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Bremelanotide

FDA ApprovedSince 2019
Also known as Vyleesi

Get a source-linked, educational explanation from this profile.

Complete Research Guide

Open each section for the available evidence. Gaps are stated rather than inferred.

Overview

Bremelanotide is listed as sexual health / melanocortin agonist.

  • •Hypoactive Sexual Desire Disorder (premenopausal women)

Regulatory status: FDA-Approved Rx.

Structure & Properties

Compound: Bremelanotide; also known as Vyleesi.

Pharmacologic class: Sexual Health / Melanocortin Agonist.

Known delivery routes: Subcutaneous (autoinjector).

Sequence, molecular weight, salt form, and excipient details are formulation-specific and are not listed unless verified by a manufacturer or laboratory COA.

How It Works

MC1R/MC4R agonist — centrally activates melanocortin pathways modulating sexual desire and arousal.

  • •Increases sexual desire scores
  • •On-demand dosing
Human Research

Evidence grade: Clinical RCT (Phase III)

Clinical RCT (Phase III). Phase III RECONNECT trials.

Laboratory Research

Phase III RECONNECT trials

Preclinical findings describe biological plausibility, not proven benefit in people. Animal and laboratory doses do not translate directly to human use.

Processing & Interactions

Timing and exposure

SubQ 45 min before anticipated sexual activity. Do not exceed 1 dose per 24 hrs or 8 doses per month.

Potential interactions and combinations to avoid

  • •Uncontrolled hypertension — bremelanotide transiently raises BP
  • •Concurrent Melanotan II — same melanocortin class
  • •Naltrexone (oral) — reduced efficacy

Absorption, half-life, metabolism, and clearance can vary by formulation and route. Use prescribing information when an approved product exists.

Safety & Precautions

Known or reported risks

  • •Nausea (~40%)
  • •Flushing
  • •Transient BP increase
  • •Hyperpigmentation

Contraindications

  • •Uncontrolled hypertension
  • •Known CV disease
  • •History of melanoma, dysplastic nevi, or numerous/atypical moles
  • •Uncontrolled hypertension or significant cardiovascular disease
  • •Fitzpatrick type I skin with extensive sun exposure and no dermatologic surveillance
  • •Concurrent PDE-5 inhibitors or antihypertensives without medical oversight (blood-pressure swings)
  • •Bleeding disorders or anticoagulant therapy without physician guidance (injection-site haematoma)
  • •Active skin infection, cellulitis, or lipohypertrophy at intended injection sites
  • •Inability to maintain sterile technique or safe sharps disposal
  • •Known hypersensitivity or prior reaction to this compound or any excipient/diluent
  • •Pregnancy, attempting conception, or breastfeeding unless prescribed and monitored by a physician
  • •Children and adolescents with open growth plates (unless under specialist endocrine care)
  • •Active or recently treated malignancy without oncology clearance
  • •Use without a confirmed diagnosis, baseline labs, and licensed clinical supervision

Unknown long-term toxicity should be assumed where controlled human data are limited. Seek urgent care for a severe or unexpected reaction.

Administration & Studied Formulations

Reference range: 1.75 mg PRN

Frequency: As needed (max 1×/24h, ≤8/month)

Cycling: PRN only; max 8 doses/month.

Subcutaneous

45 min before anticipated activity. Max 1 dose / 24 h, 8 / month.

Pre-filled auto-injector (Vyleesi) — 1.75 mg fixed dose. Abdomen or thigh. One-time single-use device.

Dosing information is educational context, not a personal recommendation. Approved products must follow their label and prescriber instructions.

Applications & Related Therapies

Potentially complementary measures

  • •Kisspeptin-10 (research) for HPG-axis pairing

Clinical use should account for diagnosis, approved alternatives, nutrition, activity, sleep, rehabilitation, current medicines, and appropriate monitoring.

Cases, Considerations & Ethics

Decision framework: establish the clinical goal, confirm evidence quality and legal status, screen contraindications and interactions, compare approved alternatives, define monitoring and stopping criteria, and use shared decision-making with a licensed clinician.

Case evidence: individual reports cannot establish safety or effectiveness and should not outweigh controlled trials.

Ethics: informed consent should distinguish established care from experimental use, disclose uncertainty and cost, avoid overstated claims, and never substitute research products for medically necessary care.

What is Bremelanotide?

In plain words

Bremelanotide, sold as Vyleesi, is a prescription medicine made from a short chain of seven amino acids. It activates signals in the brain involved in sexual desire and arousal. Researchers have studied it for persistent low sexual desire that causes distress in women who have not reached menopause. Clinical trials support its approved use, but nausea occurs in about 40% of patients; flushing, temporary blood pressure increases, and skin darkening can also occur.

