{"id":635889,"date":"2026-04-06T14:16:53","date_gmt":"2026-04-06T18:16:53","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=635889"},"modified":"2026-04-06T14:16:53","modified_gmt":"2026-04-06T18:16:53","slug":"fda-approves-foundayo","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-foundayo\/","title":{"rendered":"FDA approves new weight-loss pill Foundayo"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">A new weight-loss pill is poised to shake up the booming GLP-1 market and take on Novo Nordisk\u2019s blockbuster <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/wegovy\"><span style=\"font-weight: 400;\">Wegovy<\/span><\/a><span style=\"font-weight: 400;\">. The U.S. Food and Drug Administration has approved Foundayo (orforglipron), making it only the second GLP-1 pill cleared for weight loss in the United States. Developed by Eli Lilly and Co., the once-daily oral medication offers an alternative to injectable treatments and enters a fast-growing space dominated by drugs including Wegovy and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/zepbound\"><span style=\"font-weight: 400;\">Zepbound<\/span><\/a><span style=\"font-weight: 400;\">. Approved under the FDA\u2019s National Priority Voucher pilot program, Foundayo could expand access to GLP-1 therapies as demand for weight-loss medications continues to surge.<\/span><\/p>\n<h2 id=\"what-is-foundayo\"><span style=\"font-weight: 400;\">What is Foundayo?<\/span><\/h2>\n<p><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12898445\/\"><span style=\"font-weight: 400;\">Foundayo<\/span><\/a><span style=\"font-weight: 400;\"> (orforglipron) is an oral <\/span><a href=\"https:\/\/www.singlecare.com\/drug-classes\/glp-1-agonists\"><span style=\"font-weight: 400;\">glucagon-like peptide-1 (GLP-1) receptor agonist<\/span><\/a><span style=\"font-weight: 400;\"> that is indicated to be used in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long-term in adults with obesity or adults who are overweight in the presence of at least one weight-related comorbid condition. It is designed to help regulate appetite, slow digestion, and support weight loss. Like other medications in this class, it works by mimicking hormones that signal fullness and help control blood sugar.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Unlike earlier GLP-1 treatments that require injections, Foundayo is taken as a once-daily tablet and can be used with or without food. Treatment starts at 0.8 mg daily, with increases over time. After at least 30 days, the dose may be raised to 2.5 mg, then to 5.5 mg after another 30 days. If needed, patients can continue increasing to 9 mg, 14.5 mg, or 17.2 mg, with at least 30 days between each adjustment to assess tolerance, and hopefully, minimize side effects with dose increases. Dose increases should only be made under the supervision of the healthcare provider.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the 72-week <\/span><a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill\"><span style=\"font-weight: 400;\">ATTAIN-1 clinical trial<\/span><\/a><span style=\"font-weight: 400;\">, participants taking the highest dose of Foundayo lost an average of 27.3 pounds, compared with 2.2 pounds among those taking a placebo (inactive treatment).<\/span><\/p>\n<h2 id=\"why-this-approval-matters\"><span style=\"font-weight: 400;\">Why this approval matters<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The FDA\u2019s approval of Foundayo comes just months after the agency cleared <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/news\/fda-approval-wegovy-pill\/\"><span style=\"font-weight: 400;\">an oral version of Wegovy (semaglutide)<\/span><\/a><span style=\"font-weight: 400;\">, marking a notable shift in how GLP-1 medications can be used for weight loss. Until recently, these treatments were only available as injections. (Another oral form of semaglutide, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/rybelsus\"><span style=\"font-weight: 400;\">Rybelsus<\/span><\/a><span style=\"font-weight: 400;\">, has been available since 2019, but only for treating <\/span><a href=\"https:\/\/www.singlecare.com\/resources\/diabetes\"><span style=\"font-weight: 400;\">Type 2 diabetes<\/span><\/a><span style=\"font-weight: 400;\">.)<\/span><\/p>\n<p><span style=\"font-weight: 400;\">With Foundayo\u2019s approval, patients now have a second pill-based weight-loss option, a change that could broaden access and appeal. For some, the availability of a daily tablet may ease hesitation around starting treatment, particularly for those uncomfortable with injections.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In a statement released by Eli Lilly, Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, emphasized the added flexibility this option may offer.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;People living with obesity need treatment options that meet them where they are \u2013 and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment,&#8221; Horn said. &#8220;With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials \u2013 addressing both the clinical realities of obesity and the practical challenges patients face every day.&#8221;<\/span><\/p>\n<h2 id=\"cost-and-availability\"><span style=\"font-weight: 400;\">Cost and availability<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Patients won\u2019t have to wait long to access Foundayo. Eli Lilly and Company says the medication will begin shipping on <\/span><a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill\"><span style=\"font-weight: 400;\">April 6, 2026<\/span><\/a><span style=\"font-weight: 400;\">, making it quickly available to eligible patients in the U.S.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Pricing will vary depending on coverage. For self-pay customers, the starting 0.8 mg dose will cost $149 per month through the LillyDirect program. Patients with commercial insurance may pay as little as $25 per month when using the Foundayo Savings Card, if their plan covers the medication. These savings programs are not available to people enrolled in government-funded plans such as Medicare or Medicaid. SingleCare coupons can offer savings, with no eligibility requirements.