PT-141 / Bremelanotide
Bremelanotide (Vyleesi), Melanocortin Agonist for Sexual Desire
Evidence grade 3 of 5, Mixed. Read how the Atlas grades evidence.
The written rationale for this grade is still being prepared.
- FDA
- FDA Approved 2019 (Vyleesi, for premenopausal women with HSDD only)
Reference only. Not medical advice.
What can go wrong
Common effects include nausea (frequently dose-limiting), flushing, headache, and injection-site reactions. It can cause transient increases in blood pressure and decreases in heart rate, so it is not recommended in uncontrolled hypertension or known cardiovascular disease. Focal hyperpigmentation (darkening of skin, gums, face) can occur, especially with repeated dosing, reflecting MC1R activity. Vyleesi labeling limits use to no more than one dose per 24 hours and eight doses per month.
This is something to take to a clinician. The Atlas can tell you what is known about pt-141 / bremelanotide in general. It cannot tell you what is happening in your body, and the difference matters most for exactly the symptoms that bring people to this page.
Bremelanotide is a synthetic cyclic peptide that activates central melanocortin receptors (notably MC4R) to stimulate sexual desire and arousal. The FDA approved it in June 2019 as Vyleesi for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, an on-demand subcutaneous injection. It is not FDA-approved for men, but is widely marketed off-label through telehealth and peptide clinics for low libido and erectile dysfunction. It works on desire pathways in the brain rather than on penile blood flow, which is what distinguishes it from PDE5 inhibitors like sildenafil.
A brain-acting desire peptide approved for women and used off-label in men.
What people take it for
These are the reasons people give for taking it. They are not effects it has been shown to have.
How it is supposed to work
Bremelanotide is an agonist at melanocortin receptors, with activity at MC4R in the hypothalamus (medial preoptic area) thought to drive its pro-sexual effect, plus activity at MC1R that explains tanning/flushing effects. By acting on central neural circuits for desire and arousal rather than on peripheral vasculature, it works 'upstream' of where PDE5 inhibitors act. It was derived from the earlier tanning peptide Melanotan II, optimized to favor sexual effects.
A cyclic seven-amino-acid peptide analog of alpha-melanocyte-stimulating hormone (alpha-MSH), engineered for receptor selectivity and metabolic stability versus the parent Melanotan II.
What the off-label marketing skips
The pivotal RECONNECT trials that won approval were in premenopausal women, and the measured benefit over placebo was statistically significant but modest in absolute terms. There is no FDA-approved indication in men, and the male erectile-dysfunction program was never carried to approval. Telehealth and peptide-clinic claims of robust male efficacy outrun the published human evidence, which in men is limited to older Phase 2 work.
Safety in detail
This is a prescription drug FDA-approved only for premenopausal women; male use is off-label. It affects blood pressure and central neural pathways and requires evaluation and monitoring by a qualified physician. Compounded or 'research-grade' PT-141 of unknown purity carries additional documented risks.
What has to be monitored
The bloodwork this needs, and the reason it belongs with a clinician rather than a website.
- Blood pressure
- Cardiovascular history screening
- Nausea/tolerability
- Skin hyperpigmentation
What people get wrong
Often saidPT-141 is an FDA-approved male sex drug
ActuallyIt is FDA-approved only for premenopausal women with HSDD. All male use is off-label and not FDA-sanctioned.
Often saidIt gives you an erection like Viagra
ActuallyIt acts on brain desire circuits, not penile blood flow. Effects on erection in men are inconsistent and based on limited data.
Who profits, and who pushes back
Nobody is named here yet, because we have not done that work on this entry. Read that as unfinished. Somebody almost certainly sells this, and somebody almost certainly disputes it. Assume both until we have checked.
At a glance
- FDA approval (women)
- June 2019, Vyleesi
- Route
- Subcutaneous injection (on demand)
- Target
- Melanocortin receptors (MC4R/MC1R)
- Male approval
- None, off-label only
- Developer
- Palatin Technologies
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about PT-141 / Bremelanotide. A short entry is not a safe entry.
- Timeline. We have not built the dated record of research and regulatory events.
- Cost and market. We have not documented what it sells for or who sells it.
- Supply chain. We have not mapped where it is made.
- Who uses it. We have not documented the user groups.
- What could change. No forward-looking summary yet.
- How it compares. We have not set it against the alternatives.
- Children and teenagers. We have not checked what is known about younger people.
Sources
The studies below are named and described, but not linked. You cannot open them from here and check our reading against them, which means this page is our summary of the literature rather than a document you can verify. Weigh it accordingly until the links exist.
The studies that matter
RECONNECT Phase 3 (women)2019
Statistically significant but modest improvement in desire and reduction in distress vs placebo in premenopausal HSDD; basis for FDA approval
Safarinejad RCT (men, ED)2008
In men non-responsive to sildenafil, a larger proportion on bremelanotide than placebo reported erections sufficient for intercourse; early signal, not confirmatory