OGSIVEO Tablet Ref.[107378] Active ingredients: Nirogacestat

OGSIVEO oral tablets contain nirogacestat (as nirogacestat hydrobromide), a gamma (ɣ) secretase inhibitor. Nirogacestat hydrobromide is chemically known as (S)2(((S)-6,8-Difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)N(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl) pentanamide dihydrobromide. The empirical formula is C₂₇H₄₃Br₂F₂N₅O and the molecular weight is 651.48 g/mol. Nirogacestat hydrobromide is a white to off white powder with an aqueous solubility of 11.4 mg/mL and a pH of 4.4 in water at 25°C. Nirogacestat dihydrobromide is highly soluble at low pH, however the solubility significantly decreases at pH > 6.0. The molecule has pKa’s of 5.77 and 7.13. The structural formula for nirogacestat hydrobromide is:

OGSIVEO (nirogacestat) tablets are immediate release (IR), film-coated tablets intended for oral administration. Each tablet contains 50 mg nirogacestat as 66.525 mg nirogacestat hydrobromide. OGSIVEO tablets are round, biconvex with an approximate diameter of 8 mm. They are film coated, orange in color, and debossed with “50” on one face and plain on the other face. OGSIVEO tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate type A. The tablets are finished with Opadry QX orange film coating consisting of the following ingredients: FD&C yellow #6/sunset yellow FCF aluminum lake, glycerol monocaprylocaprate type 1/mono/diglycerides, iron oxide yellow, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.