Melanotan I Dosage: Scenesse Label and Trial Doses (2026)

Not dosing advice. This page reports doses that studies and approved labels used, with their sources. It does not recommend a dose, and we do not give mixing, injection or unit-conversion instructions. Gray-market vials often do not contain what their label says. How we report doses.

Every dose studied in people

Study	Who	People	Dose and route	What happened
Biolcati 2015, long-term observational study	People with EPP treated at porphyria centers in Rome and Zurich	115	16 mg implants, 1,023 in all; the abstract does not say how often each person had one Implant under the skin · Up to 8 years	There was no comparison group. Quality-of-life scores were 31% of the maximum before treatment, rose to 74% after it started and stayed there, and 23% of patients stopped for reasons such as pregnancy or cost⁸. Only minor side effects were put down to the drug, mainly nausea⁸.
CUV039 (Langendonk 2015), US randomized placebo-controlled trial	Adults with EPP	94	16 mg implant or a placebo implant every 60 days, three in all Implant under the skin · 180 days	Median time in direct sunlight without pain was 69.4 hours on the implant versus 40.8 hours on placebo (P=0.04)⁹. FDA’s own analysis of all randomized patients gave p=0.055, and the US label reports the trial as 93 patients with medians of 64.1 and 40.5 hours³⁴.
CUV030 (FDA review), US randomized placebo-controlled trial	Adults with EPP	77	16 mg implant or a placebo implant every 2 months, three in all Implant under the skin · 180 days	A negative trial: it did not reach statistical significance on its planned endpoints, the severity of phototoxic reactions, so FDA did not count it as evidence that the drug works³.
Fitzgerald 2006, placebo-controlled study	White adults with and without variants of MC1R, a pigment-receptor gene	77	Not given in the abstract Not given in the abstract · Not given in the abstract	Melanin density rose significantly compared with placebo (p<0.001), and more in carriers of six MC1R variants than in people without them¹⁰.
CUV029 (Langendonk 2015), European randomized placebo-controlled trial	Adults with EPP	74	16 mg implant or a placebo implant every 60 days, five in all Implant under the skin · 270 days	Median time in direct sunlight without pain was 6.0 hours on the implant versus 0.8 hours on placebo (P=0.005), and there were 77 phototoxic reactions versus 146 (P=0.04)⁹. Side effects were mostly mild⁹.
Barnetson 2006, placebo-controlled trial	Fair-skinned white volunteers	65	0.16 mg/kg, in three 10-day courses Injection under the skin of the abdomen · 3 months	The 65 are the people who completed the trial. Melanin density rose 41% in people whose skin burns easily and 12% in those whose skin burns less easily (both P<0.0001 versus placebo), and in the burn-prone group sunburn cells after a UV test fell by more than 50%⁷.
Lim 2015, randomized trial, not blinded	Adults with nonsegmental vitiligo and skin types III to VI	55	16 mg implant once a month for 4 months, after 1 month of narrowband UV-B light therapy; the other group had light therapy alone Implant under the skin · Results to day 168	Repigmentation at day 168 was 48.64% with the implant and light versus 33.26% with light alone, and it came sooner on the face (41.0 versus 61.0 days)¹¹. The gains were seen in skin types IV to VI, not type III, and the implant group had minor infections and nausea¹¹.
CUV052 (NCT06388642), open-label single-group study of blood levels	People with EPP aged 12 to 70, 14 of them aged 18 or younger	28	One 16 mg implant Implant under the skin · Blood levels to day 7; side effects followed for about 3 months	Results posted on 27 July 2026 cover blood levels and side effects, not benefit². No one had a serious adverse event, and the commonest other events were headache (6 of 28), nausea (4 of 28) and flu-like illness (4 of 28)².
