Novo Nordisk filed for approval of an oral, 25-mg formulation of its weight loss blockbuster “earlier this year,” according to a company spokesperson.
Novo Nordisk has filed for U.S. approval of an oral version of its widely popular GLP-1 drug semaglutide, a spokesperson confirmed to BioSpace on Saturday.
In an email, the spokesperson said that the company filed an application for 25-mg semaglutide “earlier this year,” proposing its use for overweight or obesity. “This is the first application and potential approval of a GLP-1 in a pill for weight loss,” the spokesperson wrote, adding that Novo will reveal more details regarding this filing during its upcoming Q1 presentation, scheduled for May 7.
This news comes after Eli Lilly last week released Phase III data for its oral obesity candidate orforglipron, demonstrating what BMO Capital Markets called “injectable like efficacy” in patients with type 2 diabetes. A once-daily 36-mg dose of orforglipron suppressed blood glucose levels by 1.5% at 40 weeks, as compared with 0.1% in the placebo group, as per Lilly’s April 17 release. Body weight dropped by 7.9% over this time frame versus 1.6% in placebo comparators.
In an interview on Fox Business last week, Lilly CEO David Ricks said the pharma is ready to launch orforglipron at scale worldwide, without supply interruptions. To that end, the company has committed to producing the drug in the U.S., for which it is building what Ricks called the “largest” active pharmaceutical manufacturing factory “in history in the country.”
Lilly is planning to file for approval for chronic weight management “by the end of the year” with a potential “launch in ’26,” Ricks said. Thereafter, the pharma will also study orforglipron in “dozens” of other indications, including inflammation and joint pain.
In its email to BioSpace, the Novo spokesperson noted that the Danish pharma has long had an oral GLP-1: Rybelsus, an early brand of semaglutide, was approved for oral dosing in September 2019 for patients with type 2 diabetes. More recently, Novo is marketing semaglutide as Ozempic for type 2 diabetes and Wegovy for obesity, though these are indicated as subcutaneous injections.
Novo has also established the efficacy of oral semaglutide as an obesity therapy, with a May 2023 readout demonstrating that a 50-mg dose could cut body weight by roughly 15% over 68 weeks, as compared with placebo.
Trying to stay ahead of the competition, Novo is also developing a next-generation weight-loss pill, a long-acting agonist of the GLP-1 and amylin receptors. A data drop in September 2024 showed that the investigational treatment could cut body weight by 13% at 12 weeks, an effect the study’s investigators said was “remarkable” and “significantly greater” than that in placebo counterparts.
