REGIMEN FOR TREATMENT WITH 2-AMINO-1-(2-(4-FLUOROPHENYL)-3-(4-FLUOROPHENYLAMINO)-8,8-DIMETHYL-5,6-DIHYDROIMIDAZO[1,2-A]PYRAZINE-7 (8H)-YL)ETHENONE AND ITS COMBINATIONS Russian patent published in 2023 - IPC A61K31/137 A61K31/4985 A61K45/06 A61P33/06 

FIELD: pharmaceutics.

SUBSTANCE: group of inventions relates to combination of an antimalarial such as 2-amino-1-(2-(4-fluorophenyl)-3-(4-fluorophenylamino)-8,8-dimethyl-5,6-dihydroimidazo[1,2-a]pyrazine-7 (8H)-yl)ethenone (KAF156) or its pharmaceutically acceptable salt with another antimalarial drug, lumefantrine, and to method for treatment with said combination. A method for preventing or treating malaria, or delaying the onset of symptoms or improving conditions associated with malaria, in a subject in need thereof, comprises administering 2-amino-1-(2-(4-fluorophenyl)-3-(4-fluorophenylamino)-8,8-dimethyl-5,6-dihydroimidazo[1,2-a]pyrazine-7 (8H)-yl)ethenone or its pharmaceutically acceptable salt to said subject; it is administered daily at a dose of about 200 mg to 1000 mg with lumefantrine in the form of solid dispersion where lumefantrine is administered daily at a dose of from about 400 mg to 1000 mg. Accordingly, the pharmaceutical combination comprises from about 400 mg to 1000 mg of lumefantrine as a solid dispersion and from about 200 mg to 1000 mg of 2-amino-1-(2-(4-fluorophenyl)-3-(4-fluorophenylamino)-8,8-dimethyl-5,6-dihydroimidazo[1,2-a]pyrazine-7 (8H)-yl)ethenone or its pharmaceutically acceptable salt.

EFFECT: when KAF156 is co-administered with lumefantrine, the effects of both lumefantrine and KAF156 are greatly increased.

30 cl, 5 dwg, 13 tab, 8 ex