{"id":791,"date":"2026-09-01T17:35:05","date_gmt":"2026-09-01T17:35:05","guid":{"rendered":"https:\/\/nhdbio.com\/resources\/melanotan-ii-human-pilot-toxicity-regulatory-evidence\/"},"modified":"2026-09-08T07:30:41","modified_gmt":"2026-09-08T07:30:41","slug":"melanotan-ii-human-pilot-toxicity-regulatory-evidence","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/ja\/melanotan-ii-human-pilot-toxicity-regulatory-evidence\/","title":{"rendered":"Melanotan II: \u4eba\u9593\u306e\u30d1\u30a4\u30ed\u30c3\u30c8 \u30c7\u30fc\u30bf\u3001\u6bd2\u6027\u3001\u898f\u5236\u72b6\u6cc1"},"content":{"rendered":"

Melanotan II \u306f\u3001\u521d\u671f\u306e\u4eba\u4f53\u66dd\u9732\u30c7\u30fc\u30bf\u3092\u9650\u5b9a\u3057\u3066\u304a\u308a\u3001\u898f\u5236\u3055\u308c\u3066\u3044\u306a\u3044\u4f7f\u7528\u306b\u3088\u308b\u5bb3\u3092\u6587\u66f8\u5316\u3057\u3066\u3044\u307e\u3059\u3002 3 \u4eba\u306e\u65e5\u713c\u3051\u30d1\u30a4\u30ed\u30c3\u30c8\u306f\u3001\u305d\u306e\u5f8c\u306e\u6bd2\u6027\u5831\u544a\u3084\u73fe\u5728\u306e\u898f\u5236\u5f53\u5c40\u306e\u8b66\u544a\u3092\u4e0a\u56de\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002<\/p>

\u4e00\u76ee\u3067\u308f\u304b\u308b\u8a3c\u62e0<\/h2>
  • 1996 \u306e\u5358\u4e00\u76f2\u691c\u30d1\u30a4\u30ed\u30c3\u30c8\u306f 3 \u4eba\u306e\u5065\u5eb7\u306a\u7537\u6027\u30dc\u30e9\u30f3\u30c6\u30a3\u30a2\u3092\u767b\u9332\u3057\u3001\u4ea4\u4e92\u306b\u751f\u7406\u98df\u5869\u6c34\u307e\u305f\u306f Melanotan II \u65e5\u3092\u4f7f\u7528\u3057\u307e\u3057\u305f\u3002<\/li>
  • 0.03 mg\/kg \u3067\u306f\u30012 \u4eba\u306e\u53c2\u52a0\u8005\u306e\u3046\u3061 1 \u4eba\u304c II \u5ea6\u306e\u50be\u7720\u3068\u75b2\u52b4\u3092\u611f\u3058\u307e\u3057\u305f\u3002\u5410\u304d\u6c17\u3084\u9577\u6642\u9593\u306e\u81ea\u767a\u7684\u52c3\u8d77\u3082\u5831\u544a\u3055\u308c\u307e\u3057\u305f\u3002<\/li>
  • 39 \u6b73\u306e\u7537\u6027\u306b\u304a\u3051\u308b 6 mg \u306e\u66dd\u9732\u304c\u78ba\u8a8d\u3055\u308c\u305f\u5f8c\u3001\u983b\u8108\u3001\u814e\u6a5f\u80fd\u969c\u5bb3\u304c\u767a\u751f\u3057\u3001CPK \u304c 1,760 \u304b\u3089 17,773 IU\/L \u306b\u4e0a\u6607\u3057\u307e\u3057\u305f\u3002<\/li><\/ul><\/div><\/div>
    \"\u81e8\u5e8a\u6bd2\u6027\u5b66\u75c7\u4f8b\u30ec\u30d3\u30e5\u30fc\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30bf\u30ea\u30fc\"
    AI \u304c\u4f5c\u6210\u3057\u305f\u30ea\u30b5\u30fc\u30c1 \u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u793a\u3059\u7de8\u96c6\u7528\u30a4\u30e9\u30b9\u30c8\u3002\u7814\u7a76\u6570\u5024\u3001\u60a3\u8005\u753b\u50cf\u3001\u88fd\u54c1\u5199\u771f\u3001\u5206\u6790\u7d50\u679c\u3001\u30ab\u30bf\u30ed\u30b0\u30ed\u30c3\u30c8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/figcaption><\/figure>

