{"id":5130,"date":"2024-09-04T15:49:00","date_gmt":"2024-09-04T10:19:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=5130"},"modified":"2025-02-05T17:08:16","modified_gmt":"2025-02-05T11:38:16","slug":"nash-emerging-therapies","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies","title":{"rendered":"NASH Emerging Therapies: The Path Forward"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69ff82a75e205\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69ff82a75e205\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#Emerging_Therapies_in_the_NASH_Pipeline\" >Emerging Therapies in the NASH Pipeline<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#Lanifibranor_Inventiva_Pharma\" >Lanifibranor: Inventiva Pharma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#MSDC-0602K_Cirius_Therapeutics\" >MSDC-0602K: Cirius Therapeutics<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#TERN-501_Terns_Pharmaceuticals\" >TERN-501: Terns Pharmaceuticals<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#HTD_1801_HighTide_Biopharma\" >HTD 1801: HighTide Biopharma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#Thiazolidinediones_TZD_Pioglitazone_and_Rosiglitazone\" >Thiazolidinediones (TZD): Pioglitazone and Rosiglitazone<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#Efruxifermin_EFX_Akero_Therapeutics\" >Efruxifermin (EFX, Akero Therapeutics)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/nash-emerging-therapies\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>If you\u2019ve been keeping up with our previous posts, you already have a solid understanding of <a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-market\" class=\"ek-link\">nonalcoholic steatohepatitis (NASH)<\/a> and its impact. We\u2019ve previously examined the dominance of off-label therapies in the NASH therapeutics market and the challenges associated with this approach. In this post, we\u2019ll take a deeper dive into the future of NASH treatments, exploring emerging therapies and innovations that could reshape the landscape in the years to come.<\/p>\n\n\n\n<p><strong>In 2024,<\/strong> the world witnessed a significant milestone with the approval of<strong> REZDIFFRA (resmetirom), <\/strong>the first drug specifically designed to treat nonalcoholic steatohepatitis (NASH) in adults. NASH, a severe form of fatty liver disease, can progress to liver scarring, dysfunction, cirrhosis, and ultimately liver failure. REZDIFFRA, a daily oral medication, works by activating a thyroid hormone receptor to reduce liver fat accumulation. The FDA granted its approval for adults with moderate to advanced liver scarring, to be used alongside diet and exercise.<\/p>\n\n\n\n<p>Approved under the FDA&#8217;s accelerated approval pathway, which expedites the availability of treatments for serious conditions, REZDIFFRA represents a major breakthrough in liver health. Its approval is seen as a pivotal moment that could pave the way for additional NASH therapies. Given the immense unmet need for effective treatments for this widespread and devastating disease, researchers and scientists are actively pursuing therapies that specifically target NASH. According to estimates from DelveInsight, several promising drugs are expected to be launched in the coming years. Key players in the NASH market include Inventiva Pharma, Zydus Therapeutics, Novo Nordisk A\/S, Eli Lilly and Company, Madrigal Pharmaceuticals, Inc., Terns, Inc., Intercept Pharmaceuticals, Enyo Pharma, 89bio, Inc., Akero Therapeutics, Inc., and others.<\/p>\n\n\n\n<p>In 2023, prominent liver disease organizations, including the <strong>American Association for the Study of Liver Diseases (AASLD)<\/strong> and the <strong>European Association for the Study of the Liver (EASL)<\/strong>, officially redefined <strong>Nonalcoholic Steatohepatitis (NASH)<\/strong> to <strong>Metabolic Dysfunction-Associated Steatohepatitis (MASH)<\/strong>, aligning the name more closely with its metabolic roots. For the most up-to-date insights, explore our comprehensive<a href=\"https:\/\/www.delveinsight.com\/report-store\/metabolic-dysfunction-associated-steatohepatitis-mash-market\"> <strong>MASH Market Report<\/strong><\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-emerging-therapies-in-the-nash-pipeline\"><span class=\"ez-toc-section\" id=\"Emerging_Therapies_in_the_NASH_Pipeline\"><\/span>Emerging Therapies in the NASH Pipeline<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>With the rising <strong>prevalence of nonalcoholic steatohepatitis<\/strong> and the severe complications it can lead to, the need for effective treatments has never been more critical. While the development of new therapeutics for NASH has faced numerous challenges, recent advancements have brought promising candidates to the forefront. As we look ahead, several emerging therapies are poised to potentially revolutionize NASH treatment, offering hope to millions affected by this condition. Here\u2019s a closer look at some key drugs in the pipeline.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-lanifibranor-inventiva-pharma\"><span class=\"ez-toc-section\" id=\"Lanifibranor_Inventiva_Pharma\"><\/span>Lanifibranor: Inventiva Pharma<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Lanifibranor, Inventiva\u2019s lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPAR\u03b1 and PPAR\u03b4, and a partial activation of PPAR\u03b3. While other PPAR agonists target only one or two PPAR isoforms for activation. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH. Currently, the drug is in Phase III stage of its clinical trial for the treatment of NASH.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-msdc-0602k-cirius-therapeutics\"><span class=\"ez-toc-section\" id=\"MSDC-0602K_Cirius_Therapeutics\"><\/span>MSDC-0602K: Cirius Therapeutics<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>MSDC-0602K, a second-generation oral insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC) while minimizing direct PPAR-gamma activation. The MPC mediates at the cellular level the effects of over nutrition, a major cause of Nonalcoholic fatty liver disease NAFLD\/NASH and Type 2 diabetes. In preclinical studies, modulation of the MPC has been shown to improve insulin sensitivity, lipid metabolism, and inflammation. Currently the drug is in Phase III stage of Clinical trial for the treatment of NASH.