{"id":755,"date":"2026-09-01T16:45:45","date_gmt":"2026-09-01T16:45:45","guid":{"rendered":"https:\/\/nhdbio.com\/resources\/bremelanotide-reconnect-phase-3-trials-and-fda-label\/"},"modified":"2026-09-01T16:45:45","modified_gmt":"2026-09-01T16:45:45","slug":"bremelanotide-reconnect-phase-3-trials-and-fda-label","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/ja\/bremelanotide-reconnect-phase-3-trials-and-fda-label\/","title":{"rendered":"\u30d6\u30ec\u30e1\u30e9\u30ce\u30c1\u30c9 RECONNECT \u8a66\u9a13: \u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u5b89\u5168\u6027\u3001\u304a\u3088\u3073 FDA \u306e\u7bc4\u56f2"},"content":{"rendered":"<p class=\"pim-standfirst wp-block-paragraph\">\u30d6\u30ec\u30e1\u30e9\u30ce\u30c1\u30c9\u306b\u306f\u3001FDA \u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u5b9f\u969b\u306e\u5b8c\u6210\u54c1\u8a18\u9332\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u305d\u306e\u7bc4\u56f2\u306f\u72ed\u3044\u3067\u3059\u3002 RECONNECT \u8a66\u9a13\u3067\u306f\u3001\u5f8c\u5929\u6027\u306e\u5168\u8eab\u6027 HSDD \u3092\u6301\u3064\u9589\u7d4c\u524d\u306e\u5973\u6027\u3092\u7814\u7a76\u3057\u307e\u3057\u305f\u3002\u7537\u6027\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u5411\u4e0a\u3084\u4e00\u822c\u7684\u306a PT-141 \u7814\u7a76\u6750\u6599\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p><div class=\"wp-block-group pim-key-takeaways\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\"><h2 class=\"wp-block-heading\">\u4e00\u76ee\u3067\u308f\u304b\u308b\u8a3c\u62e0<\/h2><ul class=\"wp-block-list\"><li>2\u76f83\u8a66\u9a13\u3067\u306f\u30011,267\u5973\u6027\u3092\u30e9\u30f3\u30c0\u30e0\u5316\u3057\u305f\u3002 1,202 \u306f\u6709\u52b9\u6027\u96c6\u56e3\u306b\u542b\u307e\u308c\u3066\u3044\u307e\u3057\u305f\u3002<\/li><li>\u30b0\u30eb\u30fc\u30d7\u9593\u306e\u5909\u5316\u306f\u3001\u6b32\u6c42\u3068\u82e6\u75db\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306b\u95a2\u3057\u3066\u30d6\u30ec\u30e1\u30e9\u30ce\u30c1\u30c9\u3092\u652f\u6301\u3057\u307e\u3057\u305f\u304c\u3001\u4e8b\u5f8c\u306e\u6e80\u8db3\u30a4\u30d9\u30f3\u30c8\u306e\u5c3a\u5ea6\u306b\u306f\u5927\u304d\u306a\u5dee\u306f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/li><li>\u5410\u304d\u6c17\u3001\u9854\u9762\u7d05\u6f6e\u3001\u982d\u75db\u306f\u5c11\u306a\u304f\u3068\u308210%\u3067\u767a\u751f\u3057\u3001\u30d7\u30e9\u30bb\u30dc\u3088\u308a\u3082\u4e00\u822c\u7684\u3067\u3057\u305f\u3002<\/li><\/ul><\/div><\/div><figure class=\"wp-block-image size-full pim-article-figure\"><img loading=\"lazy\" decoding=\"async\" width=\"1672\" height=\"941\" src=\"http:\/\/nhdbio.com\/wp-content\/uploads\/2026\/09\/bremelanotide-phase3-evidence.webp\" alt=\"\u30d6\u30ec\u30e1\u30e9\u30ce\u30c1\u30c9\u306e\u898f\u5236\u304a\u3088\u3073 2 \u3064\u306e\u6cbb\u9a13\u8a3c\u62e0\u306e\u8996\u899a\u5316\" class=\"wp-image-739\" srcset=\"https:\/\/nhdbio.com\/wp-content\/uploads\/2026\/09\/bremelanotide-phase3-evidence.webp 1672w, https:\/\/nhdbio.com\/wp-content\/uploads\/2026\/09\/bremelanotide-phase3-evidence-300x169.webp 300w, https:\/\/nhdbio.com\/wp-content\/uploads\/2026\/09\/bremelanotide-phase3-evidence-1024x576.webp 1024w, https:\/\/nhdbio.com\/wp-content\/uploads\/2026\/09\/bremelanotide-phase3-evidence-768x432.webp 768w, https:\/\/nhdbio.com\/wp-content\/uploads\/2026\/09\/bremelanotide-phase3-evidence-1536x864.webp 1536w\" sizes=\"auto, (max-width: 1672px) 100vw, 1672px\" \/><figcaption