An oral version of semaglutide, the drug marketed as Ozempic and Wegovy, led to dramatic weight loss in a trial enrolling people with obesity, manufacturer Novo Nordisk said Monday, data that could bolster what is already a blockbuster medicine.
In the study, which enrolled nearly 700 adults classified as having overweight or obesity, patients treated with a daily semaglutide tablet lost 15.1% of their body weight over the course of 17 months, while those on placebo lost 2.4%, Novo Nordisk said. The result is comparable to weekly injections of Wegovy, which in an earlier study led to 14.9% weight loss over the same period of time. In both studies, the most common side effects were gastrointestinal distress, with the majority of cases graded mild or moderate, the company said.
Novo Nordisk said it plans to submit oral semaglutide for U.S. and E.U. approvals later this year. A lower-dose version of the drug is already approved as a treatment for type 2 diabetes under the brand name Rybelsus.
Wegovy has been a runaway success since winning Food and Drug Administration approval in 2021, bringing in more than $2 billion for Novo Nordisk last year and helping usher in what many see as a sea change in obesity treatment. Adding an oral option would give the company “the first safe, highly efficacious weight-loss pill ever marketed,” TD Cowen analyst Michael Nedelcovych wrote in a note to investors Monday.
But that’s only if Novo Nordisk can consistently meet demand. The company has recently struggled to manufacture enough semaglutide, whether oral or injectable. The drug experienced monthslong shortages in 2022, and while Novo Nordisk predicted that all doses would be available at the start of this year, the company recently paused advertising “to avoid stimulating further demand for this medicine.” Earlier this month, Novo Nordisk said it would start limiting starter doses for new patients to ensure a steady supply for people already on the drug.
Accordingly, the future commercialization of oral semaglutide is “contingent on portfolio prioritizations and manufacturing capacity,” Novo Nordisk said in a statement.
Wegovy is part of a powerful class of medicines that curb appetite and slow the emptying of the stomach. Called incretin mimetics, they first found use in diabetes before demonstrating unprecedented effects in studies enrolling people diagnosed with obesity.
Novo Nordisk has dominated the market but will soon face a formidable competition from Eli Lilly’s Mounjaro, a medicine currently approved for diabetes that has potential for even greater weight loss. Pfizer, Amgen, and others are at work on rival treatments that promise to be more potent, convenient, or tolerable.
Wall Street analysts expect the market for such medicines to reach $100 billion a year by the end of the decade.