Levine 1991, randomized placebo-controlled double-blind trial	Healthy white men whose skin tans poorly (types I to II) or well (types III to IV)	28	10 injections; the abstract does not give the amount Injection under the skin · 12 days, then 7 weeks of follow-up	Skin darkened significantly in both skin-type groups and not at all on placebo, with the peak 1 to 3 weeks after the last injection; everyone used a high-potency sunscreen¹².
Dorr 2004, study 2, open-label	Volunteers	12	0.16 mg/kg a day, with small doses of UV-B light to a buttock during or after the injections Injection under the skin · 10 days	More skin sites darkened than at the lower dose used in study 1⁶.
Dorr 2004, study 1, randomized	Volunteers	8	0.08 mg/kg a day (4 people) or saline (4 people), then UV-B light to the neck Injection under the skin · 10 days	Three of the 4 people on the drug tanned, and they had 47% fewer sunburn cells where the neck was exposed to light⁶.
Dorr 2004, study 3, randomized	Volunteers	8	0.16 mg/kg 5 days a week plus sunlight to half of the back, versus sunlight alone Injection under the skin · 4 weeks	The back tanned significantly more with the drug, the tan lasted at least 3 weeks longer, and people on sunlight alone needed 50% more time in the sun for the same tan⁶. Side effects across the three studies were minor: nausea and brief facial flushing⁶.
Dorr 2000, open-label study	Volunteers with skin types III or IV, six men and one woman	7	0.16 mg/kg a day, Monday to Friday, 10 injections in all Injection under the skin · 2 weeks	Skin tanned at 3 of 8 sites, including the face, neck and forearm, and the brown-black pigment eumelanin in forearm skin rose 98% a week after the last injection (P = 0.003)¹³.
Harms 2009, open-label pilot study	People with EPP	5	Two 20 mg implants, 60 days apart Implant under the skin · Results to day 120	Tolerance to a standard light test rose from day 30 to day 120 compared with before treatment (P = 0.007), but with five patients in an open-label design, the authors said a large-scale trial was needed to confirm it¹⁴.
Ugwu 1997, randomized crossover comparison of three routes	Male volunteers	3	0.08 to 0.21 mg/kg under the skin; 0.16 mg/kg into a vein or by mouth; ten doses per route Injection under the skin, injection into a vein, or by mouth · Five days a week for 2 weeks	The skin tanned after injections under the skin or into a vein, and the tan was still present 3 weeks after the tenth dose¹⁵. Side effects were minimal: occasional stomach upset and facial flushing¹⁵.
CUV105 (NCT06109649), randomized Phase 3 trial, not blinded	People aged 12 or older with generalized vitiligo and skin types III to VI	–	Scenesse every 3 weeks plus narrowband UV-B light twice a week, versus light alone; the registry does not give the mg dose Implant under the skin · 20 weeks	No results were posted as of 7 October 2026¹. The registry lists the trial as active, not recruiting, with an estimated 200 participants and completion estimated for June 2026¹.
Three Phase 1 implant studies (CUV006, CUV007 and CUV009), in FDA’s review	Healthy volunteers	–	One 16 or 20 mg implant (CUV006, 12 people); one 10 mg implant (CUV007, 6 people); two 16 mg implants 28 days apart (CUV009, 10 people) Implant under the skin · One implant, or two 28 days apart	The company concluded that 16 and 20 mg gave comparable blood levels and comparable rises in melanin, both higher than 10 mg, and chose 16 mg; FDA’s reviewers agreed that 10 mg gave less³. These were small studies in healthy people, and the EU product information says no dose-finding studies have been done⁵.

