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Eli Lilly, the GLP-1 maker behind Mounjaro and Zepbound, said it would file for Food and Drug Administration approval of its powerful retatrutide weight-loss drug after studies found participants lost an average of nearly 56 pounds after 80 weeks on the medication.<\/p>\n
Eli Lilly says it plans to file for regulatory approval for retatrutide. (Photo by Smith Collection\/Gado\/Getty Images)<\/p>\n
Gado via Getty ImagesKey Facts<\/p>\n
Lilly announced<\/a> the results of two phase 3 trials on Thursday, saying it will file for FDA approval of the drug\u2014potentially adding another GLP-1 to its lineup\u2014in the first quarter of 2027.<\/p>\n One study of adults with severe obesity showed an average weight loss of 22.6%, or 55.8 pounds, after 80 weeks, while another study of adults with obesity and diabetes showed participants lost an average of 20.8% of their weight, or about 49.6 pounds.<\/p>\n The study also found \u201cmajor adverse cardiovascular events\u201d\u2014like heart attack or failure\u2014occurred \u201cless frequently than anticipated.\u201d<\/p>\n Retatrutide is considered likely the most powerful weight loss drug yet, as it targets multiple hormones\u2014GLP-1, GIP and glucagon\u2014that impact appetite and metabolism, whereas other drugs currently on the market target one or two of those hormones. <\/p>\n Approval of the drug would be a win for Lilly as it tries to maintain dominance over the GLP-1 market, where it has already overtaken rival company Novo Nordisk, manufacturer of Ozempic and Wegovy.<\/p>\n How Big Could Retatrutide Be?<\/p>\n Analysts have suggested retatrutide could become a blockbuster weight loss drug if approved. In January, TD Cowen analysts estimated<\/a> retatrutide could generate $3.8 billion in sales in 2030, while GlobalData forecasts sales of $15.6 billion by 2031. Demand for the drug is already so intense some people have turned to an online black market, facilitated through WhatsApp or other websites, to buy what sellers say is retatrutide from Chinese labs, the New York Times<\/a> reported. <\/p>\n tangent<\/p>\n Novo Nordisk sued<\/a> Eli Lilly on Tuesday, accusing the company of using outdated studies in its advertisements that exaggerate the efficacy of Lilly\u2019s products. The suit accused Lilly of demonstrating a \u201cnationwide pattern of deceptive advertising,\u201d saying one of its ad campaigns uses an outdated dose of Novo\u2019s Wegovy to compare it unfavorably to Lilly\u2019s Zepbound. Novo\u2019s suit seeks a permanent injunction from the court that would require Lilly to pull \u201cmisleading comparative advertising\u201d campaigns and conduct a \u201ccorrective advertising campaign.\u201d<\/p>\n key background<\/p>\n Lilly and Novo are chief rivals in the GLP-1 market, but Lilly now captures a greater share of prescriptions, CNN reported<\/a> in February. BMO analysts<\/a> said last year they expected Lilly\u2019s drugs to \u201ccontinue to take incremental U.S. share from Novo\u2019s\u201d GLP-1 medications. \u201cWhile Novo had the headstart with approval of semaglutide, we believe that this first mover advantage has waned, with Lilly’s tirezepatide taking share rapidly,\u201d the analysts wrote, adding Lilly\u2019s dominance could accelerate with retatrutide. CNBC reported<\/a> in February Novo Nordisk was bracing for a 5% to 13% decline in sales and profit for 2026, while Lilly expected about a 25% boost in sales. Earlier this year, Novo Nordisk said it would slash prices<\/a> on its flagship medications in 2027 as it tries to win over customers.<\/p>\n further reading<\/p>\n