Human RCT
Mensch
Kingsberg SA. et al. 2019
Increase in self-reported sexual-desire scores versus placebo in randomised trials (RECONNECT)
What does NOT follow: Effect size small to moderate; study discontinuation due to nausea was common.
Peptide entry · Research other
Bremelanotide
PT-141 · Vyleesi
Highest evidence
Human RCT
Studies recorded
5· 5 in humans
Legal status · US
PrescriptionScientific context only. Not medical advice, not a recommendation to use.
At a glance
Synthetic cyclic heptapeptide acting as a non-selective melanocortin-receptor agonist. FDA-approved in 2019 as Vyleesi for hypoactive sexual desire disorder (HSDD) in pre-menopausal women.
Researched for
Hypoactive sexual desire disorder (HSDD) in womenErectile dysfunction (earlier phase-2 trials)
Official status
US: Prescription
FDA-approved 2019 as Vyleesi for HSDD in pre-menopausal women. Prescription-only.
01
Mechanism of action
Bremelanotide is a cyclic peptide that binds non-selectively to melanocortin receptors (MC1R through MC5R) — with highest affinity at MC4R in the central nervous system. The precise role of MC4R activation in sexual behaviour is not fully understood; animal data show effects on hypothalamic circuits. Peripheral effects (blood pressure, hyperpigmentation) are attributed to MC1R/MC2R.
02
Evidence at a glance
Reading note. The distribution shows on which evidence tier each observation sits. Strong colours mark stronger evidence — weaker tiers are deliberately visible, not hidden.
03
What the studies show
Human RCT
Mensch
Kingsberg SA. et al. 2019
Transient blood-pressure increase within hours after subcutaneous administration observed in the registration trials
What does NOT follow: Therefore contraindicated in uncontrolled hypertension or cardiovascular disease (FDA label).
Human trial
Mensch
Focal hyperpigmentation (freckle-like) was documented in several trials
What does NOT follow: Likely via MC1R activation; mostly reversible after discontinuation, but persistent cases described.
05
Pharmacokinetics
Theoretical concentration curve at a half-life of 2.7 h. Pure pharmacokinetic model — not a dosing recommendation.
Open in PK tool →Start time: t₀ = 0h
Repeat interval: off (single dose)
06
Routes of administration in the literature
Which routes of administration the available studies describe — neutral reporting, not a usage guide.
Subcutaneous
In the RECONNECT trials administered as an auto-injector subcutaneously in the abdomen or thigh.
06b
Amounts reported in sources
Which amounts were reported in which source — ordered by context (approval, trial, animal model, secondary literature, community).
06c
Storage & stability
What prescribing information and stability literature report about storing the substance — descriptive, not a mixing or usage guide.
Reconstituted · storage
2–8 °C; limited storage below 30 °C is possible per the label.
Reconstituted · shelf life
Exact periods: see the prescribing information for the finished product (Vyleesi autoinjector).
What the stability literature describes
- •Keep protected from light.
- •Freezing is not provided for in the label.
07
Known adverse events from studies
Factual reporting of what studies observed. Not a safety statement for individual use.
Human RCT
Nausea
From aggregated RECONNECT trials; not to be read as an individual prediction.
≈40 % in RECONNECT
Human trial
Focal hyperpigmentation
Presumed MC1R-mediated; persistent cases described in the literature.
selten, persistierend möglich
07b
Interactions & combinations
Documented interactions and contraindications from studies, prescribing information and guidelines. Where no data exists, this is stated.
Reporting of risks, NOT a combination guide. The absence of an entry does not mean „safe to combine“ but „not sufficiently studied“.
ContraindicatedAntihypertensives / cardiovascular diseaseHuman RCT
Transient blood-pressure increase and heart-rate decrease after dosing; contraindicated per the label in uncontrolled hypertension or known cardiovascular disease.
Context: Contraindication per the label — risk reporting, not a combination guide.
CautionNaltrexone (oral)Human trial
Bremelanotide can significantly reduce the absorption of orally administered naltrexone — relevant for people taking naltrexone to treat dependence.
Context: Risk reporting from the label.
08
Risks & hygiene aspects in the literature
What regulatory and scientific literature reports on risks, sterility and identity in non-pharmaceutical sources — descriptive, not a hygiene guide.
Contraindication in cardiovascular disease
FDA label lists uncontrolled hypertension and known cardiovascular disease as contraindications due to the transient blood-pressure increase.
09
Regulatory voices
Direct statements from official assessment documents — paraphrased with date and source link.
FDAU.S. Food and Drug Administration
2019-06-21Press release on Vyleesi approval, June 2019.
The FDA strives to protect and advance the health of women.
10b
What online communities discuss
Recurring themes from Reddit, Quora and patient forums — synthetically summarised, sources linked. Not scientific evidence, but a signal of what users report. Deliberately separated from the study base.
Non-scientific sources. What users report in forums — synthetically summarised, paraphrased, with link to source. Not validated by studies.
Sorted by discussion frequency · 2 Themen
11
Legal status by country
12
Reconstitution calculator
Pure mg/mL maths — works like a calculator. Not a usage recommendation.
Peptides ship as a dry powder. Once dissolved in a liquid (reconstitution), this calculator answers a single question: how much substance is in one millilitre of solution afterwards?
- 1Enter the vial's substance amount (printed on the label).
- 2Enter how much solvent you add.
- 3Result = concentration in mg per mL.
Printed on the label
/
Liquid you add
=
2.50
mg / mL
5 mg in 2 mL gives 2.50 mg/mL — each millilitre contains 2.50 mg of substance.
14
Study register
Human RCTRandomised controlled trialn = 1247
Kingsberg SA. et al. · 2019
Bremelanotide for hypoactive sexual desire disorder: two phase-3 trials (RECONNECT)
Concrete results
Responder rate on desire score
25.0% vs 17.0%
vs Placebo · 24 Wochen
Human trialControlled trial
Diamond LE. et al. · 2006
An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist
Human trialControlled trial
Rosen RC. et al. · 2004
Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra
Human RCTRandomised controlled trial
Clayton AH. et al. · 2016
Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial
15
Sources & method
Reviewed by
editor-placeholder
Last reviewed
2026-05-22
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