Novo Nordisk has ushered in a new era of obesity treatment – gaining the first US Food and Drug Administration (FDA) approval for a glucagon-like peptide-1 receptor agonist (GLP-1RA) pill for weight loss.
The FDA has greenlit Novo’s oral formulation of Wegovy (semaglutide) for the treatment of patients who are obese or overweight with weight-related medical problems. The once-daily pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.
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Shares in the Copenhagen-listed drugmaker rose 5% to DKr320.00 ($50.40) at market open on 23 December, compared to a market close of DKr 303.50 on 22 December. Novo has a market cap of DKr1.449tn ($230bn), making it one of the most valuable companies in Europe.
Though oral semaglutide was first approved in 2019 under the brand name Rybelsus, this was for type 2 diabetes only, meaning oral Wegovy is the first oral GLP-1RA for the treatment of obesity in the US. Novo expects to launch the tablet in early January 2026, with manufacturing already underway at its North Carolina facilities – a site which received a $4.1bn cash injection by the company last year.
The starting dose of 1.5mg will be available in pharmacies and select telehealth providers for $149 per month. A maintenance dose of 25mg can be prescribed for patients. Novo said it will release further details on pricing and coverage during the drug’s rollout.
In November, the Danish drugmaker reached a deal with the Trump administration that included pricing provisions for oral weight loss drugs.
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By GlobalDataClinical data from the OASIS 4 Phase III clinical trial (NCT05564117) demonstrated that Novo’s pill, along with a reduced-calorie diet and exercise, achieved an average weight loss of about 17% versus about 3% with placebo. The drug also reduced cardiovascular risk factors.
With current GLP-1RAs like subcutaneous Wegovy being injected, it is likely that the availability of an oral formulation could lead to improved adherence, as well as make the drug available for a larger patient population who may have a fear of injectable medications.
Joe Nadglowski, CEO of the non-profit Obesity Action Coalition, stated: “A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1RA treatment that can fit in their daily routine and preferences.”
Turning the tide against Eli Lilly
The FDA approval is a major win for Novo’s recently appointed CEO, Maziar Mike Doustdar, as the company battles obesity market loss to rival Eli Lilly. Global sales for Lilly’s weight loss drug tirzepatide, known under the brand name Zepbound in the US, surged 185% in Q3 to bring in $3.59bn. Sales for Wegovy also increased in Q3 to DKr20.35bn ($3.2bn) compared to last year’s same quarter. However, Wegovy’s sales growth of 18% significantly lagged Zepbound.
It is significant, therefore, that Novo has now beaten its main rival to market the first oral GLP-1RA in the US. Lilly’s pill, orforglipron, is still under FDA review. Lilly has invested billions of dollars in manufacturing sites in anticipation of approval.
GlobalData senior analyst Shehroz Mahmood commented: “Novo’s first-mover advantage may prove short-lived, as Eli Lilly’s orforglipron is anticipated to receive FDA approval in early Q1 2026, placing both oral agents in the market within weeks of each other.
“This timeline significantly diminishes Novo Nordisk’s window to establish oral GLP-1RA market leadership before facing direct competition from Lilly.”
In a bid to keep momentum, Novo will be hoping the FDA also signs off on a high-dose subcutaneous Wegovy dose under review. The company submitted an application to the agency for a 7.2mg dose in November via the Commissioner’s National Priority Voucher programme.
Mahmood added that the oral GLP-1RA arena will “rapidly become a two-player dynamic between Novo Nordisk and Lilly in 2026”.
