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Approved drugFDA-approved

PT-141 (Bremelanotide)

An FDA-approved drug for one specific indication in premenopausal women, and also widely sold outside that approval.

Part 1Header & identifiers

Also known as: Melanocortin receptor agonist; marketed as Vyleesi. Class: Melanocortin.

Class
Melanocortin receptor agonist
Brand
Vyleesi (bremelanotide) injection, NDA 210557
Route studied
Subcutaneous injection, as needed
Approved use
One specific indication in premenopausal women (see status)

Last reviewed 3 Nov 2026 by The Peptide Informative editorial team. Found an error? Tell us; see our corrections policy.

Part 2Status at a glance

FDAApproved in 2019 as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that is not due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug [2].
ContraindicationsUncontrolled high blood pressure or known cardiovascular disease [2].
Enforcement news“PT-141” sold online as a research chemical is not the approved product, and was named in 2026 FDA warning letters to online vendors [3].
SportCheck the current WADA Prohibited List.

Status checked 3 Nov 2026. Regulations changed several times in 2026, so check the linked sources for updates.

Part 3Evidence grade

Approved drug

Two identical randomized, double-blind, placebo-controlled phase 3 trials, plus FDA approval for one indication.

Evidence for the approved use comes from randomized human trials. How we grade evidence.

Part 4What it is

Bremelanotide (research code PT-141) is a synthetic peptide that activates melanocortin receptors. As Vyleesi, it is given as an injection under the skin when needed, in one specific approved population [2].

Part 5What studies found

Hypoactive sexual desire disorder (RECONNECT studies 301 and 302)

Two identical 24-week phase 3 trials randomized 1,267 premenopausal women with HSDD to bremelanotide 1.75 mg as needed or placebo. Compared with placebo, bremelanotide produced statistically significant increases in a sexual-desire score (integrated difference 0.35) and reductions in distress about low desire (integrated difference −0.33) [1].

Part 6Doses used in published studies

Not a recommendationThese are doses reported in published studies, listed with their population, route and duration so readers can understand the research. They are not instructions, and they say nothing about safety for you. Talk to a licensed clinician.
StudyPopulationRouteDose studiedDurationMain result
RECONNECT 301 & 302 [1]1,267 premenopausal women with HSDDSubcutaneous, as needed1.75 mg24 weeksDesire score +0.35 and distress −0.33 vs placebo

Dosing of the approved product is set by the prescriber under the FDA label [2]. The trial dose is listed only so readers can understand the studies.

Part 7Safety & adverse events

  • In the phase 3 trials, nausea, flushing and headache occurred more often than on placebo (10% or more in both studies) [1].
  • The label warns of a transient rise in blood pressure (up to 6 mmHg systolic and 3 mmHg diastolic, peaking 2–4 hours after a dose) and a fall in heart rate, usually resolving within 12 hours [2].
  • Focal hyperpigmentation (face, gums, breasts) was reported in 1% of trial patients, and in 38% of patients in a separate study of 8 consecutive daily doses [2].
Report side effectsSuspected side effects can be reported to FDA MedWatch.

Part 8What is unknown

  • The trials studied premenopausal women with HSDD. Results do not apply to other groups or uses.
  • Products sold online as “PT-141” are not the approved drug, and their identity, strength and sterility are unknown [3].

Part 9Community discussion

PT-141 (Bremelanotide) will have its own moderated category when our forum opens. Personal experiences there are labeled as anecdotes, and claims about research must link a source.

Join the forum waitlist

Part 10References

  1. Kingsberg SA, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899-908. PubMed 31599840 ยท doi:10.1097/AOG.0000000000003500
  2. Vyleesi (bremelanotide) injection prescribing information. DailyMed, U.S. National Library of Medicine. DailyMed
  3. ArentFox Schiff. RUO-ined: Five Peptide Vendors Learn “Research Use Only” Is Not a Legal Strategy. 18 Sep 2026. afslaw.com
Educational information onlyThis profile summarizes published research. It is not medical advice and does not recommend using PT-141 (Bremelanotide). Full medical disclaimer.