Technical definition

Bremelanotide (Vyleesi) is a synthetic cyclic heptapeptide derived from the melanocortin peptide analogue melanotan II. It agonizes melanocortin receptors, including MC1R and MC4R, with central melanocortin signaling implicated in its effects on sexual desire and arousal; its precise therapeutic mechanism remains incompletely understood. It is FDA-approved as a prescription treatment for acquired, generalized hypoactive sexual desire disorder in premenopausal women, supported by phase III randomized controlled trials.

Function

Primary
Hypoactive Sexual Desire Disorder (premenopausal women)
Mechanism
MC1R/MC4R agonist — centrally activates melanocortin pathways modulating sexual desire and arousal.
Evidence
Clinical RCT (Phase III)
Research
Phase III RECONNECT trials

Dosing

Range
1.75 mg PRN
Frequency
As needed (max 1×/24h, ≤8/month)
Route
Subcutaneous (autoinjector)

Recommended Time of Day

45–60 minutes before sexual activity.

See “Timing & Interactions” below for full fasted/fed circumstances, what to avoid combining, and what pairs well.

Administration & Technique

Subcutaneous
45 min before anticipated activity. Max 1 dose / 24 h, 8 / month.
DevicePre-filled auto-injector (Vyleesi) — 1.75 mg fixed dose.
TechniqueAbdomen or thigh. One-time single-use device.

Injection & Application Sites

Front
Back
Subcutaneous
  • Abdomen — 2 in (5 cm) away from the navel, either side. Fastest, most consistent SubQ absorption.
  • Outer thigh — Upper outer quadrant, a hand-width below the hip. SubQ pinch at 45°.

Diagram is a general illustration, not a medical instruction. Rotate sites every injection, keep 1 in (2.5 cm) between recent sites, and avoid scars, moles, bruises and the navel area.

Cycling

PRN only; max 8 doses/month.

Timing & Interactions

When to take
SubQ 45 min before anticipated sexual activity. Do not exceed 1 dose per 24 hrs or 8 doses per month.
Do not combine with
  • ·Uncontrolled hypertension — bremelanotide transiently raises BP
  • ·Concurrent Melanotan II — same melanocortin class
  • ·Naltrexone (oral) — reduced efficacy
Complements
  • ·Kisspeptin-10 (research) for HPG-axis pairing

Storage & Reconstitution

Powder (Pre-Reconstitution)
Lyophilized powder: refrigerate 2–8°C for up to 24 months, or freeze at –20°C for extended storage. Keep sealed, desiccated, and protected from light.
After Reconstitution
After reconstitution with bacteriostatic water, refrigerate at 2–8°C and use within 28 days. Discard if cloudy, discolored, or precipitated.
Notes
Do not freeze after reconstitution — freeze/thaw cycles degrade most peptides.
Full BAC water & reconstitution guide →How to read a COA →

Reconstitution Calculator

Concentration
2.50 mg/mL
Volume per dose
0.100 mL
Insulin syringe
10.0 units (U-100)

1 mL = 100 units on a standard U-100 insulin syringe. Draw to the nearest 0.5 unit and confirm dosing with a clinician before injection.

Your Notes

Your Notes

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Benefits

  • ·Increases sexual desire scores
  • ·On-demand dosing

Risks

  • ·Nausea (~40%)
  • ·Flushing
  • ·Transient BP increase
  • ·Hyperpigmentation

Contraindications

  • ·Uncontrolled hypertension
  • ·Known CV disease
  • ·History of melanoma, dysplastic nevi, or numerous/atypical moles
  • ·Uncontrolled hypertension or significant cardiovascular disease
  • ·Fitzpatrick type I skin with extensive sun exposure and no dermatologic surveillance
  • ·Concurrent PDE-5 inhibitors or antihypertensives without medical oversight (blood-pressure swings)
  • ·Bleeding disorders or anticoagulant therapy without physician guidance (injection-site haematoma)
  • ·Active skin infection, cellulitis, or lipohypertrophy at intended injection sites
  • ·Inability to maintain sterile technique or safe sharps disposal
  • ·Known hypersensitivity or prior reaction to this compound or any excipient/diluent
  • ·Pregnancy, attempting conception, or breastfeeding unless prescribed and monitored by a physician
  • ·Children and adolescents with open growth plates (unless under specialist endocrine care)
  • ·Active or recently treated malignancy without oncology clearance
  • ·Use without a confirmed diagnosis, baseline labs, and licensed clinical supervision

Regulatory

FDA-Approved Rx

Veterinary Use (Pets)

No established veterinary protocol for Bremelanotide. Consult a licensed veterinarian before considering off-label use in any species.

Full veterinary reference →
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Educational reference only. Not medical advice. Consult a qualified clinician before starting any peptide protocol.

Non-FDA-approved peptides are for research use only. Not for human or animal consumption.