{
 "checked": "2026-10-24 (America/New_York)",
 "page": "https://jabbitapp.com/research/melanotan-ii-mt2-tanning-nasal-spray-evidence-teardown.html",
 "tga": {
  "alert_2026_08_17": {
   "url": "https://web.archive.org/web/20261011164221/https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/melanotan-ii-tanning-peptide-products-found-be-inconsistently-dosed",
   "bottles_tested": 5,
   "labelled_mg": 30,
   "labelled_ml": 20,
   "estimated_mg_range": [
    22,
    54
   ],
   "infringement_notices": 27,
   "total_aud": 101412,
   "recipient": "an NSW-based individual (not named by TGA)",
   "paid": "May 2026",
   "artg_products": 0
  },
  "blog_2025_01_24": {
   "url": "https://web.archive.org/web/20260709125256/https://www.tga.gov.au/news/blog/dont-risk-using-tanning-products-containing-melanotan",
   "unlawful_ads_removal_requests_2023_24": 4800
  }
 },
 "fda": {
  "category2_page": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
  "category2_status": "listed under 'Bulk drug substances nominated but withdrawn' (previously in category 2; nomination withdrawn by the nominator); page content current as of 04/22/2026",
  "pcac_page": "https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee",
  "pcac_status": "agenda item for a meeting FDA says it will host before the end of February 2027; content current as of 04/15/2026",
  "news_release_2007_09_05": "https://www.webwire.com/ViewPressRel.asp?aId=46851"
 },
 "afamelanotide_scenesse": {
  "generic": "afamelanotide (melanotan I, [Nle4-D-Phe7]-alpha-MSH)",
  "nda": "NDA210797",
  "us_approved": "20191008",
  "review": "PRIORITY",
  "orphan": true,
  "labeler": [
   "CLINUVEL INC."
  ],
  "label_effective": "20260511",
  "label_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f53286-11dd-7fbb-e053-2a95a90a7c48",
  "indication": "increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)",
  "administration": "implant inserted under the skin by a trained health care professional",
  "skin_monitoring": "full body skin examination twice yearly; may darken pre-existing nevi and ephelides",
  "table1_pct_scenesse_vs_vehicle": {
   "implant site reaction": [
    21,
    10
   ],
   "nausea": [
    19,
    14
   ],
   "skin hyperpigmentation": [
    4,
    0
   ],
   "melanocytic nevus": [
    4,
    2
   ]
  },
  "n_safety": [
   125,
   119
  ],
  "cuv039_median_hours_direct_sun_pain_free_180d": [
   64.1,
   40.5
  ],
  "cuv029_median_hours_270d": [
   6.0,
   0.75
  ],
  "eu": {
   "marketing_authorisation_issued": "2014-12-22",
   "exceptional_circumstances": true,
   "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse"
  }
 },
 "faers": {
  "query": "openFDA drug/event, patient.drug.medicinalproduct:\"melanotan\" (free-text product name; melanotan has no approved US product)",
  "endpoint": "https://api.fda.gov/drug/event.json?search=patient.drug.medicinalproduct:%22melanotan%22&limit=100",
  "openfda_last_updated": "2026-07-30",
  "total_reports": 10,
  "serious": 9,
  "death_flagged": 0,
  "reaction_terms": {
   "Renal artery thrombosis": 5,
   "Renal infarct": 3,
   "Skin texture abnormal": 1,
   "Melanocytic naevus": 1,
   "Product use issue": 1,
   "Product advertising issue": 1,
   "Abdominal pain upper": 1,
   "Biliary colic": 1,
   "Alanine aminotransferase increased": 1,
   "Hepatotoxicity": 1,
   "Blood alkaline phosphatase increased": 1,
   "Gamma-glutamyltransferase increased": 1,
   "Aspartate aminotransferase increased": 1
  },
  "reports": [
   {
    "safetyreportid": "9399172",
    "received": "20130709",
    "serious": true,
    "death_flag": false,
    "country": null,
    "drugs": [
     "CIPROFLOXACIN",
     "T500 FURY",
     "MELANOTAN",
     "ANALGESIC"
    ],
    "reactions": [
     "Abdominal pain upper",
     "Biliary colic",
     "Alanine aminotransferase increased",
     "Hepatotoxicity",
     "Blood alkaline phosphatase increased",
     "Gamma-glutamyltransferase increased",
     "Aspartate aminotransferase increased"
    ]
   },
   {
    "safetyreportid": "17827603",
    "received": "20200527",
    "serious": true,
    "death_flag": false,
    "country": "SE",
    "drugs": [
     "MELANOTAN II",
     "ESOMEPRAZOLE.",
     "DICLOFENAC"
    ],
    "reactions": [
     "Renal infarct"
    ]
   },
   {
    "safetyreportid": "17855930",
    "received": "20200603",
    "serious": true,
    "death_flag": false,
    "country": "SE",
    "drugs": [
     "MELANOTAN II",
     "DICLOFENAC",
     "ESOMEPRAZOLE."