class=\"wp-element-caption\">\u30aa\u30ea\u30b8\u30ca\u30eb\u306e\u7de8\u96c6\u8abf\u67fb\u30a4\u30e9\u30b9\u30c8\u3002\u3053\u308c\u306f\u3001\u7814\u7a76\u56f3\u3001\u60a3\u8005\u753b\u50cf\u3001\u88fd\u54c1\u5199\u771f\u3001\u63d0\u4f9b\u3055\u308c\u305f\u5206\u6790\u7d50\u679c\u3001\u307e\u305f\u306f\u30ab\u30bf\u30ed\u30b0\u30ed\u30c3\u30c8\u306e\u8868\u73fe\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/figcaption><\/figure><h2 class=\"wp-block-heading\">\u5b66\u7fd2\u8a18\u9332<\/h2><p class=\"wp-block-paragraph\">\u5171\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u306f\u3001FSFI \u6b32\u6c42\u9818\u57df\u30b9\u30b3\u30a2\u306e\u5909\u5316\u3068 FSDS-DAO \u304b\u3089\u306e\u82e6\u75db\u9805\u76ee\u3067\u3057\u305f\u3002\u7814\u7a76\u56fa\u6709\u306e\u6b32\u6c42\u306e\u9055\u3044\u306f 0.30 \u3068 0.42 \u3067\u3057\u305f\u3002\u82e6\u75db\u306e\u5dee\u306f-0.37\u3068-0.29\u3067\u3057\u305f\u3002\u7d71\u8a08\u7684\u6709\u610f\u6027\u306f\u3001\u305d\u308c\u81ea\u4f53\u3067\u3059\u3079\u3066\u306e\u500b\u4eba\u306b\u5bfe\u3059\u308b\u5229\u76ca\u306e\u898f\u6a21\u3084\u95a2\u9023\u6027\u3092\u8aac\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p><div class=\"wp-block-group pim-evidence-table\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\"><div class=\"pim-evidence-row\"><strong>\u30c7\u30b6\u30a4\u30f3<\/strong><span>2 \u3064\u306e\u540c\u4e00\u306e\u30e9\u30f3\u30c0\u30e0\u5316\u4e8c\u91cd\u76f2\u691c\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u76f8 3 \u8a66\u9a13<\/span><\/div><div class=\"pim-evidence-row\"><strong>\u30e9\u30f3\u30c0\u30e0\u5316<\/strong><span>1,267 \u9589\u7d4c\u524d\u306e\u5973\u6027<\/span><\/div><div class=\"pim-evidence-row\"><strong>\u7d71\u5408\u3055\u308c\u305f\u6b32\u671b\u306e\u9055\u3044<\/strong><span>0.35 \u5bfe\u30d7\u30e9\u30bb\u30dc; P&lt;0.001<\/span><\/div><div class=\"pim-evidence-row\"><strong>\u7d71\u5408\u3055\u308c\u305f\u82e6\u75db\u306e\u5dee<\/strong><span>\u22120.33 \u5bfe\u30d7\u30e9\u30bb\u30dc; P&lt;0.001<\/span><\/div><div class=\"pim-evidence-row\"><strong>\u30e9\u30d9\u30eb\u5883\u754c<\/strong><span>\u9589\u7d4c\u5f8c\u306e\u5973\u6027\u3001\u7537\u6027\u3001\u5b50\u4f9b\u3001\u307e\u305f\u306f\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306e\u5411\u4e0a\u306b\u306f\u9069\u5fdc\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<\/span><\/div><\/div><\/div><h2 class=\"wp-block-heading\">\u30b3\u30f3\u30c6\u30ad\u30b9\u30c8\u5185\u306e\u7d50\u679c<\/h2><p class=\"wp-block-paragraph\">\u3053\u306e\u8ad6\u6587\u3067\u306f\u3001\u4e8b\u5f8c\u5206\u6790\u3067\u6e80\u8db3\u3057\u305f\u6027\u7684\u51fa\u6765\u4e8b\u306e\u5272\u5408\u306b\u30b0\u30eb\u30fc\u30d7\u9593\u306e\u6709\u610f\u306a\u5dee\u306f\u306a\u3044\u3068\u5831\u544a\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u30cc\u30eb\u7d50\u679c\u3092\u4fdd\u6301\u3059\u308b\u3068\u3001\u7279\u5178\u306e\u307f\u306e\u6982\u8981\u3088\u308a\u3082\u8a18\u9332\u304c\u6709\u76ca\u306b\u306a\u308a\u307e\u3059\u3002<\/p><p class=\"wp-block-paragraph\">\u73fe\u5728\u306e DailyMed \u306e\u30e9\u30d9\u30eb\u8868\u793a\u3067\u306f\u3001NDA 210557 \u306b\u57fa\u3065\u304f\u30d6\u30ec\u30e1\u30e9\u30ce\u30c1\u30c9\u6ce8\u5c04\u3068\u3057\u3066 Vyleesi \u304c\u7279\u5b9a\u3055\u308c\u3066\u304a\u308a\u3001\u91cd\u8981\u306a\u5b89\u5168\u6027\u60c5\u5831\u3068\u3057\u3066\u3001\u4e00\u904e\u6027\u306e\u8840\u5727\u4e0a\u6607\u3001\u5fc3\u62cd\u6570\u306e\u4f4e\u4e0b\u3001\u5410\u304d\u6c17\u3001\u5c40\u6240\u7684\u306a\u8272\u7d20\u6c88\u7740\u904e\u5270\u304c\u6319\u3052\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30e9\u30d9\u30eb\u306f\u627f\u8a8d\u3055\u308c\u305f\u88fd\u5264\u306b\u5c5e\u3057\u3066\u304a\u308a\u3001\u7814\u7a76\u30ab\u30bf\u30ed\u30b0\u306e\u54c1\u76ee\u306b\u306f\u5c5e\u3057\u307e\u305b\u3093\u3002<\/p><h2 class=\"wp-block-heading\">\u8a3c\u62e0\u304c\u8a3c\u660e\u3067\u304d\u306a\u3044\u3082\u306e<\/h2><p