Oral Semaglutide Approved by FDA

According to press reports on Sept. 20, 2019, Novo Nordisk received FDA approval for an oral form of their blockbuster peptide drug, OzempicTm (semaglutide) (1). Semaglutide works by binding to the glucagon-like peptide-1 (GLP-1) receptor which stimulates insulin production in the pancreas, slowing digestion and helping to prevent the liver from producing too much glucose. The new oral version will be marketed as RybelsusTm (semaglutide) in a single dose per day format. This is the first of the incretin-type peptide agonists of the GLP-1 receptor to be available in an oral dosage form. With type 2 diabetes at epidemic levels worldwide, it is believed that a oral product may result in better patient compliance than the standard subcutaneous weekly injection.

Updates (December 2020)

Novo Nordisk to enter phase 3 development in Alzheimer’s disease with oral semaglutide

Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management