Peptifact

Melanotan II Dosage: One Registration, and It Copies a Real Trial's Design

Melanotan II has one interventional registration anywhere in the world. We opened it, compared it with the approved melanocortin peptide's twenty-three trials, and found the filing borrows its design from the programme it is not part of.

Robert F · Edited by Caroline S · Published 2026-09-10

Illustration: A clear glass vial with powder next to an open insulated shipping box with a teal cold pack.
Illustration

Melanotan II occupies an unusual position: it is one of the few research peptides with a genuinely close approved relative, and that relative is the reason most of the confident dosing claims about it are wrong. It is sold and searched under several spellings for that one compound — MT2, MT-2, MT-II and melanotan 2 — and they all mean Melanotan II here. This page reports what the sources state, opens the single registration that exists, and does not recommend anything. Our page on the questions we ask of any dosage figure sets out what separates a label figure from a convention. How brands appear on this site is set out on our disclosure page.

What exists, and what does not

Melanotan II is a synthetic cyclic analogue of alpha-melanocyte-stimulating hormone, an agonist across several melanocortin receptors. There is no FDA-approved product containing it: a DailyMed search on 2026-09-10 returned zero records for melanotan. No label means no dose, no titration schedule, no maximum and no reviewed safety position.

The literature is not empty — a title-and-abstract PubMed search for "melanotan II" returned 194 records, 46 of them tagged for humans — but almost all of the human material is pharmacology, case reports and dermatology commentary rather than dose-finding.

The single registration, and what its sponsor filed alongside it

Searching ClinicalTrials.gov for Melanotan II returns exactly one interventional study: NCT07437560, Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation, Phase 2, 60 planned participants, sponsor Hudson Biotech, start date 2026-02-02, one facility, recruiting, no results posted.

We opened the sponsor's other filings before citing it. Hudson Biotech has eight registrations, all with start dates inside a two-week window in February 2026, all listing a single facility, together covering MOTS-c, BPC-157, TB-500, GHK-Cu, Melanotan II, tesamorelin, tirzepatide and retatrutide — most of the research-peptide catalogue plus two approved medicines. Two of the eight carry Eli Lilly's own internal protocol identifiers: a registry search for I8F-MC-GPHK returns Lilly's completed tirzepatide study alongside a Hudson filing under I8F-MC-GPHK(b), and J1I-MC-GZBF returns Lilly's completed retatrutide study alongside a Hudson filing under the identical code. Our MOTS-c dosage page sets out that portfolio in full, and our guide to reading a dosing claim covers the checks that surface this pattern.

Here is what is new on this page, and it is specific to Melanotan II. The Hudson filing's design is not invented. Combining a melanocortin peptide with narrow-band UVB phototherapy to drive repigmentation is the design of an actual research programme — Clinuvel's. The registry holds at least three Clinuvel studies of exactly that combination:

NCT Study Phase n Sponsor
NCT01430195 Afamelanotide and narrow-band UVB in vitiligo 1 56 Clinuvel Pharmaceuticals
NCT01382589 Afamelanotide and narrow-band UVB 2 15 Clinuvel Pharmaceuticals
NCT04525157 Afamelanotide and narrow-band UVB phototherapy 2 21 Clinuvel Pharmaceuticals

So the pattern established on the tirzepatide and retatrutide filings — a real programme's identifier reused — has a third form here: a real programme's study design reused, with the unapproved analogue substituted for the approved one. The protocol codes were copied on two filings; the experimental concept appears to have been copied on this one. That is a checkable observation about what is in the registry, not a claim about intent, and both halves of it can be reproduced in a browser in under two minutes.

The approved cousin, and why its label transfers nothing

Afamelanotide is the melanocortin peptide that made it through. Its evidence base is the mirror image of Melanotan II's: 23 registrations on ClinicalTrials.gov, every single one sponsored by a Clinuvel entity — 17 by Clinuvel Pharmaceuticals Limited, 3 by Clinuvel Europe, 2 by Clinuvel Inc, 1 by Clinuvel UK. Single-sponsor evidence is its own limitation, and we have flagged it on other compounds; here it sits alongside an actual approval and Phase 3 studies with posted completions.

