SPL Set ID: 67e6f2d9-21f6-466f-9def-826c6a4b8257

DAYBUE oral solution and DAYBUE STIX for oral solution contain the active moiety trofinetide. The chemical name of trofinetide is (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). The molecular formula of trofinetide is C 13 H 21 N 3 O 6 and its molecular weight is 315.33 g/mol. The chemical structure is shown below. Trofinetide is a white to off-white solid and is freely soluble in water. DAYBUE oral solution is pink to red in color and contains 1 g of trofinetide in each 5 mL of solution (200 mg/mL). The oral solution also contains FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose as inactive ingredients. DAYBUE STIX for oral solution is a white, off-white to pinkish powder to be dissolved in a cold to room temperature water or water-based beverage before administration and contains 5,000 mg, 6,000 mg, or 8,000 mg of trofinetide in each packet. The for oral solution powder contains natural strawberry flavor and sucralose as inactive ingredients. Chemical Structure