The Food and Drug Administration on Monday approved an oral version of Novo Nordisk’s weight loss medication Wegovy, setting off the next phase of a high-stakes battle with rival Eli Lilly for control of the lucrative obesity drug market.
The approval marks a paradigm shift in obesity treatment. The market is currently dominated by weekly injections that can spur significant weight loss. The pill forms of those drugs appear to be somewhat less potent, but are more convenient to take and could substantially broaden use. Combined, injectable and oral drugs from this “GLP-1” class are expected by Wall Street analysts to generate annual sales of more than $100 billion by 2030.
Novo will have a head start with oral Wegovy, which will be launched in early January. But it could be joined swiftly by Eli Lilly’s experimental pill orforglipron, which succeeded in late-stage testing this year and may be approved within weeks thanks to a “national priority” voucher awarded by the FDA.
“The pill is here,” said Novo CEO Mike Doustdar in a statement. “No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the U.S.”
Pressured by President Trump, the FDA and other federal health agencies have intensely focused on expanding the number of available obesity medications as well as access to them. Novo and Lilly also reached deals with the White House to cut the prices of their medications for some Medicare beneficiaries and those willing to pay cash. As part of those negotiations, they pledged to price the starter doses of their oral drugs at $149 a month, too.
For Novo, the arrival of oral Wegovy comes after a series of setbacks that have depressed its share price and seen the company lose its leading position to Lilly. It’s also the result of a strategic shift. The Wegovy pill, a higher-dose version of an oral GLP-1 it sells as Rybelsus for diabetes, successfully concluded multiple Phase 3 trials in 2023. But Novo sidelined regulatory submissions at the time as it struggled to meet the surging demand for GLP-1 drugs.
Novo had also prioritized an experimental dual-acting injectable drug, only to see that therapy and another oral drug prospect generate disappointing study data. Though that dual-acting drug, CagriSema, has since been submitted to regulators, Novo has also accumulated more data for oral Wegovy and moved ahead with a filing.
Novo’s Phase 3 trials, called OASIS, tested oral Wegovy at doses reaching 50 milligrams a day. The last to report results, OASIS-4, showed that the 25 milligram dose approved Monday helped people with obesity or are overweight and have related health complications lose an average of 14% of their body weight over 71 weeks, or 17% in those who fully adhered to treatment plans.
Over the course of a week, seven 25 milligram daily doses of a Wegovy pill would amount to more than 50 times the 2.4 milligrams packed into the highest-dose weekly injection. That difference is necessitated by the difficulty of delivering a peptide drug like Wegovy through the digestive system.
By comparison, orforglipron is a chemical, or “small molecule,” drug, which requires less complex manufacturing. In clinical trials, the highest daily dose tested was 36 milligrams.
