19 December 2024 - The FDA concluded that Zealand Pharma’s application did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to be marketed dose of glepaglutide.

Zealand Pharma today announced that the US FDA has issued a complete response letter for the company’s new drug application for glepaglutide, a long-acting GLP-2 analogue, under development for the treatment of adult patients with short bowel syndrome with intestinal failure who are dependent on parenteral support.

Read Zealand Pharma press release