Vyleesi Compounding Legal Status: What Patients and Prescribers Need to Know

What exactly did FDA approve?

Bremelanotide was approved as Vyleesi on June 21, 2019, under new drug application 210557, which is now held by Cosette Pharmaceuticals [1][2]. The approved product is a 1.75 mg subcutaneous injection in a prefilled autoinjector pen, prescription only [1].

The indication is narrow. Vyleesi is for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD): low sexual desire causing marked distress or interpersonal difficulty that is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug [1]. The label states it is not indicated for HSDD in postmenopausal women or in men, and not to enhance sexual performance [1]. Vyleesi has no boxed warning, and no risk evaluation and mitigation strategy appears in the label or in the 2019 approval letter [1][7].

FDA approved a labeling supplement (S-005) on October 22, 2026, which updates Section 8 (Use in Specific Populations) and the patient information [2]. The label details below come from the DailyMed version effective November 13, 2025 [1].

Is compounded bremelanotide an FDA-approved drug?

No. Products sold as compounded 'PT-141' or as research-use peptides are not Vyleesi and are not FDA-approved drugs. Compounded drugs are not reviewed by FDA for safety, effectiveness or quality before they are marketed [1][3]. The dosing, warnings and trial results in the Vyleesi label describe the 1.75 mg autoinjector, not a compounded vial, cream or other strength [1].

Where bremelanotide sits on FDA's compounding lists

FDA's compounding pages describe lists of bulk drug substances nominated for use in compounding, including a category of substances FDA has flagged as potentially presenting significant safety risks [4]. Bremelanotide does not appear on that safety-risk page (content dated 04/22/2026), and it appears in no other category on FDA's bulk-substance lists [4][5].

Separately, HHS issued a draft enforcement-discretion policy in October 2026 covering six peptides. Bremelanotide is not one of them [6].

What the Vyleesi label covers

The dose is 1.75 mg injected subcutaneously into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. No more than one dose is to be given in 24 hours, and more than 8 doses per month is not recommended. The label says to stop after 8 weeks if there is no improvement in symptoms [1].

Blood pressure. Each dose transiently raises blood pressure and lowers heart rate. In clinical studies the maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after the dose, with a heart rate reduction of up to 5 beats per minute; values usually returned to baseline within 12 hours [1]. In a separate ambulatory study of 127 premenopausal women dosed once daily for 8 days, the mean increase in daytime blood pressure was 1.9 mmHg systolic and 1.7 mmHg diastolic [1]. Vyleesi is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease and is not recommended for patients at high risk of cardiovascular disease [1].

Nausea. Reported by 40% of Vyleesi-treated women versus 1.3% on placebo in the phase 3 trials; 13% received an anti-nausea medicine and 8% stopped the trials because of it [1]. Nausea was most common after the first dose (21% of patients) and fell to about 3% with later doses [1]. Pretreating with oral ondansetron 30 minutes before the dose did not reduce nausea in a phase 4 study of 228 healthy women, and the label says it is not recommended [1].

Hyperpigmentation. Focal darkening of the skin, gums or breasts, including the face, was reported by 1% of patients using up to 8 doses a month versus none on placebo. In another study 38% developed it after daily dosing for 8 days, and a further 14% after 8 more consecutive days [1]. Risk is higher in patients with darker skin and with daily dosing, and resolution was not confirmed in all patients [1]. The label says to consider discontinuing Vyleesi if hyperpigmentation develops [1].

Naltrexone. Vyleesi may significantly decrease the systemic exposure of oral naltrexone, and the label says to avoid Vyleesi with oral naltrexone-containing products intended to treat alcohol or opioid addiction, due to the severe consequence of naltrexone treatment failure [1]. The label also notes that Vyleesi may slow gastric emptying and affect absorption of other oral medicines, and says to avoid it with oral drugs that depend on threshold blood concentrations, such as antibiotics [1].

What the trials behind the approval showed

The approval rested on two identical phase 3 trials (RECONNECT) that randomized 1,267 premenopausal women with acquired, generalized HSDD 1:1 to bremelanotide 1.75 mg as needed or placebo for 24 weeks, with 1,247 women in the safety population and 1,202 in the efficacy analysis [8]. Versus placebo, the FSFI-desire domain improved by 0.30 points in study 301, 0.42 in study 302 and 0.35 in the integrated analysis (all P<0.001). Distress related to low desire (FSDS-DAO item 13) fell by 0.37, 0.29 and 0.33 points, with P<0.001, P=0.005 and P<0.001, respectively [8]. The trials used the 1.75 mg autoinjector [1].