Melanotan 1 Dosage Guide 2026: Clinical Trials vs Reported Use

The calculator

Five inputs, three outputs, no opinion anywhere in it: it takes the strength printed on the vial, the water volume, the syringe scale, the barrel size and a milligram figure, and returns the concentration, the draw volume and the unit count for that one combination.

Melanotan 1 dosage chart, source by source

One row per source, with the physical form printed beside it: the melanotan 1 amounts we read off the documents below, with the form each was given in and the route next to it. Two things this chart is not. It is not a claim to hold every figure ever published, and it is not a claim to have exhausted any single paper: several rows are bounded by an abstract rather than a full text, and each of those rows says so in the cell. The search that bounds which papers were considered at all is printed at the bottom of this page with its query and its date. No tier column appears below and no starting row, because the record holds nothing that would justify either.

Read the form column before the milligram column: the approved product is a solid rod replaced every two months, and the research injections were a solution pushed in all at once. The two-month figure is the interval between implants and not the length of the release: the FDA review of the application records that most of the drug leaves the implant in the first 48 hours, with over 90% gone by day 5. Sixteen milligrams in the first case and sixteen milligrams in the second are not the same exposure, and no source on this page converts one into the other.

One compound, several spellings: melanotan 1, melanotan-1, melanotan I, MT-1, MT-I, NDP-MSH and afamelanotide all point at the same 13-amino-acid peptide, and everything below applies to all of them.

The conversion we are not doing: an implant milligram is not an injected milligram, and a per-kilogram injected figure is not a fixed daily figure. No document listed above carries one across into the other, so any chart that hands you a single flat number for melanotan 1 has added a step the sources did not.

The conversion we are doing: milligrams into syringe units, further down. That step is pure division, and it stays true whatever the milligram figure is and whoever put it in front of you.

What is the approved melanotan 1 dose?

A 16mg implant, every two months: the US prescribing information states it in one line, that a single implant is inserted "subcutaneously above the anterior supra-iliac crest every 2 months". Each implant holds 16mg of afamelanotide, equivalent to 18mg of afamelanotide acetate, in 15.3 to 19.5mg of poly (DL-lactide-co-glycolide).

Who is allowed to place it: the same section restricts administration to a healthcare professional "who is proficient in the subcutaneous implantation procedure and has completed training prior to administration". The EU summary says the same thing a different way, that the medicine is prescribed by specialist doctors in centers treating erythropoietic protoporphyria and used only by doctors who have been trained.

What the thing physically is: a solid white to off-white bioresorbable sterile rod, approximately 1.7cm long and 1.45mm across. The label adds that it resorbs and "may not be able to be located from 10 days after insertion", which is a sentence about a rod, not about a syringe.

The ceiling the EU record prints and the US one does not: the European public summary states that three implants a year are recommended and "the maximum number is 4", timed before and during periods of high sunlight exposure, with patients observed for allergic reactions for 30 minutes after each one.

What it is approved for, which is not tanning: both records give one indication, erythropoietic protoporphyria. The US label describes a melanocortin 1 receptor agonist "indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)". The European Commission granted the marketing authorization on 22 December 2014, under exceptional circumstances, and the original US application was approved on 8 October 2019.

Why the release curve, not the milligram figure, is the real dose: the label reports a median time to peak of 36 hours, a peak concentration of 3.7 plus or minus 1.3 ng/mL, and a half-life of about 15 hours from the controlled release implant. The FDA multidisciplinary review is blunter about the shape of it: "most of the drug is released within the first 48 hours with over 90% released by Day 5 and levels mostly below the limit of detection by Day 7". So the two-month interval is how often a rod is replaced, not how long one keeps releasing. Sixteen milligrams released from a rod over days and sixteen milligrams pushed through a needle at once produce different curves, and only the first has an approval attached to it. What trial documents specify about route and site more generally is set out on the subcutaneous versus intramuscular page.

What dose did the injection studies use?

One number the record converged on, with tested levels on both sides of it: 0.16mg per kilogram is the amount used by Dorr 2000, by Barnetson 2006 and by the second and third of the three studies in Dorr 2004. Ugwu 1997 ran a band from 0.08 to 0.21 around it, the first study in Dorr 2004 sat at 0.08 before the same group raised it, and Levine 1999 went above it, to 0.26 and 0.4.

Dorr 2000, seven volunteers: skin types III or IV, "10 daily subcutaneous injections" of the compound the paper itself calls Melanotan-I, at 0.16mg per kilogram per day, Monday to Friday over two weeks. Forearm skin showed a mean 98% increase in eumelanin against baseline, with pheomelanin unchanged.

