US2019233465A1PendingUtilityA1

C7, c12, and c16 substituted neuroactive steroids and their methods of use

Assignee: SAGE THERAPEUTICS INCPriority: Jul 11, 2016Filed: Jul 11, 2017Published: Aug 1, 2019
Est. expiryJul 11, 2036(~10 yrs left)· nominal 20-yr term from priority
C07J 43/003C07J 41/0094C07J 7/002C07J 7/003C07J 1/0029C07J 41/005C07J 7/006A61P 25/00
65
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Claims

Abstract

Described herein are neuroactive steroids of Formula (I), Formula (V), or Formula (IX) or a pharmaceutically acceptable salt thereof; wherein each instance of R 2 , R 3 , R 4 , R 5 , R 6 , R 7 , R 11a , R 11b , R 12 , R 16 , R 17 , R 19 , and are as herein. Such compounds are envisioned, in certain embodiments, to behave as GABA modulators. Also provided are pharmaceutical compositions comprising a compound described herein and methods of use and treatment, e.g., such as for inducing sedation and/or anesthesia.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A compound of Formula (I): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein   represents a single or double bond as valency permits;
 each of R 2 , R 4 , R 6 , R 11a , and R 11b  is independently hydrogen, halogen, cyano, nitro, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, —OR A1 , —SR A1 , —N(R A1 ) 2 , —NHC(═O)R A1 , —NHC(═O)OR A1 , —S(═O)R A2 , —SO 2 R A2 , or —S(═O) 2 OR A1 , wherein each instance of R A1  is independently hydrogen, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, an oxygen protecting group when attached to an oxygen atom, a sulfur protecting group when attached to a sulfur atom, a nitrogen protecting group when attached to a nitrogen atom, or two R A1  groups are joined to form an heterocyclic or heteroaryl ring; and R A2  is alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, or heteroaryl; or R 11a  and R 11b  together form oxo; 
 R 3  is hydrogen, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, or heteroaryl; 
 R 5  is absent or hydrogen; and   represents a single or double bond, wherein when one of   at site is a double bond, the other   is a single bond; when both of   are single bonds, then R 5  is hydrogen; and when one of the   is a double bond, R 5  is absent; 
 R 17  is alkoxy, cyano, nitro, aryl, heteroaryl, or —C(O)R B1 , —C(O)CH 2 R B1 , or —C(O)CH 2 CH 2 R B1 , wherein R B1  is hydrogen, —OH, alkoxy, aryl, or heteroaryl; 
 R 19  is hydrogen or alkyl; and 
 R 7  is halogen, cyano, nitro, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, —OR A1 , —SR A1 , —N(R A1 ) 2 , —NHC(═O)R A1 , —NHC(═O)OR A1 , —S(═O)R A2 , —SO 2 R A2 , or —S(═O) 2 OR A1 . 
 
     
     
         2 - 5 . (canceled) 
     
     
         6 . The compound of claim  2 , wherein R 3  is C 1 -C 6  alkyl. 
     
     
         7 . (canceled) 
     
     
         8 . The compound of claim  2 , wherein the compound of Formula (I) is a compound of Formula (II-c) or (II-d): 
       
         
           
           
               
               
           
         
       
     
     
         9 . (canceled) 
     
     
         10 . The compound of  claim 8 , wherein R 7  is —CH 3 , —CH 2 CH 3 , —OH, —OCH 3 , or —CH 2 OCH 3 . 
     
     
         11 . The compound of  claim 8 , wherein R 17  is —OCH 3 , —CN, or —C(O)CH 3 . 
     
     
         12 . (canceled) 
     
     
         13 . The compound of  claim 8 , wherein R 17  is —C(O)CH 2 R B1 . 
     
     
         14 - 17 . (canceled) 
     
     
         18 . The compound of  claim 13 , wherein R B1  is 
       
         
           
           
               
               
           
         
       
     
     
         19 - 31 . (canceled) 
     
     
         32 . A compound of Formula (V): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, 
         wherein   represents a single or double bond as valency permits; 
         each of R 2 , R 4 , R 6 , R 11a , and R 11b  is independently hydrogen, halogen, cyano, nitro, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, —OR A1 , —SR A1 , —N(R A1 ) 2 , —NHC(═O)R A1 , —NHC(═O)OR A1 , —S(═O)R A2 , —SO 2 R A2 , or —S(═O) 2 OR A1 , wherein each instance of R A1  is independently hydrogen, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, an oxygen protecting group when attached to an oxygen atom, a sulfur protecting group when attached to a sulfur atom, a nitrogen protecting group when attached to a nitrogen atom, or two R A1  groups are joined to form an heterocyclic or heteroaryl ring; and R A2  is alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, or heteroaryl; or R 11a  and R 11b  together form oxo; R 3  is hydrogen, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, or heteroaryl; 
         R 5  is absent or hydrogen; and   represents a single or double bond, wherein when one of   at site is a double bond, the other   is a single bond; when both of   are single bonds, then R 5  is hydrogen; and when one of the   is a double bond, R 5  is absent; 
         R 17  is alkoxy, cyano, nitro, aryl, heteroaryl, —C(O)R B1 , —C(O)CH 2 R B1 , or —C(O)CH 2 CH 2 R B1 , wherein R B1  is hydrogen, —OH, alkoxy, aryl, or heteroaryl; 
         R 19  is hydrogen or alkyl; 
         and R 12  is halogen, cyano, nitro, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, —OR A1 , —SR A1 , —N(R A1 ) 2 , —NHC(═O)R A1 , —NHC(═O)OR A1 , —S(═O)R A2 , —SO 2 R A2 , or —S(═O) 2 OR A1 . 
       
