US2021087223A1PendingUtilityA1

Compositions and methods for treating cns disorders

Assignee: SAGE THERAPEUTICS INCPriority: Oct 16, 2014Filed: Dec 4, 2020Published: Mar 25, 2021
Est. expiryOct 16, 2034(~8.2 yrs left)· nominal 20-yr term from priority
C07J 75/00C07D 249/18A61K 31/58A61K 9/0053C07J 13/007A61P 25/00C07D 295/033C07D 231/14C07D 249/04C07J 43/003A61K 9/0019C07J 9/00
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Claims

Abstract

Described herein are neuroactive steroids of the Formula (I): or a pharmaceutically acceptable salt thereof; wherein , R 1 , R 2a , R 2b , R 3 and A are as defined herein. Such compounds are envisioned, in certain embodiments, to behave as GABA modulators. The present invention also provides pharmaceutical compositions comprising a compound of the present invention and methods of use and treatment, e.g., such for inducing sedation and/or anesthesia.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A compound of the Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and 
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         2 . The compound of  claim 1 , wherein R 1  is substituted or unsubstituted C 1-6  alkyl (e.g., haloalkyl). 
     
     
         3 . The compound of any one of the preceding claims, wherein R 1  is methyl or CF 3 . 
     
     
         4 . The compound of any one of the preceding claims, wherein R 2a  is methyl. 
     
     
         5 . The compound of any one of the preceding claims, wherein R 2b  is hydrogen. 
     
     
         6 . The compound of any one of the preceding claims, wherein R 2a  is methyl and R 2b  is hydrogen. 
     
     
         7 . The compound of any one of the preceding claims, wherein   represents a single bond. 
     
     
         8 . The compound of any one of the preceding claims, wherein the compound of Formula (I) is a compound of Formula (II) or Formula (III): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein A, R 1 , R 2a , and R 2b  are defined as for Formula (I). 
     
     
         9 . The compound of any one of the preceding claims, wherein the compound of Formula (II) is a compound of Formula (II-a) or Formula (II-b): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein A and R 1  are defined as for Formula (I). 
     
     
         10 . The compound of any one of the preceding claims, wherein the compound of Formula (III) is a compound of Formula (III-a) or Formula (III-b): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein A and R 1  are defined as for Formula (I). 
     
     
         11 . The compound of any one of the preceding claims, wherein A is heterocyclyl or heteroaryl (e.g., nitrogen-containing heterocyclyl or a nitrogen-containing heteroaryl). 
     
     
         12 . The compound of any one of the preceding claims, wherein A is monocyclic or bicyclic. 
     
     
         13 . The compound of any one of the preceding claims, wherein A is substituted with at least one R A , wherein R A  is C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 3-6  carbocyclyl, C 1-6  haloalkyl, halogen, cyano, —OR A6 , —C(═O)OR A6 , —SR B6 , —S(═O)R B6 , or S(═O) 2 R B6 , wherein R A6  is hydrogen or C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 3-6  carbocyclyl, or C 1-6  haloalkyl, and R B6  is C 1-6  alkyl or C 3-6  carbocyclyl. 
     
     
         14 . The compound of  claim 13 , wherein R A  is C 1-6  alkyl, halogen, or cyano. 
     
     
         15 . The compound of any one of  claims 13 - 14 , wherein A is substituted with 1-3 instances of R A . 
     
     
         16 . A compound of the Formula (IV): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; 
         R A  is C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 3-6  carbocyclyl, C 1-6  haloalkyl, halogen, cyano, —OR A6 , —C(═O)OR A6 , —SR B6 , —S(═O)R B6 , or S(═O) 2 R B6 , wherein R A6  is hydrogen or C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, C 3-6  carbocyclyl, or C 1-6  haloalkyl, and R B6  is C 1-6  alkyl or C 3-6  carbocyclyl; 
         n is 0, 1, 2 or 3; and 
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         17 . The compound of  claim 16 , wherein R 1  is substituted or unsubstituted C 1-6  alkyl (e.g., haloalkyl). 
     
     
         18 . The compound of any one of  claims 16 - 17 , wherein R 1  is methyl or CF 3 . 
     
     
         19 . The compound of any one of  claims 16 - 18 , wherein R 2a  is methyl. 
     
     
         20 . The compound of any one of  claims 16 - 19 , wherein R 2b  is hydrogen. 
     
     
         21 . The compound of any one of  claims 16 - 20 , wherein R 2a  is methyl and R 2b  is hydrogen. 
     
