Peptide dossier, updated Oct 31, 2026
Melanotan II
A synthetic cyclic peptide analog of alpha-melanocyte stimulating hormone. It was studied in small trials in the 1990s for erection and tanning effects, and later sold online as an injectable tanning product. FDA’s safety-risk page is the only one of this batch to cite specific serious adverse events, drawn from published case reports. Per two law-firm summaries it is not covered by HHS’s enforcement pause. This page lays out what each source actually says.
See all 17 verified records for Melanotan II on the Records page
Human studies
ClinicalTrials.gov returns one record that tests Melanotan II, as of Oct 31, 2026.
| Registry | Study | Sponsor | Status | What the record says |
|---|---|---|---|---|
| NCT07437560 | Phase 2: Melanotan II as an adjunct to narrowband UV-B phototherapy for repigmentation in stable nonsegmental vitiligo | Hudson Biotech | Recruiting | Randomized, Melanotan II or placebo alongside phototherapy in adults. Planned 60 participants. One site, Peking University Shenzhen Hospital. Started Feb 2, 2026. First posted Feb 27, 2026. The record gives dose and route only as “administered per protocol.” No results posted. |
Flagged record. The summary begins “This example interventional study record describes…” and the dose and route are not stated. Hudson Biotech is also the sponsor of the BPC-157, TB-500, MOTS-c and GHK-Cu records, which share the same site and a Feb 2, 2026 start. We cannot independently confirm the study is running as described.
The older human studies are published papers, listed under Published research. Registry entries are written by sponsors and are not reviewed for scientific merit.
FDA review
FDA’s safety-risk page (content current Apr 22, 2026) is the one FDA review document on Melanotan II that we read. FDA has also taken enforcement action, below.
What FDA’s page says
- FDA lists Melanotan II among bulk drug substances that were nominated and later withdrawn, previously in category 2 under its interim compounding policies.
- It says compounded drugs containing it may pose risk for immunogenicity for certain routes, due to the potential for aggregation or peptide-related impurities.
- It says published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. The page does not cite the reports. Case reports of these events exist in PubMed, listed below.
What we did not find
- We found no FDA briefing document or advisory committee evaluation for Melanotan II. FDA’s notice for the July meeting does not name it, so the safety-risk page entry is the only FDA statement on it that we read.
- No route of administration is stated on the page.
- No FDA statement on how often these events occur. Case reports cannot show that.
Published research
PubMed returns 196 results for “melanotan II” in the title or abstract. The human trials are three small studies from 1996 to 2000. The recent human literature is case reports.
Clinical trials
- Phase I pilot, 1996. 3 healthy men got injections daily for 2 weeks, escalating to 0.025–0.03 mg/kg. Grade II somnolence and fatigue occurred in one of two men at 0.03 mg/kg, and mild nausea at most doses. Spontaneous erections followed dosing and two men showed increased pigmentation. Life Sci PubMed
- Psychogenic erectile dysfunction, 1998. 10 men, double-blind crossover, 0.025 mg/kg. Erections developed in 8 of 10 men. Nausea, stretching, yawning and decreased appetite were more frequent than with placebo. J Urol PubMed
- Organic erectile dysfunction, 2000. 10 men, double-blind crossover. 4 of 19 injections were associated with severe nausea. Urology PubMed
Case reports and read-with-care
- Neurologic. A 2013 letter reports posterior reversible encephalopathy syndrome with melanotan. Ann Intern Med PubMed
- Systemic toxicity. A 2012 report of systemic toxicity and rhabdomyolysis after injection. Clin Toxicol PubMed
- Priapism. Case reports in 2019 and 2021. BMJ Case Rep PubMed Sex Med PubMed
- Melanoma. A 2014 report of melanoma in a 20-year-old woman who injected it and used sunbeds, and a 2025 report that asks whether nasal-spray use is a risk factor for oral melanoma. Dermatology PubMed Int J Oral Maxillofac Surg PubMed
- Case reports show events that followed use. They do not show that it caused them, and they cannot give a rate. The trials were tiny and tested the drug under study conditions, not products bought online. We read abstracts only.
