Evidence strength for the context described on this page.
PEPTIDE ATLAS / SEXUAL & REPRODUCTIVE / BREMELANOTIDE
FDA-approvedHigh for approved indication
Bremelanotide
ALSO KNOWN ASVyleesi · PT-141
An as-needed melanocortin therapy for acquired, generalized HSDD in selected premenopausal women.
01CATEGORYSexual & reproductive
02REGULATORY STATUSFDA-approved
03COMMON ROUTESubcutaneous autoinjector
04DOSE BASISFDA-approved label
HOW TO USE THIS PAGE
Read the profile in the order that protects the decision.
- 01Verify what it is
Confirm the exact molecule, route, regulatory lane and actual human evidence.
- 02Read limits before dose
Unsupported claims, contraindications and uncertainty come before any protocol.
- 03Build the monitoring plan
Define the target, baseline checks, reassessment point and stop rules with a qualified clinician.
RESEARCH PASSPORT
The five facts to know first.
REVIEWED
JULY 2026
Status is product-, formulation- and indication-specific.
Trial, label or reported-practice basis is always named.
Official labels, regulators, trials and indexed literature where available.
Peptide hormones, growth factors and related substances may be prohibited.
Check Global DRO ↗OVERVIEW
What Bremelanotide is.
A melanocortin receptor agonist approved for a defined diagnosis of hypoactive sexual desire disorder. It is not approved for men, postmenopausal women or performance enhancement.
HOW IT IS THOUGHT TO WORK
Acts on central melanocortin pathways involved in sexual desire; it is nonhormonal.
EFFECTS & EVIDENCE
What the evidence supports—and what it does not.
- Modest improvement in desire and related distress for the labeled population
- Sexual-performance enhancement
- Treatment of erectile dysfunction in men
- General libido enhancement without HSDD assessment
- Safety of compounded PT-141 products
Evidence grade: High for approved indication. For an approved drug, “high” refers only to its labeled indication—not every off-label or wellness claim.
DOSAGE CONTEXT
Best available dosing range.
FDA-APPROVED LABELThe Vyleesi label uses one 1.75 mg subcutaneous dose at least 45 minutes before anticipated sexual activity, no more than once in 24 hours and no more than 8 doses per month.
- Route
- Subcutaneous autoinjector
- Duration
- As needed; discontinue after 8 weeks if symptoms do not improve
- Men & women
- Approved only for selected premenopausal women with acquired, generalized HSDD—not men or postmenopausal women.
Clinician verification required. Always double-check the exact molecule or salt, concentration, route, volume, schedule, indication, patient-specific contraindications, interactions and applicable law with the prescribing clinician and dispensing pharmacy. A disclaimer does not make an unapproved product FDA-approved, and a reported-use range is not a prescription.
MONITORING
What should be tracked.
- Blood pressure and cardiovascular eligibility
- Nausea and treatment tolerability
- Meaningful change in desire-related distress
- Persistent skin or gum darkening
SAFETY
Risks, red flags and reasons to avoid it.
- Transient blood-pressure increase and heart-rate reduction
- Nausea, flushing, headache and injection reactions
- Focal hyperpigmentation that may not fully resolve
- Reduced absorption of some oral medicines due to slowed gastric emptying
- Uncontrolled hypertension
- Known cardiovascular disease
- More than label frequency
- Using it for sexual performance rather than diagnosed HSDD
Stop and seek careGet urgent medical help for trouble breathing, facial or throat swelling, chest pain, fainting, severe persistent abdominal pain, neurologic changes, severe hypoglycemia, uncontrolled vomiting or a prolonged painful erection.
CLINICIAN VISIT CHECKLIST
Six questions worth bringing with you.
Molecule or analog, salt, concentration, route, manufacturer or compounder, lot and beyond-use date.
Name the diagnosis or target, how it will be measured and the realistic time to reassess.
Ask how it compares with FDA-approved, lower-risk or better-studied alternatives.
Label, human trial, specialty guideline or clinic convention—and whether that route and formulation match.
Baseline checks, follow-up measures, interactions, pregnancy considerations and symptoms that mean stop.
Pharmacy license, prescription, identity/potency testing, sterility controls and who handles a product complaint.
Do not improvise reconstitution or convert “units” without the exact concentration. Mixing, storage and beyond-use instructions are product-specific; confirm them with the dispensing pharmacy.
PRIMARY SOURCES
Read the record yourself.
We prioritize official prescribing information, FDA regulatory material, registered trials and indexed biomedical literature. A source supports the specific statement beside it—not every claim made about the molecule.
PRODUCTS & TREATMENT ACCESS
Use a verified prescription pathway.
Prescription-only FDA-approved autoinjector; compounded bremelanotide is not the approved product.
The label is far narrower than 'libido peptide.' Diagnosis, sex, menopausal status, cardiovascular risk and dosing frequency all matter.
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