The approved schedule (Scenesse (FDA label))

Scenesse is approved in the US to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP⁴. The label says a health care professional who has completed Clinuvel’s training should place the implant, and that its safety and effectiveness have not been established in children⁴. The steps below follow that label, marked as revised in August 2024, in the version DailyMed showed on 7 October 2026⁴.

When	Dose on the label	Note
Every 2 months	One 16 mg implant under the skin	Placed by a trained health care professional, who then watches the patient for 30 minutes
After a serious allergic reaction	No further implants	The label says to treat the reaction and remove the implant if needed

Studies, animals and users: kept apart

Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.

In human studies

Approved US label: one 16 mg implant placed under the skin above the front of the hip bone (anterior supra-iliac crest) every 2 months⁴. EU label: one implant every 2 months before and during times of increased sun exposure, with the length of treatment left to the specialist⁵. FDA’s review describes a maximum of five implants a year³. The pivotal trials gave three implants (US) or five (EU), 60 days apart⁹. Tanning studies used injections under the skin dosed by body weight: 0.08 or 0.16 mg/kg a day for 10 days⁶, and 0.16 mg/kg in three 10-day courses over 3 months⁷. A 3-man comparison gave ten doses of 0.08 to 0.21 mg/kg under the skin, and 0.16 mg/kg by vein or by mouth¹⁵. The vitiligo trial gave a 16 mg implant monthly for 4 months¹¹. We found no human study of the fixed microgram doses described for online vials.

In animal studies

Pregnant rats given 0.2, 2 or 20 mg/kg/day under the skin during organ formation showed no harm to the developing young, and fertility was unaffected at up to 20 mg/kg/day⁴. In a 90-day study, rats got 0.2, 2 or 20 mg/kg under the skin once a day; FDA reviewers set the no-observed-adverse-effect level at 2 mg/kg/day³. FDA noted that no accurate animal model exists to test whether it could cause melanoma³.

What users report Anecdotal · not validated · not a recommendation

One community site lists 250 µg (micrograms) per dose, injected two days a week¹⁶.

Half-life and how it is taken

Half-life: About 30 minutes; the implant releases most of it within 48 hours⁵The EU product information adds that over 90% has left the implant by day 5⁵. The US label instead gives an apparent half-life of about 15 hours for the slow-release implant, with blood levels peaking at a median of 36 hours⁴. In 3 men given injections under the skin, the elimination half-life was 0.8 to 1.7 hours¹⁵.
Routes: Implant under the skin (Scenesse): the approved form, tested in large controlled trials
Injection under the skin: used in the tanning trials, and how online vials are used
Intravenous: one small study in 3 men
By mouth: no drug reached the blood in that study

How many implants a year

The US label gives the interval, one implant every 2 months, but no yearly maximum⁴. FDA’s 2019 review describes at most five implants a year for each patient, and it quotes the EU product information of that time, which recommended three a year and a maximum of four³.

The current EU product information sets no yearly number either: it leaves the overall length of treatment to the specialist and notes limited data on 4 to 6 implants a year⁵. It adds that people in the European trial CUV029 and a later safety study received five or up to six a year, with a safety profile similar to that of the US trial⁵.

Tanning is not an approved use

Scenesse’s approvals in the US and the EU cover only adults with EPP, so no label sets a dose for tanning⁴⁵. The tanning studies in the table gave repeated injections under the skin, dosed by body weight, over days or weeks, rather than one implant every 2 months⁶⁷¹³.

Vials sold online as ‘MT1’ are not Scenesse, and as of 7 October 2026 the testing service Finnrick listed no test results for any melanotan I product, so what such vials contain is unknown¹⁷.

Melanotan II doses do not carry over

Melanotan II is a different molecule: a shortened, ring-shaped (cyclic) peptide that was tested mainly for erectile dysfunction, while melanotan I is a linear peptide that was tested for tanning¹⁸. Its small studies in men used their own doses, set by body weight, and those doses do not carry over to melanotan I; the melanotan II dose page reports them¹⁹²⁰.

Questions people ask

How much melanotan 1 should I take?

No label sets a dose for tanning: the only approved dose, one 16 mg implant every 2 months placed by a trained health care professional, is for adults with EPP⁴⁵. The tanning studies used research doses set by body weight, such as 0.16 mg/kg a day for 10 days⁶. No dose is established for tanning, so any decision about using it belongs with a licensed prescriber.

How often is the Scenesse implant given?

Every 2 months, as one 16 mg implant placed under the skin⁴. The US label sets no yearly maximum, while the EU product information leaves the overall length of treatment to the specialist and notes limited data on 4 to 6 implants a year⁴⁵.

What dose of melanotan 1 was used for tanning?

Tanning studies injected it under the skin at doses set by body weight: 0.08 or 0.16 mg/kg a day for 10 days in one set of studies, and 0.16 mg/kg in three 10-day courses over 3 months in a trial that 65 people completed⁶⁷. No label approves it for tanning⁴⁵.

