PT-141 is bremelanotide, a melanocortin receptor agonist. One FDA-approved product (Vyleesi) treats acquired, generalized low desire in premenopausal women; use in men is off-label, and compounded PT-141 is not FDA-approved.
PT-141 is the research name for bremelanotide, a peptide that activates melanocortin receptors in the body. One bremelanotide product, Vyleesi, is FDA-approved, and only for premenopausal women with a specific, diagnosed form of low sexual desire. Any use in men is off-label, and compounded PT-141 is a different category of product that the FDA has not approved. This article explains what the approved label says, what the trials found, which safety warnings matter, and how approved and compounded versions differ.
Bremelanotide was developed under the code name PT-141, which is why many people still use that name. According to the FDA-approved Vyleesi label, bremelanotide is a melanocortin receptor agonist that nonselectively activates several receptor subtypes.
The label is candid on one important point: the mechanism by which bremelanotide improves low sexual desire is unknown. In other words, researchers know which receptors it activates, but not exactly how that translates into a change in desire.
The FDA approved Vyleesi in 2019. The approval package describes the indication precisely: premenopausal women with acquired, generalized HSDD, characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance.
Two terms in that definition matter:
The current label lists clear limitations of use. Vyleesi is not indicated for postmenopausal women or for men, and it is not indicated to enhance sexual performance. It is given as a subcutaneous injection with a single-dose autoinjector, and how and when to use it is set by the prescriber.
No bremelanotide product is FDA-approved for men, and the approved label states that it is not indicated for men. When a licensed provider prescribes PT-141 for a man, that is off-label use. It means the FDA has not reviewed evidence for that use, and a prescriber should explain the reasoning and the uncertainty.
Vyleesi was studied in two identical 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women, published in 2019 in Obstetrics & Gynecology. The trials measured two main outcomes: a desire score and a score for how often women felt bothered by low desire.
According to the label, the average improvement in the desire score was 0.5 with Vyleesi compared with 0.2 with placebo in one study, and 0.6 compared with 0.2 in the other. The average reduction in the distress score was 0.7 with Vyleesi compared with 0.4 with placebo in both studies. Both differences were statistically significant. The label also reports no significant difference between groups in the number of satisfying sexual events, which was a secondary outcome.
These are averages on rating scales, and individual results vary. More women stopped treatment early in the Vyleesi groups (40% compared with 13% in one study, and 39% compared with 25% in the other).
A 52-week open-label extension, also published in Obstetrics & Gynecology in 2019, followed women who chose to continue. Of 684 participants who enrolled, 272 completed it. The authors reported no new safety signals and sustained improvements in desire and distress scores, though open-label studies have no placebo comparison and their results are less certain.
The Vyleesi label includes several warnings that apply to bremelanotide generally.
| Warning | What the label reports |
|---|---|
| Blood pressure and heart rate | A temporary rise of up to about 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after a dose, with heart rate dropping by up to 5 beats per minute. Values usually return to baseline within 12 hours. |
| Nausea | Reported by about 40% of patients. About 13% needed anti-nausea medication and 8% stopped early. For most, it improved after the second dose. |
| Focal hyperpigmentation | Darkening of the skin, including the face, gums and breasts, in 1% of trial patients. It was more likely in people with darker skin, and it did not resolve in all patients. |
| Other common effects | Flushing (about 20%), injection site reactions (about 13%), headache (about 11%) and vomiting (about 5%). |
Because of the blood pressure effect, Vyleesi is contraindicated in people with uncontrolled high blood pressure or known cardiovascular disease, and the label says it is not recommended for people at high risk of cardiovascular disease. The label also advises assessing blood pressure before starting and periodically during treatment. It may significantly reduce levels of oral naltrexone, so the two should not be combined when naltrexone is used to treat alcohol or opioid dependence. Effective contraception is advised, and treatment should stop if pregnancy is suspected.
| Vyleesi (approved) | Compounded PT-141 | |
|---|---|---|
| FDA review | Reviewed for safety, effectiveness and manufacturing quality | Not FDA-approved; not reviewed before sale |
| Approved use | Premenopausal women with acquired, generalized HSDD | No approved use |
| Labeling | Full prescribing information with warnings | Pharmacy label only |
The FDA describes compounding as a practice in which a licensed pharmacist combines, mixes or alters ingredients to create a medication tailored to an individual patient. In the FDA's words, compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed. Compounded PT-141 available through NewDay Wellness is prescribed by a licensed provider and dispensed by a licensed US pharmacy, and it is not FDA-approved.
It is also worth separating pharmacy compounding from products sold online as "research peptides." In an August 2026 warning letter, the FDA told one online seller that its PT-141 product was an unapproved new drug. Unapproved products like these have not been evaluated by the FDA, and they are a separate risk from prescription products dispensed by a licensed pharmacy.
They contain the same active molecule, bremelanotide. Vyleesi is the FDA-approved brand product with a defined indication and full prescribing information. Compounded PT-141 contains bremelanotide prepared by a pharmacy and is not FDA-approved.
The approved label states that Vyleesi is not indicated to enhance sexual performance. In the trials, it was studied for desire and related distress, and the number of satisfying sexual events did not differ significantly from placebo.
The label lists uncontrolled high blood pressure and known cardiovascular disease as contraindications and advises against use in people at high cardiovascular risk. A licensed provider will also ask about pregnancy plans, other medications such as oral naltrexone, and your skin's history with pigmentation changes.
Dosing and frequency are set by the prescriber based on your history and the product prescribed. Do not change how you use it without talking to your provider.
Low desire has many possible causes, and a licensed provider can help sort out which apply to you before any medication is considered. If PT-141 is discussed, ask whether the product is approved or compounded, whether the use is on-label or off-label, and how your blood pressure will be checked. You can learn more on our sexual health page. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
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