Barnetson 2006, sixty-five completers: the same 0.16mg per kilogram, into the abdomen, for three 10-day cycles over three months. Its abstract counts the sixty-five as the people who completed the trial, not the people who started it, and it reports its melanin results against a placebo group. Melanin density rose 41% in the low minimal erythemal dose group and 12% in the high one, and thymine dimer formation in the epidermal basal layer fell 59%.

Ugwu 1997, three volunteers and a three-route pharmacokinetic comparison: subcutaneous amounts from 0.08 to 0.21mg per kilogram in a randomized crossover against 0.16mg per kilogram intravenously and orally. The subcutaneous route showed complete bioavailability against the intravenous dose. The oral arm produced no detectable plasma levels at all. It is the injected pharmacokinetic paper on this page, but it is not the only such record here: the FDA review states that afamelanotide pharmacokinetics were assessed "in solution and implants" across eight phase 1 studies, and its bioanalytical table names them, without printing what the solution studies gave.

Dorr 2004, three phase 1 studies at two amounts: the same Arizona group that ran Dorr 2000 published three combined light-exposure studies in one paper. The first randomized 8 subjects, 4 to 0.08mg per kilogram per day subcutaneously and 4 to saline, for 10 days before neck irradiation at three times the minimal erythemal dose, and reports tanning in 3 of the 4 on drug and 47% fewer sunburn cells at the irradiated site. The second raised the amount to 0.16mg per kilogram per day for 10 days in 12 subjects, all on drug, and reports that "More skin sites darkened with the higher dose"; its tanning analysis covers the 11 who completed dosing, of whom 10 darkened significantly at one or more body sites. The third ran 0.16mg per kilogram 5 days a week for 4 weeks against sunlight alone. Its abstract calls that third study randomized and its own Results call it an "open-label trial in 8 subjects", split 3 starting sunlight with the peptide, 3 starting after ten doses, and 3 on sunlight only, with one dropout leaving 8 for analysis. We print both descriptions because the paper carries both.

Levine 1991, the earliest of the injection studies here: 28 healthy men in a "randomized, placebo-controlled, double-blind clinical trial", given "10 subcutaneous injections of either a purified NDP preparation or saline over 12 days" and followed for seven weeks, with skin darkening measured by serial chromaticity. Its own abstract records the schedule and the design and never prints the amount. Dorr 2004 supplies it thirteen years later, calling it "our original study of a 0.08-mg/kg dose in 28 male subjects", which is why the chart row above carries that figure with Dorr's name on it rather than Levine's.

Levine 1999, the dose-ranging study: the same Arizona group published an "open-label, dose-finding study" in the Journal of Dermatological Treatment, in "eight male volunteers with 'tannable' skin types III-IV", giving the peptide "subcutaneously for 10 days at three dose levels of 0.16 mg/kg per dose, 0.26 mg/kg per dose and 0.4 mg/kg per dose". All subjects tanned, and "there was no evidence of improved tanning beyond that obtained at the 0.16 mg/kg dose (P = 0.04)". The most responsive site was the forehead and "the anterior leg and buttock did not darken". There were no grade 2 or worse toxicities at 0.16, while "the two higher doses produced moderate gastrointestinal upset and some mild to moderate fatigue".

What we could not retrieve, so it is not on this page: the Levine 1999 full text sits behind a publisher paywall that refused every request from us, so everything in the paragraph above comes from the published abstract. How many of the eight men sat at each of the three levels is not in that abstract, and no figure for that split appears anywhere here.

Why the Arizona group stopped at 0.16: not because they stopped there arbitrarily, but because a study built to find the top of the curve found it. Dorr 2004's methods say so outright: "Melanotan-1 doses were not escalated beyond 0.16 mg/kg, since this is the maximally effective daily dose for tanning by MT-1 without sunlight." Its discussion makes the comparison downward too, that 0.16 "is superior to the 0.08-mg/kg dose used in the original clinical study" both in degree of tanning and in the number of sites that responded.

The full injected span, and the one comparison still missing: across the record the amounts run from 0.08 to 0.4mg per kilogram. 0.08 in Levine 1991 and in the first Dorr 2004 study, a 0.08 to 0.21 band in Ugwu 1997, 0.16 in Dorr 2000, Barnetson 2006 and the other two Dorr 2004 studies, and 0.16, 0.26 and 0.4 in Levine 1999. What no paper here reports is a single trial that randomized one group of people to two injected amounts and compared them head to head: Levine 1999 was open-label and put different men at each level.

What is 0.16mg per kilogram in milligrams?

