pancrelipase (Aptalis Pharma Inc., 044c0d)

Ultresa (pancrelipase) is an FDA-approved pancreatic enzyme replacement therapy (PERT) formerly indicated for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis or other conditions. It is a porcine-derived biologic product containing a mixture of digestive enzymes, specifically lipases, proteases, and amylases. These enzymes act as exogenous replacements for endogenous pancreatic secretions, catalyzing the hydrolysis of fats into fatty acids and glycerol, proteins into peptides and amino acids, and starches into dextrins and short-chain sugars within the duodenum and proximal small intestine. Formulated as delayed-release capsules with an enteric coating, Ultresa is designed to protect the enzymes from degradation by gastric acid, releasing them only when the local pH exceeds 5.5. Originally developed by Aptalis Pharma, the product was approved by the FDA in 2012 but was discontinued in the U.S. market in 2016.

Brand names

Ultresa

Other names

pancrelipase