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-tern-501-terns-pharmaceuticals\"><span class=\"ez-toc-section\" id=\"TERN-501_Terns_Pharmaceuticals\"><\/span>TERN-501: Terns Pharmaceuticals<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>TERN-501 is a THR-\u03b2 agonist with high metabolic stability, enhanced liver distribution and greater selectivity for THR-\u03b2 compared to other THR-\u03b2 agonists in development. Agonism of THR-\u03b2 increases fatty acid metabolism via mitochondrial oxidation and affects cholesterol synthesis and metabolism. As a result, THR-\u03b2 stimulation has the ability to reduce hepatic steatosis and improve serum lipid parameters including LDL cholesterol and triglycerides. In vivo NASH studies in a rodent model have demonstrated that low-doses of TERN-501 achieved complete resolution of steatosis and reductions in serum lipids, hepatic inflammation and fibrosis. TERN-501 has high liver distribution and is 23-fold more selective for THR-\u03b2 than for THR-\u03b1 activation in a cell free assay, thereby minimizing the risk of cardiotoxicity and other off-target effects associated with non-selective THR stimulation. Currently, the drug is in Phase II stage of its clinical trial for the treatment of NASH.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"393\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-1024x393.png\" alt=\"Emerging Therapies for Nonalcoholic Steatohepatitis\" class=\"wp-image-30045\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-1024x393.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-300x115.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-150x58.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-768x295.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-1536x590.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/10\/14162034\/Emerging-Therapies-for-Nonalcoholic-Steatohepatitis-2048x787.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-htd-1801-hightide-biopharma\"><span class=\"ez-toc-section\" id=\"HTD_1801_HighTide_Biopharma\"><\/span>HTD 1801: HighTide Biopharma<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The company&#8217;s lead drug candidate, HTD1801, is a first-in-class new molecular entity (ionic salt of two active moieties). It is a novel orally active ionic salt of berberine and ursodeoxycholic acid, substantially reduced liver fat while improving glycemic control and other cardiometabolic biomarkers in adults with nonalcoholic steatohepatitis (NASH) and type 2 diabetes (T2DM). Currently, it is in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-thiazolidinediones-tzd-pioglitazone-and-rosiglitazone\"><span class=\"ez-toc-section\" id=\"Thiazolidinediones_TZD_Pioglitazone_and_Rosiglitazone\"><\/span>Thiazolidinediones (TZD): Pioglitazone and Rosiglitazone<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>TZDs, including pioglitazone and rosiglitazone, are PPAR\u03b3 agonists primarily located in adipose tissue, where they play a crucial role in regulating adipocyte differentiation, adipogenesis, and lipid metabolism. They have been shown to improve glucose uptake, increase fatty acid oxidation, and enhance insulin secretion, leading to improved insulin sensitivity. A novel dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 receptor agonist. In a Phase II trial, tirzepatide showed promising results in reducing liver fat content and improving markers of liver injury in <a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-epidemiology-forecast\">NASH patients<\/a>. It is currently in Phase III trials.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-efruxifermin-efx-akero-therapeutics\"><span class=\"ez-toc-section\" id=\"Efruxifermin_EFX_Akero_Therapeutics\"><\/span>Efruxifermin (EFX, Akero Therapeutics)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Efruxifermin is a fusion protein combining the human IgG1 Fc domain with a modified human FGF21 (Fc-FGF21), designed to balance in vitro agonist potency at FGFR1c, FGFR2c, and FGFR3c. Efruxifermin has a longer half-life of 3\u20133.5 days compared to most FGF21 analogs. Initially studied in patients with Type 2 Diabetes (T2D), it demonstrated improvements in lipoprotein profiles and glycemic control, which led to further investigation in NASH patients. The drug aims to mimic the metabolic benefits of FGF21, a key regulator of metabolism. In a Phase IIa trial, EFX showed significant improvements in liver fat content, liver enzymes, and markers of fibrosis in NASH patients. Currently, it is being evaluated in Phase IIb trials, focusing on the safety and efficacy of weekly subcutaneous administration for 16 weeks.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-conclusion\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-market\">NASH market<\/a> is witnessing intense competition as numerous pharmaceutical companies strive to secure a significant market share. The anticipated launch of new and emerging drugs is expected to propel the market forward, addressing the substantial unmet needs in this area. Regulatory bodies also play a crucial role by offering special designations to promising therapies and encouraging their development. A comprehensive analysis of the strengths and weaknesses of these late-stage pipeline products and their potential impact on sales will be vital for ensuring their commercial success. Ultimately, the rising prevalence of NASH, increased disease awareness, and the promising pipeline of emerging therapies are poised to expand the market in the coming years significantly.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-market\"><img decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner-1024x194.png\" alt=\"Nonalcoholic-Steatohepatitis-Market-Banner\" class=\"wp-image-29437\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner-1024x194.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner-300x57.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner-150x28.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner-768x145.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner-1536x291.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/04173852\/Nonalcoholic-Steatohepatitis-Market-Banner.png 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>If you\u2019ve been keeping up with our previous posts, you already have a solid understanding of nonalcoholic steatohepatitis (NASH) and its impact. We\u2019ve previously examined the dominance of off-label therapies in the NASH therapeutics market and the challenges associated with this approach. In this post, we\u2019ll take a deeper dive into the future of NASH [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":29417,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[1469,1450,1451,4185,4184,4186,2316],"industry":[17225],"therapeutic_areas":[17239],"class_list":["post-5130","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-nash","tag-nash-cirrhosis","tag-nash-decompensated-cirrhosis","tag-nash-market-share","tag-nash-market-size","tag-nash-treatments","tag-nonalcoholic-steatohepatitis-nash","industry-pharmaceutical","therapeutic_areas-gastroenterology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin 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