A per-kilogram figure is not a dose until a body weight is supplied: multiplying 0.16 by body weight in kilograms is the whole operation, and it is the step that turns a research figure into something with the same units as a vial.

The line that surprises people: at 70kg the published research amount is 11.2mg a day, which is more than an entire 10mg vial. Ten days of that is 112mg, or eleven and a fifth vials for one cycle.

The coincidence worth naming so nobody builds on it: at exactly 100kg the arithmetic lands on 16mg, the same digits as the approved implant. That is two unrelated numbers colliding. One is a solid rod that empties over days and gets replaced every two months, the other is a daily bolus, and nothing in the sources treats them as interchangeable.

The total-exposure comparison, with the caveat attached: the EU record recommends three implants a year, which is 48mg of afamelanotide across twelve months, with four implants and 64mg as the ceiling. A single 10-day injection cycle at 70kg is 112mg. The two numbers are not comparable as exposures, because the release profiles differ, but the size of the gap is the point.

How often was it given, and how long did a course run?

The approved rhythm: one implant every two months, three a year recommended in the EU and four the stated maximum, timed before and during periods of high sunlight exposure.

The trial rhythms: the two trials in Langendonk 2015 gave an implant every 60 days, five of them in the European study and three in the US one. The vitiligo trial gave 16mg monthly for four months, starting after a month of narrowband UV-B. The smaller implant records use their own intervals rather than a common one: 28 days between two 16mg implants in study CUV009, 60 days between two 20mg implants in Harms 2009, two 20mg implants two months apart in study CUV010, one implant on day 0 and a second on day 30 in Biolcati 2014, a single implant in Haylett 2011, and days 0 and 1 with a repeat on days 7 and 8 in Stanislaus 2023. So the two-month figure on the label is the approved rhythm, not the only one people have been given.

The injection rhythms: ten injections over twelve days (Levine 1991), ten doses Monday to Friday across two weeks (Dorr 2000, and the first two of the three Dorr 2004 studies), twenty doses Monday to Friday across four weeks (the third Dorr 2004 study), ten days at each level (Levine 1999), and three 10-day cycles spread over three months (Barnetson 2006). Every weekday schedule in that list has a weekend without injections inside it, and a second week that follows the first. Barnetson's are the only gaps in that list that the paper itself names as cycles. One paper that may belong in that list is absent from it, Fitzgerald 2006, because its abstract prints neither a schedule nor a route and we did not retrieve the full text. So this is the set of schedules we could read, not a survey of every schedule ever run.

How long the effect outlasted the course: Ugwu 1997 reports visible tanning peaking about a week after dosing stopped and persisting for three weeks. Levine 1991 puts peak darkening at one to three weeks after therapy was completed. Both are observations about pigment, not about how long the peptide stays in circulation, which the same pharmacokinetic paper puts at a beta-phase half-life of 0.8 to 1.7 hours.

What no source we traced describes: a prespecified washout, or a course deliberately repeated after a defined off phase, for the injected form. Weekend gaps and Barnetson's three cycles are what the schedules we retrieved actually hold. A melanotan 1 cycle with a named off phase and a stated reason for its length is a convention, not a published protocol.

Do melanotan 1 and melanotan 2 dose the same way?

No, and the two differ in shape, in size and in the amounts anyone has tested: conflating them is the error that matters here, because the human data on each belongs to a different molecule and does not transfer. The tested amounts do not reduce to one ratio either. Melanotan 1 has implant strengths of 10, 16 and 20mg and injected figures from 0.08 to 0.4mg per kilogram; melanotan 2 has 0.01 to 0.03mg per kilogram in three volunteers. A single multiplier between them exists only if you pick one number from each column and drop the others, and a fixed implant strength cannot be ratio-compared with a weight-based amount at all without first assuming a body weight and a release profile.

The side effect that belongs to the second column and not the first: the 1996 pilot reports mild nausea at most dose levels, and "a stretching and yawning complex appeared to correlate with the onset of spontaneous, penile erections". The paper puts those at one to five hours after dosing and says the effect varied "depending on the MT-II dose", across a range that started at 0.01 and reached 0.03mg per kilogram, so it belongs to the range rather than to the starting amount. Either way it is an observation about the cyclic molecule, and reprinting it under a melanotan 1 heading attributes a finding to a compound that did not produce it.

Everything past the numbers is a separate question: the structural, regulatory and case-report differences between the two are worked through on the melanotan 1 versus melanotan 2 page, which is where that comparison belongs. The same approved-versus-loosely-sold split runs through the rest of this peptide family, and the PT-141 page covers what the Vyleesi approval actually includes.

Where do microgram-per-day melanotan 1 figures come from?

