Bremelanotide (PT-141): the molecule behind Vyleesi, and compounded versions
Bremelanotide, also called PT-141, is the active ingredient in Vyleesi, an FDA-approved medicine for low sexual desire in premenopausal women. Pharmacies can also be asked to prepare it. This page covers what the molecule does, what the trials show, and what changes when the product is compounded instead of approved.
Information current as of November 10, 2026. Educational only. Confirm everything here with your own clinician before starting, stopping or changing any medication.
At a glance
What it is
A synthetic peptide that activates melanocortin receptors. It is not a hormone and not a PDE5 drug like sildenafil.
Approved use
Vyleesi is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
Off-label use
Use in men, or in women outside the approved group, is off-label. The approval trials did not study it.
What trials showed
A small average gain in desire and a small drop in distress, compared with placebo, over 24 weeks.
Main side effects
Nausea in about 4 in 10, flushing, headache. Blood pressure rises briefly after each dose.
Compounded status
Not FDA-approved. The approved brand product is available, which limits compounded copies.
Uses
What bremelanotide is used for
The one approved use is for premenopausal women with acquired, generalized HSDD. That means low sexual desire that developed after a period of normal desire, occurs in every situation, causes marked distress, and is not explained by a medical or psychiatric condition, relationship problems or a medication. It is not approved for men, for postmenopausal women, or to improve sexual performance.
Some clinics also offer it to men with low desire or erectile problems. That use is off-label, and the approval trials did not study men. For erectile dysfunction, the evidence-based options are described on our tadalafil page. The full details of the brand drug are on the Vyleesi page.
If low desire began around menopause, the first step is a look at hormones. See estradiol and testosterone.
How it works
How bremelanotide works
Bremelanotide activates melanocortin receptors, which are found on nerve cells in the brain and on other tissues. The FDA label states that how it improves desire in women is unknown. It does not change hormone levels.
It is given by injection under the skin before expected sexual activity, according to the prescription. It can darken skin in some people, which is one reason the label limits how often it can be used. This page does not give amounts or schedules.
Evidence
What the trials showed
Two identical phase 3 trials, called RECONNECT, tested the brand product against placebo for 24 weeks in 1,267 premenopausal women with HSDD. Both found statistically significant gains in desire and drops in distress. Across both trials, the average gain on the 1.2 to 6 desire scale was 0.35 points more than placebo, and distress on a 0 to 4 scale fell by 0.33 points more.
More women on bremelanotide left the trials early. In one trial 40 percent stopped, versus 13 percent on placebo. A 52-week open-label extension showed no new safety signals, but with no comparison group it cannot show benefit with confidence.
All of this evidence is for the FDA-approved product, in the approved group of women. Results with a compounded version, or in men, have not been tested in the same way. Individual results vary, and trials in different populations are not directly comparable.
Safety
Side effects and cautions
In the pooled trials, nausea occurred in about 40 percent of women on the drug and 1 percent on placebo. Flushing occurred in about 20 percent, headache in 11 percent, and injection site reactions in about 13 percent. Blood pressure rises by a few points for several hours after a dose, and heart rate dips slightly.
The label reports focal skin darkening in about 1 percent of women using it as directed, and in 38 percent after 8 daily doses. It is more likely in darker skin and may not fully resolve.
The brand label contraindicates use in people with uncontrolled high blood pressure or known cardiovascular disease. It advises avoiding oral naltrexone with it, and it is not recommended in pregnancy.
Call your physician for
- Nausea that does not settle, or vomiting
- New dark patches on the skin, gums or breasts
- Chest pain, a very fast or very slow heartbeat, or a severe headache
Regulatory status
Compounded bremelanotide and the ‘essentially a copy’ limit
Bremelanotide is a component of an FDA-approved drug, Vyleesi. That meets the first test for use in compounding. The second rule is the limit. Vyleesi is commercially available, and under the FDA’s January 2018 guidance a 503A pharmacy may not regularly compound a drug that is essentially a copy of a commercially available product.
A compounded version is not a copy if the prescriber documents a significant difference for an identified patient. That determination belongs to the prescriber, for that patient. When no such difference exists, the right product is the brand drug.
Compounded drugs are not FDA-approved. The FDA does not evaluate them for safety, effectiveness or quality before they are sold. The brand label has trial data, defined limits on use per day and per month, and a medication guide. A compounded product does not come with that review.
Summit’s role
What Summit does with bremelanotide
Dr. Miranda prescribes bremelanotide after a physician evaluation. For women in the approved group, the usual route is the FDA-approved brand product, filled by a pharmacy. A compounded preparation from an independent, state-licensed pharmacy is considered only when a documented clinical reason supports it. Summit does not dispense or sell it, and it keeps no stock in the office.
Nothing on this page promises a prescription. If bremelanotide does not fit your history, labs and goals, you will hear why. See pricing for what the program includes, including labs.
Common questions
Questions people ask
Is bremelanotide the same as PT-141?
Yes. PT-141 is another name for bremelanotide. The FDA-approved version is sold as Vyleesi.
Can men use it?
It is not approved for men. Any use in men is off-label, and the approval trials did not study it.
Is compounded bremelanotide FDA-approved?
No. The FDA does not evaluate compounded drugs for safety, effectiveness or quality. The brand product, Vyleesi, is the approved version.
How is it different from Viagra?
Sildenafil and tadalafil improve blood flow. Bremelanotide acts on receptors in the brain and was studied for desire, not for erections.
Does it cause skin darkening?
It can. The label reports focal hyperpigmentation, which was more common with daily dosing and in darker skin, and it did not always fully resolve.
Sources
Where this comes from
All retrieved November 10, 2026.
- VYLEESI (bremelanotide injection) prescribing information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
- Kingsberg SA et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol 2019. https://pubmed.ncbi.nlm.nih.gov/31599840/
- Clayton AH et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol 2019. https://pubmed.ncbi.nlm.nih.gov/31599847/
- Safety Profile of Bremelanotide Across the Clinical Development Program. 2022. https://pubmed.ncbi.nlm.nih.gov/35147466/
- FDA. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A. Guidance, January 2018. https://www.fda.gov/media/98973/download
Confirm with your provider. This page is general education, not medical advice, and it does not diagnose or treat anything. Every medication carries risks and is not right for everyone. Medication is prescribed only after a physician evaluation determines it is appropriate for you. Individual results vary and no outcome is guaranteed. Information current as of November 10, 2026.
Next step
Start with a physician evaluation
Dr. Miranda reviews your history, blood pressure and medications first.