US2023373932A1PendingUtilityA1

Dihydropyrimidin-2-one compounds and medical use thereof

77
Assignee: JAPAN TOBACCO INCPriority: Dec 12, 2014Filed: Dec 20, 2022Published: Nov 23, 2023
Est. expiryDec 12, 2034(~8.4 yrs left)· nominal 20-yr term from priority
C07D 239/22A61P 37/00C07D 413/04A61P 43/00A61K 31/505A61P 17/00C07D 401/04A61K 31/695A61P 27/00A61K 31/506C07C 265/02C07C 275/06C07F 7/0812A61P 25/00C07F 7/12A61P 3/00C07D 403/04C07D 405/04C07D 405/10A61P 29/00C07D 239/36C07D 403/06A61P 1/04A61P 3/10A61P 17/06A61P 19/02A61P 19/04A61P 19/08A61P 37/06
77
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Claims

Abstract

A compound of Formula [I] or a pharmaceutically acceptable salt thereof:wherein each symbol is defined as in the specification.

Claims

exact text as granted — not AI-modified
1 - 37 . (canceled) 
     
     
         38 . A method of inhibiting RORγ, comprising administering to a mammal a therapeutically effective amount of a compound selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt of any of the foregoing. 
       
     
     
         39 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         40 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         41 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         42 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         43 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         44 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         45 . The method of  claim 38 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         46 . A method of treating a disease selected from the group consisting of allergic disease, dry eye, fibrosis, and metabolic disease, comprising administering to a mammal an effective amount of a compound selected from the group consisting of: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt of any of the foregoing. 
       
     
     
         47 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         48 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         49 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         50 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         51 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         52 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         53 . The method of  claim 46 , wherein the compound is: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         54 . The method according to any one of  claims 46  to  53 , wherein the disease is allergic disease. 
     
     
         55 . The method according to any one of  claims 46  to  53 , wherein the disease is dry eye. 
     
     
         56 . The method according to any one of  claims 46  to  53 , wherein the disease is fibrosis. 
     
     
         57 . The method according to any one of  claims 46  to  53 , wherein the disease is metabolic disease. 
     
     
         58 . A method of preparing a compound of Formula [Q-109]: 
       
         
           
           
               
               
           
         
         the method comprising reacting a compound of Formula [Q-107]: 
       
       
         
           
           
               
               
           
         
         with a compound of Formula [Q-108]:
   H 2 N—R 5q   [Q108]
 
 
         in a solvent and optionally in the presence of a base, wherein
 R 1  is 
 (1) C 4-8  alkyl, 
 (2) C 3-8  alkyl substituted with one hydroxy, 
 (3) C 4-8  alkyl substituted with one halogen, 
 (4) C 4-8  alkenyl, 
 (5) C 4-8  alkynyl, 
 (6) C 3-7  alkyl substituted with one trifluoromethyl, 
 (7) C 1-5  alkyl substituted with one substituent selected from Group X a1 , 
 (8) C 3-6  alkoxy, 
 (9) C 2-7  alkoxy substituted with one trifluoromethyl, 
 (10) C 1-3  alkoxy substituted with one substituent selected from Group X a2 , 
 (11) C 4-6  cycloalkyl, 
 (12) C 3-6  cycloalkyl substituted with the same or different one to two C 1-5  alkyl, 
 (13) C 5-6  cycloalkenyl optionally substituted with the same or different one to two C 1-4  alkyl, 
 (14) spiro C 6-11  cycloalkyl, 
 (15) C 1-3  alkoxycarbonyl, 
 (16) C 3-6  alkylsulfanyl, 
 (17) C 3-6  alkylsulfinyl, 
 (18) C 3-6  alkylsulfonyl, 
 (19) C 3-6  cycloalkylsulfanyl, 
 (20) C 3-6  cycloalkylsulfinyl, 
 (21) C 3-6  cycloalkylsulfonyl, 
 (22) cyclobutylidenemethyl, 
 (23) cyclopentylidenemethyl, 
 (24) cyclohexylidenemethyl optionally substituted with the same or different one to two C 1-3  alkyl, 
 (25) tetrahydropyran-4-ylidenemethyl, 
 (26) C 3-6  cycloalkyl substituted with one to the same two halogen, or 
 (27) C 5-6  cycloalkenyl substituted with one to the same two halogen; 
 Group X a1  is 
 (a) C 3-6  cycloalkyl optionally substituted with the same or different one to three C 1-5  alkyl, 
 (b) C 3-6  cycloalkyl substituted with the same or different one to two halogen, 
 (c) phenyl, 
 (d) C 2-4  alkoxy, 
 (e) trimethylsilyl, 
 (f) carboxy, or 
 (g) tetrahydropyran-4-yl; 
 Group X a2  is 
 (a) C 3-6  cycloalkyl, 
 (b) phenyl, or 
 (c) C 1-4  alkoxy; 
 R 2  is 
 (1) halogen, 
 (2) C 1-6  alkyl, 
 (3) C 1-3  alkoxy optionally substituted with phenyl, or 
 (4) trifluoromethyl; 
 n is an integer of 0, 1 or 2, provided that when n is 2, each R 2  may be different from each other; or 
 R 1  and R 2  may combine together with the benzene ring to which they attach to form indanyl where the indanyl may be substituted with the same or different one to two C 1-6  alkyl; 
 R 3q i is —Y b —CH 2 OP 2 , C 1-6  alkyl optionally substituted with hydroxy protected with one P 2 , C 3-6  cycloalkyl optionally substituted with the same or different one to three substituents from Group X b , 4-tetrahydropyranyl, or I-methanesulfonyl-3-azetidinyl; 
 Y b  is C 1-6  alkylene or C 3-6  cycloalkylene; 
 P 2  is a protective group selected from the group consisting of trimethylsilyl (TMS) and tertbutyldimethylsilyl; 
 Group X b  is halogen or C 1-6  alkyl; 
 R 4  is 
 (1) hydrogen or 
 (2) methyl; 
 R 5q  is —Y c —COO—R 50 , hydrogen, C 1-4  alkyl optionally substituted with one C 1-3  alkoxy, or C 3-6  cycloalkyl optionally substituted with hydroxy-C 1-4  alkyl protected with one P 2 ; 
 R q50  is C 1-4  alkyl; 
 Y c  is C 1-6  alkylene optionally substituted with hydroxy protected with one P 2 , CH 2 —CH 2 —O—CH 2 , or (CH 2 ) m —Y c1 —(CH 2 ) w ; 
 m is an integer of 0, 1, or 2; 
 w is an integer of 0, 1, or 2; and 
 Y c1  is C 3-6  cycloalkylene optionally substituted with one C 1-3  alkyl, phenylene, crosslinked C 5-8  cycloalkylene, or 
 
