Novo Nordisk A/S has become the first developer of a weight loss drug to have its medicine approved by the US Food and Drug Administration as a pill. The decision, announced on 22 December, enables Wegovy (semaglutide) to be administered orally, in addition to its four earlier approvals as an injectable treatment. This puts the Danish company in a stronger position than before, relative to its competitor Eli Lilly and Co which only recently submitted an oral obesity treatment to the FDA for review. “The pill is here,” Mike Doustdar, Novo’s chief executive said in a prepared statement on the day of the FDA decision. “With today’s approval of the Wegovy pill, patients will have a convenient once-daily pill that can help them lose as much weight as the original Wegovy injection,” he added.
Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist which activates receptors in the brain involved in the regulation of appetite. It received its first FDA approval in 2021 to treat adults with obesity. This was followed in 2022 with an approval to treat obese adolescents. In 2024, Wegovy was approved to treat the risk of further cardiovascular problems in people who are obese and have cardiovascular disease. In 2025 Wegovy received an accelerated approval for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a disorder in which excess fat cells build up in the liver. This causes inflammation and can lead to cirrhosis and liver cancer.
The newest indication for Wegovy is based on the results of the Phase 3 OASIS-4 trial in which participants were given oral semaglutide 25 mg once per day compared with a placebo. The results showed a 16.6% mean weight loss in adults with obesity or overweight with one or more comorbidities. The weight loss was similar to that achieved by the injectable version of the same drug. At the same time, one in three people experienced a 20% or greater weight loss. The safety and tolerability profile of the oral drug was comparable to pervious trials of injectable semaglutide, according to Novo.
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