PT-141
Melanocortin receptor agonist · bremelanotide
Bremelanotide is an FDA-approved melanocortin receptor agonist for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
Reference dose
1.75 mg as needed
Source-specific educational reference, not an individualized recommendation.
Reference schedule
As needed · On-demand
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At a glance
Approved name
Bremelanotide
PT-141 is the common development/research name.
Approved product
Vyleesi
1.75 mg / 0.3 mL single-dose autoinjector.
Approved population
Premenopausal women
With acquired, generalized HSDD meeting label criteria.
Not approved for
Performance enhancement
The label specifically excludes this use.
What it is
PT-141 is the development name widely used for bremelanotide, a cyclic peptide melanocortin receptor agonist.
The approved U.S. product Vyleesi is supplied as a fixed-dose subcutaneous autoinjector for a specific form of HSDD in premenopausal women.
Research focus
How it works
Bremelanotide is a melanocortin receptor agonist that acts centrally. The precise pathway by which it improves acquired, generalized HSDD is not fully established, but the approved effect is linked to melanocortin signalling rather than peripheral vasodilation alone.
Important context
PT-141 is the research/development name commonly used for bremelanotide. The approved U.S. product Vyleesi has a narrow indication and should not be presented as a general sexual-performance enhancer for men, postmenopausal women or people without diagnosed HSDD.
What it is studied for
Clinical development focused on central sexual-desire pathways rather than treating low desire purely as a blood-flow problem.
The pivotal programme measured both sexual desire and distress because HSDD is defined by more than the frequency of sexual activity alone.
Off-label discussion in men and other populations exists, but it should be separated from the evidence that established the approved indication.
More contextWhat the approval actually coversSee the deeper context, evidence details and practical distinctions behind this profile.
Vyleesi is approved for premenopausal women with acquired, generalized HSDD that causes marked distress or interpersonal difficulty and is not explained by another condition, relationship problem or medication/substance effect.
The phase 3 programme demonstrated statistically significant improvements in sexual desire and reduction in distress related to low desire, but the treatment also has clinically important blood-pressure, nausea and pigmentation considerations.
- The labelled dose is 1.75 mg delivered by a single-dose autoinjector at least 45 minutes before anticipated sexual activity.
- The label limits use to no more than one dose in 24 hours and no more than eight doses per month.
- Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease.
- It is not indicated to enhance sexual performance and is not approved for HSDD in men or postmenopausal women.
Why people are interested
What makes PT-141 worth researching.
Phase 3 human trials
Sexual desire
Two phase 3 randomized trials found statistically significant improvements in the prespecified sexual-desire endpoint versus placebo in premenopausal women with HSDD.
Phase 3 human trials
Distress related to low desire
The same phase 3 programme found reductions in distress related to low sexual desire, one of the core features of the approved HSDD indication.
Established pharmacology
Central melanocortin signalling
Bremelanotide acts as a melanocortin receptor agonist. The precise relationship between individual receptor effects and the clinical HSDD response is not fully resolved.
Clinical trials + approved label
Meaningful tolerability tradeoffs
Nausea is common, and the label also addresses transient blood-pressure increases, heart-rate decreases and focal hyperpigmentation.
Evidence
Where the evidence is strongest, and what kind of evidence it is.
Human · randomized · placebo controlled
RECONNECT phase 3 programme
Two identically designed 24-week trials enrolled more than 1,200 women and supported the approved indication through improvements in desire and distress endpoints.
FDA-approved indication
Labelled population
Approval is limited to premenopausal women with acquired, generalized HSDD and does not extend to men, postmenopausal women or general sexual-performance enhancement.
Approved label warning
Cardiovascular effects
Bremelanotide transiently increases blood pressure and reduces heart rate after dosing, which is why uncontrolled hypertension and known cardiovascular disease are contraindications.
Approved label
Dose frequency
The autoinjector is used as needed, with a maximum of one dose per 24 hours and no more than eight doses per month.
Human research
Two randomized double-blind phase 3 RECONNECT studies evaluated 1.75 mg subcutaneous bremelanotide as needed in premenopausal women with HSDD.
Across the trials, bremelanotide produced statistically significant improvements in sexual desire and reductions in distress related to low desire compared with placebo.
Nausea, flushing and headache were among the more common adverse events in the phase 3 programme.
Preclinical research
Preclinical melanocortin research helped establish central neural pathways relevant to sexual response, but the strongest evidence for the approved use comes from human randomized trials.
Reference dosing
Reference amount, schedule and conversion.
