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Melanotan II research

What published studies found for Melanotan II: 11 papers, 2 in humans, with sample sizes and key results, plus 1 registered clinical trials.

B
Some human evidence
Why: One 20-man placebo-controlled crossover RCT (erections) and a 3-man tanning pilot; the rest is animal work and case reports of harm from unlicensed use.

Melanotan II was never approved; human data are limited to a 3-man phase I tanning study and a 20-man placebo-controlled crossover study in erectile dysfunction, plus animal research. Much of the recent literature consists of case reports of harm (melanoma, priapism, rhabdomyolysis, renal infarction) in people using unlicensed online products.

✓ 2 positive✗ 8 negative? 1 inconclusive

Unlicensed products; no controlled long-term human safety data.

US compounding: Under review, not compoundable yet. Removed from Category 2 in April 2026; FDA plans to put it to its compounding advisory committee before the end of February 2027. Until FDA adds it to the 503A bulks list, US pharmacies can't compound it from bulk. Status for every peptide.

Browse and filter these papersMelanotan II prices and vendors

Reported side effects

Registered clinical trials

1 trials of Melanotan II on ClinicalTrials.gov: 1 active, 0 completed. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental VitiligoNCT07437560 · started 2026-02-02RecruitingPhase 260Hudson Biotech

All 1 Melanotan II trials, with countries and recruiting status

Human studies

✓ Positivehuman RCTInt J Impot Res · 2000

Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II.

n = 20 humansDouble-blind, placebo-controlled crossoverPenile rigidity monitored for 6 h

20 men with erectile dysfunction, double-blind placebo-controlled crossover: MT-II produced erections in 17 of 20 without sexual stimulation and increased sexual desire (68% vs 19% of doses, P<0.01); nausea and yawning were frequent, with severe nausea in 12.9% at 0.025 mg/kg.

Key resultErection without sexual stimulation in 17 of 20 men; increased desire after 13/19 (68%) doses of Melanotan II vs 4/21 (19%) of placebo (P<0.01).
Studied
Men with psychogenic and organic erectile dysfunction
Compared with
Placebo
Main outcome
Penile erection (RigiScan), sexual desire, side effects
Sample
20 men with psychogenic and organic erectile dysfunction
Authors' conclusion
Melanotan II is a potent initiator of penile erection in men with erectile dysfunction, warranting further investigation of melanocortin agonists and antagonists. Nausea and yawning were frequent side effects.
Limitations
Small crossover study; at 0.025 mg/kg, 12.9% of subjects had severe nausea.
PubMed 11035391DOI
? Inconclusivehuman trialLife Sci · 1996

Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study.

n = 3 humansPilot phase I single-blind, alternating-day, placebo-controlled trial of subcutaneous MT-II2 consecutive weeks

Pilot phase I in 3 healthy men: a few low doses produced measurable tanning in 2; spontaneous erections, stretching/yawning and mild nausea were common, and one subject had grade II somnolence and fatigue at the top dose.

Key resultTwo subjects had increased pigmentation; 0.03 mg/kg caused Grade II somnolence and fatigue in one of two subjects; spontaneous erections occurred for 1-5 hours after dosing.
Studied
Normal male volunteers
Compared with
Saline on alternate days
Main outcome
Tolerability, pigmentation and side effects
Sample
3 normal male volunteers
Authors' conclusion
MT-II has tanning activity in humans at low subcutaneous doses; the recommended single dose for future phase I studies is 0.025 mg/kg/day.
Limitations
Only 3 volunteers.
PubMed 8637402DOI

Reviews

✗ NegativereviewInt J Dermatol · 2017

Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review.

No new dataNarrative review

Review of unregulated melanotan I/II use: case reports link it to changes in existing moles, new dysplastic nevi and four melanomas; preparation and dosing are uncontrolled, though conclusive causal evidence is lacking.

Studied
Unregulated users of melanotan I and II (literature overview)
Main outcome
Risks of unregulated α-MSH analogue use
Authors' conclusion
Illegal melanotans are likely risky; case reports link them to melanocytic changes in moles and new dysplastic nevi, including four melanomas, though conclusive evidence is lacking. Afamelanotide is tested and approved for limited uses.
Limitations
Evidence is case reports; no conclusive causal link.
PubMed 28266027DOI

Human studies

✗ Negativecase reportDermatology · 2014

Melanoma associated with the use of melanotan-II.

Single case reportCase report3- to 4-week MT-II self-injection course

A 20-year-old woman developed melanoma three months after a 3-4 week course of self-injected MT-II combined with sunbed use.

Studied
20-year-old woman, Fitzpatrick skin type II, who used melanotan-II and sunbeds
Main outcome
Cutaneous melanoma diagnosis
Authors' conclusion
Melanoma coincided with melanotan-II and sunbed use; the authors warn that the unlicensed drug is incompletely tested and clinicians should counsel at-risk patients. Causality is not established.
Limitations
Single case; temporal association only.
PubMed 24355990DOI
✗ Negativecase reportClin Toxicol (Phila) · 2012

Melanotan II injection resulting in systemic toxicity and rhabdomyolysis.

