PT-141
PT-141 is another name commonly used for bremelanotide, a synthetic cyclic peptide that acts on melanocortin receptors involved in central nervous system pathways associated with sexual desire. Unlike many peptides used in wellness settings, bremelanotide has an FDA-approved pharmaceutical formulation with a defined indication.
What Is PT-141?
Bremelanotide is a synthetic melanocortin receptor agonist related to alpha-melanocyte-stimulating hormone. Its effects are thought to involve central melanocortin pathways rather than acting primarily through local blood-vessel dilation.
In 2019, FDA approved bremelanotide injection under the brand name Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that causes marked distress or interpersonal difficulty and is not due to another medical or psychiatric condition, relationship problems, or the effects of a medication or drug.
The FDA-approved indication does not extend to men, postmenopausal women, or enhancement of sexual performance.
How Bremelanotide Signals
- Acts as an agonist at melanocortin receptors
- Has activity at MC4R and other melanocortin receptor subtypes
- Acts through central nervous system pathways associated with sexual response
- Does not work through the same primary mechanism as PDE5 inhibitors
- Has been evaluated in controlled human clinical trials of sexual desire
What Does the Research Show?
Bremelanotide has been evaluated in two large randomized, double-blind, placebo-controlled phase 3 studies known as RECONNECT. Together, the trials randomized 1,267 premenopausal women with HSDD.
Compared with placebo, bremelanotide produced statistically significant improvements in measured sexual desire and reductions in distress associated with low desire. These trials formed an important part of the evidence supporting FDA approval.
Nausea was the most common adverse effect and occurred frequently in the clinical development program. Flushing and headache were also common. The FDA-approved product also carries important precautions related to transient increases in blood pressure and decreases in heart rate.
Why Patients Ask About PT-141
Topics commonly discussed include:
- Low sexual desire and associated distress
- Changes in libido or sexual interest
- Questions about centrally acting sexual-health therapies
- Differences between PT-141 and blood-flow-focused medications
- Whether bremelanotide is appropriate for an individual's clinical situation
FDA approval applies specifically to acquired, generalized HSDD in premenopausal women who meet the labeled criteria. Other uses are outside the FDA-approved indication.
What to Know
FDA-approved Vyleesi contains bremelanotide and has a specific formulation, dose, delivery system, indication, and prescribing information. A compounded PT-141 preparation is not itself the FDA-approved Vyleesi product.
The FDA-approved product is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease. Important adverse effects include nausea, flushing, headache, injection-site reactions, and transient blood-pressure increases. Focal hyperpigmentation can also occur.
A provider should review cardiovascular history, blood pressure, medications, sexual-health concerns, underlying causes of low desire, formulation, and established treatment options before bremelanotide or a compounded PT-141 preparation is considered.
Interested in PT-141?
Schedule a consultation to discuss your sexual-health goals, medical history, and available treatment options.