People who are squeamish about needles will soon have an alternative, as the Food and Drug Administration has approved a pill version of Wegovy that could be available as soon as next month.
Novo Nordisk, maker of the GLP-1 weight-loss drug, announced on Monday that it has received FDA approval for its once-daily pill that has been shown to achieve comparable weight-loss results as the injectable Wegovy. The Danish drugmaker said the pill could launch in the U.S. in early January, while it is still awaiting approval from regulatory authorities elsewhere.
The news marks a new era for the spate of popular weight-loss drugs. While there is a 14-milligram oral semaglutide currently on the market—the diabetes drug Rybelsus—the Wegovy pill will be made available in a higher, 25-milligram dose. There’s not yet a pill version of Ozempic, which is also made by Novo Nordisk.
“As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey,” Mike Doustdar, president and CEO of Novo Nordisk, said in a statement. “We are very excited for what this will mean for patients in the U.S.”
THE PILL RACE
The race to get a weight-loss pill on the market has been a long time coming, as Novo Nordisk began clinical trials of the Wegovy pill more than two years ago. Eli Lilly, maker of Zepbound and Mounjaro, is currently testing a weight-loss pill called orforglipron in clinical trials and the drug is part of an FDA priority voucher program that comes with a faster timeframe for reviewing medications. Wegovy is also part of that program.
As with the shot, the Wegovy pill will require a prescription from a doctor. About one in eight American adults were taking a GLP-1 drug as of several weeks ago, according to a KFF Health Tracking Poll released last month. These drugs are especially popular among middle-aged adults, as 30% of people between the ages of 50 and 64 reported that they’ve used one of these drugs at some point, the highest share among any demographic.
A pill version could mean that even more people are on weight-loss medications.
“We believe it will expand access and options for patients,” Dr. Jason Brett, principal U.S. medical head for Novo Nordisk, told CNN in an interview. “We know there are some patients who just won’t take an injectable medication.”
COST IN FOCUS
But the cost of these drugs has also become a concern, and particularly if insurance doesn’t cover them. Last month, President Donald Trump announced a plan to lower the costs of popular prescription drugs, including Wegovy and Ozempic, if people purchase through TrumpRX.
The Wegovy pill will be available for as little as $149 per month for the starting dose of 1.5 milligrams as part of that deal the drugmaker struck with the Trump administration last month. That said, the starting dose of these drugs typically doesn’t yield the same type of weight loss and are intended to help people build up a tolerance.
Novo Nordisk didn’t provide information about the pricing for the higher dosage of the pill that was approved by the FDA. Shares of the Danish drugmaker have surged more than 8% so far this week.