AU2025205083A1 — CRF1 receptor antagonist, pharmaceutical formulations and solid forms thereof for the treatment of congenital adrenal hyperplasia

USPTO Abstract

#$%^&*AU2025205083A120250724.pdf##### 1 ABSTRACT Provided are methods related to treating congenital adrenal hyperplasia in a subject in need thereof comprising administering 4-(2-chloro-4-methoxy-5-methylphenyl)-N- [(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3- thiazol-2-amine (Formula I), or a pharmaceutically acceptable salt thereof. Further provided are pharmaceutical formulations and solid forms of 4-(2-chloro-4-methoxy- 5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl- N-prop-2-ynyl-1,3-thiazol-2-amine, or a pharmaceutically acceptable salt thereof, and their use in the treatment of congenital adrenal hyperplasia (CAH). ABSTRACT Provided are methods related to treating congenital adrenal hyperplasia in a subject in need thereof comprising administering 4-(2-chloro-4-methoxy-5-methylphenyl)-N- [(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-yny1-1,3- thiazol-2-amine (Formula I), or a pharmaceutically acceptable salt thereof. Further provided are pharmaceutical formulations and solid forms of 4-(2-chloro-4-methoxy- 5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl- N-prop-2-ynyl-1,3-thiazol-2-amine, or a pharmaceutically acceptable salt thereof, and their use in the treatment of congenital adrenal hyperplasia (CAH). 1 20 25 20 50 83 03 J ul 2 02 5 A B S T R A C T P r o v i d e d a r e m e t h o d s r e l a t e d t o t r e a t i n g c o n g e n i t a l a d r e n a l h y p e r p l a s i a i n a s u b j e c t i n 2 0 2 5 2 0 5 0 8 3 0 3 J u l 2 0 2 5 n e e d t h e r e o f c o m p r i s i n g a d m i n i s t e r i n g 4 - ( 2 - c h l o r o - 4 - m e t h o x y - 5 - m e t h y l p h e n y l ) - N - [ ( 1 S ) - 2 - c y c l o p r o p y l - 1 - ( 3 - f l u o r o - 4 - m e t h y l p h e n y l ) e t h y l ] - 5 - m e t h y l - N - p r o p - 2 - y n y l - 1 , 3 - t h i a z o l - 2 - a m i n e ( F o r m u l a I ) , o r a p h a r m a c e u t i c a l l y a c c e p t a b l e s a l t t h e r e o f . F u r t h e r p r o v i d e d a r e p h a r m a c e u t i c a l f o r m u l a t i o n s a n d s o l i d f o r m s o f 4 - ( 2 - c h l o r o - 4 - m e t h o x y - 5 - m e t h y l p h e n y l ) - N - [ ( 1 S ) - 2 - c y c l o p r o p y l - 1 - ( 3 - f l u o r o - 4 - m e t h y l p h e n y l ) e t h y l ] - 5 - m e t h y l - N - p r o p - 2 - y n y l - 1 , 3 - t h i a z o l - 2 - a m i n e , o r a p h a r m a c e u t i c a l l y a c c e p t a b l e s a l t t h e r e o f , a n d t h e i r u s e i n t h e t r e a t m e n t o f c o n g e n i t a l a d r e n a l h y p e r p l a s i a ( C A H ) . 1