RYBELSUS®

Company: Novo Nordisk

Therapeutic Area: Diabetes, Weight Management

Drug Type: Peptide Therapeutics

Molecule: Semaglutide (oral)

Clinical Phase: Approved

Pipeline Status: Active

Indication: RYBELSUS® (oral semaglutide) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise. In October 2025, the FDA additionally approved RYBELSUS® for reducing the risk of major adverse cardiovascular events (MACE), including cardiovascular death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, covering both primary and secondary prevention.

Mechanism of Action: Semaglutide is an analogue of the natural physiological hormone GLP-1. It binds to and activates the GLP-1 receptor selectively, which stimulates increased insulin secretion by the pancreas and decreased glucagon secretion, thereby lowering blood sugar levels. Oral delivery is enabled by Emisphere's Eligen™ technology, the culmination of more than 30 years of research and development in peptide drug delivery.

Approved Countries

• UNITED STATES