Wegovy Pill Becomes First Oral GLP-1 Weight-Loss Drug Approved in U.S.

US approves Wegovy diet pill – a move that could change healthcare

TO Lauren J. Young edited by Claire Cameron

Diet pills that use the same mechanism as wildly popular drugs Wegovy and Ozempic come to the USA

On Monday, Novo Nordisk announced that the U.S. Food and Drug Administration approved its oral glucagon-like peptide 1 (GLP-1) formulation for weight loss and obesity in adults.

This is an important milestone for the industry, which have struggled to create effective versions of weight loss injections in pill form. for many years. Most people are more comfortable taking pills than regularly injecting themselves, says Daniel Drucker, an endocrinologist at the University of Toronto who previously consulted for Novo Nordisk. “It’s just good to have more options for people,” he says. At the same time, tablets can significantly improve access to medicines by reducing costs—injections can cost hundreds of dollars a month out of pocket.

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Pills are also easier to transport and manufacture, says Rosalina McCoy, an endocrinologist and internist at the University of Maryland, adding that she hopes the new FDA approval will expand access to the drugs.

Prior to this approval, Novo Nordisk, which also makes the semaglutide injectables Ozempic and Wegovy, had received promising trial results for a diet pill that will also be sold under the Wegovy brand. In the company's latest Phase 3 clinical trial, the highest dose of the tablet resulted in weight loss of 16.6 percent in 64 weeks. compared with a 2.7 percent loss among those taking placebo. By comparison, tests of Wegovy's 2.4-milligram injections showed weight loss up to 17.4 percent. (Injection and tablet were not compared in a head-to-head study.)

GLP-1 drugs have changed the weight loss industry and revolutionized it treatment of metabolic diseases. But until now, they have mostly been available in the U.S. only as injections. Novo Nordisk's type 2 diabetes pill, Ribelsus, was approved by the FDA in 2019. But oral versions of these drugs have not achieved the same success as injectable ones, despite even early data showing that weight loss and health benefits are relatively comparable.

Wegovy tablet taken once daily works similarly to weekly injections:mimicking the activity of intestinal hormone this slows down the rate at which people's stomachs empty and makes them feel fuller. People who take the pill eat less overall. Side effects are very similar to side effects from injections of the drug and may include nausea, diarrhea and vomiting.

The tablets also need to be taken on an empty stomach to be effective.

“Nothing else should be taken orally for at least 30 minutes to allow the drug to be absorbed into the bloodstream,” says John Buse, an endocrinologist at the University of North Carolina at Chapel Hill and a consultant and researcher for Novo Nordisk. “If patients take the medication with other medications, food, or even large amounts of water or coffee, the effectiveness is dramatically reduced.”

The pill will be available in U.S. pharmacies and select telehealth providers in early January, a Novo Nordisk spokesman said. Scientific American. A starting dose of 1.5 mg is expected to cost $149 per month out of pocket, but could be lower depending on a person's insurance.

It's important to note that the success of Novo Nordisk's latest clinical trials was based on a maximum daily dose of 25 mg, McCoy says. Unlike injections, which go directly into the bloodstream, tablets are broken down in the stomach, meaning “oral doses have to be much, much higher” than Wegovy injections, which have a maximum dose of 2.4 mg, McCoy explains.

“I expect that effective doses of the oral Wegovy drug will unfortunately be much more expensive than the advertised $149. But I would like to see this drug more affordable,” she says.

This was announced by a Novo Nordisk representative. Scientific American that prices for higher doses will be split in the new year. “We believe this is the most affordable self-pay price for GLP-1 for weight loss available today,” the spokesperson said.

Other companies are working on their own weight-loss pills: Eli Lilly, which makes Zepbound, is developing a GLP-1 pill, or forglyprone, for weight loss and type 2 diabetes. FDA approval is expected in March 2026. More tablet options – combined with other effective versions of these drugs in the works — will open up the market and hopefully drive down prices, Drucker says.

“I think that in the next 12 to 18 months we will move away from these two main [injection] options from Novo Nordisk and Eli Lilly to a half-dozen variants of this class of drugs,” says Drucker. “This will only benefit people. They will have more choice.”

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