    ],
    "reactions": [
     "Renal infarct"
    ]
   },
   {
    "safetyreportid": "17874407",
    "received": "20200609",
    "serious": true,
    "death_flag": false,
    "country": "SE",
    "drugs": [
     "MELANOTAN II",
     "DICLOFENAC"
    ],
    "reactions": [
     "Renal infarct"
    ]
   },
   {
    "safetyreportid": "25999493",
    "received": "20251105",
    "serious": true,
    "death_flag": false,
    "country": "AU",
    "drugs": [
     "TESTOSTERONE",
     "MELANOTAN II"
    ],
    "reactions": [
     "Renal artery thrombosis"
    ]
   },
   {
    "safetyreportid": "26028813",
    "received": "20251112",
    "serious": true,
    "death_flag": false,
    "country": "AU",
    "drugs": [
     "ANDROGEL",
     "TESTOSTERONE",
     "MELANOTAN II"
    ],
    "reactions": [
     "Renal artery thrombosis"
    ]
   },
   {
    "safetyreportid": "26028833",
    "received": "20251112",
    "serious": true,
    "death_flag": false,
    "country": "AU",
    "drugs": [
     "ANDROGEL",
     "TESTOSTERONE",
     "MELANOTAN II"
    ],
    "reactions": [
     "Renal artery thrombosis"
    ]
   },
   {
    "safetyreportid": "26426781",
    "received": "20260224",
    "serious": true,
    "death_flag": false,
    "country": null,
    "drugs": [
     "AVEED",
     "MELANOTAN II"
    ],
    "reactions": [
     "Renal artery thrombosis"
    ]
   },
   {
    "safetyreportid": "26558421",
    "received": "20260331",
    "serious": true,
    "death_flag": false,
    "country": "AU",
    "drugs": [
     "TESTOSTERONE",
     "MELANOTAN II"
    ],
    "reactions": [
     "Renal artery thrombosis"
    ]
   },
   {
    "safetyreportid": "26571696",
    "received": "20260401",
    "serious": false,
    "death_flag": false,
    "country": null,
    "drugs": [
     "MELANOTAN II"
    ],
    "reactions": [
     "Skin texture abnormal",
     "Melanocytic naevus",
     "Product use issue",
     "Product advertising issue"
    ]
   }
  ],
  "caveat": "FAERS reports are unverified and often duplicated (several reports here share the same country, drugs and reaction and were received within weeks); they do not show that melanotan caused an event."
