US2022306606A1PendingUtilityA1

Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator

71
Assignee: VERTEX PHARMAPriority: Sep 30, 2016Filed: Oct 20, 2021Published: Sep 29, 2022
Est. expirySep 30, 2036(~10.2 yrs left)· nominal 20-yr term from priority
C07D 401/14A61K 31/4439C07B 59/002C07B 2200/05A61P 11/00C07D 471/14A61K 31/5365A61P 1/16C07D 498/14A61K 31/519A61P 11/12A61P 43/00A61P 1/18
71
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Claims

Abstract

Compounds of Formula I:pharmaceutically acceptable salts thereof, deuterated derivatives of any of the foregoing, and metabolites of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed.

Claims

exact text as granted — not AI-modified
1 - 62 . (canceled) 
     
     
         63 . A compound of Formula I: 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein:
 one of Y 1  and Y 2  is N and the other is CH; 
 X is chosen from O, NH, and N(C 1 -C 4  alkyl) groups; 
 R 1  is chosen from —(CR 2 ) k —O—(CR 2 ) m (CR) n (Ring A) n+1  groups,
 wherein each Ring A is independently chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens, and 
 wherein each R is independently chosen from H, OH, and C 1 -C 2  alkyl groups optionally substituted with one or more halogens; 
 
 each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, C 1 -C 2  alkoxy groups, halogens, and cyano; 
 each R 3  is independently chosen from C 1 -C 2  alkyl groups optionally substituted with one or more OH groups; 
 each R 4  is independently chosen from halogens; 
 k is 0 or 1; 
 r is 0 or 1; 
 m is 0, 1, 2, or 3; 
 n is 0 or 1; 
 p is 0, 1, 2, 3, 4, or 5; and 
 q is 0, 1, 2, 3, 4, 5, 6, 7, or 8. 
 
     
     
         64 . A compound of  claim 63 , wherein the compound is of Formula II: 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein:
 X is chosen from O, NH, and N(C 1 -C 4  alkyl) groups; 
 R 1  is chosen from —(CR 2 ) k —O—(CR 2 ) m (CR) n (Ring A) n+1  groups,
 wherein each Ring A is independently chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens, and wherein each R is independently chosen from H, OH, and C 1 -C 2  alkyl groups optionally substituted with one or more halogens; 
 
 each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, C 1 -C 2  alkoxy groups, halogens, and cyano; 
 each R 3  is independently chosen from C 1 -C 2  alkyl groups optionally substituted with one or more OH groups; 
 each R 4  is independently chosen from halogens; 
 k is 0 or 1; 
 r is 0 or 1; 
 m is 0, 1, 2, or 3; 
 n is 0 or 1; 
 p is 0, 1, 2, 3, 4, or 5; and 
 q is 0, 1, 2, 3, 4, 5, 6, 7, or 8. 
 
     
     
         65 . A compound of  claim 63 , wherein the compound is of Formula III: 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein:
 R 1  is chosen from —(CR 2 ) k —O—(CR 2 ) m (CR) n (Ring A) n+1  groups,
 wherein each Ring A is independently chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens, and 
 wherein each R is independently chosen from H, OH, and C 1 -C 2  alkyl groups optionally substituted with one or more halogens; 
 
 each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, C 1 -C 2  alkoxy groups, halogens, and cyano; 
 each R 3  is independently chosen from C 1 -C 2  alkyl groups optionally substituted with one or more OH groups; 
 each R 4  is independently chosen from halogens; 
 k is 0 or 1; 
 r is 0 or 1; 
 m is 0, 1, 2, or 3; 
 n is 0 or 1; 
 p is 0, 1, 2, 3, 4, or 5; and 
 q is 0, 1, 2, 3, 4, 5, 6, 7, or 8. 
 
     
     
         66 . A compound according to  claim 63 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein if R 2  is cyano, then R 2  is meta or para relative to the sulfur atom. 
     
     
         67 . A compound according to  claim 63 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein:
 each Ring A is independently chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens, and   each R is independently chosen from H and OH;   each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, C 1 -C 2  alkoxy groups, and halogens;   R 4  is F;   k is 0;   p is 0, 1, or 2;   q is 0, 1, 2, 3, or 4;   r is 0; and   wherein m and n are not 0 at the same time.   
     
     
         68 . A compound according to  claim 67 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein:
 R 1  is chosen from —O—(CR 2 ) m -Ring A groups,
 wherein Ring A is chosen from C 3 -C 10  cycloalkyl groups groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2  alkyl groups, and halogens, and 
   m is 1 or 2.   
     
