# Melanotan II: FDA Status, Research and Uses

> Melanotan II safety and legal page: FDA actions, import alert, compounding status, published case reports of harm, and WADA status.

- Canonical URL: https://livingpluspeptides.com/peptides/melanotan-ii/
- Last updated: October 25, 2026
- Publisher: Living+

Melanotan II is a lab-made peptide that mimics alpha-MSH and activates melanocortin receptors. It is not FDA approved for any use, and FDA has treated it as an unapproved new drug. Published case reports describe melanoma, priapism, kidney injury and posterior reversible encephalopathy syndrome (PRES) in users. This page covers safety and legal status only [1, 4, 8].

## Regulatory status

- FDA approved: No
- 503A compounding: [Nomination withdrawn or removed](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). Listed by FDA as 'nominated but withdrawn' from 503A Category 2 (page current April 22, 2026); FDA still lists safety concerns. FDA plans a PCAC meeting before end of February 2027 that will discuss Melanotan II for the 503A bulks list.
- 503B bulks list: [Not nominated](https://www.fda.gov/media/94164/download). Not on the FDA 503B nominated substances list (updated March 21, 2025).
- WADA prohibited: [Unclear](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 or 2027 List. S0 (non-approved substances) may apply, since it covers substances no government has approved for human use. The 2027 List, in force January 1, 2027, adds peptides as an S0 example.)
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22melanotan%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: Certain bulk drug substances that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks), [FDA: Upcoming Pharmacy Compounding Advisory Committee meeting](https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee), [FDA: Import Alert 66-41](https://www.accessdata.fda.gov/cms_ia/importalert_190.html), [Federal Register: FDA debarment order for a Melanotan II seller (Nov 14, 2016)](https://www.federalregister.gov/d/2016-27244), [FDA: 503B nominated bulk drug substances list (March 21, 2025)](https://www.fda.gov/media/94164/download), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA Drugs@FDA query: melanotan (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22melanotan%22), [openFDA drug shortages query: melanotan](https://api.fda.gov/drug/shortages.json?search=generic_name:%22melanotan%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Synthetic melanocortin receptor agonist (alpha-MSH analog) [8, 15]
- Amino-acid length: 7 amino acids (cyclic heptapeptide) [8]
- Half-life: Not established; there is no FDA-approved label [4]
- Route used in studies: Subcutaneous injection in an early study; nasal spray in case reports [8, 17]
- First studied: 1989 (first described); first small human study in 1996 [8, 9]

## How it works

Melanotan II is a man-made copy of part of alpha-melanocyte stimulating hormone (alpha-MSH), a natural hormone that controls skin pigment. It is a ring-shaped chain of seven amino acids, held closed by a chemical bridge called a lactam [8, 9].

Chemists first described this family of ring-shaped alpha-MSH analogs in 1989. In skin tests on frogs and lizards, some of them were far stronger than natural alpha-MSH and acted longer [9].

Melanotan II is called a non-selective melanocortin receptor agonist. That means it binds several melanocortin receptors in the body instead of just one. Its reported effects include darker skin, spontaneous erections and sexual stimulation [15].

Because it acts on pigment cells, it darkens the skin. In the first small human study, published in 1996, two of three men had darker skin on the face, upper body and buttocks. The same study reported spontaneous erections, nausea, yawning and stretching [8].

The brain effects explain why it was studied for erectile dysfunction in the 1990s [16]. They also help explain the sexual side effects, such as priapism, seen in case reports of people who used unregulated products [13, 14].

FDA has called Melanotan II an unapproved new drug [4]. Bremelanotide (PT-141) is described as a variation of Melanotan II [12]. Bremelanotide is FDA approved as Vyleesi for one specific use [20].

## What the research shows

This page covers safety and the law only. It does not summarize research for this product.

## Doses used in studies

This page does not list doses.

**Dosing is set by a licensed provider.**

## Side effects and safety

This section draws mainly on published case reports. A case report describes one person or a few people. It cannot prove that melanotan caused the problem or show how often it happens, but it can flag serious risks. Some cases involved products bought online, where the actual contents may be unknown [12].

FDA summary: FDA says published case reports discuss serious adverse events with Melanotan II, including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. FDA also says compounded Melanotan II may pose a risk of immune reactions for some routes because of clumping or peptide impurities [1].

Skin and melanoma (case reports): reports describe melanoma in a melanotan user [10], new moles appearing quickly after injections [11], a mucosal melanoma in the mouth of a 22-year-old woman who used a Melanotan II nasal spray for tanning [17], and five melanomas in situ in one patient who also used tanning beds and anabolic hormones [18].

Toxicity and kidneys (case reports): a 39-year-old man developed sympathomimetic toxicity, rhabdomyolysis (muscle breakdown) and kidney problems after injecting a product confirmed by testing to be Melanotan II [12]. Another report describes a kidney infarction most likely linked to Melanotan II [15].

Priapism and brain (case reports): two reports describe lasting erections (priapism) after melanotan injection, one needing surgery [13, 14]. A report in Annals of Internal Medicine describes melanotan and posterior reversible encephalopathy syndrome (PRES), a brain swelling disorder [19].