The approved product is SCENESSE, and its label states the dose plainly:

a single implant containing 16 mg of afamelanotide, inserted subcutaneously above the anterior supra-iliac crest, administered every 2 months, by a healthcare professional trained in the implantation procedure. (US approval 2019; DailyMed record)

Its indication is increasing pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria — a rare inherited disorder in which sunlight causes pain. Not tanning.

Nothing in that label converts. Four separate variables differ at once:

  • Different molecule. Afamelanotide and Melanotan II are distinct analogues with different receptor profiles; milligram equivalence across two peptides is not something a reader can assume, and the industry's own labels refuse the equivalent assumption even between two products of the same molecule.
  • Different dosage form. A solid implant releasing over weeks is not a bolus of solution. The peak concentration, the duration and the shape of the exposure curve are all different quantities.
  • Different interval. Two months against the daily-then-weekly pattern circulating for Melanotan II.
  • Different purpose. A dose selected to prevent phototoxic pain in a rare disease was not selected to produce pigmentation in healthy people.

A page that cites "the approved melanocortin dose" as context for a Melanotan II figure is citing a number that survives none of those four transitions. As far as we can tell, no page making that move states the differences.

What the sources state as a quantity

Every figure below is a convention with no study behind it, reported as what circulates rather than as anything derived.

Phase Figure stated Where it comes from
Loading 250–500 µg per day Vendor and forum pages; no stated origin
Maintenance 500–1,000 µg, once or twice weekly Vendor and forum pages; no stated origin
Approved comparator 16 mg implant every 2 months (afamelanotide) SCENESSE label, not transferable — see above

The gap between the third row and the first two is worth naming because it is the only quantitative anchor in the field, and it is unusable. We could not locate a single source that states where the 250–500 µg loading figure originated. It is quoted, not cited.

The arithmetic, if a figure is being converted

A 10 mg vial in 2 mL of bacteriostatic water gives 5 mg/mL. A stated 500 µg is then 0.1 mL — 10 units on a U-100 insulin syringe. A stated 250 µg is 5 units.

The same vial in 1 mL gives 10 mg/mL and halves both: 5 units and 2.5 units. At 2.5 units the graduation on a standard U-100 syringe is a substantial fraction of the quantity, which is a measurement fact rather than advice. Our reconstitution page carries the arithmetic for other combinations and our breakdown of the U-100 unit scale works through dead space.

What is not established

  • No approved product, anywhere, so no regulator has reviewed a dose for this molecule and published its reasoning.
  • No completed trial. The one registration is recruiting, states no dose in its record, and comes from the sponsor described above.
  • No stated origin for the circulating figures. They are conventions passed between pages.
  • No dose-response data in humans from which a loading or maintenance quantity could be derived even in principle.
  • The approved relative's label does not fill the gap, for the four reasons set out above.

What a reader can check in five minutes

  1. Search DailyMed for melanotan — zero records; then for afamelanotide — one, SCENESSE.
  2. Search ClinicalTrials.gov for melanotan — one interventional study, and read who filed it.
  3. Search the registry for Hudson Biotech and read all eight filings, their dates and their facility.
  4. Search the registry for afamelanotide and note that all 23 studies share one corporate sponsor.
  5. Compare the Hudson study's title with NCT01430195, NCT01382589 and NCT04525157.

Our MOTS-c dosage page documents the Hudson Biotech portfolio in full, including the two filings under Eli Lilly's protocol codes. How to read a dosing claim sets out the checks that catch a borrowed figure, and our certificate-of-analysis guide covers what a vendor's paperwork can and cannot tell you about what is in a vial.

