At a glance
- Melanotan II is not an FDA-approved drug: Drugs@FDA has no record of it.
- It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
- PubMed lists 199 publications mentioning it, including 1 randomized controlled trial and 137 animal-only studies.
- ClinicalTrials.gov lists 1 registered study testing it (1 active).
- FDA's adverse event system (FAERS) holds 9 reports mentioning it; 8 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Compounded drugs containing Melanotan II may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Peptides in urology and sexual medicine: clinical effectiveness, dosing, indications, and safety: a narrative review.
- Dangers of Injectable Peptides and Other Unregulated "Biohacking" Drugs.
- Changes in Oral Mucosa Associated with Melanotan II Injections: A Case Report.
- Melanotan II nasal spray: a possible risk factor for oral mucosal malignant melanoma?
- 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.
- Barbie drug identification: Not a child's play.
- Recommended Tool Compounds for the Melanocortin Receptor (MCR) G Protein-Coupled Receptors (GPCRs).
- Therapeutic Strategies Against Metabolic Imbalance in a Male Mouse Model With 5-HT2CR Loss-of-Function.
- Multiple metabolic signals in the CeA regulate feeding: The role of AMPK.
- 5-Hydroxypyrroloindoline Affords Tryptathionine and 2,2'-bis-Indole Peptide Staples: Application to Melanotan-II.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 1
- Active
- 1
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo | Recruiting | Phase 2 | February 2, 2026 |
All 1 study on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 9
- Serious
- 8
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.