<\/span><\/p>\n<h2 id=\"how-do-foundayo-and-wegovy-compare\"><span style=\"font-weight: 400;\">How do Foundayo and Wegovy compare?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">In late March, the <\/span><a href=\"https:\/\/apnews.com\/article\/glp1-weight-loss-healthy-habit-41e4c84a7fed9586057b9b49fc4738dc\"><span style=\"font-weight: 400;\">Associated Press<\/span><\/a><span style=\"font-weight: 400;\"> reported that oral Wegovy had already generated more than 600,000 prescriptions, signaling strong early demand for a pill-based GLP-1 option. Now, Foundayo is entering the same space, setting up the first real competition among oral weight-loss drugs in this class.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As oral GLP-1 medications begin to gain traction, patients and providers now have more than one pill-based option to consider. While separate clinical trials suggest oral semaglutide may lead to slightly higher average weight loss, those results aren\u2019t directly comparable. In a <\/span><a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head\"><span style=\"font-weight: 400;\">head-to-head study by Eli Lily<\/span><\/a><span style=\"font-weight: 400;\">, Foundayo showed superior weight loss.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">While both Foundayo and oral Wegovy aim to support weight loss, they differ in dosing flexibility, effectiveness, cost, and ease of use, all factors that may shape real-world decisions. Here\u2019s how the two compare.<\/span><\/p>\n<table class=\" singlecare-table\" role=\"table\">\n<thead>\n<tr>\n<th class=\"title\" role=\"columnheader\" colspan=\"3\" scope=\"col\">\n<h2 id=\"foundayo-vs-wegovy\"><span style=\"font-weight: 400;\">Foundayo vs. Wegovy<\/span><\/h2>\n<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr class=\"header-row\">\n<td><b>Feature<\/b><\/td>\n<td><b>Foundayo<\/b><\/td>\n<td><b>Wegovy<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Drug class<\/span><\/td>\n<td><span style=\"font-weight: 400;\">GLP-1 receptor agonist (small-molecule, nonpeptide)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">GLP-1 receptor agonist\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Dosing restrictions<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Can be taken any time of day with or without food<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Must be taken on an empty stomach before eating<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Price<\/span><\/td>\n<td>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Self-pay starting price is $149\/month<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">As low as $25 per month with commercial coverage and a manufacturer savings card<\/span><\/li>\n<\/ul>\n<\/td>\n<td>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Self-pay price starting at $149 per month (lower doses); up to ~$299 at higher doses<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">As low as $25 per month with savings programs<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Average weight loss<\/span><\/td>\n<td><a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill\"><span style=\"font-weight: 400;\">12.4%<\/span><\/a><span style=\"font-weight: 400;\"> at the highest dose (27.3 pounds over 72 weeks)<\/span><\/td>\n<td><a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head\"><span style=\"font-weight: 400;\">5.3%<\/span><\/a><span style=\"font-weight: 400;\"> at a 14 mg dose (11 pounds over 52 weeks)<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 id=\"bottom-line\"><span style=\"font-weight: 400;\">Bottom line<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Foundayo may be the latest GLP-1 medication to reach the U.S. market, but it likely won\u2019t be the last. A growing <\/span><a href=\"https:\/\/www.nature.com\/articles\/s41366-024-01473-y\"><span style=\"font-weight: 400;\">pipeline<\/span><\/a><span style=\"font-weight: 400;\"> of obesity treatments, including next-generation options like Eli Lilly\u2019s triple agonist <\/span><a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lillys-triple-agonist-retatrutide-delivered-weight-loss-average\"><span style=\"font-weight: 400;\">retatrutide<\/span><\/a><span style=\"font-weight: 400;\">, signals that more choices, and potentially more effective ones, are on the way.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For now, having multiple oral GLP-1 options could make treatment more accessible and appealing. Still, these medications aren\u2019t one-size-fits-all. Anyone considering a GLP-1 should talk with a healthcare provider to weigh factors such as overall health, weight-loss goals, cost, and long-term use.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Safety matters, too. Foundayo, like other drugs in this class, isn\u2019t appropriate for people with certain thyroid cancers and can cause <\/span><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12270588\/\"><span style=\"font-weight: 400;\">side effects<\/span><\/a><span style=\"font-weight: 400;\"> ranging from mild gastrointestinal issues to more serious risks such as pancreatitis, stomach problems, and low blood sugar.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A new weight-loss pill is poised to shake up the booming GLP-1 market and take on Novo Nordisk\u2019s blockbuster Wegovy. The U.S. Food and Drug Administration has approved Foundayo (orforglipron), making it only the second GLP-1 pill cleared for weight loss in the United States. Developed by Eli Lilly and Co., the once-daily oral medication [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":635890,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[4141,21067,9825],"coauthors":[9482],"class_list":["post-635889","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approvals","tag-glp-1-drugs","tag-weight-loss","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves Foundayo as second GLP-1 weight-loss pill<\/title>\n<meta name=\"description\" content=\"The FDA has approved Foundayo (orforglipron), the second GLP-1 weight-loss pill. 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