Bremelanotide

Bremelanotide is a prescription drug. It is a lab-made peptide, a short chain of the building blocks of protein ^[2]. It switches on melanocortin receptors, which are signal points in the brain and skin ^[2]. The ones in the skin can darken it ^[2].

FDA approved it in June 2019 under the brand name Vyleesi ^{[1] [4]}. It comes as a single-use pen with a shot under the skin of the belly or thigh ^[2]. It is used as needed before sex, not every day ^[2].

It is approved for one condition: low sexual desire in women who have not gone through menopause ^{[2] [4]}. The low desire must cause real distress. It must not come from another illness, a relationship problem or another drug ^[2].

Bremelanotide is FDA-approved: FDA approved it as Vyleesi in June 2019 for low sexual desire in women before menopause ^{[1] [4]}. That covers Vyleesi, with a prescription, for that one use. It does not cover men, women after menopause, or boosting sex. It does not make PT-141 sold for research legal ^{[2] [9]}. Checked 24 October 2026.

There is a gap between the approved use and what sellers offer it for. The label says it is not for men and not to improve sexual performance ^[2]. In July 2026, FDA reviewed five seller websites ^{[9] [10] [11] [12] [23]}. They described PT-141 for arousal, desire, libido and sexual function ^{[10] [12] [23]}. One site pointed to a study in men with erection problems ^[9]. FDA called every one of those products an unapproved new drug ^{[9] [10] [11] [12] [23]}.

The drug's maker today is Cosette Pharmaceuticals ^{[1] [2]}. In October 2026, FDA approved a change to part of its label ^[5]. Bremelanotide is not on FDA's Category 1 or Category 2 lists of raw ingredients for compounding ^{[7] [8]}. Those lists are for ingredients that are not part of an approved drug ^[6]. Because bremelanotide is part of Vyleesi, a pharmacy may use it to make a drug ^[6]. Under section 503A, that is only for one patient with a prescription ^[24]. A pharmacy may not make copies of Vyleesi regularly or in large amounts ^[24].

The evidence grade is moderate-human: two large trials in women before menopause agree it helps desire a little ^{[15] [16]}. Experts disagree on whether the gain is worth its known risks ^[19].

The two main trials lasted 24 weeks and included 1,247 women with low desire ^{[2] [15]}. Women on it scored higher for desire than women on a dummy shot. They also felt less upset about low desire ^[15]. The gains were small, on scales that run from about 1 to 6 and from 0 to 4 ^[2]. It did not raise the number of satisfying sexual events ^[2].

More women on it than on a dummy shot quit before the end. In one trial it was 40% compared with 13% ^[2]. A 2021 reanalysis of the data FDA reviewed found similar gains. It said the benefits were modest and the trial reports left many results out ^[19].

In a 52-week follow-up with no dummy shot, 684 women took it, and the gains held ^[16]. An earlier 12-week trial in 327 women found similar results ^[17]. A 2026 review of nine trials found it among the most studied drugs for this condition. It said differences between trials make them hard to compare ^[20].

These trials tested the approved drug in women. They tell us nothing about PT-141 sold for research, which FDA has not approved ^[9].

The legal way to get bremelanotide is a prescription for Vyleesi ^{[1] [2]}. The label is for women before menopause with low sexual desire that causes distress ^[2].

The label says to stop if there is no improvement after 8 weeks ^[2]. It is not for women with high blood pressure that is not under control, or with heart disease ^[2].

A pharmacy may also make it, because it is part of an approved drug ^[6]. Under section 503A, that is only for one patient with a prescription ^[24]. A pharmacy may not make copies of Vyleesi regularly or in large amounts ^[24].

Outside a prescription, bremelanotide reaches people as PT-141 from online sellers that label it for research use ^{[9] [13]}. On 24 August 2026, FDA sent warning letters to five such sellers ^{[9] [10] [11] [12] [23]}. Each letter names PT-141 ^{[9] [10] [11] [12] [23]}.

The sellers' labels said the products were for research only, or not for people ^{[9] [10] [12] [23]}. FDA said their websites showed the products were meant for people anyway ^{[9] [10] [12] [23]}. It called them unapproved new drugs, and sending them across state lines breaks federal law ^{[9] [14]}. FDA warns that injected products skip some of the body's defenses against germs and toxins ^[9].

No FDA page we found names bremelanotide at a clinic, an online prescriber, or as a fake or imported product. So this page does not describe those channels.