    \u5b66\u7fd2\u8a18\u9332<\/h2>

    \u3053\u306e\u7b2cI\u76f8\u4e88\u5099\u8a66\u9a13\u306f\u77ed\u671f\u7684\u306a\u5f71\u97ff\u306e\u89b3\u5bdf\u3092\u76ee\u7684\u3068\u3057\u3066\u304a\u308a\u3001\u96c6\u56e3\u306b\u304a\u3051\u308b\u5b89\u5168\u6027\u306e\u78ba\u7acb\u3092\u76ee\u7684\u3068\u3057\u305f\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u53c2\u52a0\u8005\u4e09\u4eba\u3067\u306f\u3001\u307e\u308c\u306a\u6709\u5bb3\u4e8b\u8c61\u306e\u983b\u5ea6\u3092\u63a8\u5b9a\u3059\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002\u307e\u305f\u3001\u3053\u306e\u7d50\u679c\u306f\u73fe\u5728\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u4e0a\u3067\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u306e\u59a5\u5f53\u6027\u3092\u88cf\u4ed8\u3051\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>

    1996 \u30d1\u30a4\u30ed\u30c3\u30c8<\/strong>3 \u5065\u5eb7\u306a\u7537\u6027\u3002\u751f\u7406\u98df\u5869\u6c34\/MT-II\u3092\u4ea4\u4e92\u306b\u3002 0.01 \uff5e 0.025\u20130.03 mg\/kg<\/span><\/div>
    \u30d1\u30a4\u30ed\u30c3\u30c8\u4fe1\u53f7<\/strong>2\u306e\u8272\u7d20\u6c88\u7740\u3002\u5410\u304d\u6c17\u3001\u50be\u7720\/\u75b2\u52b4\u3001\u52c3\u8d77\u304c\u5831\u544a\u3055\u308c\u307e\u3057\u305f<\/span><\/div>
    2012\u30b1\u30fc\u30b9<\/strong>39 \u6b73\u306e\u7537\u6027\u3002 6 mg \u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u3067\u8cfc\u5165\u3057\u305f\u7269\u8cea\u3092\u8cea\u91cf\u5206\u6790\u6cd5\u3067\u78ba\u8a8d<\/span><\/div>
    \u30d4\u30fc\u30af CPK<\/strong>17,773 IU\/L \u6642\u523b 12 \u6642\u9593<\/span><\/div>
    \u898f\u5236\u5883\u754c\u7dda<\/strong>FDA \u306f\u3001Melanotan II \u3092\u672a\u627f\u8a8d\u306e\u65b0\u85ac\u3068\u3057\u3066\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002 TGA \u304c\u30aa\u30f3\u30e9\u30a4\u30f3\u88fd\u54c1\u30b3\u30f3\u30c6\u30f3\u30c4\u306b\u4e00\u8cab\u6027\u304c\u306a\u3044\u3053\u3068\u3092\u767a\u898b\u3057\u307e\u3057\u305f<\/span><\/div><\/div><\/div>

    \u30b3\u30f3\u30c6\u30ad\u30b9\u30c8\u5185\u306e\u7d50\u679c<\/h2>

    2012\u5e74\u306e\u4e2d\u6bd2\u75c7\u4f8b\u3067\u306f\u3001\u5fc3\u62cd\u6570\u304c\u6bce\u5206146\u62cd\u3001\u30af\u30ec\u30a2\u30c1\u30cb\u30f3\u304c2.25 mg\/dL\u3068\u306a\u308a\u3001\u305d\u306e\u5f8cCPK\u306f17,773 IU\/L\u3067\u30d4\u30fc\u30af\u306b\u9054\u3057\u307e\u3057\u305f\u3002\u96c6\u4e2d\u6cbb\u7642\u306f\u4e09\u65e5\u9593\u7d9a\u304d\u307e\u3057\u305f\u3002\u8cea\u91cf\u5206\u6790\u3067\u6a19\u6e96\u7269\u8cea\u3068\u306e\u6bd4\u8f03\u306b\u3088\u308aMelanotan II\u304c\u78ba\u8a8d\u3055\u308c\u3001\u66dd\u9732\u7269\u8cea\u306e\u7279\u5b9a\u3092\u88cf\u4ed8\u3051\u307e\u3057\u305f\u304c\u3001\u3042\u304f\u307e\u3067\u5358\u4e00\u75c7\u4f8b\u306e\u5831\u544a\u3067\u3059\u3002<\/p>

    8\u6708\u30012026\u306f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306eTGA\u306f\u3001\u62bc\u53ce\u3055\u308c\u305f5\u3064\u306e\u70b9\u9f3b\u30b9\u30d7\u30ec\u30fc\u30dc\u30c8\u30eb\u306b30 mg\u3068\u30e9\u30d9\u30eb\u304c\u8cbc\u3089\u308c\u3066\u304a\u308a\u3001\u63a8\u5b9a\u91cf\u306f22\u304b\u308954 mg\u307e\u3067\u542b\u307e\u308c\u3066\u3044\u305f\u3068\u5831\u544a\u3057\u305f\u3002\u3053\u306e\u73fe\u5b9f\u4e16\u754c\u306e\u4e0d\u4e00\u81f4\u306f\u3001\u5206\u5b50\u306e\u85ac\u7406\u3068\u306f\u5225\u306e\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u6295\u4e0e\u306e\u30ea\u30b9\u30af\u3067\u3059\u3002<\/p>

