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Melanocortin · Reproductive & sexual health

Bremelanotide

An FDA-approved melanocortin agonist for one specific sexual-health diagnosis — endlessly mis-sold as a general performance enhancer.

L5Practice-changingApproved — narrow indicationApprovedHigh confidenceLast reviewed 2026-08-23
SC injection

Also known as: Vyleesi, PT-141

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
80/100
Human safety
75/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved (2019) with completed pivotal trials

Overview

Human evidence80/100
Preclinical evidence70/100
Human safety evidence75/100

Clinical maturity: Approved (2019) with completed pivotal trials

Routes & formulations

Studied / approved routes

SC injection

The approved product is an on-demand subcutaneous autoinjector used within the labelled indication. Marketing of 'PT-141' outside that indication is unapproved use of a research-market product.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A melanocortin receptor agonist developed from the same research lineage as Melanotan II, but taken through a full regulated development programme for one narrow indication.

What people claim

  • Improves sexual desire in premenopausal women with HSDD
  • Marketed online as a libido enhancer for everyone

What the evidence actually says

Within its approved indication the evidence is solid: randomised pivotal trials supported approval for acquired, generalised HSDD in premenopausal women. Outside it, the evidence is absent. The approval's narrowness is the point most marketing deliberately skips.

Human evidence

  • Pivotal randomised controlled trials in premenopausal women with acquired, generalised HSDD.
  • Post-marketing safety surveillance under a regulated label.

Preclinical evidence

  • Melanocortin receptor pharmacology; animal studies of sexual behaviour pathways.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Central MC4R activation modulates sexual desire circuitry in the brain.

Safety and unknowns

  • Labelled effects include nausea, flushing, injection-site reactions and transient blood-pressure increases.
  • Known interactions and contraindications are defined in the FDA label.

Cancer relevance

No concern identified

No established human cancer signal within its approved use.

Regulatory status

FDA-approved in 2019 (Vyleesi) for acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women. That is the entire approval: it is not indicated for men, for postmenopausal women, or for general sexual performance enhancement.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • New trial programmes in populations outside the approved indication.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.

Related claims we’ve checked

MisleadingL5Practice-changingMelanocortin

“PT-141 / bremelanotide is an approved sexual-performance enhancer for everyone.”

Misleading — the approval is deliberately narrow.

  • Vyleesi (bremelanotide) is FDA-approved for acquired, generalised hypoactive sexual desire disorder in premenopausal women — a specific diagnosis, not a performance claim.
  • It is not approved for men, for postmenopausal women, or for general sexual enhancement.
  • Products marketed as 'PT-141' outside that indication are unapproved uses of a research-market product.
Last reviewed 2026-08-23Compound profile