SPL Set ID: 32ac719c-49f0-4105-9c46-18c19583a5c2

SEPHIENCE (sepiapterin) contains the drug substance sepiapterin, a PAH activator. Sepiapterin is a yellow to orange powder. Sepiapterin is slightly soluble in water with the solubility at 1.4 mg/mL. The chemical name of sepiapterin is (S) -2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4 (3H) -one. The molecular formula is C 9 H 11 N 5 O 3 and the molecular weight is 237.22 g/mol. The structural formula is: SEPHIENCE oral powder contains either 250 mg or 1,000 mg of sepiapterin to be administered orally. The inactive ingredients are: colloidal silicon dioxide, croscarmellose sodium, isomalt, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, and xanthan gum. Chemical Structure