A reference amount is only useful when you know the formulation, concentration and delivery device it belongs to. Do not transfer a vial amount into a pen, a pen click count into another pen, or a syringe-unit number into a different concentration.
01
Identify the format
Vial, reusable cartridge pen, prefilled multi-dose pen or single-dose autoinjector.
02
Confirm concentration
Know the total peptide amount and liquid volume or the manufacturer/vendor concentration.
03
Understand the units
Keep mg/mcg, mL and syringe units or device clicks separate.
04
Then use the reference
Only convert a known reference amount with the calculator that matches the actual device.
Source-specific reference
1.75 mg as needed
As needed · On-demand
The 1.75 mg as-needed amount is the reference used on The Pep Report and aligns with the current Vyleesi label. Product-specific instructions and clinical context still take priority.
Calculator connection
This profile does not currently use a vial or pen calculator. Follow the formulation-specific information shown for the product or reference you are using.
Vyleesi is supplied as a fixed single-dose autoinjector containing 1.75 mg in 0.3 mL. The generic pen/vial calculator is disabled because the approved device is not intended for user-defined click or concentration calculations.
Storage
Start with the format. Then verify the exact product.
Rule of thumb, not a product instruction
Storage belongs to the exact formulation. Generic advice can orient you, but the label, pharmacy directions or formulation-specific stability data should determine the final temperature and usable-life limits.
Pens
Treat a pen as a finished drug-device product: protect it from unnecessary heat and light, do not freeze unless the exact label explicitly permits it, and use that device's own unopened and in-use storage window.
Vials
Treat dry and reconstituted vials as different stability states. Refrigeration after mixing is common for some formulations but is not a universal peptide rule.
Product-specific notes
Follow the storage instructions on the Vyleesi product label. The current product is supplied as a single-dose prefilled autoinjector and should be protected from freezing and excessive heat/light as specified by the label.
Practical reference
Formats
Single-dose prefilled autoinjector
Reconstitution & units
The approved Vyleesi autoinjector is a finished product and does not require user reconstitution.
This profile does not provide a generic PT-141 vial-reconstitution protocol because that is not the approved formulation.
Each approved autoinjector delivers 1.75 mg bremelanotide in 0.3 mL.
The generic pen/vial calculator is intentionally disabled because Vyleesi is a fixed-dose device rather than a user-configured peptide pen.
Safety, status & open questionsOpen the practical cautionsBremelanotide is an FDA-approved prescription medicine, but only for a defined form of HSDD in premenopausal women. Claims about male sexual performance, erectile dysfunction or generalized libido enhancement are outside the approved indication and require separate evidence.
Open questions
Clinical benefit demonstrated in the approved population should not automatically be generalized to men, postmenopausal women or people seeking performance enhancement.
The exact receptor-level mechanism responsible for the HSDD benefit remains incompletely defined.
Individual benefit can be modest and should be interpreted together with adverse effects and the requirement for an accurate HSDD diagnosis.
Regulatory notes
Vyleesi is FDA approved for premenopausal women with acquired, generalized HSDD that meets the label definition.
It is not indicated for treatment of HSDD in postmenopausal women or men.
It is not indicated to enhance sexual performance.
Practical notes
Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease because it can transiently increase blood pressure and reduce heart rate.
Nausea is common and can be severe enough to require antiemetic treatment in some patients.
Focal hyperpigmentation can occur and may be more likely with frequent dosing or darker skin; some pigmentation may not fully resolve.
Bremelanotide delays gastric emptying and can affect absorption of some oral medications, which can be clinically important for time-sensitive drugs.
The label advises discontinuation in pregnancy and includes pregnancy-related precautions.
Common mistakes
Calling PT-141 an FDA-approved sexual-performance enhancer for everyone.
Assuming evidence in premenopausal women with diagnosed HSDD proves efficacy for men or erectile dysfunction.
Treating the fixed-dose autoinjector like a generic click pen.
Ignoring the maximum-frequency limits or cardiovascular contraindications in the prescribing information.
Common questions
Is PT-141 the same as bremelanotide?
PT-141 is the common development/research name for bremelanotide, the active ingredient in the approved product Vyleesi.
Is PT-141 approved for men?
No. Vyleesi's FDA-approved HSDD indication is for premenopausal women meeting specific diagnostic criteria.
Is Vyleesi an erectile-dysfunction drug?
No. Its approved indication is acquired, generalized HSDD in premenopausal women, and the label states that it is not intended to enhance sexual performance.
Why is there no calculator button?
The approved product is a fixed 1.75 mg single-dose autoinjector, so generic vial or click calculations are not appropriate for the labelled formulation.
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References