METHODS OF MANUFACTURING A BIFUNCTIONAL COMPOUND, ULTRAPURE FORMS OF THE BIFUNCTIONAL COMPOUND, AND DOSAGE FORMS COMPRISING THE SAME

• Main Authors: REECE, Hayley, REEVE, Maxwell Marco, DONG, Hanqing, ZAHEDI, Mohammad Mehdi, HASKELL, III, Royal J, LLOYD, Rhys, ROBERTSON, Jerod, JAGER, Casey Keith, ALLAN, Laura E.N, REO, Joseph P, GROSSO, John A, KATTUBOINA, Venkata A, KENNEDY, Samuel Elliott, QIU, Yuping, DUGUID, Robert J, KAUSHAL, Aditya Mohan, NEESER, Miranda Annell, CHEN, Chungpin Herman
• Format: Patent
• Language: English; French; German
• Published: 15.03.2023
• Subjects: CHEMISTRY; HETEROCYCLIC COMPOUNDS; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; METALLURGY; ORGANIC CHEMISTRY; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The present disclosure relates to ultra-pure forms, polymorphs, amorphous forms, and formulations of N-[(1r,4r)-4-(3-chloro-4-cyanophenoxy)cyclohexyl]-6-[4-({4-[2-(2,6-dioxopiperidin-3-yl)-6-fluoro-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl]piperazin-1-yl}methyl)piperidin-1-yl]pyridazine-3-carboxamide, referred to herein as Compound A:The present disclosure also relates methods of manufacturing and purifying the same, as well as intermediates useful in the synthesis of Compound A. The ultra-pure forms, polymorphs, amorphous forms, and formulations of Compound A can be used as therapeutic agents for the treatment of various diseases and conditions such as cancer.