US2005222121A1PendingUtilityA1

Atypical antipsychotic agents having low affinity for the D2 receptor

Assignee: KAPUR SHITIJPriority: Jun 26, 2001Filed: Jan 10, 2005Published: Oct 6, 2005
Est. expiryJun 26, 2021(expired)· nominal 20-yr term from priority
A61P 25/18C07D 281/16C07D 267/20
44
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Claims

Abstract

The present invention provides novel compounds of Formula I: The invention further relates to pharmaceutical compositions comprising compounds of Formula I and to methods of using compounds of Formula I to treat neuropsychiatric disorders (e.g., psychosis, depression, schizophrenia).

Claims

exact text as granted — not AI-modified
1 . A compound of Formula I or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said Formula I is represented by:  
     
       
         
         
             
             
         
       
     
     and wherein 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S; and  
 n is an integer selected from 2, 3, 4 and 5.  
 
   
   
       2 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein X is O.  
   
   
       3 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein X is S.  
   
   
       4 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein R 2  is C 2-4  alkyl.  
   
   
       5 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein R 2  is selected from the group consisting of ethyl, n-propyl, isopropyl, n-butyl and (CH 2 ) 2 OH.  
   
   
       6 . The compound of  claim 5 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein R 2  is selected from the group consisting of ethyl and (CH 2 ) 2 OH.  
   
   
       7 . The compound of  claim 6 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein R 1  is selected from the group consisting of halo and CF 3 .  
   
   
       8 . The compound of  claim 7 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein R 1  is selected from the group consisting of F, Cl, Br and I.  
   
   
       9 . The compound of  claim 7 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein R 1  is selected from the group consisting of Cl and CF 3 .  
   
   
       10 . The compound of  claim 1 , wherein said compound of Formula (I) is selected from the group consisting of:  
     
       
         
         
             
             
         
       
       (A-1)=8-Trifluoromethyl-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-2)=8-Trifluoromethyl-11-(4-(2′-hydroxyethyl)piperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-3)=8-Trifluoromethyl-11-(4-propylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-4)=8-Trifluoromethyl-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-5)=8-Trifluoromethyl-11-(4-butylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-8)=8-Chloro-11-(4-propylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-9)=8-Chloro-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-10)=8-Chloro-11-(4-butylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-11)=8-Fluoro-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-12)=8-Chloro-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine;  
       
         
           
           
               
               
           
         
       
       (A-14)=8-Chloro-11-(4-propylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine;  
       
         
           
           
               
               
           
         
       
       (A-15)=8-Chloro-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine; and  
       
         
           
           
               
               
           
         
       
       (A-16)=8-Chloro-11-(4-butylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine.  
     
   
   
       11 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value of at least 30 nM.  
   
   
       12 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value from 30 nM to about 500 nM.  
   
   
       13 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value of at least about 40 nM.  
   
   
       14 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value from about 40 nM to about 500 nM.  
   
   
       15 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value from about 40 nM to about 180 nM.  
   
   
       16 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value from about 40 nM to about 80 nM.  
   
   
       17 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value of at least about ½ times (K i  for clozapine).  
   
   
       18 . The compound of  claim 1 , or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, wherein said compound has a K i  value from about ½ times (K i  for clozapine) to about 2 times (K i  for clozapine).  
   
   
       19 . (canceled)  
   
   
       20 . A method for the treatment of psychosis, said method comprising the step of administering, to a subject in need thereof, a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, of Formula I:  
     
       
         
         
             
             
         
       
     
     wherein: 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S; and  
 n is an integer selected from 2, 3, 4, and 5.  
 
   
   
       21 . The method of  claim 20 , wherein said compound, or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, of Formula I is selected from the group consisting of:  
     
       
         
         
             
             
         
       
       (A-1)=8-Trifluoromethyl-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-2)=8-Trifluoromethyl-11-(4-(2′-hydroxyethyl)piperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-3)=8-Trifluoromethyl-11-(4-propylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-4)=8-Trifluoromethyl-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-5)=8-Trifluoromethyl-11-(4-butylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-8)=8-Chloro-11-(4-propylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-9)=8-Chloro-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-10)=8-Chloro-11-(4-butylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-11)=8-Fluoro-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]oxazepine;  
       
         
           
           
               
               
           
         
       
       (A-12)=8-Chloro-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine;  
       
         
           
           
               
               
           
         
       
       (A-14)=8-Chloro-11-(4-propylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine;  
       
         
           
           
               
               
           
         
       
       (A-15)=8-Chloro-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine; and  
       
         
           
           
               
               
           
         
       
       (A-16)=8-Chloro-11-(4-butylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine.  
     
   
   
       22 . A pharmaceutical composition comprising a compound of Formula I, or its pharmaceutical salt, hydrate or solvate thereof, and a pharmaceutically acceptable carrier, said Formula I represented by:  
     
       
         
         
             
             
         
       
     
     wherein: 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S; and  
 n is an integer selected from 2, 3, 4, and 5.  
 
   
   
       23 . The method of  claim 20 , wherein said administering step comprises orally administering, for the treatment of schizophrenia, said compound, or a pharmaceutically acceptable salt, hydrate, prodrug or solvate thereof, of Formula I.  
   
