought to work
Melanocortin receptor agonist with relative MC4R selectivity, acting centrally on pathways involved in sexual arousal rather than on vascular tissue as PDE5 inhibitors do.
What the studies found
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Approved for hypoactive sexual desire disorder
The RECONNECT trials in premenopausal women with HSDD showed statistically significant improvement in desire and reduction in distress versus placebo. Approved by the FDA in 2019.
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Effect size is modest
The improvements, while statistically significant, were small in absolute terms — a point made in regulatory review and in subsequent commentary.
What the evidence does not show
- Licensed only for HSDD in premenopausal women. Evidence in other populations is limited.
- An earlier intranasal formulation was abandoned after blood pressure increases.
- Not approved in the UK or EU.
Reported risks and adverse effects
- Nausea is the most common adverse effect and was a frequent reason for discontinuation in trials.
- Transient blood pressure increase and heart rate decrease after each dose; contraindicated in uncontrolled hypertension or known cardiovascular disease.
- Focal hyperpigmentation reported with repeated use.
This is a summary of what has been reported in the literature, not a complete safety profile. For anything concerning your own health, speak to a doctor.
Regulatory status
FDA-approved, prescription-only. Not licensed in the UK or EU.