Is the melanotan 1 dose the same as melanotan 2?

No. Melanotan II is a different, ring-shaped molecule, and its small studies in men used their own body-weight doses, which do not carry over to melanotan I¹⁸¹⁹²⁰.

Is Scenesse approved for children?

Not in the US or the EU as of 7 October 2026: the US label says its safety and effectiveness have not been established in pediatric patients, and the EU product information says the same for ages up to 17⁴⁵. A study that gave one 16 mg implant to 28 people with EPP, 14 of them aged 18 or younger, posted blood-level and safety results in July 2026².

How long does a Scenesse implant last?

The EU product information says the implant is absorbed by the body within 50 to 60 days⁵. FDA’s reviewers found that the rise in skin pigment lasted about 60 days, which supported giving one implant every 2 months³.

Go deeper

Sources

1A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo (NCT06109649) ClinicalTrials.gov, 8 Jul 2025. clinicaltrials.gov
2Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients (NCT06388642), record with posted results ClinicalTrials.gov, 27 Jul 2026. clinicaltrials.gov
3NDA 210797 Multi-discipline Review and Evaluation (Scenesse, afamelanotide) U.S. Food and Drug Administration, CDER, 8 Oct 2019. accessdata.fda.gov
4SCENESSE (afamelanotide) implant prescribing information Clinuvel via DailyMed (U.S. National Library of Medicine), 11 May 2026. dailymed.nlm.nih.gov
5Scenesse: EPAR product information European Medicines Agency, 7 Oct 2026. ema.europa.eu
6Effects of a superpotent melanotropic peptide in combination with solar UV radiation on tanning of the skin in human volunteers Archives of Dermatology, Jul 2004. pubmed.ncbi.nlm.nih.gov
7[Nle4-D-Phe7]-alpha-melanocyte-stimulating hormone significantly increased pigmentation and decreased UV damage in fair-skinned Caucasian volunteers Journal of Investigative Dermatology, Aug 2006. pubmed.ncbi.nlm.nih.gov
8Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria British Journal of Dermatology, Jun 2015. pubmed.ncbi.nlm.nih.gov
9Afamelanotide for Erythropoietic Protoporphyria New England Journal of Medicine, 2 Jul 2015. pubmed.ncbi.nlm.nih.gov
10Effect of MELANOTAN, [Nle(4), D-Phe(7)]-alpha-MSH, on melanin synthesis in humans with MC1R variant alleles Peptides, Feb 2006. pubmed.ncbi.nlm.nih.gov
11Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial JAMA Dermatology, Jan 2015. pubmed.ncbi.nlm.nih.gov
12Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin JAMA, 20 Nov 1991. pubmed.ncbi.nlm.nih.gov
13Increased eumelanin expression and tanning is induced by a superpotent melanotropin [Nle4-D-Phe7]-alpha-MSH in humans Photochemistry and Photobiology, Oct 2000. pubmed.ncbi.nlm.nih.gov
14Mitigating photosensitivity of erythropoietic protoporphyria patients by an agonistic analog of alpha-melanocyte stimulating hormone Photochemistry and Photobiology, Nov 2009. pubmed.ncbi.nlm.nih.gov
15Skin pigmentation and pharmacokinetics of melanotan-I in humans Biopharmaceutics & Drug Disposition, Apr 1997. pubmed.ncbi.nlm.nih.gov
16Melanotan I: How It Works, Mechanism & Evidence (2026) The Peptide Catalog, 18 Apr 2026. thepeptidecatalog.com
17Melanotan I Safety Testing Results & Vendor Ratings Finnrick, accessed 7 Oct 2026. finnrick.com
18Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization Peptides, Apr 2006. pubmed.ncbi.nlm.nih.gov
19Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study Life Sciences, 1996. pubmed.ncbi.nlm.nih.gov
20Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction Urology, 1 Oct 2000. pubmed.ncbi.nlm.nih.gov

Not medical advice. Talk to a licensed clinician before using any drug. Report an error.