Melanotan I and Melanotan II: regulatory history and the UK enforcement position

Last reviewed 9 August 2026

Two peptides share a prefix and an origin in the same academic chemistry. They do not share a regulatory history. One is the active substance of a medicine authorised in the European Union, the United Kingdom and the United States. The other has never held a UK marketing authorisation, and the UK medicines regulator has recorded in writing that it has been removing products containing it from the market for more than ten years.

What follows is that history taken from the documents: which body decided what, on what date, under which provision. Every statement here is about a rule, a determination or a published record. Where an effect is described it is only as part of an authorised indication quoted from the regulator that granted it, and nothing on this page asserts an effect of either peptide in NovoVita’s own voice.

The two molecules, named precisely

Naming is the first place this subject goes wrong. Several designations circulate for each compound and the secondary literature exchanges them freely, which is how a fact about one ends up attached to the other.

The molecule now called afamelanotide was first reported in 1980, when Sawyer and colleagues described the synthesis of [Nle⁴, D‑Phe⁷]‑α‑MSH and characterised it in frog skin bioassay and mouse melanoma cell preparations. Hadley and Dorr, reviewing the melanocortin field in 2006, record that both analogues were patented and taken into clinical study. That is the shared starting point from which the two paths diverge.

What makes a substance a medicine in UK law

The question is not answered by chemistry. Regulation 2 of the Human Medicines Regulations 2012 defines a medicinal product in two limbs, which MHRA Guidance Note 8 sets out as:

“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings” — the presentational limb, limb one — and “Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” — the functional limb, limb two.

Falling under either limb is sufficient, and “disease” is defined broadly — the guidance records it as including “any injury, ailment or adverse condition, whether of body or mind”.

Two consequences follow. First, regulation 46(1) provides that “A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product”, and regulation 279 separately prohibits advertising a medicinal product unless an authorisation is in force for it. Second, limb one is about presentation, not composition: the factors Guidance Note 8 lists under it are claims explicit and implicit, including on websites and in social media; product names, which may themselves carry a claim; context and overall presentation; labelling, packaging and graphics; product form; and any targeting of the marketing material.

The same guidance records, summarising the case law, that a statement that a product is not medicinal is persuasive evidence a national court may consider but is not in itself conclusive. That is why the wording of a reference page matters more than any notice appended to the foot of it, and it is examined at length in the MHRA position on research peptides.

Melanotan I: the route through the regulatory system

European authorisation, December 2014

The European Commission granted a marketing authorisation for SCENESSE on 22 December 2014, under exceptional circumstances, the holder being Clinuvel Europe Limited. The active substance is afamelanotide, the ATC code D02BB02, the pharmaceutical form a controlled-release implant, and the authorised therapeutic indication “Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)”. “Exceptional circumstances” is a specific route, used where an applicant cannot supply comprehensive data under normal conditions of use; the stated reason here is the rarity of the condition, and the product remains under additional monitoring. It held EU orphan designation from 8 May 2008, withdrawn in December 2024 at the end of the ten-year exclusivity period.

United States approval, October 2019

The US Food and Drug Administration approved SCENESSE under NDA 210797 on 8 October 2019, for increasing pain-free light exposure in adults with a history of phototoxic reactions arising from erythropoietic protoporphyria. Nearly five years separate the European and American decisions on the same finished product — worth noting whenever a page calls a compound “approved” without naming a jurisdiction and a date.

What the authorisation covers, and what it does not

NICE highly specialised technologies guidance HST27, published 26 July 2023, records that afamelanotide holds a marketing authorisation in the UK under ‘exceptional circumstances’, recommends against its use within that authorisation for NHS funding purposes, and records that the product had not been launched in England at that date. An authorisation states that a regulator assessed a dossier and permitted a product onto the market. It does not state that the product is funded, stocked or obtainable, and the three are routinely collapsed into one.

What is authorised is a specified finished product: a defined pharmaceutical form, made to medicinal product standard, with an approved summary of product characteristics and administration restricted to accredited clinicians in recognised centres. The molecule at large is not authorised. This is where the named-medicine position has to be stated exactly, so it is.

The same molecule is the active ingredient in Scenesse, a UK-authorised medicine. NovoVita’s material is not that medicine, is not manufactured to medicinal standard, and is not supplied for human or veterinary use.

