{"id":12065,"date":"2026-09-11T14:26:21","date_gmt":"2026-09-11T14:26:21","guid":{"rendered":"https:\/\/www.musclestationth.com\/?p=12065"},"modified":"2026-09-11T14:26:21","modified_gmt":"2026-09-11T14:26:21","slug":"ss-31","status":"publish","type":"post","link":"https:\/\/www.musclestationth.com\/en\/ss-31\/","title":{"rendered":"SS-31: Elamipretide and the Forzinity approval"},"content":{"rendered":"<p>SS-31 is a name used for elamipretide, a peptide developed in mitochondrial research. In 2025, the US FDA granted accelerated approval to Forzinity for a specific Barth syndrome indication. That decision does not approve every vial labelled SS-31.<\/p><h2>What the research shows<\/h2><p>Forzinity&#x27;s indication covers improving muscle strength in adults and children with Barth syndrome weighing at least 30 kg. The accelerated decision used knee muscle strength as a surrogate endpoint and requires confirmatory clinical evidence. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-first-treatment-barth-syndrome\">[1]<\/a> <a href=\"https:\/\/www.fda.gov\/drugs\/drug-trials-snapshots\/drug-trials-snapshots-forzinity\">[2]<\/a><\/p><h2>Distinguishing substances and products<\/h2><p>Forzinity evidence should not be extended to general energy, fatigue or anti-ageing promises. It also does not establish Thai registration or the quality of another manufacturer&#x27;s product.<\/p><h3>Reading a specific brand\u2019s label<\/h3><p>Start with the exact substance and product name, then match the label to the manufacturer\u2019s documents. This article does not establish Thai registration or current availability for an unspecified product.<\/p><h2>Frequently asked questions<\/h2><h3>Is there an approved elamipretide product?<\/h3><p>Yes. US approval of Forzinity concerns a specific Barth syndrome indication, not all SS-31 products.<\/p><h3>What does accelerated approval mean here?<\/h3><p>The FDA relied on a surrogate endpoint and requires further confirmation of clinical benefit.<\/p><h3>What information helps identify a specific product?<\/h3><p>The brand, product name, full label and matching manufacturer documents. Evidence about the substance alone does not establish a product\u2019s identity, registration or quality.<\/p><h2>Related information<\/h2><ul><li><a href=\"https:\/\/www.musclestationth.com\/en\/mots-c\/\">MOTS-c and mitochondrial research<\/a><\/li><li><a href=\"https:\/\/www.musclestationth.com\/en\/product-category\/type\/peptide\/\">Peptide category and existing listings<\/a><\/li><\/ul><p>For general questions about names or label details, contact <a href=\"https:\/\/line.me\/R\/ti\/p\/@musclestationth\">LINE: @musclestationth<\/a><\/p><h2>Sources and review date<\/h2><ol><li><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-first-treatment-barth-syndrome\">FDA \u2014 Forzinity accelerated approval, 2025<\/a><\/li><li><a href=\"https:\/\/www.fda.gov\/drugs\/drug-trials-snapshots\/drug-trials-snapshots-forzinity\">FDA \u2014 Forzinity trial snapshot<\/a><\/li><\/ol><p class=\"scope\">Sources checked: 11 September 2026. This page explains selected primary sources; it is not a systematic review of every study.<\/p>","protected":false},"excerpt":{"rendered":"<p>SS-31 is a name used for elamipretide, a peptide developed in mitochondrial research. In 2025, the US FDA granted accelerated approval to Forzinity for a specific Barth syndrome indication. That decision does not approve every vial labelled SS-31.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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href=\"https:\/\/www.musclestationth.com\/en\/category\/uncategorized\/\" rel=\"category tag\">Uncategorized<\/a>","rttpg_excerpt":"SS-31 \u0e40\u0e1b\u0e47\u0e19\u0e0a\u0e37\u0e48\u0e2d\u0e17\u0e35\u0e48\u0e43\u0e0a\u0e49\u0e40\u0e23\u0e35\u0e22\u0e01 elamipretide \u0e40\u0e1b\u0e1b\u0e44\u0e17\u0e14\u0e4c\u0e17\u0e35\u0e48\u0e16\u0e39\u0e01\u0e1e\u0e31\u0e12\u0e19\u0e32\u0e40\u0e01\u0e35\u0e48\u0e22\u0e27\u0e01\u0e31\u0e1a\u0e01\u0e32\u0e23\u0e17\u0e33\u0e07\u0e32\u0e19\u0e02\u0e2d\u0e07\u0e44\u0e21\u0e42\u0e17\u0e04\u0e2d\u0e19\u0e40\u0e14\u0e23\u0e35\u0e22 FDA \u0e2a\u0e2b\u0e23\u0e31\u0e10\u0e2f \u0e2d\u0e19\u0e38\u0e21\u0e31\u0e15\u0e34\u0e1c\u0e25\u0e34\u0e15\u0e20\u0e31\u0e13\u0e11\u0e4c Forzinity \u0e41\u0e1a\u0e1a\u0e40\u0e23\u0e48\u0e07\u0e23\u0e31\u0e14\u0e43\u0e19\u0e1b\u0e35 2025 \u0e2a\u0e33\u0e2b\u0e23\u0e31\u0e1a\u0e42\u0e23\u0e04 Barth syndrome \u0e15\u0e32\u0e21\u0e02\u0e49\u0e2d\u0e1a\u0e48\u0e07\u0e43\u0e0a\u0e49\u0e40\u0e09\u0e1e\u0e32\u0e30 \u0e44\u0e21\u0e48\u0e43\u0e0a\u0e48\u0e01\u0e32\u0e23\u0e2d\u0e19\u0e38\u0e21\u0e31\u0e15\u0e34\u0e2a\u0e34\u0e19\u0e04\u0e49\u0e32\u0e17\u0e38\u0e01\u0e02\u0e27\u0e14\u0e17\u0e35\u0e48\u0e23\u0e30\u0e1a\u0e38 SS-31","_links":{"self":[{"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/posts\/12065","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/comments?post=12065"}],"version-history":[{"count":1,"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/posts\/12065\/revisions"}],"predecessor-version":[{"id":12077,"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/posts\/12065\/revisions\/12077"}],"wp:attachment":[{"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/media?parent=12065"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/categories?post=12065"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.musclestationth.com\/en\/wp-json\/wp\/v2\/tags?post=12065"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}