    \u8a3c\u62e0\u304c\u8a3c\u660e\u3067\u304d\u306a\u3044\u3082\u306e<\/h2>

    3 \u3064\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30b5\u30f3\u30d7\u30eb\u3067\u306f\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u3092\u78ba\u7acb\u3067\u304d\u307e\u305b\u3093\u3002<\/p>

    \u75c7\u4f8b\u5831\u544a\u3067\u306f\u767a\u751f\u7387\u3092\u63a8\u5b9a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u304c\u3001\u3082\u3063\u3068\u3082\u3089\u3057\u3044\u91cd\u5927\u306a\u4e8b\u8c61\u3092\u8a18\u9332\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u3059\u3002<\/p>

    \u898f\u5236\u3055\u308c\u3066\u3044\u306a\u3044\u88fd\u54c1\u306e\u5185\u5bb9\u3092\u30e9\u30d9\u30eb\u304b\u3089\u63a8\u6e2c\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u305a\u3001\u30ab\u30bf\u30ed\u30b0\u306e\u7814\u7a76\u8cc7\u6599\u306f\u627f\u8a8d\u3055\u308c\u305f\u533b\u85ac\u54c1\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>","protected":false},"excerpt":{"rendered":"

    Melanotan II \u306f\u3001\u521d\u671f\u306e\u4eba\u4f53\u66dd\u9732\u30c7\u30fc\u30bf\u3092\u9650\u5b9a\u3057\u3066\u304a\u308a\u3001\u898f\u5236\u3055\u308c\u3066\u3044\u306a\u3044\u4f7f\u7528\u306b\u3088\u308b\u5bb3\u3092\u6587\u66f8\u5316\u3057\u3066\u3044\u307e\u3059\u3002 3 \u4eba\u306e\u65e5\u713c\u3051\u30d1\u30a4\u30ed\u30c3\u30c8\u306f\u3001\u305d\u306e\u5f8c\u306e\u6bd2\u6027\u5831\u544a\u3084\u73fe\u5728\u306e\u898f\u5236\u5f53\u5c40\u306e\u8b66\u544a\u3092\u4e0a\u56de\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002<\/p>","protected":false},"author":1,"featured_media":775,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pim_family_ids":"350","pim_article_type":"Published evidence review","pim_evidence_level":"Three-person phase I pilot, case reports and current regulatory safety warnings","pim_reviewer":"Site evidence editorial team","pim_reviewed_date":"2026-09-02","pim_editorial_note":"Source-checked on 2026-09-02. Null results, sample size, model\/population limits and regulatory scope are retained. This is not medical advice, a customer case or validation of a catalog lot.","pim_review_status":"reviewed","pim_review_reason":"Primary and official sources, numerical results, null findings, limitations, product-evidence boundary and image disclosure checked for batch 4.","pim_creation_method":"This article discusses the source records listed below, with the study models and limitations stated alongside the findings. AI-assisted drafting and image generation were used. The reference list identifies the records behind this article; it is not an independent peer review or verification of a supplied catalog lot.","pim_sources":"[{\"title\":\"Melanotan II pilot phase I study\",\"url\":\"https:\/\/pubmed.ncbi.nlm.nih.gov\/8637402\/\",\"note\":\"Three-person single-blind pilot; PMID 8637402.\"},{\"title\":\"Melanotan II systemic toxicity and rhabdomyolysis\",\"url\":\"https:\/\/pubmed.ncbi.nlm.nih.gov\/23121206\/\",\"note\":\"Mass-spectrometry-confirmed case report; PMID 23121206.\"},{\"title\":\"TGA finds inconsistent Melanotan II content\",\"url\":\"https:\/\/www.tga.gov.au\/safety\/safety-monitoring-and-information\/safety-alerts\/melanotan-ii-tanning-peptide-products-found-be-inconsistently-dosed\",\"note\":\"Official August 2026 laboratory-testing safety alert.\"},{\"title\":\"FDA Melanotan II enforcement record\",\"url\":\"https:\/\/www.fda.gov\/regulatory-information\/electronic-reading-room\/notice-opportunity-hearing-nooh-manookian-edward-8516\",\"note\":\"Official record describing Melanotan II as an unapproved new drug.\"},{\"title\":\"PubChem Melanotan II record\",\"url\":\"https:\/\/pubchem.ncbi.nlm.nih.gov\/compound\/melanotan-II\",\"note\":\"Cyclic sequence, formula and molecular weight; CID 92432.\"}]","footnotes":""},"categories":[19],"tags":[],"class_list":["post-791","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-published-study-cases"],"yoast_head":"\nMelanotan II: Human Pilot Data, Toxicity and Regulatory Status<\/title>\n<meta name=\"description\" content=\"Melanotan II has limited early human exposure data and documented harms from unregulated use. 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