What laboratory-grade material is not manufactured to is a subject in its own right, covered in what “research grade” does not mean.

Melanotan II: no UK marketing authorisation

No product containing melanotan II holds a UK marketing authorisation. The position was put on the parliamentary record in a written answer of June 2014: the MHRA considers melanotan products to be medicinal products within the meaning of the Human Medicines Regulations 2012; manufacture, sale and supply are subject to UK regulatory control; no melanotan product holds a marketing authorisation for use in the UK; and advertising, sale or supply would consequently breach regulatory requirements. The same answer records supply through gyms and beauty salons as well as the internet, and work with internet service providers to suspend websites trading in the products.

Every UK document cited here locates melanotan in medicines law. None invokes misuse-of-drugs legislation, and the distinction matters: control derives from the authorisation regime rather than from drug-control schedules, and the two carry entirely different consequences.

The UK enforcement record, by document

Where the line actually falls: product form, and claim

Two Freedom of Information responses from the MHRA are the most precise public statements on how the agency classifies these products, and they repay reading side by side, because they are not worded the same way.

FOI 21/1237, dated 20 December 2021, declines to make classification turn on form alone:

“The definition of a medicine does not allow us to consider mode of administration in isolation so injectable tanning products containing melanotan II are not automatically medicines. Similarly, where no medicinal claims are made, nasal tanning sprays containing melanotan II will not generally be regulated as medicinal products.”

FOI 24/274, dated 17 April 2024, states a categorical rule for one form and a claim-conditional rule for the other:

“Products containing Melanotan II are not always classified as medicines. Products containing Melanotan II are classified as medicines if they are injectable or pens. If a product contains Melanotan II and is in the form of a nasal spray, it will be determined as a medicine only if sold with claims to treat or prevent disease.”

Read together, three things are established and one is left open. Established: classification is a determination about a product, not about a molecule; the presence or absence of a claim is decisive for at least one product form; and the same substance can therefore sit inside and outside the regime at once, depending on how it is placed on the market. Left open: whether the categorical wording in the later letter reflects settled policy or shorthand, given that the earlier letter expressly declined to treat form in isolation. An FOI response states an agency’s position to a correspondent; it is not a determination.

The open question is narrower than it looks, because both letters agree on the part that governs a page of reference content: where a claim is attached, the product is a medicine. The claim is the operative fact. That is the conclusion the case-law summary in Guidance Note 8 reaches from the other direction, and it is why the entries in the pigmentation section of the compound library report the state of the literature rather than describing an effect.

Both letters record the enforcement posture in near-identical terms: the MHRA has repeatedly acted to remove melanotan products from the market for over ten years and will continue to do so where products fall within the definition of a medicinal product.

What the Yellow Card figures do and do not measure

These two responses are the only public source for melanotan II-specific spontaneous reporting figures: 13 suspected adverse drug reaction reports between 1 January 2011 and 9 December 2021, and 16 between 1 January 2012 and 31 December 2022. The 2014 written answer had earlier given a combined figure of 22 reports across Melanotan I, Melanotan II and Ubertan as at 12 June 2014.

The MHRA’s own caveats are more informative than the counts. Inclusion of a report does not mean the events were caused by the product; a reporter needs only a suspicion. The scheme carries an unknown and variable level of under-reporting, so the number of reports does not equate to the number of people affected, and reporting rates are influenced by how serious reactions are, how easily they are recognised, how widely a product is used, and publicity. A spontaneous reporting figure measures a reporting system, not an incidence rate — the distinction that also governs how evidence is graded across this site, set out in the evidence grading method.

Anti-doping status

The 2026 WADA Prohibited List, in force from 1 January 2026, was downloaded and searched in full for this page. It contains no occurrence of “melanotan”, “afamelanotide”, “melanocortin”, “melanocyte” or “MSH” in any section, including S2. Sources asserting an explicit S2 listing describe something that is not in the document.

Section S0 is a residual class, and its wording determines whether an unnamed substance is caught:

“Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times.”

On the face of that wording the test is approval status, and the two compounds sit on opposite sides of it: afamelanotide holds approval from governmental regulatory health authorities for human therapeutic use; melanotan II holds none. The List does not enumerate what S0 reaches, so whether a given substance falls inside it is a question for the anti-doping organisation applying it, and the List is revised annually.