 },
 "registry": {
  "melanotan": {
   "query": "ClinicalTrials.gov API v2, query.intr = melanotan, pulled 2026-10-24",
   "total": 1,
   "studies": [
    {
     "nct": "NCT07437560",
     "title": "Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo",
     "status": "RECRUITING",
     "start": "2026-02-02",
     "lead_sponsor": "Hudson Biotech",
     "conditions": [
      "NonSegmental Vitiligo",
      "Nonsegmental Vitiligo (Stable)"
     ],
     "has_results": false
    }
   ],
   "note": "The only record (NCT07437560, lead sponsor listed as Hudson Biotech) describes itself as an 'example interventional study record'; we set it aside, as on our Oct 20 TikTok page. Older melanotan II studies (1996-2000) predate registration."
  },
  "afamelanotide": {
   "query": "ClinicalTrials.gov API v2, query.intr = afamelanotide, pulled 2026-10-24",
   "total": 23,
   "lead_sponsor_clinuvel": 23,
   "with_posted_results": 12,
   "by_status": {
    "COMPLETED": 18,
    "UNKNOWN": 4,
    "ACTIVE_NOT_RECRUITING": 1
   },
   "studies": [
    {
     "nct": "NCT00472901",
     "title": "Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)",
     "status": "COMPLETED",
     "start": "2007-05",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Polymorphic Light Eruption (PLE)"
     ],
     "has_results": false
    },
    {
     "nct": "NCT00829192",
     "title": "Phase II AK Study in Organ Transplant Patients",
     "status": "UNKNOWN",
     "start": "2007-11",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Actinic Keratoses",
      "Carcinoma, Squamous Cell",
      "Organ Transplant Recipients"
     ],
     "has_results": false
    },
    {
     "nct": "NCT00859534",
     "title": "Phase II Solar Urticaria (SU) Pilot Study",
     "status": "COMPLETED",
     "start": "2008-12",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Solar Urticaria"
     ],
     "has_results": false
    },
    {
     "nct": "NCT00979745",
     "title": "Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)",
     "status": "COMPLETED",
     "start": "2009-09",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Erythropoietic Protoporphyria"
     ],
     "has_results": true
    },
    {
     "nct": "NCT01097044",
     "title": "Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)",
     "status": "COMPLETED",
     "start": "2010-04",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Erythropoietic Protoporphyria"
     ],
     "has_results": true
    },
    {
     "nct": "NCT01382589",
     "title": "Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo",
     "status": "COMPLETED",
     "start": "2011-09",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Vitiligo"
     ],
     "has_results": false
    },
    {
     "nct": "NCT01430195",
     "title": "Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)",
     "status": "COMPLETED",
     "start": "2011-06",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Vitiligo"
     ],
     "has_results": false
    },
    {
     "nct": "NCT01605136",
     "title": "Phase III Confirmatory Study in Erythropoietic Protoporphyria",
     "status": "COMPLETED",
     "start": "2012-05",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Erythropoietic Protoporphyria"
     ],
     "has_results": true
    },
    {
     "nct": "NCT03634137",
     "title": "Implant Pharmacokinetic and Pharmacodynamic Study",
     "status": "COMPLETED",
     "start": "2009-09",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Healthy"
     ],
     "has_results": false
    },
    {
     "nct": "NCT04053270",
     "title": "Multicentre Phase III Erythropoietic Protoporphyria Study",
     "status": "COMPLETED",
     "start": "2007-05",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Erythropoietic Protoporphyria"
     ],
     "has_results": true
    },
    {
     "nct": "NCT04425746",
     "title": "Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium",
     "status": "COMPLETED",
     "start": "2008-08-05",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Patients Undergoing Photodynamic Therapy Using Porfimer Sodium"
     ],
     "has_results": true
    },
    {
     "nct": "NCT04525157",
     "title": "Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)",
     "status": "COMPLETED",
