Danish biotechnology company Zealand Pharma A/S (CPH:ZEAL) reported on Tuesday that pharmaceutical company Boehringer Ingelheim has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for survodutide (BI 456906) for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis (stages 2 or 3).

In addition, Boehringer has initiated two Phase III clinical trials for survodutide, called LIVERAGE and LIVERAGE-Cirrhosis. These trials will evaluate the effectiveness of survodutide in treating MASH and fibrosis (scarring) in adults.

Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which are critical to controlling metabolic functions. It is licensed by Zealand Pharma to Boehringer Ingelheim, with Boehringer solely responsible for development and commercialisation globally.