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

The primary oral GLP-1 weight reduction drug has been permitted to be used within the US

The Wegovy capsule, from drugmaker Novo Nordisk, was permitted by the Meals and Drug Administration to cut back extra physique weight, preserve long-term weight reduction and decrease the chance of great cardiovascular occasions.

Approval of the 25 mg once-daily semaglutide capsule was primarily based on the outcomes of two medical trials: the OASIS Trial Program and the SELECT Trial.

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The Wegovy capsule confirmed a median weight lack of 16.6% amongst overweight or chubby adults with a number of comorbidities (different medical situations) within the OASIS 4 examine, based on a press launch. In the identical examine, one in three contributors skilled a weight lack of 20% or extra.

The primary oral GLP-1 weight reduction drug has been permitted to be used within the US (iStock)

Novo Nordisk reported that the burden loss achieved with the capsule is corresponding to that of injectable Wegovy and has the same security profile.

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

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

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“As the primary oral GLP-1 therapy for chubby or overweight individuals, the Wegovy capsule provides sufferers a brand new, handy therapy choice that may assist sufferers begin or proceed their weight reduction journey.”

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

“Most unwanted side effects might be GI associated and must be much like these of the injectable, comparable to nausea, vomiting and constipation,” stated one knowledgeable. (iStock)

Dr. Sue Decotiis, a medical weight reduction physician in New York Metropolis, confirmed in an interview with Fox Information Digital that research present oral Wegovy is much like the weekly injection, simply with out the needles.

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Whereas the capsule could lead to higher compliance and ease of use, Decotiis cautioned that some sufferers could not take in the medicine by way of the gastrointestinal tract in addition to the injectable model because of particular person quirks within the physique.

“Most unwanted side effects might be GI associated and must be much like the injectable, comparable to nausea, vomiting and constipation,” she stated.

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“In my observe, I’ve discovered that tirzepatide (Mounjaro and Zepbound) produces roughly 20% extra weight reduction and fats loss than semaglutide,” the physician added. ‘This has usually been proven in research [with] fewer unwanted side effects.”

In line with Decotiis, extra oral GLP-1s may comply with in 2026, together with an Orforglipron software from Lilly and a brand new mixture of Novo Nordisk drug, which is awaiting approval later subsequent yr.

One knowledgeable warned that some sufferers could not take in the drug by way of the gastrointestinal tract in addition to with the injectable model. (iStock)

“Extra new drugs will develop into accessible sooner or later that might be more practical for sufferers who’re extra insulin resistant and haven’t responded as properly to semaglutide and/or tirzepatide,” he stated. “That is nice information, as a result of new medicine that have an effect on extra receptors imply higher long-term outcomes in additional sufferers.”

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As these drugs develop into cheaper and extra simply accessible, Decotiis emphasised that sustaining wholesome way of life habits – together with good vitamin with satisfactory protein and fiber, in addition to elevated hydration – is important to make sure lasting outcomes.

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

Fox Information Digital contacted Novo Nordisk for remark.