Not from any trial on this page, and the arithmetic settles it: the 0.16mg per kilogram figure comes to 11.2mg a day at 70kg. A figure of 500mcg a day is about one twenty-second of that. A figure of 1mg a day is about one eleventh. The one place a microgram-per-day melanotan figure does appear in the sources below is a 2026 case report, and it is there as what a patient said he injected, not as what anyone administered and measured.

What that gap does and does not prove: it does not prove a smaller amount does nothing, because the smallest injected amount we traced to a study is 0.08mg per kilogram, which is 5.6mg a day at 70kg and still eleven times a 500mcg figure. It proves only that a hundreds-of-micrograms figure was not derived from Dorr 2000, Dorr 2004, Barnetson 2006, Ugwu 1997, Levine 1991 or Levine 1999, because dividing any of their numbers down to it is not a step any of them describe. Levine 1999 is the one that went looking for the edges of the range, and it looked upward, at 0.26 and 0.4, never downward.

No figure on this page is offered as yours. Every injected amount a study below administered is a per-kilogram number, and the one microgram-per-day figure here is a patient's account of what he injected rather than a level any study set.

Melanotan 1 reconstitution by vial size: 5mg, 10mg and 20mg

First, the part everything else depends on: the approved product is a solid implant and is never reconstituted, while every injected study in the chart above was given as a solution. Dorr 2004 is the one whose full text we read, and its methods state that the "white powder was reconstituted in bacteriostatic sodium chloride for injection", was "stored frozen prior to thawing immediately before injection", and "was diluted to a concentration of 20 mg/mL, and therefore all subcutaneous injection volumes were less than 1.0 mL". We read abstracts rather than methods sections for the other injection papers, so we do not claim Dorr 2004 is the only one that describes the mixing, only that it is the one we can quote.

What that still does not give you: a vial. Dorr 2004 reports a final concentration, not a vial size and not the milliliters of diluent added to one, because its material was compounded for the trial rather than sold in a carton. So there is a tested concentration in the record, 20mg per mL, and no tested water volume for any commercial vial.

So the table does the only thing that can be done honestly: it runs the arithmetic for three vial sizes and three water volumes and shows what one syringe unit is worth in each case. The sizes are here because they divide cleanly and cover the range, not because any source on this page tested them. The milligram column uses 1mg throughout, again because it divides cleanly and not as a suggested amount. For any other vial and any other water volume, the same division is laid out in concentration versus dose and run for you by the reconstitution calculator.

What a larger water volume changes, and what it leaves alone: the same milligram figure spreads across more unit gradations, so a misread of one unit shifts it by proportionally less. The cost is a bigger volume in the barrel for the same amount of peptide. The peptide in the glass never moves: ten milligrams is ten milligrams at 1mL and at 2.5mL.

The consequence for the published research figure: 11.2mg on a 10mg vial in 2mL, which is 5mg per mL, comes to 2.24mL. That is more than two full 1mL barrels, and more than the vial holds. It is a useful sanity check on any chart that presents the research amount as something an insulin syringe delivers in one go.

How many units is 1mg of melanotan 1?

A fourfold spread across three ordinary mixes: on a 10mg vial in 1mL, which is 10mg per mL, 1mg reads as 10 units on a U-100 syringe. The same vial in 2mL reads 20 units. A 5mg vial in 2mL reads 40 units.

Why the syringe cannot answer the question on its own: the heading asks about milligrams and the barrel answers in volume, so the number that reconciles them is the concentration, and the concentration was set by whoever chose the water volume. A U-100 barrel reads 100 units to the milliliter, so one unit is a hundredth of a milliliter, and what that hundredth carries in milligrams changes with every mix.

One number every row above quietly assumes: the counts here are U-100 counts. Pulled on the other scale in circulation, each one delivers two and a half times the volume it was worked out for, and that multiplier sits on top of whichever concentration row applies rather than replacing it. The two syringe scales have their own page.

What's not known yet?

Not approved for tanning, in either record: the US and EU indications both name erythropoietic protoporphyria and nothing else. Cosmetic pigmentation is what the injection studies measured, and it is not what either regulator here has approved a product for.

No recent dose-finding for the injected form: the escalation that landed on 0.16mg per kilogram was published in 1999, in eight men, and no injection study on this page repeats it. Levine 1999 did find a ceiling, no improvement in tanning above 0.16, so the gap is not that the question went unasked. It is that no paper we traced has asked it again since, and none has ever looked below 0.08.

