PT-141 is the development code for bremelanotide, which became Vyleesi in 2019. It is one of two peptides on this site with an approved product and a full label. Almost everything sold under the name PT-141 is being sold for a use the label does not cover, to a population the trials did not enrol.
What it is
Bremelanotide is a cyclic seven-amino-acid melanocortin receptor agonist, a metabolite of melanotan II (itself an analogue of alpha-melanocyte-stimulating hormone). It acts on melanocortin receptors in the brain rather than on blood vessels, which is why it was pursued for desire rather than erection after early erectile-dysfunction studies in men stalled. Palatin Technologies developed it; AMAG launched it; Cosette Pharmaceuticals holds the current label.
The human evidence
| Year | Design | Result | PubMed |
|---|---|---|---|
| 2019 | RECONNECT: two identical phase 3 randomised, double-blind, placebo-controlled trials; 1,267 premenopausal women with HSDD; 24 weeks; subcutaneous as needed | Both co-primary endpoints met (FSFI desire domain up, desire-related distress down) vs placebo. Mean age 39; 96.6% US sites. | 31599840 |
| 2019 | 52-week open-label extension of RECONNECT | Effects and adverse-event profile maintained. | 31599847 |
| 2022 | Safety analysis across the programme: 3,500 subjects, 43 studies, up to 18 months' exposure | Nausea 40.0% vs 1.3%, flushing 20.3% vs 1.3%, headache 11.3% vs 1.9%, injection-site reactions 5.4% vs 0.5%, drug vs placebo. | 35147466 |
| 2017 | Ambulatory blood-pressure study | Characterised the transient post-dose blood-pressure rise that became label warning 5.1. | 27977473 |
That is what an A grade looks like: replicated phase 3 trials, a long-term extension, a pooled safety analysis, and a dedicated study of the main safety signal, all reviewed by a regulator.
Regulatory status
FDA approved Vyleesi (NDA 210557) on June 21, 2019 for premenopausal women with acquired, generalised hypoactive sexual desire disorder not due to a medical or psychiatric condition, a relationship problem or a medication. The product is a single-dose prefilled autoinjector. Because bremelanotide is the active ingredient of an approved drug, it is one of the substances a 503A pharmacy may in principle compound with, subject to the other conditions; a compounded PT-141 is not Vyleesi and has not been reviewed by FDA. Bremelanotide does not appear on FDA's Category 2 page. The compounding site covers the "essentially a copy" limit that applies when an approved product exists.
Safety signals, from the label
- Transient increase in blood pressure and decrease in heart rate (5.1). Maximal increases of 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after a dose, with heart rate down by up to 5 beats per minute, usually back to baseline within 12 hours. Not recommended in patients with uncontrolled hypertension or known cardiovascular disease. No more than one dose in 24 hours; more than 8 doses a month is not recommended.
- Focal hyperpigmentation (5.2). Face, gingiva and breasts. 1% of patients at up to 8 doses a month in phase 3, versus none on placebo; 38% after daily dosing for 8 days in a separate study, with an additional 14% on continuing. Resolution was not confirmed in some patients. More likely with darker skin.
- Nausea (5.3). 40% of treated patients; anti-emetic therapy in 13%; discontinuation in 8%. Improves for most with the second dose.
The label's discontinuation rule is unusual and worth knowing: stop after 8 weeks if there is no reported improvement.
Storage, per label
Store at or below 25 C (77 F). Do not freeze. Protect from light. Single-use autoinjector; discard after the dose. See the storage and handling guide.
Grade: A
A for the labelled indication, because the approved product exists and FDA reviewed the trials. The grade does not transfer to men, to erectile dysfunction, to "libido" in general, or to any product that is not Vyleesi. Those uses have either no completed programme or an unapproved product, and are not graded A here.
Questions people ask
Is PT-141 approved for men or for erectile dysfunction?
No. Vyleesi (bremelanotide) is approved for premenopausal women with acquired, generalised hypoactive sexual desire disorder. Early-2000s studies of bremelanotide in men with erectile dysfunction did not lead to an approval, and the current label does not cover men. A PT-141 product sold for men is either off-label use of Vyleesi or an unapproved compounded or research-chemical product.
What did the phase 3 trials show?
Two identical 24-week randomised, double-blind, placebo-controlled trials (RECONNECT, PubMed 31599840) randomised 1,267 women. Both met their co-primary endpoints: an increase in the desire domain of the Female Sexual Function Index and a decrease in desire-related distress, versus placebo. An open-label 52-week extension (PubMed 31599847) followed.
What are the main safety warnings?
From the label: a transient rise in blood pressure and fall in heart rate after each dose (not recommended in uncontrolled hypertension or known cardiovascular disease); focal hyperpigmentation of the face, gums and breasts, in 1% at up to 8 doses a month and 38% after daily dosing for 8 days, which may not resolve; and nausea in 40%. No more than one dose in 24 hours and no more than 8 doses a month.
Sources
- DailyMed: VYLEESI (bremelanotide) injection, prescribing information, revised 03/2024 Accessed September 4, 2026.
- Drugs@FDA: VYLEESI, NDA 210557, approved June 21, 2019 Accessed September 4, 2026.
- Kingsberg SA et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Obstet Gynecol 2019. PubMed 31599840 Accessed September 4, 2026.
- Simon JA et al. Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. Obstet Gynecol 2019. PubMed 31599847 Accessed September 4, 2026.
- Clayton AH et al. Safety profile of bremelanotide across the clinical development program. J Womens Health 2022. PubMed 35147466 Accessed September 4, 2026.
- White WB et al. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. J Hypertens 2017. PubMed 27977473 Accessed September 4, 2026.
Canonical URL: https://formblendspeptides.com/peptides/pt-141. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.