Compound library/Primary-source evidence guide

PT-141 (Bremelanotide)

An approved bremelanotide product is not evidence for every product sold as PT-141

PT-141 is a name commonly used for bremelanotide. FDA approval is product- and indication-specific: Vyleesi is an approved bremelanotide injection for certain premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). That approval does not extend to products sold as PT-141, other formulations, men, postmenopausal women, sexual-performance enhancement, or other claimed uses.

Editorial status

This page aggregates regulatory documents and published human research. Its claims, citations, populations, and limitations received an independent editorial evidence check. Last editorial audit: .

It has not been medically reviewed by a clinician. It provides general education, not diagnosis, treatment, dosing instructions, or advice for an individual. Use the product-specific official information and consult a qualified clinician or pharmacist for personal decisions.

Product and regulatory distinctions

A compound name is not one interchangeable set of instructions. Product, formulation, indication, labeling, and jurisdiction matter.

Vyleesi (bremelanotide injection)

FDA-approved for premenopausal women with acquired, generalized HSDD meeting the label's criteria. The label states that it is not indicated for postmenopausal women or men and is not indicated to enhance sexual performance.

Current source

Products marketed as PT-141 or generic bremelanotide outside the approved Vyleesi product

The name of an active ingredient does not establish FDA approval, equivalence to Vyleesi, or the identity, strength, sterility, and quality of a seller's product.

Current source

Claim-by-claim evidence map

Each finding is tied to the population and product actually studied. Trial results are not personal predictions.

Regulatory labeling

Vyleesi has a narrow FDA-approved indication rather than a general approval for libido or sexual performance.

Population
Premenopausal women with acquired, generalized HSDD that causes marked distress or interpersonal difficulty and is not attributable to a coexisting condition, relationship problem, medication, or drug substance.
Finding
The FDA label identifies this population and explicitly excludes use for HSDD in postmenopausal women or men and use to enhance sexual performance.
Limits
The label applies to the approved Vyleesi injection and cannot be extrapolated to a differently manufactured product, a different formulation, or an unapproved population or purpose.
Vyleesi (bremelanotide injection) Prescribing Information
Randomized human trial

Two phase 3 trials found statistically significant but measured improvements in desire and distress outcomes with the studied bremelanotide product.

Population
1,267 randomized premenopausal women with HSDD across two 24-week, double-blind, placebo-controlled RECONNECT trials; 1,202 were included in the modified intention-to-treat efficacy population.
Finding
The integrated estimated treatment differences versus placebo were 0.35 points for the Female Sexual Function Index desire-domain score and -0.33 points for the prespecified low-desire distress item.
Limits
Most participants were white and enrolled at U.S. sites, the trials were sponsor-funded, and the endpoint changes do not establish benefit for other populations, other outcomes, or products marketed as PT-141.
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 TrialsA Study of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (RECONNECT Study 301)A Study of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (RECONNECT Study 302)
Regulatory labeling

The approved product can transiently raise blood pressure and lower heart rate.

Population
People exposed to Vyleesi in the FDA-reviewed clinical program.
Finding
The label warns that transient blood-pressure increases and heart-rate reductions occur after a dose and identifies uncontrolled hypertension or known cardiovascular disease as contraindications.
Limits
An approved label describes known risks under reviewed manufacturing and use conditions; it cannot characterize the contents or risks of an unverified product sold as PT-141.
Vyleesi (bremelanotide injection) Prescribing Information
Randomized human trial

Nausea, flushing, and headache were common in the phase 3 program.

Population
Premenopausal women in the two RECONNECT phase 3 trials.
Finding
The publication reports nausea, flushing, and headache in at least 10% of bremelanotide-treated participants and more often than with placebo.
Limits
Trial tolerability findings may not capture uncommon, delayed, population-specific, formulation-specific, or product-quality risks.
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials

What this evidence does not answer

  • The pivotal evidence does not establish efficacy or safety in men, postmenopausal women, people without acquired generalized HSDD, or for sexual-performance enhancement.
  • Published Vyleesi evidence does not validate the identity, strength, sterility, purity, or clinical equivalence of products sold as PT-141.
  • Longer-term and broader real-world evidence is more limited than the controlled trial and label evidence for the approved population.

Useful information to organize between visits

  • The exact product name, manufacturer, and FDA approval status
  • Whether the population and intended use match the FDA-approved indication
  • Blood-pressure and cardiovascular history discussed with a licensed clinician
  • All medicines and supplements disclosed to the clinician and pharmacist
  • Adverse effects and product-quality concerns recorded with dates and product identifiers

Questions to bring to a clinician or pharmacist

  1. 1.Does my situation meet the specific diagnostic and population limits in the approved Vyleesi label?
  2. 2.Which cardiovascular, pregnancy, and medication-related factors matter for the approved product?
  3. 3.How can I verify that a product is FDA-approved rather than merely marketed under the name PT-141?
  4. 4.Which symptoms or adverse effects require prompt medical attention or an FDA MedWatch report?

Primary sources

  1. Vyleesi (bremelanotide injection) Prescribing InformationU.S. Food and Drug Administration · Published 2020 · Accessed July 12, 2026
  2. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 TrialsObstetrics & Gynecology via PubMed · Published 2019 · Accessed July 12, 2026
  3. A Study of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (RECONNECT Study 301)ClinicalTrials.gov · Published 2015 · Accessed July 12, 2026
  4. A Study of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (RECONNECT Study 302)ClinicalTrials.gov · Published 2015 · Accessed July 12, 2026
  5. How do I find out if a drug is approved?U.S. Food and Drug Administration · Published 2017 · Accessed July 12, 2026

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