   
       24 . A compound of Formula (A-12) or a pharmaceutically acceptable salt, hydrate, or solvate thereof, wherein said Formula (A-12) is represented by:  
     
       
         
         
             
             
         
       
       (A-12)=8-Chloro-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine.  
     
   
   
       25 . A compound of Formula (A-15) or a pharmaceutically acceptable salt, hydrate, or solvate thereof, wherein said Formula (A-15) is represented by:  
     
       
         
         
             
             
         
       
       (A-15)=8-Chloro-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine.  
     
   
   
       26 . A method for the treatment of psychosis, said method comprising the step of administering a therapeutically effective amount of a compound of Formula (A-12) or a pharmaceutically acceptable salt, hydrate, or solvate thereof, wherein said Formula (A-12) is represented by:  
     
       
         
         
             
             
         
       
       (A-12)=8-Chloro-11-(4-ethylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine.  
     
   
   
       27 . A method for the treatment of psychosis, said method comprising the step of administering a therapeutically effective amount of a compound of Formula (A-15) or a pharmaceutically acceptable salt, hydrate, or solvate thereof, wherein said Formula (A-15) is represented by:  
     
       
         
         
             
             
         
       
       (A-15)=8-Chloro-11-(4-isopropylpiperazin-1-yl)-dibenzo[b,f][1,4]thiazepine.  
     
   
   
       28 . A compound of Formula I or a pharmaceutically acceptable salt, or solvate thereof, wherein said Formula I is represented by:  
     
       
         
         
             
             
         
       
     
     and wherein 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S;  
 n is an integer selected from 2, 3, 4 and 5, and  
 wherein said Formula I has a K i  of at least about 30 nM.  
 
   
   
       29 . A compound of Formula I or a pharmaceutically acceptable salt, or solvate thereof, wherein said Formula I is represented by:  
     
       
         
         
             
             
         
       
     
     and wherein 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S;  
 n is an integer selected from 2, 3, 4 and 5, and  
 wherein said Formula I has a K i  of at least about 40 nM.  
 
   
   
       30 . A method for the treatment of psychosis, said method comprising the step of administering, to a subject in need thereof, a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt, or solvate thereof, of Formula I:  
     
       
         
         
             
             
         
       
     
     wherein: 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S;  
 n is an integer selected from 2, 3, 4, and 5, and  
 wherein said Formula I has a K i  of at least about 30 nM.  
 
   
   
       31 . A method for the treatment of psychosis, said method comprising the step of administering, to a subject in need thereof, a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt, or solvate thereof, of Formula I:  
     
       
         
         
             
             
         
       
     
     wherein: 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-5  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S;  
 n is an integer selected from 2, 3, 4, and 5, and  
 wherein said Formula I has a K i  of at least about 40 nM.  
 
   
   
       32 . The compound of  claim 1 , wherein said Formula I represents an atypical antipsychotic drug.  
   
   
       33 . A method for the treatment of psychosis, said method comprising the step of administering to a human a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt, or solvate thereof, of Formula I:  
     
       
         
         
             
             
         
       
     
     wherein: 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-4  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S;  
 n is an integer selected from 2, 3, 4, and 5, and  
 wherein said Formula I has a K i  of at least about 30 nM.  
 
   
   
       34 . The method of  claim 33  wherein said administering step further comprises administering said compound of Formula I by an administration route selected from the group consisting of a parenteral route, a nasal route, and an oral route.  
   
   
       35 . The method of  claim 34 , wherein said parenteral route is selected from the group consisting of an intravenous route, an intramuscular route and a subcutaneous route.  
   
   
       36 . The method of  claim 35  wherein said administration route is said subcutaneous route and said compound of Formula I is an atypical antipsychotic drug in humans.  
   
   
       37 . A method for the treatment of psychosis, said method comprising the step of administering to a human a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt, or solvate thereof, of Formula I:  
     
       
         
         
             
             
         
       
     
     wherein: 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-4  alkyl and (CH 2 ) n OH;  
 X is selected from the group consisting of O and S;  
 n is an integer selected from 2, 3, 4, and 5, and  
 wherein said Formula I has a K i  of at least about 40 nM.  
 
   
   
       38 . The method of  claim 37  wherein said administering step further comprises administering said compound of Formula I by an administration route selected from the group consisting of a parenteral route, a nasal route, and an oral route.  
   
   
       39 . The method of  claim 38 , wherein said parenteral route is selected from the group consisting of an intravenous route, an intramuscular route and a subcutaneous route.  
   
   
       40 . The method of  claim 38  wherein said administration route is said subcutaneous route and said compound of Formula I is an atypical antipsychotic drug in humans.  
   
   
       41 . A compound of Formula I or a pharmaceutically acceptable salt, or solvate thereof, wherein said Formula I is represented by:  
     
       
         
         
             
             
         
       
     
     and wherein 
 R 1  is selected from the group consisting of halo, CF 3 , CF 3 O, cyano, CH 3  and CH 3 O;  
 R 2  is selected from the group consisting of C 2-4  alkyl and (CH 2 ) n OH;  
 X is selected from the group consiting of O and S; and  
 n is an integer selected from 2, 3, 4 and 5.

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