SPL Set ID: d7a11334-6e7a-445b-9a16-bdcd9acbe61f
1 drug(s) with this SPL Set ID
HYRNUO tablets contain sevabertinib, a kinase inhibitor. The chemical name of the drug substance is 3-(3-chloro-2-methoxyanilino)-2-{3-[(2S)-1,4-dioxan-2-ylmethoxy]pyridin-4-yl}-1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one hydrate. The molecular formula is C 24 H 25 ClN 4 O 5 (anhydrate) and the molecular weight is 484.93 g/mol (anhydrate). The structural formula is shown below: Sevabertinib is present as a non-stoichiometric hydrate as a white to off-white to yellow to pinkish powder. It is slightly soluble in aqueous solution at pH 2, and practically insoluble in aqueous solutions at pH 4.5 and above. The strength of HYRNUO is based on the anhydrate form. Each HYRNUO tablet for oral use contains 10 mg of sevabertinib. The inactive ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, and magnesium stearate. The tablet film coating contains ferric oxide red, hypromellose 5 cP, and macrogol 3350. Chemical Structure