class=\"wp-block-paragraph\">\u8a3c\u62e0\u306e\u6bcd\u96c6\u56e3\u3068\u9069\u5fdc\u75c7\u306f\u5177\u4f53\u7684\u3067\u3059\u3002\u3088\u308a\u5e83\u7bc4\u306a\u6027\u7684\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306b\u95a2\u3059\u308b\u4e3b\u5f35\u306f\u652f\u6301\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<\/p><p class=\"wp-block-paragraph\">\u6975\u3081\u3066\u91cd\u8981\u306a\u8a66\u9a13\u306b\u306f\u696d\u754c\u304b\u3089\u306e\u8cc7\u91d1\u63d0\u4f9b\u304c\u3042\u3063\u305f\u3002<\/p><p class=\"wp-block-paragraph\">\u627f\u8a8d\u3055\u308c\u305f\u6d3b\u6027\u90e8\u5206\u306f\u3001\u72ec\u7acb\u3057\u3066\u8abf\u9054\u3055\u308c\u305f\u6750\u6599\u3092\u627f\u8a8d\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u30d6\u30ec\u30e1\u30e9\u30ce\u30c1\u30c9\u306b\u306f\u3001FDA \u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u5b9f\u969b\u306e\u5b8c\u6210\u54c1\u8a18\u9332\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u305d\u306e\u7bc4\u56f2\u306f\u72ed\u3044\u3067\u3059\u3002 RECONNECT \u8a66\u9a13\u3067\u306f\u3001\u5f8c\u5929\u6027\u306e\u5168\u8eab\u6027 HSDD \u3092\u6301\u3064\u9589\u7d4c\u524d\u306e\u5973\u6027\u3092\u7814\u7a76\u3057\u307e\u3057\u305f\u3002\u7537\u6027\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u5411\u4e0a\u3084\u4e00\u822c\u7684\u306a PT-141 \u7814\u7a76\u6750\u6599\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>","protected":false},"author":1,"featured_media":739,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pim_family_ids":"358","pim_article_type":"Published evidence review","pim_evidence_level":"Two randomized phase 3 trials plus current FDA-approved prescribing information","pim_reviewer":"Site evidence editorial team","pim_reviewed_date":"2026-09-02","pim_editorial_note":"Source-checked on 2026-09-02. Null results, study size, model\/population limits and relevant conflicts are retained. This is not medical advice, a customer case or validation of a catalog lot.","pim_review_status":"reviewed","pim_review_reason":"Primary\/regulatory sources, factual claims, numerical results, limitations and product-evidence boundary checked for batch 3.","pim_creation_method":"The editorial workflow began with linked PubMed primary papers, systematic reviews, PubChem identity records and FDA\/DailyMed regulatory records. Population or model, denominators, endpoints, numerical results, null findings, limitations and conflicts were extracted before drafting. AI-assisted drafting and original image generation were used; the final facts and evidence boundaries were checked against the linked records on 2026-09-02. This is not independent peer review.","pim_sources":"[{\"title\":\"RECONNECT bremelanotide phase 3 trials\",\"url\":\"https:\/\/pubmed.ncbi.nlm.nih.gov\/31599840\/\",\"note\":\"Primary phase 3 publication; PMID 31599840.\"},{\"title\":\"DailyMed Vyleesi prescribing information\",\"url\":\"https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf\",\"note\":\"Current FDA-approved finished-drug label.\"},{\"title\":\"PubChem Bremelanotide record\",\"url\":\"https:\/\/pubchem.ncbi.nlm.nih.gov\/compound\/Bremelanotide\",\"note\":\"Free-base peptide identity; CID 9941379.\"}]","footnotes":""},"categories":[19],"tags":[],"class_list":["post-755","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-published-study-cases"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bremelanotide RECONNECT Trials: Endpoints, Safety and FDA Scope<\/title>\n<meta name=\"description\" content=\"Bremelanotide has a real FDA-approved finished-drug record, but its scope is narrow. 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