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Peptide Evidence Registry

Melanocortin · Reproductive & sexual health

Bremelanotide

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

L5Repeated human trialsApproved for a specific indication · FDA (US)Approved
How settled this rating is:
high confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
Vyleesi, PT-141
Last reviewed:
2026-08-23
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Evidence passport

Bremelanotide

A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.

Reviewed 2026-08-23
Evidence level
L5Repeated human trials
Confidence
High confidence in rating
Regulatory status
Approved for a specific indication · See jurisdiction details
Development status
Approved

Evidence strength

Human efficacy evidence80 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Human safety evidence75 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.

Evidence base
Includes human studies
Furthest established stage
Approved
Human research maturity
Approved (2019) with completed pivotal trials
Source curation
Sources fully curated

Routes recorded

SC injection

Overview

Human efficacy evidence strength80 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Preclinical (animal / lab) evidence strength70 of 100 evidence strength

Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.

Human safety evidence strength75 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

How to read these scores

Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.

  • Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
  • Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
  • Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
  • Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
  • Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.

None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.

How far human research has progressed: 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.

Related evidence

Useful next reads based on this compound — not recommendations.

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

This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.

No concern identified

No established human cancer signal within its approved use.

Regulatory status

Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.

Named regulators: FDA (US)

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

L5Repeated human trialsHigh confidence in rating

Substantial, consistent controlled human evidence supporting a specified outcome, preferably independently replicated. Approval is reported separately.

What would change our rating?

  • New trial programmes in populations outside the approved indication.

References and sources

Source transparency

A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.

Sources fully curated
Last editorial review
2026-08-23
Recently reviewed · 54 days ago
Linked curated sources
2
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Regulatory / label: 2

Review provenance

Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.

Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.

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

These entries record changes to our assessment of the published evidence — not changes to the compound itself.

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

Related claims we’ve checked — in full

Claim verdict

Melanocortin

MisleadingL5Repeated human trials

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

This verdict applies to the exact claim above. It is not a verdict on the compound overall, a safety guarantee, or a recommendation to use it.

Registry verdict

Misleading — the approval is deliberately narrow.

Why this verdict

  • 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.