       
       
         
           
           
               
               
           
         
         
            and 
           R 6  is 
           (1) hydrogen or 
           (2) methyl. 
         
       
     
     
         59 . The method of  claim 58 , wherein
 the base is triethylamine; and   the solvent is benzene, toluene, dichloromethane, chloroform, diethyl ether, tetrahydrofuran, 1,2-dimethoxyethane, ethyl acetate, N,N-dimethylformamide, dimethylsulfoxide, acetonitrile, acetone, or any mixture of the foregoing; and   the reacting is carried out at a temperature of from 0° C. to 80° C.   
     
     
         60 . The method of  claim 58 , wherein the compound of Formula [Q-107] is obtained by reacting a compound of Formula [Q-106]: 
       
         
           
           
               
               
           
         
         with an azidation agent followed by a Curtius rearrangement in the presence of a base and a solvent. 
       
     
     
         61 . The method of  claim 60 , wherein
 the azidation agent is diphenylphosphoryl azide (DPPA);   the base is triethylamine or diisopropylethylamine;   the solvent is benzene, toluene, or xylene; and   the reacting is carried out at a temperature of from 0° C. to 140° C.   
     
     
         62 . The method of  claim 60 , wherein the compound of Formula [Q-106] is obtained by an Ireland Claisen rearrangement reaction of Formula [Q-105]: 
       
         
           
           
               
               
           
         
         by in a solvent, in the presence of a base and a chlorosilane compound, and optionally in the presence of an additive. 
       
     
     
         63 . The method of  claim 62 , wherein
 the base is lithium diisopropylamide (LDA), lithium hexamethyldisilazide (LFMDS), or lithium 2,2,6,6-tetramethylpiperidide (LiTMP);   the chlorosilane compound is trimethylsilyl chloride or tert-butyldimethylsilyl chloride;   the additive is hexamethylphosphoric triamide (HMPA) or N,N′-dimethylpropyleneurea (DMPU);   the solvent is diethyl ether, 1,2-dimethoxyethane, or tetrahydrofuran; and   the Ireland Claisen rearrangement reaction is carried out at a temperature of from −78° C. to 80° C.   
     
     
         64 . The method of  claim 62 , wherein the compound of Formula [Q-105] is obtained by reacting a compound of formula [Q-103]: 
       
         
           
           
               
               
           
         
         with a compound of Formula [Q-104]: 
       
       
         
           
           
               
               
           
         
         in the presence of a condensation agent, a solvent, and optionally an additive. 
       
     
     
         65 . The method of  claim 64 , wherein
 the condensation agent is 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide hydrochloride, N,N′-dicyclohexylcarbodiimide (DCC), diphenylphosphoryl azide (DPPA), or carbonyldiimidazole;   the additive is 1-hydroxy-1H-benzotriazole monohydrate (HOBt·H 2 O) or 4-dimethylaminopyridine (DMAP); and   the solvent is toluene, dichloromethane, chloroform, tetrahydrofuran, dixoane, N,N-dimethylformamide, dimethylsulfoxide, acetonitrile, acetone, or any mixture of the foregoing; and   the reacting is carried out at a temperature of from 0° C. to 100° C.   
     