What the history establishes

1. An authorisation attaches to a finished product, not to a molecule. Afamelanotide is authorised in one presentation, to one standard, under one distribution restriction. Material that is the same peptide but not that product falls outside the authorisation entirely.
2. Under the presentational limb, the claim is the operative fact. The factor list published under limb one concerns claims, names, context, packaging and targeting; it does not concern composition. A supplier can move a product into the medicines regime by writing a sentence, without changing anything in the vial.
3. A disclaimer is evidence, not an answer. Guidance Note 8 records that a statement that a product is not medicinal may be considered but is not in itself conclusive. What decides the outcome is the presentation as a whole — a property of the page, the product name and the surrounding material, not of a line at the bottom.

The compound-level records for both peptides, including sequence, identification data and the published literature reported study by study, are in the library entries for Melanotan I and Melanotan II.

References

1. The Human Medicines Regulations 2012 (SI 2012/1916), regulation 2 — definition of “medicinal product”. Model: regulatory document. legislation.gov.uk.
2. The Human Medicines Regulations 2012 (SI 2012/1916), regulation 46 — requirement for authorisation. Model: regulatory document. legislation.gov.uk.
3. Medicines and Healthcare products Regulatory Agency. MHRA Guidance Note 8: A guide to what is a medicinal product, published September 2025. Sections 4, 5 and 6, and Appendix 3 (summary of case law). Model: regulatory guidance.
4. Medicines and Healthcare products Regulatory Agency. FOI 21/1237, response dated 20 December 2021 — Yellow Card reports for melanotan II products, 2011–2021. Model: regulatory document.
5. Medicines and Healthcare products Regulatory Agency. FOI 24/274, response dated 17 April 2024 — side effects reports for melanotan II products, 2012–2022. Model: regulatory document.
6. UK Parliament. Written question UIN 200340, Melanotan, tabled 11 June 2014, answered on behalf of the Department of Health. Model: parliamentary record.
7. European Medicines Agency. Scenesse (afamelanotide) European public assessment report. Marketing authorisation issued 22 December 2014 under exceptional circumstances; ATC D02BB02; orphan designation 8 May 2008, withdrawn December 2024. Model: regulatory document.
8. US Food and Drug Administration. Approval of SCENESSE (afamelanotide) implant, NDA 210797, 8 October 2019. Model: regulatory document.
9. National Institute for Health and Care Excellence. Highly specialised technologies guidance HST27, published 26 July 2023. Model: health technology assessment.
10. World Anti-Doping Agency. International Standard: Prohibited List 2026, in force 1 January 2026, section S0. Model: regulatory document.
11. Chartered Trading Standards Institute. Nasal tanning sprays linked with skin cancer and serious respiratory problems, news item, 16 May 2025. Model: enforcement body publication.
12. Sawyer TK, Sanfilippo PJ, Hruby VJ, Engel MH, Heward CB, Burnett JB, Hadley ME. 4-Norleucine, 7-D-phenylalanine-alpha-melanocyte-stimulating hormone: a highly potent alpha-melanotropin with ultralong biological activity. Proc Natl Acad Sci USA. 1980;77(10):5754–8. Model: in vitro and amphibian bioassay. PMID 6777774. DOI 10.1073/pnas.77.10.5754.
13. Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006;27(4):921–30. Model: review. PMID 16412534. DOI 10.1016/j.peptides.2005.01.029.
14. Evans-Brown M, Dawson RT, Chandler M, McVeigh J. Use of melanotan I and II in the general population. BMJ. 2009;338:b566. Model: editorial. PMID 19224885. DOI 10.1136/bmj.b566.
15. Habbema L, Halk AB, Neumann M, Bergman W. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56(10):975–980. Model: review. PMID 28266027. DOI 10.1111/ijd.13585.
16. National Center for Biotechnology Information. PubChem Compound Summary for CID 16197727 (afamelanotide) and CID 92432 (melanotan II). Model: chemical database record.
17. Medicines and Healthcare products Regulatory Agency. Media release, ‘Tan jab’ is an unlicensed medicine and may not be safe — warns medicines regulator, 17 November 2008. Model: regulatory document. Archived; full text not retrievable from a primary source at the time of writing, and recorded here as unverified.