Melanotan II

Melanotan II is a lab-made peptide, a short chain of the building blocks of protein ^[11]. It copies part of alpha-MSH, a natural hormone that darkens the skin ^[11]. It switches on melanocortin receptors, signal points that affect skin color and sexual response ^[19].

Researchers at the University of Arizona first tested it in people in the 1990s ^{[11] [12]}. Today people use it outside medical care to tan without sun and as a sexual stimulant ^{[17] [18]}. Its other short name is MT-II ^[11].

Bremelanotide is a variation of Melanotan II, made for sexual stimulation ^[17]. It is a different molecule with its own record on this site. Its studies say nothing about Melanotan II. Afamelanotide, another related peptide, is also a different molecule ^[20].

Melanotan II is in limbo: FDA lists it as withdrawn from Category 2, and it has not added it to Category 1 ^{[1] [2]}. That is not approval, and it does not make compounding lawful. Checked 25 October 2026.

Category 2 is FDA's list of substances that may raise significant safety risks ^[1]. Category 1 is the list of substances under review that pharmacies may use while FDA decides ^[3]. In April 2026, the groups that nominated Melanotan II withdrew, so it came off Category 2 ^{[1] [8]}. Taking a substance off Category 2 does not by itself let pharmacies use it ^{[8] [9]}. FDA's 503A list of 14 May 2026 does not name Melanotan II in any category ^[2].

FDA says its Pharmacy Compounding Advisory Committee will discuss Melanotan II at a meeting before the end of February 2027 ^{[4] [22]}. The notice gives no exact date and no meeting materials ^[4]. It does not say which use the committee will review ^[4]. People use Melanotan II to tan and as a sexual stimulant ^{[17] [18]}. The committee gives advice only. FDA decides by writing a rule ^[8].

A June 2026 pharmacy column expected Melanotan II to stay restricted ^[23]. FDA's own page lists it as withdrawn from Category 2 ^[1]. The FDA page is what this page follows.

Until FDA acts, a pharmacy may not use Melanotan II under the federal compounding law ^{[3] [5]}.

The evidence grade is limited-human: three small studies in men, all from one university group, point the same way ^{[11] [12] [13]}. No large trial has been published. Each study lasted hours or weeks, so none shows what long-term use does.

Tanning: in a 1996 pilot study of 3 healthy men, two tanned on the face and upper body ^[11]. Mild nausea was common, and erections came on without sexual stimulation ^[11].

Erection problems: in a 1998 study, 10 men whose erection problems had no physical cause got Melanotan II and a dummy shot ^[12]. Neither the men nor the staff knew which was which ^[12]. Eight of the 10 had erections with Melanotan II ^[12]. In a 2000 study, 10 men with physical risk factors were tested the same way ^[13]. Erections followed 12 of 19 shots of Melanotan II and 1 of 21 dummy shots ^[13]. Sexual desire was also higher after Melanotan II ^[13].

Borrowed evidence: bremelanotide is a variation of Melanotan II, not the same molecule ^[17]. A study of bremelanotide does not show what Melanotan II does. The same holds for afamelanotide, a related peptide ^[20].

Harms are known mostly from case reports, not trials ^{[1] [20]}. A case report shows that a harm can happen. It does not show how often it happens.

There is no legal way to get Melanotan II in the US today ^{[1] [2]}. In 2020, FDA said no approved drug contains it ^[5]. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list ^{[3] [5]}. Melanotan II is neither, and FDA is still deciding whether to add it ^{[2] [4]}.

One trial in the registry is testing Melanotan II for vitiligo ^[21]. Its only site is in China, so it is not a US route ^[21]. The trials block below lists open trials, with the date the registry was last checked.

Case reports describe people who bought Melanotan II online to tan ^{[17] [18]}. A 2021 report says unlicensed clinics also use it as a sexual stimulant ^[18]. A 2017 review calls these products untested and likely risky ^[20]. It adds that several national health groups have warned against them ^[20].

FDA has warned a seller of research-use peptides that a "research use only" label does not stop a product from being a drug ^[7]. That letter did not name Melanotan II ^[7].

Pharmacies are the other channel a federal record names ^[5]. In 2020, FDA warned a compounding pharmacy that its Melanotan II products did not meet the rules for compounding ^[5]. Later that year, the pharmacy pleaded guilty to a federal charge of selling unapproved new drugs, Melanotan II among them ^[6]. FDA warns that Melanotan II made by a pharmacy may set off the immune system ^[1].