     
     
         33 - 35 . (canceled) 
     
     
         36 . The compound of  claim 32  wherein R 3  is C 1 -C 6  alkyl. 
     
     
         37 . (canceled) 
     
     
         38 . The compound of  claim 32 , wherein the compound of Formula (V) is a compound of Formula (VI-c) or (VI-d): 
       
         
           
           
               
               
           
         
       
     
     
         39 . (canceled) 
     
     
         40 . The compound of  claim 38 , wherein R 12  is —CH 3 , —CH 2 CH 3 , —OH, —OCH 3 , or —CH 2 OCH 3 . 
     
     
         41 . The compound of  claim 38 , wherein R 17  is —OCH 3 , —CN, or —C(O)CH 3 . 
     
     
         42 . (canceled) 
     
     
         43 . The compound of  claim 38 , wherein R 17  is —C(O)CH 2 R B1 . 
     
     
         44 - 47 . (canceled) 
     
     
         48 . The compound of  claim 43 , wherein R B1  is 
       
         
           
           
               
               
           
         
       
     
     
         49 - 57 . (canceled) 
     
     
         58 . A compound of Formula (IX): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein   represents a single or double bond as valency permits; 
         each of R 2 , R 4 , R 6 , R 11a , and R 11b  is independently hydrogen, halogen, cyano, nitro, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, —OR A1 , —SR A1 , —N(R A1 ) 2 , —NHC(═O)R A1 , —NHC(═O)OR A1 , —S(═O)R A2 , —SO 2 R A2 , or —S(═O) 2 OR A1 , wherein each instance of R A1  is independently hydrogen, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, an oxygen protecting group when attached to an oxygen atom, a sulfur protecting group when attached to a sulfur atom, a nitrogen protecting group when attached to a nitrogen atom, or two R A1  groups are joined to form an heterocyclic or heteroaryl ring; and R A2  is alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, or heteroaryl; or R 11a  and R 11b  together form oxo; 
         R 3  is hydrogen, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, or heteroaryl; 
         R 5  is absent or hydrogen; and   represents a single or double bond, wherein when one of   at site is a double bond, the other   is a single bond; when both of   are single bonds, then R 5  is hydrogen; and when one of the   is a double bond, R 5  is absent; 
         R 17  is alkoxy, cyano, nitro, aryl, heteroaryl, —C(O)R B1 , —C(O)CH 2 R B1 , or —C(O)CH 2 CH 2 R B1 , wherein R B1  is hydrogen, —OH, —N(R A1 ) 2 , alkoxy, aryl, or heteroaryl; 
         R 19  is hydrogen or alkyl; 
         and R 16  is halogen, cyano, nitro, alkyl, alkenyl, alkynyl, carbocyclyl, heterocyclyl, aryl, heteroaryl, —OR A1 , —SR A1 , —N(R A1 ) 2 , —NHC(═O)R A1 , —NHC(═O)OR A1 , —S(═O)R A2 , —SO 2 R A2 , or —S(═O) 2 OR A1 . 
       
     
     
         59 . (canceled) 
     
     
         60 . (canceled) 
     
     
         61 . The compound of  claim 58 , wherein R 3  is C 1 -C 6  alkyl. 
     
     
         62 . (canceled) 
     
     
         63 . The compound of  claim 58 , wherein the compound of Formula (IX) is a compound of Formula (X-c) or (X-d): 
       
         
           
           
               
               
           
         
       
     
     
         64 . (canceled) 
     
     
         65 . The compound of  claim 63 , wherein R 16  is —CH 3 , —CH 2 CH 3 , —OH, —OCH 3 , or —CH 2 OCH 3 . 
     
     
         66 . The compound of  claim 63 , wherein R 17  is —OCH 3 , —CN, or —C(O)CH 3 . 
     
     
         67 . (canceled) 
     
     
         68 . The compound of  claim 63 , wherein R 17  is —C(O)CH 2 R B1 . 
     
     
         69 - 72 . (canceled) 
     
     
         73 . The compound of  claim 68 , wherein R B1  is 
       
         
           
           
               
               
           
         
       
     
     
         74 - 81 . (canceled) 
     
     
         82 . A compound of  claim 1 , selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         83 . A pharmaceutically acceptable salt of a compound of  claim 1  selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         84 . A pharmaceutical composition comprising a compound of  claim 1  and a pharmaceutically acceptable excipient. 
     
     
         85 - 99 . (canceled) 
     
     
         100 . A composition for use in treating disorders related to GABA function in a subject in need thereof, comprising a therapeutically effective amount of a compound of  claim 1 . 
     
     
         101 . A method of treating a CNS-related disorder in a subject in need thereof, comprising an effective amount of a compound of  claim 1 . 
     
     
         102 . The method of  claim 101 , wherein the CNS-related disorder is a sleep disorder, a mood disorder, a schizophrenia spectrum disorder, a convulsive disorder, a disorder of memory and/or cognition, a movement disorder, a personality disorder, autism spectrum disorder, pain, traumatic brain injury, a vascular disease, a substance abuse disorder and/or withdrawal syndrome, or tinnitus. 
     
     
         103 - 104 . (canceled) 
     
     
         105 . A compound of  claim 32 , selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         106 . A compound of  claim 58 , selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         107 . A pharmaceutically acceptable salt of a compound of  claim 32 , selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         108 . A pharmaceutically acceptable salt of a compound of  claim 58 , selected from the group consisting of:

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