     
         66 . A compound selected from the group consisting of: 
       
         
           
           
               
               
           
         
         wherein
 R 1  is 
 (1) C 4-8  alkyl, 
 (2) C 3-8  alkyl substituted with one hydroxy, 
 (3) C 4-8  alkyl substituted with one halogen, 
 (4) C 4-8  alkenyl, 
 (5) C 4-8  alkynyl, 
 (6) C 3-7  alkyl substituted with one trifluoromethyl, 
 (7) C 1-5  alkyl substituted with one substituent selected from Group X a1 , 
 (8) C 3-6  alkoxy, 
 (9) C 2-7  alkoxy substituted with one trifluoromethyl, 
 (10) C 1-3  alkoxy substituted with one substituent selected from Group X a2 , 
 (11) C 4-6  cycloalkyl, 
 (12) C 3-6  cycloalkyl substituted with the same or different one to two C 1-5  alkyl, 
 (13) C 5-6  cycloalkenyl optionally substituted with the same or different one to two C 1 _4 alkyl, 
 (14) spiro C 6-11  cycloalkyl, 
 (15) C 1-3  alkoxycarbonyl, 
 (16) C 3-6  alkylsulfanyl, 
 (17) C 3-6  alkylsulfinyl, 
 (18) C 3-6  alkylsulfonyl, 
 (19) C 3-6  cycloalkylsulfanyl, 
 (20) C 3-6  cycloalkylsulfinyl, 
 (21) C 3-6  cycloalkylsulfonyl, 
 (22) cyclobutylidenemethyl, 
 (23) cyclopentylidenemethyl, 
 (24) cyclohexylidenemethyl optionally substituted with the same or different one to two C 1-3  alkyl, 
 (25) tetrahydropyran-4-ylidenemethyl, 
 (26) C 3-6  cycloalkyl substituted with one to the same two halogen, or 
 (27) C 5-6  cycloalkenyl substituted with one to the same two halogen; 
 Group X a1  is 
 (a) C 3-6  cycloalkyl optionally substituted with the same or different one to three C 1-5  alkyl, 
 (b) C 3-6  cycloalkyl substituted with the same or different one to two halogen, 
 (c) phenyl, 
 (d) C 2-4  alkoxy, 
 (e) trimethylsilyl, 
 (f) carboxy, or 
 (g) tetrahydropyran-4-yl; 
 Group X a2  is 
 (a) C 3-6  cycloalkyl, 
 (b) phenyl, or 
 (c) C 1-4  alkoxy; 
 R 2  is 
 (1) halogen, 
 (2) C 1-6  alkyl, 
 (3) C 1-3  alkoxy optionally substituted with phenyl, or 
 (4) trifluoromethyl; 
 n is an integer of 0, 1 or 2, provided that when n is 2, each R 2  may be different with each other; or 
 R 1  and R 2  may combine together with the benzene ring to which they attach to form indanyl where the indanyl may be substituted with the same or different one to two C 1-6  alkyl; 
 R 3q1  is —Y b —CH 2 OP 2 , C 1-6  alkyl optionally substituted with hydroxy protected with one P 2 , C 3-6  cycloalkyl optionally substituted with the same or different one to three substituents from Group X b , 4-tetrahydropyranyl, or 1-methanesulfonyl-3-azetidinyl; 
 Y b  is C 1-6  alkylene or C 3-6  cycloalkylene; 
 P 2  is a protective group selected from the group consisting of trimethylsilyl (TMS) and tertbutyldimethylsilyl; 
 Group X b  is halogen or C 1-6  alkyl; 
 R 4  is 
 (1) hydrogen or 
 (2) methyl; 
 R 5q  is —Y c —COO—R q50 , hydrogen, C 1-4  alkyl optionally substituted with one C 1-3  alkoxy or C 3-6  cycloalkyl optionally substituted with hydroxy-C 1-4  alkyl protected with one P 2 ; 
 R q50  is C 1-4  alkyl; 
 Y c  is C 1-6  alkylene optionally substituted with hydroxy protected with one P 2 , CH 2 —CH 2 —O—CH 2  or (CH 2 ) m —Y c1 —(CH 2 ) w ; 
 m is an integer of 0, 1, or 2; 
 w is an integer of 0, 1, or 2; and 
 Y c1  is C 3-6  cycloalkylene optionally substituted with one C 1-3  alkyl, phenylene, crosslinked C 5-8  cycloalkylene, or 
 
       
       
         
           
           
               
               
           
         
         
            and 
           R 6  is 
           (1) hydrogen or 
           (2) methyl. 
         
       
     
     
         67 . The compound of  claim 66 , wherein the compound is 
       
         
           
           
               
               
           
         
       
     
     
         68 . The compound of  claim 66 , wherein the compound is

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