Single case reportCase report3-day ICU stay

A 39-year-old man who injected 6 mg of internet-bought MT-II (confirmed by mass spectrometry) developed sympathomimetic toxicity, rhabdomyolysis (CPK peak 17,773 IU/L) and kidney dysfunction requiring ICU care.

Key resultCPK rose to 17773 IU/L at 12 hours and fell to 2622 IU/L; creatinine improved to 1.23 mg/dL at ICU discharge.
Studied
39-year-old man who injected 6 mg of internet-purchased Melanotan II
Main outcome
Systemic toxicity, rhabdomyolysis, renal function
Authors' conclusion
Melanotan II use resulted in systemic toxicity with sympathomimetic symptoms, rhabdomyolysis and renal dysfunction.
Limitations
Single case; the dose was six times the stated recommended starting dose.
PubMed 23121206DOI
✗ Negativecase reportBMJ Case Rep · 2019

Melanotan-induced priapism: a hard-earned tan.

Single case reportCase report4-week follow-up

Low-flow priapism after subcutaneous melanotan injection, treated by aspiration and phenylephrine; erectile function had not recovered at 4-week follow-up.

Studied
Patient with acute priapism after subcutaneous melanotan injection
Main outcome
Priapism management and erectile function recovery
Authors' conclusion
Acute priapism is an unreported side effect of melanocortin analogue use; this patient avoided surgical shunting but had not recovered erectile function at 4 weeks.
Limitations
Single case.
PubMed 30796078DOIFree full text
✗ Negativecase reportCEN Case Rep · 2020

Melanotan II: a possible cause of renal infarction: review of the literature and case report.

Single case report with literature reviewCase report and review of the literature

Case of renal infarction most likely attributed to MT-II, with a literature review noting prior reports of MT-II-associated rhabdomyolysis and renal failure.

Studied
Patient with renal infarction attributed to Melanotan II
Main outcome
Possible renal effects of Melanotan II
Authors' conclusion
Renal infarction was most likely attributed to Melanotan II; thrombotic pharmacological effects and possible direct renal toxicity must be considered.
Limitations
Single case; causality is probable, not proven.
PubMed 31953620DOIFree full text
✗ Negativecase reportInt J Oral Maxillofac Surg · 2025

Melanotan II nasal spray: a possible risk factor for oral mucosal malignant melanoma?

1 patientCase report with literature review

A 22-year-old woman who used Melanotan II nasal spray for tanning developed a maxillary mucosal malignant melanoma, treated with resection and immunotherapy; the authors raise a possible association, which a single case cannot establish.

Studied
22-year-old woman using Melanotan II nasal spray for tanning
Main outcome
Diagnosis of oral mucosal malignant melanoma
Authors' conclusion
The authors highlight the need for awareness of possible serious side effects of Melanotan II nasal spray.
Limitations
Single case; causation not established.
PubMed 40210573DOI
✗ Negativecase reportLife (Basel) · 2026

Changes in Oral Mucosa Associated with Melanotan II Injections: A Case Report.

HumansCase report with 3-month follow-up64 days of use; 3-month follow-up

A man who self-injected Melanotan II for 64 days developed brown oral pigmentation; buccal pigmentation nearly resolved by 1 month after stopping, while gingival pigmentation persisted, fainter, at 3 months.

Studied
Patient who self-administered Melanotan II injections for 64 days to tan
Main outcome
Oral mucosal pigmentation
Authors' conclusion
The authors present the case as data on how long Melanotan II oral pigmentation takes to resolve, noting the drug is unlicensed and unregulated.
Limitations
Single case.
PubMed 41752902DOIFree full text
✗ Negativecase reportNed Tijdschr Geneeskd · 2022

[The risks of tanning with the Barbie drug].

HumansCase report

A 27-year-old man presented to the emergency department with sympathomimetic symptoms two hours after self-injecting Melanotan II bought online; treated with lorazepam, potassium and fluids.

Studied
27-year-old man with no relevant history after subcutaneous Melanotan II
Main outcome
Acute toxicity
Authors' conclusion
The authors conclude self-administration of Melanotan II is not without side effects despite easy availability online and in gyms.
Limitations
Single case; product contents not described in the abstract.
PubMed 35736369

Animal & lab studies

✓ PositiveanimalEur J Pharmacol · 2024

Antidepressant-like and antistress effects of the ACTH(4-10) synthetic analogs Semax and Melanotan II on male rats in a model of chronic unpredictable stress.

AnimalsControlled animal study with saline and stress control groups

In stressed male rats, daily low-dose MTII (and Semax) reversed or attenuated chronic-stress anhedonia, adrenal hypertrophy and the fall in hippocampal BDNF, but did not change forced-swim immobility.

Studied
Male Sprague-Dawley rats in a chronic unpredictable stress model
Compared with
Saline
Main outcome
Sucrose preference, body weight, adrenal weight, hippocampal BDNF, forced swim test
Authors' conclusion
The authors conclude that systemically administered ACTH(4-10) analogs, including MTII, show antidepressant-like activity in this paradigm.
Limitations
Rat model; no effect in forced swim test; no human data.
PubMed 39442746DOI

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.