No pharmacokinetics for a reconstituted vial: the injected pharmacokinetic paper in this source pack is Ugwu 1997, on a purified preparation made for a clinical study, and the FDA review records that afamelanotide pharmacokinetics were assessed "in solution and implants" across eight phase 1 studies without printing what the solution studies gave. The other pharmacokinetic numbers on this page come from the implant, which releases on its own schedule. None of them is a vial anyone bought.

Long-term safety is formally open even for the approved product: the EU authorization was granted under exceptional circumstances precisely because complete information could not be obtained, with a patient registry imposed to supply longer-term data. The label's answer to the same gap is a twice-yearly full body skin examination.

Three holes, and none of them is small:

• No tested injected amount below 0.08mg per kilogram. The published injected levels run 0.08 to 0.4, and Levine 1999 escalated upward through 0.16, 0.26 and 0.4 to find the top of the range. No paper we traced has gone the other way. 0.08 at 70kg is still 5.6mg a day, and no injected amount in the hundreds of micrograms appears as a study-administered figure in anything we traced.
• No long-term controlled safety data for the injected form. Three of the papers we can confirm as injection studies report against a placebo group: Levine 1991 in 28 men, the first of the three Dorr 2004 studies in 8, and Barnetson 2006 in the 65 who completed. A fourth placebo-controlled paper, Fitzgerald 2006 in 77, states neither its route nor its amount in the abstract we read, and we did not retrieve its full text, so we cannot put it in or out of that group and we do not count it either way. The longest course among the three ran three 10-day cycles across three months, and none followed anyone for years. The mole and pigment signals sit in the label's adverse reaction table and in the case reports cited below, which is a signal worth watching and not a measurement.
• No identity, purity or strength verification for a vial bought loose. The 2017 review names product quality as one of its three concerns and there is no independent check behind a label.

Any figure that closes those three gaps was supplied by whoever printed it, not by a study.

Which makes it a vial question before it is a dose question: every unit count in the tables above assumes the strength printed on the glass is true, and it is that assumption, not the arithmetic, we would lose sleep over. What trial records specify about where an injection goes is collected on the injection sites page.

How this page is sourced

Read off the labels and the papers themselves: every figure on this page was taken from the cited document, never from somebody else's summary of it. Abstracts, label sections and the four regulator records were read on 2 August 2026, along with the full text of Dorr 2004. The ten entries added on 3 August 2026 were retrieved and read that day, together with the full text of the FDA multi-discipline review, which is where the 10mg and 20mg implant figures come from, and the full text of Schwartzmann-Solon 1998, which is where the 36.5 microgram topical figure comes from.

Twenty-four sources, and five of them print an injected melanotan 1 amount that a study administered: four regulator records and twenty peer-reviewed papers, one of which is a review, one a 2026 case report whose injected microgram figures are one patient's own account rather than anything a study set, one a study of the other molecule so the comparison is not made from memory, and one the first-approval review of a different alpha-MSH analogue. Each is listed below with its identifier, and every figure on this page traces back to one of them.

How the chart was bounded, because a chart like that is easy to read as a claim about a whole literature: on 3 August 2026 the search string (melanotan-I OR afamelanotide OR "Nle4-D-Phe7" OR "NDP-MSH") AND (clinical trial[pt] OR randomized controlled trial[pt]) returned 17 records on PubMed, rerun and reproduced on the same date. Fifteen of the seventeen have a row in the chart above. The two that do not are an obesity-genetics paper that used the peptide only as a receptor agonist in cell work, and an immunogenicity study that measured antibodies in patients rather than an amount given to them. Two of those fifteen rows carry no figure, because Toh 2020 is indexed with no abstract and Fitzgerald 2006 prints no amount in its abstract, and we retrieved neither full text. Six further rows sit outside that query on purpose: the three regulator records, Levine 1999, which PubMed does not index at all, the melanotan 2 pilot, which is there so the two molecules are separated from a source, and the 2026 case report, which is a case report and not a trial. So the chart heading says source by source rather than every amount published. It is a list of what these named documents print, on a named date, and nothing larger than that.

How the absence claims here were searched, because an absence claim is a claim about a whole literature: on 2 August 2026 we searched PubMed across all fields for melanotan-I OR afamelanotide OR "Nle4-D-Phe7", which returns 467 records, then Levine N[Author] AND melanotan, which returns 8, and Nle4-D-Phe7 alpha-MSH AND tanning, which returns 9. We then ran the same searches through Crossref, OpenAlex and Europe PMC, and read the reference list of every paper we retrieved.