     
         22 . The compound of any one of  claims 16 - 21 , wherein   represents a single bond. 
     
     
         23 . The compound of  claims 16 - 22 , wherein the compound of Formula (IV) is a compound of Formula (V) or Formula (VI): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein A, R 1 , R 2a , R 2b , R A , and n are defined as for Formula (IV). 
     
     
         24 . The compound of any one of  claims 16 - 23 , wherein the compound of Formula (V) is a compound of Formula (V-a) or Formula (V-b): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein A, R 1 , R 2 , R b , R A , and n are defined as for Formula (IV). 
     
     
         25 . The compound of any one of  claims 16 - 24 , wherein the compound of Formula (VI) is a compound of Formula (VI-a) or Formula (VI-b): 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, wherein A, R 1 , are defined as for Formula (I). 
     
     
         26 . The compound of any one of the preceding claims, wherein A is selected from: 
       
         
           
           
               
               
           
         
       
     
     
         27 . The compound of any one of the preceding claims, wherein A is selected from: 
       
         
           
           
               
               
           
         
       
     
     
         28 . The compound of any one of the preceding claims, wherein the compound is selected from: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof. 
     
     
         29 . A pharmaceutical composition comprising a compound of any one of the preceding claims and a pharmaceutically acceptable excipient. 
     
     
         30 . A method of inducing sedation and/or anesthesia in a subject, comprising administering to the subject an effective amount of a compound of the Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and 
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         31 . A method of administering an effective amount of a compound, a pharmaceutically acceptable salt thereof, or pharmaceutical composition of any one of the preceding claims to a subject in need thereof, wherein the subject experiences sedation and/or anesthesia within two hours of administration. 
     
     
         32 . The method of  claim 31 , wherein the subject experiences sedation and/or anesthesia within one hour of administration. 
     
     
         33 . The method of  claim 31 , wherein the subject experiences sedation and/or anesthesia instantaneously. 
     
     
         34 . The method of  claim 31 , wherein the compound is administered by intravenous administration. 
     
     
         35 . The method of  claim 31  wherein the compound is administered chronically. 
     
     
         36 . The method of  claim 31 , wherein the subject is a mammal. 
     
     
         37 . The method of  claim 36 , wherein the subject is a human. 
     
     
         38 . The method of  claim 31 , wherein the compound is administered in combination with another therapeutic agent. 
     
     
         39 . A method for treating seizure in a subject, comprising administering to the subject an effective amount of a compound of the Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and 
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         40 . A method for treating epilepsy or status or status epilepticus in a subject, the method comprising administering to the subject an effective amount of a compound of the Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and 
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         41 . A method for treating disorders related to GABA function in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a compound or pharmaceutical composition comprising a compound of Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and    
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         42 . A method for treating a CNS-related disorder in a subject in need thereof, comprising administering to the subject an effective amount a compound of Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and 
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent. 
       
     
     
         43 . The method of  claim 42 , 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. 
     
     
         44 . The method of  claim 42 , wherein the compound is administered orally. 
     
     
         45 . The method of  claim 42 , wherein the compound is administered intramuscularly. 
     
     
         46 . The method of  claim 42 , wherein the subject is a subject with Rett syndrome, Fragile X syndrome, or Angelman syndrome. 
     
     
         47 . The method of  claim 42 , wherein the CNS-related disorder is a sleep disorder, an eating 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. 
     
     
         48 . The method of  claim 42 , wherein the CNS-related disorder is depression (e.g., post-partum depression). 
     
     
         49 . The method of  claim 42 , wherein the CNS-related disorder is tremor (e.g., essential tremor). 
     
     
         50 . The method of  claim 42 , wherein the CNS-related disorder is an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge-eating disorder, cachexia). 
     
     
         51 . A kit comprising a solid composition comprising a compound of Formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, wherein: 
         A is aryl, heterocyclyl or heteroaryl; 
         R 1  is C 1-6  alkyl; 
         R 2a  is C 1-6  alkyl; 
         R 2b  is hydrogen or C 1-6  alkyl; 
         or R 2a  and R 2b  are joined to form an oxo (═O) group; 
         or R 2a  and R 2b  together with the carbon atom to which they are attached form a ring (e.g., a 3-6-membered ring (e.g., carbocycyl or heterocyclyl ring)); 
         R 3  is absent or hydrogen; and    
            represents a single or double bond, wherein when one of   is a double bond, the other   is a single bond; and when one of the   is a double bond, R 3  is absent; and a sterile diluent.

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