Vyleesi (Bremelanotide) Regulatory Status: US, EU, Canada, UK

United States: approved since June 2019

FDA approved bremelanotide as Vyleesi on June 21, 2019, under NDA 210557; the current holder is Cosette Pharmaceuticals, and the product was originally AMAG's [1][2]. It is a 1.75 mg subcutaneous injection in a prefilled autoinjector, available by prescription only [1].

The approved indication is narrow. It covers premenopausal women with acquired, generalized HSDD: low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, relationship problems, or a medication or drug [1]. The label states Vyleesi is not indicated for postmenopausal women or for men, and not to enhance sexual performance [1].

The label describes use as a subcutaneous injection into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity [1]. It says not to use more than one dose in 24 hours and does not recommend more than eight doses per month. It also says to stop after 8 weeks if symptoms have not improved, and it states that the duration of effect after a dose is unknown [1].

What the US label does and does not carry

Vyleesi has no boxed warning, and no risk evaluation and mitigation strategy appears in the label or in the 2019 approval letter [1][2]. The warnings that do appear are specific: a transient blood pressure rise and heart rate fall after each dose, with maximal increases of 6 mmHg systolic and 3 mmHg diastolic peaking 2 to 4 hours after dosing and a heart rate reduction of up to 5 beats per minute, usually back to baseline within 12 hours [1]. Those 6 and 3 mmHg figures are maximal, not average; in a separate ambulatory study of 127 premenopausal women the mean daytime rise was 1.9 mmHg systolic and 1.7 mmHg diastolic [1]. Focal hyperpigmentation was reported by 1% of patients using up to 8 doses a month [1]. Nausea occurred in 40% versus 1.3% on placebo, 13% needed an anti-nausea medicine and 8% stopped the trials [1]. Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease [1].

European Union, Canada and the United Kingdom

No marketing authorization for bremelanotide in the European Union, Canada or the United Kingdom has been established. The authorization that is documented is the US approval of Vyleesi as a prescription-only branded autoinjector [1][2].

Sport regulation

Bremelanotide is not named on WADA's 2026 Prohibited List [3]. Because it holds FDA approval, WADA's S0 class for substances with no approval from any health authority does not cover it by definition [3].

Compounded and research-use PT-141

Vyleesi is the only FDA-approved bremelanotide product. Products sold as compounded or research-use PT-141 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][4]. Bremelanotide does not appear on FDA's list of bulk substances that may present significant safety risks when compounded, and it is not one of the six peptides named in HHS's October 2026 draft enforcement-discretion policy [5][6][7].