Why that last step is printed here instead of buried: an earlier version of this page searched PubMed alone, found no dose-ranging study, and told you none existed. One exists. Levine 1999 is invisible to PubMed because PubMed indexes no article at all from that journal for that year. On 2 August 2026, for the query "J Dermatolog Treat"[jour] PubMed returned 3,282 records across the journal's whole run, and for the query "J Dermatolog Treat"[jour] AND 1999[dp] it returned 0. Its coverage of that journal before 2001 is sporadic rather than simply absent: 11 records in 1992, and none at all in any other year from 1990 to 2000. Coverage becomes continuous in 2001, which returned 47. Crossref and OpenAlex both return the paper by DOI. Dorr 2004 cites it as its own reference 13. The check that would have caught this in ten seconds is asking whether an index holds anything at all from that journal and year before concluding the paper does not exist, and that check now runs before any absence claim on this page ships.

What we still could not find, stated plainly: no trial that randomized one group of people to two injected amounts and compared them head to head, no pharmacokinetics for a commercially sold vial, and no tested injected amount below 0.08mg per kilogram. A microgram-per-day figure used to sit on that list and no longer does: one is published, in the 2026 case report cited below, as what a patient reported injecting rather than as anything a study administered. Those are absences we searched for across four indexes and did not close, not claims that they cannot exist.

Where the rules behind that live: our sourcing and citation-verification standard sits on the methodology page. Any number here that ever needs correcting gets corrected there first.

Last reviewed: 2 August 2026.

1. 1

   SCENESSE (afamelanotide) implant, for subcutaneous use. US prescribing information, DailyMed, set id 94f53286-11dd-7fbb-e053-2a95a90a7c48. Source for the 16mg implant strength, the every-2-months interval, the anterior supra-iliac crest site, the training requirement, the rod dimensions, the amino acid sequence, the pharmacokinetic figures, the twice-yearly skin examination and the adverse reaction table. Read 2 August 2026. dailymed.nlm.nih.gov.

2. 2

   US Food and Drug Administration. Drugs@FDA record for NDA 210797, SCENESSE, afamelanotide 16mg implant, subcutaneous, prescription. Original application approved 8 October 2019; most recent supplement 12 August 2024. Retrieved through the openFDA drug application endpoint on 2 August 2026. api.fda.gov, Drugs@FDA endpoint.

3. 3

   US Food and Drug Administration. NDA 210797 multi-discipline review and evaluation, SCENESSE (afamelanotide) implant. Source for the implant release profile: "most of the drug is released within the first 48 hours with over 90% released by Day 5 and levels mostly below the limit of detection by Day 7". Also the source for the 10mg, 16mg and 20mg implant strengths compared in the phase 1 dose-selection studies CUV006, CUV007 and CUV009, for the 20mg implant and five enrolled patients in study CUV010, and for the statement that "the PK of afamelanotide in solution and implants were assessed in healthy volunteers in 8 Phase I studies". Retrieved and read 2 August 2026, and retrieved again with the dose-selection and pharmacokinetics sections read on 3 August 2026. accessdata.fda.gov, 210797Orig1s000MultidisciplineR.pdf.

4. 4

   European Medicines Agency. Scenesse: EPAR summary for the public, EMA/668463/2014, EMEA/H/C/002548. Source for the every-2-months interval, "Three implants per year are recommended; the maximum number is 4", the 30-minute observation, the specialist-center restriction, the orphan designation of 8 May 2008, the exceptional-circumstances basis and the marketing authorization date of 22 December 2014. Read 2 August 2026. ema.europa.eu, EPAR summary.

5. 5

   Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for erythropoietic protoporphyria. N Engl J Med. 2015;373(1):48-59. doi:10.1056/NEJMoa1411481. PMID 26132941.

6. 6

   Levine N, Sheftel SN, Eytan T, et al. Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin. JAMA. 1991;266(19):2730-2736. Abstract read for the 28-subject design and the 10 injections over 12 days; it publishes no milligram amount. PMID 1658407.

7. 7

   Ugwu SO, Blanchard J, Dorr RT, et al. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharm Drug Dispos. 1997;18(3):259-269. Source for the 0.08 to 0.21mg per kg subcutaneous range, the complete subcutaneous bioavailability, the undetectable oral levels and the beta-phase half-life of 0.8 to 1.7 hours. PMID 9113347.

