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Melanotan II: What Lakeland Readers Should Know

Also known as: MT-II, MT2, MII, Melanotan 2, Tanning injection

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Last updated

At a glance

Type
Synthetic alpha-MSH analogue (melanocortin agonist)
Human evidence
Very limited human data Only small or early human studies exist.
FDA status
Not FDA-approved for any use; FDA has treated it as an unapproved new drug (as of November 12, 2026)
How it is given
Injection under the skin (as studied); also sold as nasal sprays

Melanotan II is a lab-made peptide sold online as a “tanning injection” or nasal spray. It has never been approved by the FDA, and its human research is very thin. This page explains what is known, what has been reported, and why caution is warranted. It is general information, not advice for your situation.

What it is and how it works

Melanotan II is a lab-made, ring-shaped copy of alpha-MSH (alpha-melanocyte-stimulating hormone). Alpha-MSH is a natural hormone that helps the skin make melanin, the pigment that darkens skin. Melanotan II was developed at the University of Arizona in the 1990s.1

It belongs to the same family as bremelanotide (PT-141), which acts on melanocortin receptors in the skin and brain.2 Melanotan II is thought to work in a similar way. That would explain both the tanning and the effects seen in early trials, such as erections, nausea and yawning. This link has not been fully studied, and the two are different substances.

Today it is sold without authorization, mainly online, as injections or nasal sprays used for tanning.3

What the research shows (and where evidence is weak)

The human trial evidence is very small and old:

  • Two tiny trials in men. In the late 1990s, researchers tested melanotan II in two crossover studies of 10 men each with erectile dysfunction. In a crossover study, each man gets both the drug and a placebo at different times. In the first study, 8 of 10 men developed erections on the drug.1 In the second, erections followed 12 of 19 drug injections vs 1 of 21 placebo doses.4
  • Same research group. Both trials came from the group that developed the drug, so they are not independent of each other.
  • No tanning or skin-cancer trials found. This research found no controlled trial of melanotan II for tanning or for preventing skin cancer. Sellers have claimed it protects against skin cancer, but no human trial supports that.5
  • Harms come from case reports. Most of what is known about risks comes from single-patient reports. Case reports cannot prove that a drug caused a problem. Many users also used sunbeds or tanned heavily, which muddies the picture.36
  • Unknown frequency. Because use is unregulated, no one knows how often problems happen. Product content and strength are also uncertain.3

FDA and regulatory status

Melanotan II has never been FDA-approved, and FDA’s drug database has no listing for it as of November 12, 2026.7 In 2007, FDA sent a warning letter to an online U.S. seller. It said melanotan II, marketed as an injectable tanning product with skin-cancer claims, was an unapproved new drug. The company’s owner later pleaded guilty (2015) to conspiracy for continuing to ship it, and FDA moved to bar him from the drug industry in 2016.5

Melanotan II was once on FDA’s “Category 2” compounding list, meaning FDA had found possible significant safety risks. The nominations to allow compounding were withdrawn, but as of April 22, 2026, FDA still posts its safety concerns. These include possible immune reactions and impurities, and published case reports of melanoma, a brain-swelling syndrome (posterior reversible encephalopathy syndrome), an overstimulation reaction (sympathomimetic toxidrome) and priapism.8

According to a law-firm summary of FDA’s July 2026 advisory committee meeting, the committee is expected to consider melanotan II at a meeting before the end of February 2027.9 As of November 13, 2026, we did not find a meeting date or outcome for that review. Check FDA’s advisory committee calendar for updates.

Outside the U.S., the authors of one 2025 case report wrote that melanotan II is unlicensed and illegal to sell in the United Kingdom and many other countries.10 A 2017 review noted that several national health agencies have issued safety warnings.3

Because it is not approved anywhere this research could find, it is likely covered by WADA’s ban on unapproved substances.11 Athletes should check with their anti-doping organization.

See our guides to research chemical peptide risks and whether peptides are legal in Florida.

Common side effects and safety

In the two small trials, side effects included nausea, stretching and yawning, and reduced appetite. In one study, 4 of 19 injections caused severe nausea.4

In case reports (single patients, which cannot prove cause):

  • Mole changes. A man with a past melanoma developed crops of new moles, some with abnormal features, and his existing moles darkened and grew. They lightened after he stopped.12 A review found a growing number of similar reports.3
  • Melanoma. Melanoma has been reported in several users. One case was a young woman who also used sunbeds.6 Another was an early melanoma confined to the top layer of skin (melanoma in situ).13 A third was a melanoma inside the mouth in a 22-year-old who used a nasal spray.10 A 2017 review counted four melanoma reports and said conclusive evidence of a link is lacking.3
  • Priapism. This is a painful erection that will not go away, and it is a medical emergency. A 2021 case needed surgery, and its authors found only two earlier published reports.14

Product risks. Unlicensed products are untested. How they are made, their dose and their contents are uncertain, and FDA notes possible immune reactions and impurities.38

If you have used melanotan II, tell a provider, and have any new or changing moles checked by a clinician.

