United States: US regulators have approved the first daily pill for the treatment of obesity to significantly broaden access to weight-loss medicines and reshape a market long dominated by injectable drugs.
The Food and Drug Administration cleared an oral version of Wegovy, giving Novo Nordisk a decisive early advantage over rival Eli Lilly in the race to launch an obesity pill. Lilly’s oral candidate, orforglipron, remains under regulatory review.
The newly approved pill uses semaglutide, the same active ingredient found in Novo Nordisk’s injectable Wegovy and Ozempic, as well as in the diabetes pill Rybelsus. Like other GLP-1 drugs, it works by mimicking a natural hormone that suppresses appetite and increases feelings of fullness.
Injectable GLP-1 medicines have transformed obesity care in recent years, particularly in the United States, where around 100 million people are affected by the disease. However, high costs and the need for weekly injections have limited uptake. Health experts say an oral option could bring treatment to a much wider group of patients.
Novo Nordisk said the pill version of Wegovy would be available within weeks. Clinical trial data showed that patients taking oral Wegovy lost an average of 13.6 per cent of their body weight over roughly 15 months, compared with a 2.2 per cent reduction among those given a placebo. The results were close to those seen with injectable Wegovy, which has produced an average weight loss of about 15 per cent.
#PRESS The first GLP-1 pill for the treatment of obesity is now approved by the US Food and Drug Administration (FDA).
Learn more in our company announcement here: https://t.co/w9RVHx6Suy pic.twitter.com/p7wfdvXi0O
— Novo Nordisk (@novonordisk) December 22, 2025
Trial participants reported reduced appetite and fewer food cravings. One participant, a Wisconsin-based physician, lost about 40 pounds during the study after starting the daily pill.
Lilly’s competing drug has also demonstrated strong results. In trials, patients taking the highest dose of orforglipron lost an average of 11.2 per cent of their body weight over nearly 17 months, compared with 2.1 per cent for those on a placebo. That performance, however, falls short of Lilly’s injectable Zepbound, which has delivered an average weight loss of about 21 per cent by targeting two gut hormones. Side effects for oral and injectable GLP-1 drugs are broadly similar, with nausea and diarrhea among the most common complaints.
The Wegovy pill must be taken in the morning with a small amount of water on an empty stomach, followed by a 30-minute wait before eating or drinking. Novo Nordisk designed the pill to protect the drug from being broken down in the stomach before it can be absorbed.
Lilly’s orforglipron does not have the same dosing restrictions and is being reviewed under a faster approval pathway aimed at shortening drug review times. A regulatory decision is expected by spring.
Cost remains a central issue. GLP-1 injections can cost more than $1,000 a month in the US. Novo Nordisk said the starting dose of its obesity pill would be available for $149 per month through some providers, with further pricing details expected in January.