8. 8

   Levine N, Dorr RT, Ertl GA, Brooks C, Alberts DS. Effects of a potent synthetic melanotropin, Nle4-D-Phe7-alpha-MSH (Melanotan-I) on tanning: a dose-ranging study. J Dermatolog Treat. 1999;10(2):127-132. Source for the three dose levels of 0.16, 0.26 and 0.4mg per kg, the eight male volunteers, the 10-day subcutaneous schedule, the absence of improved tanning above 0.16mg per kg and the gastrointestinal upset and fatigue at the two higher levels. Not retrievable through PubMed, which indexes no 1999 article from this journal at all; resolved instead through Crossref and OpenAlex, and cited as reference 13 of Dorr 2004. Abstract read 2 August 2026. The full text is paywalled and we did not retrieve it: rechecked on 3 August 2026, the open-access index reports no free or repository copy, and the publisher's page and the author-upload copy each returned a challenge page rather than the article. So no per-level split is reported anywhere on this page, and that is a limit on our retrieval rather than a statement that the split is unpublished. doi:10.3109/09546639909056014.

9. 9

   Dorr RT, Dvorakova K, Brooks C, et al. Increased eumelanin expression and tanning is induced by a superpotent melanotropin [Nle4-D-Phe7]-alpha-MSH in humans. Photochem Photobiol. 2000;72(4):526-532. Source for the seven volunteers, the 0.16mg per kg per day Monday-to-Friday schedule and the 98% forearm eumelanin increase. PMID 11045725.

10. 10

    Barnetson RS, Ooi TK, Zhuang L, et al. [Nle4-D-Phe7]-alpha-melanocyte-stimulating hormone significantly increased pigmentation and decreased UV damage in fair-skinned Caucasian volunteers. J Invest Dermatol. 2006;126(8):1869-1878. doi:10.1038/sj.jid.5700317. PMID 16763547.

11. 11

    Dorr RT, Ertl G, Levine N, et al. Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers. Arch Dermatol. 2004;140(7):827-835. Source for the 0.08mg per kg per day first study, the increase to 0.16mg per kg per day in the second, the 4-on-drug and 4-on-saline split, the 3 of 4 tanning result and the 47% reduction in sunburn cells. Full text read 2 August 2026 for the reconstitution and 20mg per mL dilution, the blinded pathologist, the 11 analyzed in the second study, the open-label description and arm structure of the third, the statement that doses "were not escalated beyond 0.16 mg/kg", the comparison of 0.16 against 0.08, the description of Levine 1991 as "our original study of a 0.08-mg/kg dose in 28 male subjects", and its reference 13, which is the Levine 1999 dose-ranging paper. doi:10.1001/archderm.140.7.827. PMID 15262693.

12. 12

    Lim HW, Grimes PE, Agbai O, et al. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015;151(1):42-50. doi:10.1001/jamadermatol.2014.1875. PMID 25230094.

13. 13

    Dorr RT, Lines R, Levine N, et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sci. 1996;58(20):1777-1784. Cited only for the melanotan 2 structure, the 0.01mg per kg starting dose and the reported side effects, so the two compounds are separated from a source rather than from memory. doi:10.1016/0024-3205(96)00160-9. PMID 8637402.

14. 14

    Habbema L, Halk AB, Neumann M, Bergman W. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. 2017;56:975-980. Source for the four melanoma case reports, the dysplastic nevi observation, the quality and dosing concerns and the statement that causal evidence is not conclusive. doi:10.1111/ijd.13585. PMID 28266027.

15. 15

    Schwartzmann-Solon AM, Visconti MA, Castrucci AM. Topical application of a melanotropin analogue to vulgar vitiligo dermo-epidermal minigrafts. Braz J Med Biol Res. 1998;31(12):1557-1564. Source for the topical row: eighteen subjects, "the hormone (50 microliters, 0.4 mM) was applied topically to 30-cm2 lesions", and no difference against the placebo group. Full text read 3 August 2026 for the 9 on the analogue against 9 on the vehicle, the twice-weekly application for 2 months by the therapist and a further 5 months self-applied, and the statement that "The final dose per application was 36.5" micrograms per "30 cm2 (2 x 10-8 mol)", which is the one fixed mass in the record that a study administered outside an implant. Abstract read 3 August 2026. doi:10.1590/s0100-879x1998001200008. PMID 9951552.

16. 16

    Fitzgerald LM, Fryer JL, Dwyer T, Humphrey SM. Effect of MELANOTAN, [Nle(4), D-Phe(7)]-alpha-MSH, on melanin synthesis in humans with MC1R variant alleles. Peptides. 2006;27(2):388-394. Cited for the 77 individuals and the treated-against-placebo comparison. Its abstract publishes no amount and no route, and the full text was not retrieved, so it contributes no figure to the chart. Abstract read 3 August 2026. doi:10.1016/j.peptides.2004.12.038. PMID 16293341.