FDA enforcement
We found one FDA warning letter that names Melanotan II among other substances, and one FDA order, from 2016, that arose from the sale of Melanotan II. This rests on web searches, not a full pull of FDA’s database.
| Recipient | Date | Document | What it says |
|---|---|---|---|
| Tailor Made Compounding LLC, a compounding pharmacy | Apr 1, 2020 | Warning letter 594743 | FDA says an inspection found the firm compounding with a list of 22 bulk substances that includes Melanotan II, and that drugs made from them were not eligible for the section 503A exemptions. The letter says none of them is covered by a USP or NF monograph or is a component of an FDA-approved drug, and that the listed substances “have not been nominated” for the bulks list. We read the letter text. |
| An individual who owned a company that sold Melanotan II (name omitted) | Nov 14, 2016 | Debarment order, 81 FR 79501 | FDA permanently debarred the owner from providing services to anyone with an approved or pending drug application, after a federal felony conviction in Aug 2015 on two counts of conspiracy. The order says the company advertised Melanotan II, an unapproved new drug, as an injectable tanning product, received an FDA warning letter in Aug 2007, and kept shipping it after telling FDA it had stopped selling in the US. It says some product advertised as made in the US was made in and imported from China. |
A warning letter is FDA’s statement about one firm’s conduct on one date. A debarment order concerns a person’s conviction. Neither is a finding about the substance’s safety. We omit the name of the individual in the order. The 2007 letter to that company is not among the documents we read.
SEC filings
We found one SEC filing that names Melanotan II as a peptide of interest. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.
| Filer | Filing | What it says |
|---|---|---|
| BioScience Health Innovations Inc. | Form 10-Q Filed May 11, 2026 | Lists “Melanotan II — Skin pigmentation” among 14 peptides it expects to return to Category 1, following a Feb 27, 2026 statement by the HHS Secretary on a podcast. It adds that reclassification would not be FDA approval and that formal rulemaking had not been published as of April 2026. |
What a company says in a filing is its own claim about its business. It is not a finding about Melanotan II. FDA’s page lists it as a safety risk and HHS’s Oct 30 draft policy does not cover it, per the summaries we read. We read the passage naming Melanotan II, not the whole document.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six peptides; Melanotan II is not one of them
Per two law-firm summaries the six are BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c. The policy is a draft and not FDA approval. We could not open the policy attachment, so this rests on the summaries.
- July 23–24, 2026RegulatoryFDA advisory committee meets on seven peptides; Melanotan II is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list Melanotan II.
- Apr 22, 2026RegulatoryFDA’s safety-risk page lists Melanotan II
FDA cites published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism.
- Feb 2, 2026TrialsMelanotan II vitiligo study starts, per its registry entry
Hudson Biotech’s record was first posted Feb 27, 2026. See the flag above.
- Apr 1, 2020EnforcementFDA warning letter to a compounding pharmacy names Melanotan II among 22 substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
- Nov 14, 2016EnforcementFDA permanently debars the owner of a company that sold Melanotan II
Based on a 2015 federal conviction. The order describes Melanotan II as an unapproved new drug marketed as an injectable tanning product.
- 2014LiteratureCase report of melanoma in a young woman who injected Melanotan II and used sunbeds
A temporal association, not proof of cause.
- 2013LiteratureCase report of posterior reversible encephalopathy syndrome with melanotan
Published in Ann Intern Med as a letter.
- 2000LiteratureSmall trial in men with organic erectile dysfunction
4 of 19 injections were associated with severe nausea.
- 1996LiteraturePhase I pilot study in 3 healthy men
Reports somnolence, nausea, spontaneous erections and increased pigmentation.
Still not covered
Left off rather than guessed:
- Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. That Melanotan II is outside it comes from two law-firm summaries, not from the document itself.
- FDA review: We found no FDA briefing document or advisory committee evaluation for Melanotan II. FDA’s notice for the July meeting does not name it, so the safety-risk page entry is the only FDA statement on it that we read.
- Patents: not researched for this dossier.
- Seller claims and independent lab reports: how it is marketed versus what testing finds. We have not collected testing data.
- Case-report counts: we listed examples. We did not count all case reports or search for reports of other events.
- Unread items: full text of every paper; WADA lists for years other than 2022 and 2026; EU and other non-US trial registries.
- Warning letter and SEC completeness: web searches only.