AU2025220696A1 — Sustained release peptide formulations

USPTO Abstract

#$%^&*AU2025220696A120250904.pdf##### ABSTRACT This disclosure provides, at least in part, a pharmaceutical product comprising: setmelanotide (also known as RM493); setmelanotide as sole active pharmaceutical ingredient formulated for injection; setmelanotide as the sole active ingredient; setmelanotide as the active pharmaceutical ingredient; setmelanotide as the active pharmaceutical ingredient for injection; or another pharmaceutical composition that has its primary mechanism of action at the MC4 receptor as an agonist (referred to herein as an MC4RAP), e.g., a lipid excipient, and/or a pharmaceutically acceptable carrier. The pharmaceutical product described herein provides a sustained release of setmelanotide or another pharmaceutical composition, which may result in a more desirable pharmacokinetic and pharmacodynamic profile upon administration. ABSTRACT This disclosure provides, at least in part, a pharmaceutical product comprising: setmelanotide (also known as RM493); setmelanotide as sole active pharmaceutical ingredient formulated for injection; setmelanotide as the sole active ingredient; setmelanotide as the active pharmaceutical ingredient; setmelanotide as the active pharmaceutical ingredient for injection; or another pharmaceutical composition that has its primary mechanism of action at the MC4 receptor as an agonist (referred to herein as an MC4RAp), e.g., a lipid excipient, and/or a pharmaceutically acceptable carrier. The pharmaceutical product described herein provides a sustained release of setmelanotide or another pharmaceutical composition, which may result in a more desirable pharmacokinetic and pharmacodynamic profile upon administration. 20 25 22 06 96 19 A ug 2 02 5 A B S T R A C T T h i s d i s c l o s u r e p r o v i d e s , a t l e a s t i n p a r t , a p h a r m a c e u t i c a l p r o d u c t c o m p r i s i n g : s e t m e l a n o t i d e ( a l s o k n o w n a s R M 4 9 3 ) ; s e t m e l a n o t i d e a s s o l e a c t i v e p h a r m a c e u t i c a l i n g r e d i e n t 2 0 2 5 2 2 0 6 9 6 1 9 2 0 2 5 A u g f o r m u l a t e d f o r i n j e c t i o n ; s e t m e l a n o t i d e a s t h e s o l e a c t i v e i n g r e d i e n t ; s e t m e l a n o t i d e a s t h e a c t i v e p h a r m a c e u t i c a l i n g r e d i e n t ; s e t m e l a n o t i d e a s t h e a c t i v e p h a r m a c e u t i c a l i n g r e d i e n t f o r i n j e c t i o n ; o r a n o t h e r p h a r m a c e u t i c a l c o m p o s i t i o n t h a t h a s i t s p r i m a r y m e c h a n i s m o f a c t i o n a t t h e M C 4 r e c e p t o r a s a n a g o n i s t ( r e f e r r e d t o h e r e i n a s a n M C 4 R A p ) , e . g . , a l i p i d e x c i p i e n t , a n d / 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 c a r r i e r . T h e p h a r m a c e u t i c a l p r o d u c t d e s c r i b e d h e r e i n p r o v i d e s a s u s t a i n e d r e l e a s e o f s e t m e l a n o t i d e o r a n o t h e r p h a r m a c e u t i c a l c o m p o s i t i o n , w h i c h m a y r e s u l t i n a m o r e d e s i r a b l e p h a r m a c o k i n e t i c a n d p h a r m a c o d y n a m i c p r o f i l e u p o n a d m i n i s t r a t i o n .