FDA clears oral Wegovy
The FDA approved oral semaglutide (Wegovy) for chronic weight management, marking the first GLP‑1 pill cleared for this use—Phase III data showed substantial weight loss and cardiometabolic benefit. This widens access to GLP‑1 therapy and signals a likely shift in adherence patterns and demand across metabolic‑health channels. (appliedclinicaltrialsonline.com)
The FDA decision was announced in a Novo Nordisk press release dated Dec. 22, 2025, and the company said it was prepared for a full U.S. launch in early January 2026. (prnewswire.com) Novo Nordisk offered a cash-pay entry price for a 1.5 mg starter dose at $149 per month with savings offers, and stated tablets are being produced in North Carolina with “robust supply on‑hand.” (prnewswire.com) The pivotal OASIS 4 phase 3 trial randomized 307 adults and reported a mean body‑weight change at week 64 of about −14% with oral semaglutide versus −2% with placebo in the primary analysis. (acc.org) Novo’s trial reporting additionally noted an estimated ~16.6% mean weight loss if all patients remained on treatment and ~13.6% when analyzed regardless of treatment continuation. (prnewswire.com) Cardiometabolic signals in OASIS 4 included improvements in glycated hemoglobin, lipids and C‑reactive protein, and the label/press materials state the tablet is indicated to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established CVD. (acc.org) Adverse events were predominantly gastrointestinal (reported in ~74% of oral semaglutide participants versus ~42% with placebo) with trial discontinuations of 7% versus 6%, and prescribing information carries a boxed warning about thyroid C‑cell tumors based on rodent findings. (acc.org) Novo reported the Wegovy brand has been prescribed to roughly 3.2 million people in the U.S. historically, and the company said more than 170,000 U.S. patients were taking the Wegovy pill within weeks after the launch. (prnewswire.com)