17. 17

    Harms JH, Lautenschlager S, Minder CE, Minder EI. Mitigating photosensitivity of erythropoietic protoporphyria patients by an agonistic analog of alpha-melanocyte stimulating hormone. Photochem Photobiol. 2009;85(6):1434-1439. Source for the 20mg implant row: "a sustained-release subcutaneous implant of 20 mg afamelanotide was administered twice, with a 60-day interval to five EPP patients", open-label. Abstract read 3 August 2026. doi:10.1111/j.1751-1097.2009.00595.x. PMID 19656325.

18. 18

    Haylett AK, Nie Z, Brownrigg M, Taylor R, Rhodes LE. Systemic photoprotection in solar urticaria with alpha-melanocyte-stimulating hormone analogue [Nle4-D-Phe7]-alpha-MSH. Br J Dermatol. 2011;164(2):407-414. Source for the single-implant row: "five patients with solar urticaria received a single dose of 16 mg subcutaneous afamelanotide implant in winter time", followed to day 60. Abstract read 3 August 2026. doi:10.1111/j.1365-2133.2010.10104.x. PMID 20969564.

19. 19

    Böhm M, Ehrchen J, Luger TA. Beneficial effects of the melanocortin analogue Nle4-D-Phe7-alpha-MSH in acne vulgaris. J Eur Acad Dermatol Venereol. 2014;28(1):108-111. Source for the acne row: "afamelanotide (16 mg) was given in a phase II open-label pilot study subcutaneously as a sustained-release resorbable implant formulation to 3 patients with mild-to-moderate facial acne vulgaris", assessed 56 days after the first injection. Abstract read 3 August 2026. doi:10.1111/j.1468-3083.2012.04658.x. PMID 22845050.

20. 20

    Biolcati G, Aurizi C, Barbieri L, Cialfi S, Screpanti I, Talora C. Efficacy of the melanocortin analogue Nle4-D-Phe7-alpha-melanocyte-stimulating hormone in the treatment of patients with Hailey-Hailey disease. Clin Exp Dermatol. 2014;39(2):168-175. Source for the Hailey-Hailey row: "afamelanotide 16 mg was administered subcutaneously as a sustained-release resorbable implant formulation to two patients with HHD", in a phase II open-label pilot study, and its methods add that "the two patients each received one implant on day 0, and a second implant on day 30". Full text read 3 August 2026. doi:10.1111/ced.12203. PMID 24256215.

21. 21

    Toh JJH, Chuah SY, Jhingan A, Chong WS, Thng STG. Afamelanotide implants and narrow-band ultraviolet B phototherapy for the treatment of nonsegmental vitiligo in Asians. J Am Acad Dermatol. 2020;82(6):1517-1519. Listed because it falls inside the search that bounds the chart, and for no figure: the record is indexed with no abstract and the full text was not retrieved on 3 August 2026. doi:10.1016/j.jaad.2020.01.035. PMID 31987791.

22. 22

    Stanislaus V, Kam A, Murphy L, et al. A feasibility and safety study of afamelanotide in acute stroke patients, an open label, proof of concept, phase IIa clinical trial. BMC Neurol. 2023;23(1):281. Source for the stroke row: "afamelanotide 16 mg implants were administered subcutaneously on Day 0 (D0, day of recruitment), D1 and repeated on D7 and D8, if not well recovered", in six patients, two of whom received four implants and four of whom received two. Abstract read 3 August 2026. doi:10.1186/s12883-023-03338-9. PMID 37496004.

23. 23

    Vadner DJ, Smith S. Five primary melanomas in situ in a patient with recent tanning bed use, melanotan exposure, and anabolic hormone use. JAAD Case Rep. 2026;73:111-114. Case report. Source for the only microgram-per-day melanotan figure on this page, which is the patient's own account, "daily injections with dose escalation over approximately 1 week from 250 mcg to 500 mcg to 1000 mcg", first on melanotan 2 and then on melanotan 1 "using a similar dosing and titration schedule"; for the five melanomas in situ "arising in severely dysplastic nevi"; and for the authors' statements that "independent verification of compound composition, dosing, and purity was not available" and that "causality between melanotan exposure and melanoma development cannot be established from a single observational case". Full text read 3 August 2026. doi:10.1016/j.jdcr.2026.05.009. PMID 42328529.

24. 24

    Dhillon S, Keam SJ. Bremelanotide: first approval. Drugs. 2019;79(14):1599-1606. Cited only to date the end of afamelanotide's status as the sole approved alpha-MSH analogue: this first-approval review describes bremelanotide as "a synthetic peptide analogue of the neuropeptide hormone alpha melanocyte-stimulating hormone (alpha-MSH) with high affinity for the melanocortin type 4 receptor" and records its 2019 US approval for a different indication. Abstract read 3 August 2026. doi:10.1007/s40265-019-01187-w. PMID 31429064.