Typical cost range

There is no approved product and no official price. Products are sold without authorization online, so price says nothing about quality or safety. We did not find reliable price data.

Questions to ask a provider

  • Is there an FDA-approved option for what I want, such as a sunless tanning product or an approved treatment for a sexual health concern?
  • Can you check my skin and moles, given that I have used or am thinking about melanotan II?
  • What are the warning signs of melanoma or priapism that mean I should get care right away?
  • If someone offered me melanotan II, what does it mean that it is not approved or regulated?

For background, see the skin and hair goal page and the sexual health goal page.

Footnotes

  1. Wessells H, Fuciarelli K, Hansen J, et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol. 1998;160(2):389-393. https://pubmed.ncbi.nlm.nih.gov/9679884/ ↩ ↩2

  2. Cosette Pharmaceuticals. VYLEESI (bremelanotide injection) prescribing information. DailyMed. Revised October 2026. Accessed November 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf ↩

  3. Habbema L, Halk AB, Neumann M, et al. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56(10):975-980. https://doi.org/10.1111/ijd.13585 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7

  4. Wessells H, Gralnek D, Dorr R, et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology. 2000;56(4):641-646. https://doi.org/10.1016/s0090-4295(00)00680-4 ↩ ↩2

  5. U.S. Food and Drug Administration. Notice of opportunity for hearing, proposal to debar: Edward Manookian (Melanocorp). Docket FDA-2015-N-4169. August 5, 2016. https://www.fda.gov/regulatory-information/electronic-reading-room/notice-opportunity-hearing-nooh-manookian-edward-8516 ↩ ↩2

  6. Hjuler KF, Lorentzen HF. Melanoma associated with the use of melanotan-II. Dermatology. 2014;228(1):34-36. https://doi.org/10.1159/000356389 ↩ ↩2

  7. U.S. Food and Drug Administration. Drugs@FDA data (openFDA drugsfda endpoint): query for melanotan. Data updated November 12, 2026. Accessed November 2026. https://api.fda.gov/drug/drugsfda.json ↩

  8. U.S. Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Content current as of April 22, 2026. Accessed November 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ↩ ↩2

  9. McDermott Will & Schulte. Bulk list bound: PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Accessed November 2026. https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ ↩

  10. Yassin Alsabbagh A, Bhujel N, Singh RP. Melanotan II nasal spray: a possible risk factor for oral mucosal malignant melanoma? Int J Oral Maxillofac Surg. 2025;54(9):806-808. https://doi.org/10.1016/j.ijom.2025.03.014 ↩ ↩2

  11. World Anti-Doping Agency. The Prohibited List (2026). Accessed November 2026. https://www.wada-ama.org/en/prohibited-list ↩

  12. Cardones AR, Grichnik JM. Alpha-melanocyte-stimulating hormone-induced eruptive nevi. Arch Dermatol. 2009;145(4):441-444. https://doi.org/10.1001/archdermatol.2008.623 ↩

  13. Ong S, Bowling J. Melanotan-associated melanoma in situ. Australas J Dermatol. 2012;53(4):301-302. https://doi.org/10.1111/j.1440-0960.2012.00915.x ↩

  14. Mallory CW, Lopategui DM, Cordon BH. Melanotan tanning injection: a rare cause of priapism. Sex Med. 2021;9(1):100298. https://doi.org/10.1016/j.esxm.2020.100298 ↩

Frequently asked questions

Is melanotan II FDA-approved?

No. It has never been approved by the FDA for any use. FDA called it an unapproved new drug in a 2007 warning letter to an online seller, and a criminal conviction later followed for continued sales.

Does melanotan II protect against skin cancer?

No controlled human trial has shown that. Doctors have instead published case reports of new or changing moles and melanoma in people who used it, although case reports cannot prove it caused them.

Is melanotan II the same as PT-141?

No. They are different substances. PT-141 (bremelanotide) is FDA-approved for one use in women, while melanotan II was never approved. Both come from the same family of lab-made hormones.

What side effects have been reported?

In two tiny trials, nausea, yawning and stretching, and lower appetite were common. Case reports describe new or changing moles, melanoma and painful erections that would not go away, which can need emergency surgery.

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