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Compound reference

PT-141

Bremelanotide · Vyleesi

Peptides2 cited findingsClinical review: not reviewed

Regulatory record

Regulatory recordSupporting passage inspected

Vyleesi (bremelanotide) is FDA approved for acquired, generalized hypoactive sexual desire disorder in premenopausal women when the disorder is not explained by another medical or psychiatric condition, relationship problems or a drug. It is not a general sexual-performance indication.[1]

Jurisdiction
United States
Product
VYLEESI (bremelanotide)
Indication
Acquired, generalized hypoactive sexual desire disorder in premenopausal women meeting label criteria
Record date
2026-09-08
  • Approval of Vyleesi does not establish equivalence of research-market PT-141 products.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Reopened the live DailyMed label; reconfirmed the exact indication and limitations-of-use wording verbatim, and noted a repackager-metadata-vs-label-revision date distinction recorded on the source. No qualified clinical review.

Safety findings

Regulatory recordSupporting passage inspected

Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease. Its label describes transient blood-pressure increases and heart-rate decreases, nausea and focal hyperpigmentation.[1]

  • These label findings are specific to the approved subcutaneous formulation.
  • The label reports nausea in about 40% of patients receiving up to 8 doses/month (13% needed anti-emetic therapy, 8% discontinued) and focal hyperpigmentation in about 1% with higher risk in darker skin and daily dosing; consult the full label for complete frequencies.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Reopened the live DailyMed label; reconfirmed the contraindication and added the exact nausea/hyperpigmentation frequencies stated in Sections 5.2-5.3. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Replaced with the exact Vyleesi indication and key label restrictions and adverse effects.

  • Research-market PT-141 product equivalence and off-label population outcomes need separate evidence.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

  1. VYLEESI (bremelanotide) US prescribing information

    Cosette Pharmaceuticals, Inc. 2024-03. Product label.

    Inspected location: Highlights and Sections 1, 4, 5.1, 5.2, 5.3 and 6.1

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-vyleesi-2024: Sections 1, 4, 5.1 and adverse reactions

View this compound in the research library →

Related records in this class

Grouped under Peptides for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.

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