Will oral semaglutide be approved for the treatment of obesity by the FDA or EMA by 2027?

Semaglutide (also known as Wegovy, Ozempic, or Rybelsus) is a drug approved in June 2021 which has demonstrated 15-18% weight loss in subjects. However, it does come with the inconvenient administration method of a once-per-week injection.

Semaglutide is a (modified) protein, which creates technical challenges. First, it’s expensive to produce and requires specialized facilities. Second, it’s most naturally administered as an injection, because if a person ingests it, it gets digested and inactivated just like the proteins in a piece of cheese. However, Novo Nordisk has developed technology that allows the protein to be absorbed intact from the digestive tract into circulation, allowing it to be delivered in pill form. The oral semaglutide pill is FDA approved for the treatment of diabetes and marketed as Rybelsus.

Oral semaglutide is convenient for patients, but it has not yet been approved for the treatment of obesity. Novo Nordisk plans to initiate a phase 3a trial of oral semaglutide for obesity this year (2021), suggesting that the company will probably seek regulatory approval for the treatment of obesity. The trial will last 68 weeks.