     
         69 . A compound according to  claim 68 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein each R 3  is a methyl group and q is 3 or 4. 
     
     
         70 . A compound according to  claim 69  having Formula IV: 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein:
 Ring A is chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C2alkyl groups, and halogens; and 
 each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, F, Cl, and C 1 -C 2  alkoxy groups; 
 m is 1 or 2; and 
 p is 0, 1, or 2. 
 
     
     
         71 . A compound according to  claim 70 , wherein p is 0 or 1. 
     
     
         72 . A compound according to  claim 70  having Formula V: 
       
         
           
           
               
               
           
         
         a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein: 
         Ring A is chosen from 0 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens; and 
         each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, F, Cl, and C 1 -C 2  alkoxy groups; 
         m is 1 or 2; and 
         p is 0, 1, or 2. 
       
     
     
         73 . A compound according to  claim 63 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein each R 2  is independently chosen from CH 3 , OH, F, and OCH 3 . 
     
     
         74 . A compound according to  claim 73 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein p is 0 or 1. 
     
     
         75 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein Ring A is a cyclopropyl group substituted with a halogenated C 1  alkyl group or a halogenated C 2  alkyl group. 
     
     
         76 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein Ring A is a cyclopropyl group substituted with a CF 3  group. 
     
     
         77 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein m is 1, Ring A is a cyclopropyl group substituted with a CF 3  group, p is 0 or 1, and R 2 , if present, is a methyl group, a hydroxy group, or a methoxy group. 
     
     
         78 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein m is 2, Ring A is a C 3  cycloalkyl group substituted with a CF 3  group, p is 0 or 1, and R 2 , if present, is a methyl group, a hydroxy group, or a methoxy group. 
     
     
         79 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein m is 2, Ring A is a cyclopropyl group substituted with a CF 3  group, and p is 0. 
     
     
         80 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein Ring A is chosen from C5 bicycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2  alkyl groups, and halogens. 
     
     
         81 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein Ring A is a C 5  bicycloalkyl group optionally substituted with a halogen. 
     
     
         82 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein Ring A is chosen from C 7  bicycloalkyl groups and C 7  tricycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2  alkyl groups, and halogens. 
     
     
         83 . A compound according to  claim 72 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, wherein Ring A is an unsubstituted C 7  tricycloalkyl group. 
     
     
         84 . A compound according to  claim 63  having a formula chosen from any one of the formulae depicted below: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing. 
     
     
         85 . A compound according to  claim 63  having:
 (a) the following formula: 
 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing; or
 (b) the following formula: 
 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing; or
 (c) the following formula: 
 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing; or
 (d) the following formula: 
 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing; or
 (e) the following formula: 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof; or
 (f) the following formula: 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof; or
 (g) the following formula: 
 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof. 
     
     
         86 . A pharmaceutical composition comprising a compound, a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, as defined in  claim 63 . 
     
     
         87 . A pharmaceutical composition comprising at least one compound chosen from the compound of  claim 63 , a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing, and optionally one or more of:
 (a) Compound II:   
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing;
 (b) Compound III: 
 
       
         
           
           
               
               
           
         
       
       a deuterated derivative thereof, or a pharmaceutically acceptable salt of any of the foregoing; and
 (c) a pharmaceutically acceptable carrier. 
 
     
     
         88 . The pharmaceutical composition according to  claim 87  for use in a method of treating cystic fibrosis. 
     
     
         89 . A method of preparing a compound of Formula (F): 
       
         
           
           
               
               
           
         
       
       or a deuterated derivative thereof, or a salt of any of the foregoing, comprising reacting a compound of Formula (D) or salt thereof with a compound of Formula (E) or a salt thereof to generate a compound of Formula (F) or a salt thereof: 
       
         
           
           
               
               
           
         
         wherein in each of the formulae: 
         one of Y 1  and Y 2  is independently N and the other is independently CH; 
         each R 1  is independently chosen from —(CR 2 ) k —O—(CR 2 ) m (CR) n (Ring A) n+1  groups,
 wherein each Ring A is independently chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens, and 
 wherein each R is independently chosen from H, OH, and C 1 -C 2  alkyl groups optionally substituted with one or more halogens; 
 
         each R 2  is independently chosen from C 1 -C 2  alkyl groups, OH, C 1 -C 2  alkoxy groups, halogens, and cyano; 
         each R 4  is independently chosen from halogens; 
         X a  is chosen from F or Cl; 
         each k is independently 0 or 1; 
         each r is independently 0 or 1; 
         each m is independently 0, 1, 2, or 3; 
         each n is independently 0 or 1; and 
         each p is independently 0, 1, 2, 3, 4, or 5; optionally, wherein each Y 2  is independently N; and each Y 1  is independently CH. 
       
