APR-OD031

**APR-OD031** is an investigational, orally administered, extended-release, phenylalanine-free amino acid formulation developed for **phenylketonuria**. It uses APR Applied Pharma Research's Physiomimic Technology to formulate amino acids as small coated granules that gradually release in the gastrointestinal tract, intended to approximate the absorption kinetics of intact dietary protein. The formulation is designed to reduce phenylalanine fluctuations and catabolism-associated muscle proteolysis, particularly in patients with classic phenylketonuria who do not respond to sapropterin, while masking the unpleasant taste and odor associated with conventional amino acid mixtures. The FDA granted orphan-drug designation for phenylketonuria in March 2020. ([prnewswire.com](https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-apr-od031-for-the-treatment-of-phenylketonuria-pku-301030421.html))