     "start": "2014-06-06",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Vitiligo"
     ],
     "has_results": true
    },
    {
     "nct": "NCT04578496",
     "title": "A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)",
     "status": "COMPLETED",
     "start": "2011-07-11",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Erythropoietic Protoporphyria"
     ],
     "has_results": true
    },
    {
     "nct": "NCT04704713",
     "title": "Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)",
     "status": "COMPLETED",
     "start": "2010-05-05",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Polymorphic Light Eruption"
     ],
     "has_results": true
    },
    {
     "nct": "NCT04943159",
     "title": "Afamelanotide in Patients Suffering With Acne Vulgaris",
     "status": "COMPLETED",
     "start": "2010-08-24",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Acne Vulgaris"
     ],
     "has_results": true
    },
    {
     "nct": "NCT04962503",
     "title": "A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)",
     "status": "COMPLETED",
     "start": "2021-06-03",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Arterial Ischemic Stroke"
     ],
     "has_results": true
    },
    {
     "nct": "NCT05159752",
     "title": "A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)",
     "status": "UNKNOWN",
     "start": "2021-10-19",
     "lead_sponsor": "Clinuvel Europe Limited",
     "conditions": [
      "Xeroderma Pigmentosum"
     ],
     "has_results": false
    },
    {
     "nct": "NCT05210582",
     "title": "A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face",
     "status": "UNKNOWN",
     "start": "2022-10-11",
     "lead_sponsor": "Clinuvel, Inc.",
     "conditions": [
      "Vitiligo"
     ],
     "has_results": false
    },
    {
     "nct": "NCT05368857",
     "title": "DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers",
     "status": "COMPLETED",
     "start": "2022-01-19",
     "lead_sponsor": "Clinuvel (UK) Ltd.",
     "conditions": [
      "Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers"
     ],
     "has_results": false
    },
    {
     "nct": "NCT05370235",
     "title": "A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V",
     "status": "UNKNOWN",
     "start": "2022-03-28",
     "lead_sponsor": "Clinuvel Europe Limited",
     "conditions": [
      "Xeroderma Pigmentosum"
     ],
     "has_results": false
    },
    {
     "nct": "NCT05854784",
     "title": "Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)",
     "status": "COMPLETED",
     "start": "2023-03-28",
     "lead_sponsor": "Clinuvel Pharmaceuticals Limited",
     "conditions": [
      "Variegate Porphyria"
     ],
     "has_results": true
    },
    {
     "nct": "NCT06109649",
     "title": "A 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",
     "status": "ACTIVE_NOT_RECRUITING",
     "start": "2023-10-11",
     "lead_sponsor": "Clinuvel, Inc.",
     "conditions": [
      "Vitiligo"
     ],
     "has_results": false
    },
    {
     "nct": "NCT06388642",
     "title": "Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients",
     "status": "COMPLETED",
     "start": "2024-03-07",
     "lead_sponsor": "Clinuvel Europe Limited",
     "conditions": [
      "Erythropoietic Protoporphyria"
     ],
     "has_results": true
    }
   ]
  }
 },
 "analysis": {
  "tga_low_pct_of_label": 73,
  "tga_high_pct_of_label": 180,
  "tga_spread_fold": 2.5,
  "breindahl_2015_pct_of_label": [
   43,
   88
  ],
  "breindahl_impurities_pct": [
   4.1,
   5.9
  ],
  "pubmed_melanotan_records": 280,
  "case_reports_read_by_harm": {
   "melanoma or melanoma in situ": [
    "21564053",
    "22724573",
    "24355990",
    "40210573",
    "42328529"
   ],
   "new or changing moles": [
    "19174439",
    "19380666",
    "19575725",
    "24334249"
   ],
   "priapism": [
    "23537392",
    "30796078",
    "33460908"
   ],
   "kidney or muscle injury": [
    "23121206",
    "31953620"
   ],
   "brain swelling (PRES)": [
    "23648958"
   ],
   "other skin or mouth changes": [
    "41487785",
    "41752902"
   ]
  },
  "note": "Our arithmetic and grouping. Case reports show that harms happened to individual users; they cannot show how often harms happen or prove cause."
 }
}