Effect of Oral CNSA-001 (sepiapterin, PTC923) on gastric accommodation in women with diabetic gastroparesis: A randomized, placebo-controlled, Phase 2 trial.

Aims: Diabetic gastroparesis may be associated with impaired nitric oxide metabolism and reduced tetrahydrobiopterin (BH) synthesis. Oral treatment with CNSA-001 (sepiapterin, currently known as PTC923) increased BH levels in humans in a previous study. This Phase 2 study evaluated CNSA-001 in women with diabetic gastroparesis.