{"id":85308,"date":"2026-04-27T22:33:33","date_gmt":"2026-04-27T22:33:33","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/efimosfermin-nabs-fda-breakthrough-status-for-potential-fibrosis-reversal-in-mash\/"},"modified":"2026-04-27T22:33:33","modified_gmt":"2026-04-27T22:33:33","slug":"efimosfermin-nabs-fda-breakthrough-status-for-potential-fibrosis-reversal-in-mash","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/efimosfermin-nabs-fda-breakthrough-status-for-potential-fibrosis-reversal-in-mash\/","title":{"rendered":"Efimosfermin nabs FDA breakthrough status for potential fibrosis reversal in MASH"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\" article__posted-date\">\n<p>April 27, 2026<\/p>\n<p>1 min read<\/p>\n<\/p><\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n            <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hgld\/healio_gastro.svg?la=en&amp;h=40&amp;w=152&amp;hash=2C654A538F2E250F5183D42A89FE0EC0\" class=\"logo-img\" height=\"40\" alt=\"Healio Logo - Gastroenterology\" width=\"152\"\/>\n          <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse uc31399db16fb4586af8196d7259f723c\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<h2>Key takeaways:<\/h2>\n<ul>\n<li>Phase 2 trial data show fibrosis improvement and MASH resolution with efimosfermin compared with placebo.<\/li>\n<li>Multiple phase 3 trials are underway or in development.<\/li>\n<\/ul>\n<p>The FDA granted breakthrough therapy designation to efimosfermin \u2014 an investigational, once-monthly fibroblast growth factor 21 analogue \u2014 for treatment of patients with metabolic dysfunction-associated steatohepatitis.<\/p>\n<p>According to a manufacturer press release, efimosfermin (GSK) is a liver therapy \u201cdesigned to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation and reverse liver fibrosis in patients with MASH.\u201d<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.jpg?w=800\" alt=\"Generic FDA News infographic\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      The FDA granted breakthrough therapy designation to efimosfermin \u2014 an investigational, once-monthly fibroblast growth factor 21 analogue \u2014 for treatment of patients with metabolic dysfunction-associated steatohepatitis.<\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>\u201cMASH affects millions of people worldwide and is one of the leading causes of liver transplant in the U.S. and Europe, but treatment options are limited for most and nonexistent for those with the most advanced form of disease,\u201d <b>Kaivan Khavandi<\/b><b>,<\/b><b> MD, PhD,<\/b> senior vice president and global head of translational and development sciences at GSK, said in the release.<\/p>\n<p>\u201cWe believe efimosfermin has the potential to significantly advance the standard of care by directly targeting liver fibrosis.\u201d<\/p>\n<p>The FDA based its decision on data from a randomized, phase 2 trial of patients with MASH with moderate to advanced and cirrhotic fibrosis.<\/p>\n<p>As Healio previously reported, results of the trial showed a higher proportion of patients who received efimosfermin vs. placebo had improvement in fibrosis by at least one stage without worsening of MASH (45.2% vs. 20.6%; <i>P<\/i> = .038).<\/p>\n<p>A greater proportion of patients who received efimosfermin also achieved MASH resolution without worsening of fibrosis (67.7% vs. 29.4%; <i>P<\/i> = .002).<\/p>\n<p>According to the release, the most common adverse events included nausea, diarrhea and vomiting, which were mild and transient.<\/p>\n<p>The ZENITH-1 and ZENITH-2 phase 3 trials are currently underway to assess efficacy and safety of efimosfermin among patients with MASH with F2\/F3 fibrosis. A phase 3 trial that includes patients with F4 fibrosis is expected to begin this year.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n    <span>Published by:<\/span><br \/>\n    <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hgld\/healio_gastro.svg?la=en&amp;h=40&amp;w=152&amp;hash=2C654A538F2E250F5183D42A89FE0EC0\" class=\"logo-img\" height=\"40\" alt=\"Healio Logo - Gastroenterology\" width=\"152\"\/>\n  <\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse uc31399db16fb4586af8196d7259f723c\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. 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