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AssigneeSignal Pharmaceuticals, LLC
InventorsNathan Andrew Boersen, Indrajit Ghosh, Lianfeng Huang, Daozhong Zou
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Provided are pharmaceutical compositions and dosage forms of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide, or a pharmaceutically acceptable stereoisomer, tautomer, solid form, polymorph, salt, hydrate, clathrate, or solvate thereof. Also provided are methods of treating, managing, or preventing various disorders, such as diseases or disorders treatable or preventable by inhibition of a JNK pathway in mammals using such pharmaceutical compositions or dosage forms. Further provided are salts of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide and methods of preparation of such salts.
A method for achieving an area under the plasma concentration versus time curve from time zero to the last quantifiable concentration of 8330 ng·h/mL to 15600 ng·h/mL of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, or isotopologue thereof in a patient having a liver fibrotic disorder, diabetes, interstitial pulmonary fibrosis or a metabolic syndrome leading to a liver fibrotic disorder, comprising administering to the patient an effective amount of a pharmaceutical composition comprising 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof,
A method for achieving an area under the plasma concentration versus time curve from time zero to infinity of 8540 ng·h/mL to 15990 ng·h/mL of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, or isotopologue thereof in a patient having a liver fibrotic disorder, diabetes, interstitial pulmonary fibrosis or a metabolic syndrome leading to a liver fibrotic disorder, comprising administering to the patient an effective amount of a pharmaceutical composition comprising 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof,
A method for achieving a maximum observed plasma concentration of 1211 ng/mL to 2392 ng/mL of 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, or isotopologue thereof in a patient having a liver fibrotic disorder, diabetes, interstitial pulmonary fibrosis or a metabolic syndrome leading to a liver fibrotic disorder, comprising administering to the patient an effective amount of a pharmaceutical composition comprising 2-(tert-butylamino)-4-((1R,3R,4R)-3-hydroxy-4-methylcyclohexylamino)-pyrimidine-5-carboxamide or a pharmaceutically acceptable salt, stereoisomer, solvate, hydrate, isotopologue or solid form thereof,
Dependencies are inferred from the claim text.