Sources and dates

Opened 2026-09-10: DailyMed's SPL search API for melanotan (zero records) and afamelanotide (one record, SCENESSE, Clinuvel Inc.); the SCENESSE structured product label, set id 94f53286-11dd-7fbb-e053-2a95a90a7c48, for the 16 mg implant, the supra-iliac placement, the two-month interval and the erythropoietic protoporphyria indication; the ClinicalTrials.gov v2 API for Melanotan II (one interventional registration, NCT07437560) and for afamelanotide (23 registrations, sponsor breakdown by Clinuvel entity); the study records NCT01430195, NCT01382589 and NCT04525157; the Hudson Biotech sponsor portfolio and the protocol identifiers I8F-MC-GPHK and J1I-MC-GZBF, as documented on our MOTS-c page; PubMed counts through the NCBI E-utilities for "melanotan II"[tiab] (194) and the same restricted to human-tagged records (46); the 2026 WADA Prohibited List. Corrections go to the contact page.

Frequently asked questions

What is the standard Melanotan II dose?

There is no standard in any regulatory sense: no approved label anywhere, no completed trial, and no dose stated in the single registration that exists. The figures that circulate are a loading phase of roughly 250 to 500 micrograms per day followed by maintenance of 500 to 1,000 micrograms once or twice weekly. Those numbers appear on vendor and forum pages only. No source we could find states where they originally came from, and none cites a study.

Is there a clinical trial of Melanotan II?

One registration names it: NCT07437560, a Phase 2 study of Melanotan II as an adjunct to narrow-band UVB phototherapy for repigmentation, 60 planned participants, filed by Hudson Biotech with a start date of 2026-02-02. It was recruiting when we checked and has posted no results. Before it is treated as evidence, the sponsor's other seven filings are worth reading, which is what the section below does.

What is different about that registration?

Two things. First, its sponsor filed eight registrations inside a two-week window, all at one facility, covering most of the research-peptide catalogue plus two approved medicines — and two of the eight carry Eli Lilly's own protocol codes, which a registry search will show you. Second, its design is not novel: combining a melanocortin peptide with narrow-band UVB for repigmentation is exactly what Clinuvel has run in at least three registered afamelanotide studies. The filing borrows the design of a programme it has no part in.

Melanotan II is approved as SCENESSE, isn't it?

No, and this is the most common confusion about the compound. SCENESSE contains afamelanotide, a different melanocortin peptide. It is a 16 mg implant placed under the skin every two months by a trained clinician, approved in the US since 2019, and its indication is increasing pain-free light exposure in adults with erythropoietic protoporphyria — a rare disorder in which sunlight causes pain. It is not approved for tanning, it is not an injection, and nothing in its label converts to a milligram figure for Melanotan II.

Why can't the approved label be used as a reference point?

Because every variable that determines a dose is different. It is a different molecule, so potency at the receptor does not carry across. It is a solid implant releasing over weeks rather than a solution injected in seconds, so the exposure profile is not comparable. Its interval is two months rather than daily. And its indication is a rare photosensitivity disease rather than pigmentation for its own sake. A figure borrowed across four such differences is not a derived dose, it is a guess with a citation attached.

Is Melanotan II banned in sport?

Melanotan II is not named on the 2026 WADA Prohibited List, which does not mean it is permitted. The list's classes are written to cover substances of similar chemical structure or similar biological effect, and S0 covers any pharmacological substance with no current approval by any governmental regulatory health authority for human therapeutic use. Melanotan II has no such approval anywhere, so a tested athlete should treat it as an S0 question rather than an absence. It also appears in the analytical literature on seized pharmaceutical preparations, which is usually the first sign a compound is circulating.

Is MT2 the same as Melanotan II?

Yes. MT2, MT-2, MT-II and melanotan 2 are all written for the same compound, Melanotan II, and this page covers it under every one of those spellings. The inconsistency is in the market rather than in the chemistry: there is no separate MT2 product with separate evidence, and nothing on this page changes depending on which spelling brought you here.