LEQSELVI Film-coated tablet Ref.[116129] Active ingredients: Deuruxolitinib

LEQSELVI (deuruxolitinib) tablets contain the phosphate salt of deuruxolitinib, a Janus kinase (JAK) inhibitor, for oral administration.

Deuruxolitinib phosphate is a white to off-white crystalline solid with the chemical name 1HPyrazole-1-propanenitrile, β-(cyclopentyl-2,2,3,3,4,4,5,5d₈)-4-(7Hpyrrolo[2,3d]pyrimidin-4-yl)-, (βR)-, phosphate (1:1).

Deuruxolitinib has high aqueous solubility at low pH. Deuruxolitinib phosphate has a molecular weight of 412.42 g/mol and a molecular formula of C₁₇H₁₃D₈N₆O₄P. The structural formula is:

Each tablet contains 8 mg of deuruxolitinib (equivalent to 10.50 mg of deuruxolitinib phosphate) and the following excipients: colloidal silicon dioxide, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone. The tablet film coating contains the following excipients: carmine, FD&C blue #2 aluminum lake, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.