The emblem of pharmaceutical firm Novo Nordisk is displayed in entrance of its workplaces in Bagsvaerd, on the outskirts of Copenhagen, Denmark, Nov. 24, 2025.
Tom Little | Reuters
The U.S. Meals and Drug Administration on Monday permitted the first-ever GLP-1 tablet for weight problems from Wegovy maker Novo Nordisk, a landmark choice that well being consultants say might open up therapy entry to extra sufferers.
Novo Nordisk stated it expects to launch the tablet in early 2026. The Danish drugmaker stated beginning in early January, the beginning dose of 1.5 milligrams will likely be accessible in pharmacies and by way of choose telehealth suppliers with financial savings affords for $149 per 30 days.
That is the identical value that cash-paying sufferers can entry the beginning dose of the tablet on President Donald Trump’s direct-to-consumer web site, TrumpRx, beneath a deal Novo Nordisk struck along with his administration final month. Trump’s web site additionally launches in January.
Novo Nordisk didn’t say how a lot larger doses of the drug would price, however stated extra info on protection and financial savings choices for eligible sufferers will likely be accessible at the moment as properly.
Shares of Novo Nordisk gained roughly 10% in prolonged buying and selling Monday.
The FDA’s approval additionally clears the tablet to be used to scale back the danger of main cardiovascular occasions, similar to demise, coronary heart assault or stroke, in adults with weight problems and established heart problems, in response to Novo Nordisk.
That is per the approval label of the corporate’s blockbuster weight reduction drug Wegovy, which shares the identical lively ingredient, semaglutide. Each work by mimicking the intestine hormone GLP-1 to suppress urge for food.
“What we have realized by means of years of analysis is that having an oral possibility actually sort of opens up, prompts and motivates totally different segments to hunt therapy,” Dave Moore, Novo Nordisk’s government vice chairman of U.S. operations, informed CNBC forward of the approval. “To have that dialog with their physician to see if that is one thing that may be proper for them.”
“That is what we’re enthusiastic about — to have the ability to give folks an possibility and ensure we’ve entry and ease of entry like we’ve been doing with our injections,” he continued. He added that sufferers could have the “consolation and familiarity” on the protection and efficacy facet for the reason that tablet accommodates the identical lively ingredient as Wegovy.
Some well being consultants stated tablets might attain people who find themselves afraid of needles or sufferers who may profit from the prevailing injections however do not take them as a result of they do not view their want as extreme sufficient.
It is unclear precisely how many individuals are utilizing GLP-1s within the U.S., particularly for weight problems specifically. However round 1 in 8 adults stated they had been taking a GLP-1 drug to shed pounds or deal with one other persistent situation as of November, in response to a ballot from well being coverage analysis group KFF.
The approval provides Novo Nordisk a head begin over its chief rival Eli Lilly, which is at the moment the dominant participant out there and is racing to launch its personal weight problems tablet. Tablets are the subsequent battleground for the 2 drugmakers, which established the booming GLP-1 area that some analysts say might be price roughly $100 billion by the 2030s.
Wall Road thinks there’s loads of room for tablets out there, with Goldman Sachs analyst saying in August that tablets might seize a 24% share — or round $22 billion — of the 2030 world weight reduction drug market.
In a word Monday, BMO Capital Markets analyst Evan Seigerman stated the approval of Novo Nordisk’s tablet provides the corporate a “much-needed win in mild of current challenges sustaining incretin market share dominance.”
Incretins check with remedies that mimic intestine hormones similar to GLP-1. Eli Lilly earlier this yr gained the bulk share of the market because of its blockbuster weight problems injection Zepbound, which has proven to be more practical than Novo Nordisk’s Wegovy.
“Novo will possible profit from first-mover benefit, capturing sufferers with a choice for comfort and luxury offered by an oral dosing routine,” Seigerman stated. However he additionally famous that the market is “quickly evolving with aggressive property in growth” and an approval for Eli Lilly’s tablet, orforglipron, “simply across the nook.”
What to know in regards to the Wegovy tablet
The approval relies on a section three trial that adopted greater than 300 adults with weight problems however not diabetes.
In that examine, a 25-milligram dose of Novo Nordisk’s oral semaglutide helped sufferers lose as much as 16.6% of their weight on common after 64 weeks, in response to outcomes from the trial offered at a medical convention in 2024. That weight reduction was 13.6% when the corporate analyzed all sufferers no matter whether or not they stopped the drug.
The tablet seems to be barely more practical than an experimental oral drug from Eli Lilly, which remains to be ready for FDA approval.
However not like Novo Nordisk’s tablet, Eli Lilly’s therapy is just not a peptide medicine. Meaning it’s absorbed extra simply by the physique and doesn’t require dietary restrictions. Individuals who take Novo Nordisk’s tablet have to attend half-hour earlier than consuming or consuming every day.
However Moore stated a number of present medicines have the identical dietary necessities, so “we do not see it as one thing that impacts adherence to therapy.” He famous that Novo Nordisk’s analysis has discovered that it helps sufferers to recollect to take their medication within the morning with a number of sips of water.
“It is truly a reinforcement issue for sufferers,” Moore stated.
He added that the costs of the tablet get prices nearer to what some individuals are paying for unapproved, compounded variations of branded GLP-1s, a few of that are nonetheless being illegally mass-marketed and bought within the U.S.
Sufferers flocked to the cheaper copycats when Ozempic and Wegovy had been in brief provide during the last two years on account of skyrocketing demand, or in the event that they did not have insurance coverage protection for the pricey remedies. Throughout FDA-declared shortages, pharmacists can legally make compounded variations of brand-name medicines. However the company earlier this yr decided that the scarcity of semaglutide is over, barring the apply in lots of instances.
“It continues to be alarming and disturbing for us,” Moore informed CNBC, referring to illegitimate elements which are imported into the U.S. illegally and utilized by some compounding pharmacies to create copycat variations of branded GLP-1s.
When it comes to manufacturing, Moore stated the corporate is “ready to have the ability to fulfill a giant demand right here within the U.S., and we’re fairly enthusiastic about it.” Novo Nordisk stated manufacturing is underway at its North Carolina services.