- [FDA: Bulk substances that may present significant safety risks (Melanotan II, nominated but withdrawn)](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) (2026-04-22)
- [FDA Import Alert 66-41: detention without physical examination of unapproved new drugs (Melanotan entries)](https://www.accessdata.fda.gov/cms_ia/importalert_190.html) (2026-10-22)

## Legal and regulatory status

- 2026-10-22: FDA's current Import Alert 66-41 on unapproved new drugs promoted in the U.S. lists firms with Melanotan (I and II) and Melanotan II products for detention without physical examination [5]. [Source](https://www.accessdata.fda.gov/cms_ia/importalert_190.html)
- 2026-04-22: FDA's safety risks page, current as of this date, lists Melanotan II among substances previously in 503A Category 2 whose nominations were withdrawn. The safety concerns are still listed [1]. [Source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- 2026-04-15: FDA said it will hold a Pharmacy Compounding Advisory Committee meeting before the end of February 2027 that will discuss Melanotan II for possible inclusion on the 503A bulks list. No date is set [2]. [Source](https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee)
- 2026-01-01: The WADA 2026 Prohibited List took effect. Melanotan II is not named. Class S0 bans any pharmacological substance with no current government approval for human therapeutic use, but WADA has not ruled on Melanotan II by name [7]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2020-04-01: An FDA warning letter to a compounding pharmacy said Melanotan II had not been nominated for the 503A bulks list and did not meet section 503A [6]. [Source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
- 2016-11-14: FDA published a permanent debarment order for a seller of Melanotan II, an unapproved new drug marketed online as an injectable tanning product. The seller was convicted of federal felonies in 2015 [4]. [Source](https://www.federalregister.gov/d/2016-27244)
- 2007-08-30: According to the later FDA debarment order, FDA sent a warning letter on or about this date saying Melanotan II was a new drug that could not be sold without an approved application [4]. [Source](https://www.federalregister.gov/d/2016-27244)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-melanotan-ii).

## Frequently asked questions

### Is Melanotan II FDA approved?

No. FDA has described Melanotan II as an unapproved new drug [4]. No FDA-approved Melanotan II product exists.

### Is Melanotan II legal in the US?

Selling it for human use without FDA approval violates federal drug law. FDA has sent warning letters, put melanotan products on an import alert, and debarred a convicted seller [4, 5].

### Can a compounding pharmacy make Melanotan II?

Its Category 2 nomination was withdrawn, and FDA still lists safety concerns [1]. FDA plans an advisory committee review on the 503A bulks list before the end of February 2027 [2].

### Does Melanotan II cause skin cancer?

Case reports describe melanoma and new moles in users [10, 11, 17]. Case reports cannot prove cause or show how often this happens, but FDA lists melanoma among reported serious events [1].

### What are the dangers of melanotan nasal spray?

A 2025 case report describes mucosal melanoma in the mouth of a young woman who used a Melanotan II nasal spray for tanning [17].

### Can Melanotan II cause priapism?

Yes, case reports describe priapism after melanotan injection, including one case that needed surgery [13, 14]. FDA lists priapism among reported serious events [1].

### Is Melanotan II the same as PT-141?

No. They are related peptides. Bremelanotide (PT-141) is described as a variation of Melanotan II [12]. Bremelanotide is FDA approved as Vyleesi for a specific use, while Melanotan II is not [4, 20].

### Is Melanotan II banned in sports?

Unclear. It is not named on the WADA 2026 List. The S0 class bans pharmacological substances with no government approval for human therapeutic use, and Melanotan II has no FDA approval, but WADA has not ruled on it by name [7, 4].

## Sources

1. [FDA: Certain bulk drug substances that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
2. [FDA: Upcoming Pharmacy Compounding Advisory Committee meeting](https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee)
3. [FDA: 503A nominated bulk drug substances categories (updated May 14, 2026)](https://www.fda.gov/media/94155/download)
4. [Federal Register: FDA debarment order for a Melanotan II seller (Nov 14, 2016)](https://www.federalregister.gov/d/2016-27244)
5. [FDA: Import Alert 66-41](https://www.accessdata.fda.gov/cms_ia/importalert_190.html)
6. [FDA warning letter to a compounding pharmacy (Apr 1, 2020)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
7. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
8. [Dorr et al. 1996, Life Sci (PubMed)](https://pubmed.ncbi.nlm.nih.gov/8637402/)
9. [Al-Obeidi et al. 1989, J Med Chem (PubMed)](https://pubmed.ncbi.nlm.nih.gov/2555512/)
10. [Paurobally et al. 2011, Br J Dermatol, case report (PubMed)](https://pubmed.ncbi.nlm.nih.gov/21564053/)
11. [Cousen et al. 2009, Br J Dermatol, case report (PubMed)](https://pubmed.ncbi.nlm.nih.gov/19575725/)
12. [Nelson et al. 2012, Clin Toxicol, case report (PubMed)](https://pubmed.ncbi.nlm.nih.gov/23121206/)
13. [Dreyer et al. 2019, BMJ Case Rep (PubMed)](https://pubmed.ncbi.nlm.nih.gov/30796078/)
14. [Mallory et al. 2021, Sex Med, case report (PubMed)](https://pubmed.ncbi.nlm.nih.gov/33460908/)
15. [Peters et al. 2020, CEN Case Rep (PubMed)](https://pubmed.ncbi.nlm.nih.gov/31953620/)
16. [Wessells et al. 1998, J Urol (PubMed)](https://pubmed.ncbi.nlm.nih.gov/9679884/)
17. [Yassin Alsabbagh et al. 2025, Int J Oral Maxillofac Surg, case report (PubMed)](https://pubmed.ncbi.nlm.nih.gov/40210573/)
18. [Vadner et al. 2026, JAAD Case Rep (PubMed)](https://pubmed.ncbi.nlm.nih.gov/42328529/)
19. [Kaski et al. 2013, Ann Intern Med, case report (PubMed)](https://pubmed.ncbi.nlm.nih.gov/23648958/)
20. [DailyMed: VYLEESI (bremelanotide injection) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf)

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