Bremelanotide (Vyleesi): the approved drug related to Melanotan II

Bremelanotide is often mentioned alongside Melanotan II because it came out of the same line of melanocortin research. Unlike Melanotan II, it went through clinical trials and is FDA-approved, for one specific use.

What it's approved for

According to the FDA-approved Vyleesi prescribing information (2019), Vyleesi (bremelanotide injection) is a melanocortin receptor agonist for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that isn't due to a medical or psychiatric condition, relationship problems, or the effects of a medication or drug. It's prescription-only. It is not approved or intended for tanning.

Labeled warnings and side effects

The prescribing information and MedlinePlus: Bremelanotide injection list, among others:

• Nausea, flushing, injection-site reactions and headache, which are among the most common adverse reactions in the label.
• Transient increases in blood pressure and decreases in heart rate after each dose. The label says it shouldn't be used by people with uncontrolled high blood pressure or known cardiovascular disease.
• Focal hyperpigmentation: darkening of areas such as the face, gums and breasts. It didn't go away in every patient after stopping, and the label says the risk rises with more frequent use.

Why this matters for melanotan

Bremelanotide shows what a melanocortin drug looks like after regulators review it: a narrow approved use, a known product, and a label listing its risks. Melanotan II sold online has none of that. It has no approved use, no quality control and no official labeling. The approved drug's warnings (nausea, blood pressure effects, skin darkening) overlap with effects reported by melanotan users (see reported side effects).

Only a licensed prescriber can decide whether bremelanotide is appropriate for someone. Related: what is melanotan? · risks

Published October 25, 2026. Sources are linked in the text. See our Medical Disclaimer.