     
     
         90 . The method of  claim 89 , wherein reacting a compound of Formula (D) or a salt thereof with a compound of Formula (E) or salt thereof is performed in the presence of a base;
 or comprises reacting a compound of Formula (D-1) with a coupling reagent and subsequently with a compound of Formula (E-1) in the presence of a base.   
     
     
         91 . The method of  claim 89  which is a method of preparing a compound of Formula (F-1): 
       
         
           
           
               
               
           
         
       
       or a deuterated derivative thereof, or a salt of any of the foregoing, comprising reacting a compound of Formula (D-1) and a compound of Formula (E-1) to generate a compound of Formula (F-1) or a salt thereof: 
       
         
           
           
               
               
           
         
       
       wherein each Xa is independently chosen from F or Cl. 
     
     
         92 . The method of  claim 91 , wherein reacting a compound of Formula (D-1) or a salt thereof with a compound of Formula (E-1) or a salt thereof is performed in the presence of a base; or comprises reacting a compound of Formula (D-1) with a coupling reagent and subsequently with a compound of Formula (E-1) in the presence of a base. 
     
     
         93 . A method of preparing a compound of Formula (D): 
       
         
           
           
               
               
           
         
       
       or a deuterated derivative thereof, or a salt of any of the foregoing, comprising:
 reacting a compound of Formula (A) or a salt thereof with a compound of Formula (B) or a salt thereof to generate a compound of Formula (C) or a salt thereof: 
 
       
         
           
           
               
               
           
         
       
       and
 (ii) hydrolyzing the —C(O)OR a  group of a compound of Formula (C) to generate a compound of Formula (D) or a salt thereof, wherein in each of the formulae: 
 one of Y 1  and Y 2  is independently N and the other is independently CH; 
 each R 1  is independently chosen from —(CR 2 ) k —O—(CR 2 ) m (CR) n (Ring A) n+1  groups,
 wherein each Ring A is independently chosen from C 3 -C 10  cycloalkyl groups optionally substituted with one or more substituents each independently chosen from C 1 -C 2  alkyl groups, halogenated C 1 -C 2 alkyl groups, and halogens, and 
 wherein each R is independently chosen from H, OH, and C 1 -C 2  alkyl groups optionally substituted with one or more halogens; 
 
 each R 4  is independently chosen from halogens; 
 each R a  is independently chosen from C 1 -C 4  alkyl; 
 each X a  is independently chosen from F or Cl; 
 each k is independently 0 or 1; 
 each r is independently 0 or 1; 
 each m is independently 0, 1, 2, or 3; and 
 each n is independently 0 or 1; 
 optionally, wherein each Y 2  is independently N; and each Y 1  is independently CH. 
 
     
     
         94 . The method of  claim 93 , wherein the hydrolysis of the —C(O)OR a  group is performed in the presence of a base; optionally, wherein reacting a compound of Formula (A) or a salt thereof with a compound of Formula (B) or salt thereof is performed in the presence of a base. 
     
     
         95 . The method of  claim 93 , wherein R a  is ethyl or t-butyl. 
     
     
         96 . The method of  claim 93  which is a method of preparing a compound of Formula (D-1). 
       
         
           
           
               
               
           
         
         or a deuterated derivative thereof, or a salt of any of the foregoing, comprising: 
         reacting a compound of Formula (A-1) or a salt thereof and a compound of Formula (B-1) or a salt thereof to generate a compound of Formula (C-1) or a salt thereof: 
       
       
         
           
           
               
               
           
         
       
       and
 (ii) hydrolyzing the —C(O)OR a  group of a compound of Formula (C-1) or a salt thereof to generate a compound of Formula (D-1) or a salt thereof, 
 wherein each R a  is independently chosen from C 1 -C 4  alkyl; and each —X a  is independently chosen from F or Cl; optionally, wherein the hydrolysis of the —C(O)OR a  group is performed in the presence of a base. 
 
     
     
         97 . The method of  claim 96 , wherein reacting a compound of Formula (A-1) or a salt thereof and a compound of Formula (B-1) or a salt thereof is performed in the presence of a base; optionally, wherein R a  is ethyl or t-butyl.

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