FDA has approved first oral GLP-1 weight-loss drug in the US

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The primary oral GLP-1 medicine for weight loss has been authorized to be used within the U.S.

The Wegovy capsule, from drugmaker Novo Nordisk, was cleared by the Meals and Drug Administration to scale back extra physique weight, preserve long-term weight discount and decrease the danger of main cardiovascular occasions.

Approval of the once-daily 25mg semaglutide capsule was primarily based on the outcomes of two scientific trials — the OASIS trial program and the SELECT trial.

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The Wegovy pill demonstrated a imply weight lack of 16.6% within the OASIS 4 trial amongst adults who had been overweight or chubby and had a number of comorbidities (different medical situations), in accordance with a press launch. In the identical trial, one in three individuals skilled 20% or higher weight reduction.

man pours pills into hand from bottle

The primary oral GLP-1 medicine for weight reduction has been authorized to be used within the U.S. (iStock)

Novo Nordisk reported that the load loss achieved with the capsule is just like that of injectable Wegovy and has the same security profile.

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“With right this moment’s approval of the Wegovy capsule, sufferers can have a handy, once-daily capsule that may assist them lose as a lot weight as the unique Wegovy injection,” mentioned Mike Doustdar, president and CEO of Novo Nordisk, within the press launch.

weogovy box with four injectables

Novo Nordisk reported that the load loss achieved with the capsule is just like that of injectable Wegovy and has the same security profile. (James Manning/PA Photographs by way of Getty Photographs)

“As the primary oral GLP-1 therapy for folks residing with chubby or weight problems, the Wegovy capsule offers sufferers with a brand new, handy therapy possibility that may assist sufferers begin or proceed their weight-loss journey.”

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The oral GLP-1 is predicted to launch within the U.S. in early January 2026. Novo Nordisk has additionally submitted oral semaglutide for weight problems to the European Medicines Company (EMA) and different regulatory authorities.

Woman seen sitting on coach holding abdomen area indicating pain or discomfort.

“Most uncomfortable side effects might be GI-related and ought to be just like the injectable, similar to nausea, vomiting and constipation,” an knowledgeable mentioned. (iStock)

Dr. Sue Decotiis, a medical weight-loss physician in New York Metropolis, confirmed in an interview with Fox Information Digital that research present oral Wegovy is similar to the weekly injectable, simply with out the needles.

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Though the capsule might lead to higher compliance and ease of use, Decotiis warned that some sufferers might not soak up the medicine by way of the gastrointestinal tract in addition to with the injectable model on account of particular person idiosyncrasies within the physique.

“Most uncomfortable side effects might be GI-related and ought to be just like the injectable, similar to nausea, vomiting and constipation,” she mentioned.

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“In my apply, I’ve discovered tirzepatide (Mounjaro and Zepbound) to yield extra weight reduction and fat loss than semaglutide by about 20%,” the physician added. “This has been proven in research, typically [with] fewer uncomfortable side effects.”

Extra oral GLP-1s could also be coming in 2026, in accordance with Decotiis, together with an Orforglipron utility by Lilly and a brand new mixture Novo Nordisk drug, which is pending approval later subsequent 12 months.

woman injects glp-1 into her stomach

One knowledgeable warned that some sufferers might not soak up the medicine by way of the gastrointestinal tract in addition to with the injectable model. (iStock)

“There might be extra new medicine out there sooner or later that might be more practical for sufferers who’re extra insulin-resistant and haven’t responded as nicely to semaglutide and/or tirzepatide,” the physician mentioned. “That is nice information, as novel medicine affecting extra receptors imply higher long-term results in additional sufferers.”

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As these drugs change into cheaper and simpler to entry, Decotiis emphasised that maintaining with wholesome life-style habits — together with correct diet with ample protein and fiber, in addition to elevated hydration — is important to making sure lasting outcomes.

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“If not, sufferers will regain weight and will lose muscle and never sufficient physique fats,” she mentioned.

Fox Information Digital reached out to Novo Nordisk for remark.

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