Servier Pharmaceuticals LLC

Les Laboratoires Servier

Jacob Paul Sizemore

Shijie Zhang

Chong-Hui Gu

Nha Huu Vo

The present application relates to a method for preparing a substantially and diastereomerically pure crystalline ethanol solvate of Compound IIa and its use for synthesizing Ivosidenib.

Method for preparing ivosidenib and an intermediate thereof

Provided herein are various salts, including tris(hydroxymethyl)aminomethane salts and sodium salts, as well as various crystalline forms of the compound represented by the structural formula: Also provided are pharmaceutical compositions comprising these salts and crystalline forms, methods for their manufacture, and uses thereof for treating conditions, including but not limited to conditions that would benefit from inhibition of dihydroorotate dehydrogenase (DHODH).

Crystalline and salt forms of an organic compound and pharmaceutical compositions thereof

Provided are formulations of ivosidenib including a number of polymorphs. Further provided are formulations of ivosidenib containing a number of known impurities. Still further provided are stable compositions of ivosidenib.

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Grayslake, IL, United States of America

Jacob Paul Sizemore