US2023151016A1PendingUtilityA1

Pyrrolidine-pyrazoles as pyruvate kinase activators

Assignee: GLOBAL BLOOD THERAPEUTICS INCPriority: Feb 8, 2021Filed: Jan 17, 2023Published: May 18, 2023
Est. expiryFeb 8, 2041(~14.5 yrs left)· nominal 20-yr term from priority
C07D 487/04A61P 7/06
68
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Claims

Abstract

The subject matter described herein is directed to pyruvate kinase activating compounds of Formula I and pharmaceutical salts thereof, methods of preparing the compounds, pharmaceutical compositions comprising the compounds and methods of administering the compounds for the treatment of diseases associated with PKR and/or PKM2, such as pyruvate kinase deficiency, sickle cell disease, and beta-thalassemia.

Claims

exact text as granted — not AI-modified
1 . A compound of Formula I: 
       
         
           
           
               
               
           
         
         wherein,
 R a1  is hydroxy, C 1 -C 3  alkoxy, hydroxy-C 1 -C 3  alkoxy, or hydroxy-C 1 -C 3  alkyl; 
 R a2  is hydrogen or C 1 -C 3  alkyl; 
 or R a1  and R a2 , together with the carbon atom to which they are each attached, form a 4- to 5-membered heterocyclyl; 
 R c  is phenyl or pyridinyl, each optionally substituted with one or two substituents independently selected in each instance from the group consisting of halo, C 1 -C 3  alkyl, C 1 -C 3  alkoxy, hydroxy-C 1 -C 3  alkoxy, (C 1 -C 3  alkoxy)-C 1 -C 3  alkoxy, hydroxy-C 1 -C 3  alkyl, and (C 1 -C 3  alkoxy)-C 1 -C 3  alkyl; and 
 R b  is a thiazol-2(3H)-one or a 5-membered heteroaryl ring, each optionally substituted with one, two, or three substituents independently selected in each instance from the group consisting of C 1 -C 3  alkyl, halo-C 1 -C 3  alkyl, halo-C 1 -C 3  alkoxy, halo, C 1 -C 3  alkoxy, (C 1 -C 3  alkoxy)-C 1 -C 3  alkyl, (C 1 -C 3 -alkoxy)-C 1 -C 3  alkoxy, 3- to 6-membered cycloalkyl, 4- to 6-membered heterocyclyl, phenyl, and 5- or 6-membered heteroaryl; or a pharmaceutically acceptable salt thereof. 
 
       
     
     
         2 . The compound of  claim 1 , or a pharmaceutically acceptable salt thereof, wherein R a1  is hydroxy-C 1 -C 3  alkyl. 
     
     
         3 . The compound of  claim 1 , or a pharmaceutically acceptable salt thereof, wherein R a1  is —OH, —CH 2 OH, —CH(OH)CH 3 , —OCH 3 , or —OCH 2 CH 2 OH. 
     
     
         4 . The compound of  claim 3 , or a pharmaceutically acceptable salt thereof, wherein R a1  is —CH 2 OH. 
     
     
         5 . The compound of any one of  claims 1 - 4 , or a pharmaceutically acceptable salt thereof, wherein R a2  is hydrogen or —CH 3 . 
     
     
         6 . The compound of  claim 5 , or a pharmaceutically acceptable salt thereof, wherein R a2  is hydrogen. 
     
     
         7 . The compound of  claim 1 , or a pharmaceutically acceptable salt thereof, wherein R a1  and R a2 , together with the carbon atom to which they are each attached, form an oxetanyl ring. 
     
     
         8 . The compound of any one of  claims 1 - 7 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl or pyridinyl, each optionally substituted with one or two halos. 
     
     
         9 . The compound of  claim 8 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl or pyridinyl, each optionally substituted with one halo. 
     
     
         10 . The compound of  claim 9 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl or pyridinyl, each optionally substituted with fluoro or chloro. 
     
     
         11 . The compound of any one of  claims 8 - 10 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl, 2-fluorophenyl, 2-chlorophenyl, or pyridin-2-yl. 
     
     
         12 . The compound of any one of  claims 1 - 11 , or a pharmaceutically acceptable salt thereof, wherein R c  is 
       
         
           
           
               
               
           
         
         wherein, X is CH or N; and 
         R c  is hydrogen, fluoro, or chloro. 
       
     
     
         13 . The compound of  claim 12 , or a pharmaceutically acceptable salt thereof, wherein R c  is 
       
         
           
           
               
               
           
         
       
     
     
         14 . The compound of any one of  claims 1 - 13 , wherein R c  is phenyl. 
     
     
         15 . The compound of any one of  claims 1 - 7 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl substituted ortho with C 1 -C 3  alkyl, (C 1 -C 3 -alkoxy)-C 1 -C 3  alkoxy, C 1 -C 3  alkoxy, or hydroxy-C 1 -C 3  alkoxy. 
     
     
         16 . The compound of  claim 15 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl substituted ortho with —CH 3 , —CH 2 CH 3 , —CH 2 CH 2 CH 3 , —OCH 3 , —OCH 2 CH 3 , methoxy-C 1 -C 3  alkoxy, —OCH 2 CH 2 OH, or —OCH 2 CH 2 CH 2 OH. 
     
     
         17 . The compound of  claim 16 , or a pharmaceutically acceptable salt thereof, wherein R c  is phenyl substituted ortho with —CH 2 CH 3 , —OCH 3 , —OCH 2 CH 2 OH, or —OCH 2 CH 2 OCH 3 . 
     
     
         18 . The compound of any one of  claims 1 - 17 , or a pharmaceutically acceptable salt thereof, wherein R b  is a thiazol-2(3H)-one or a 5-membered heteroaryl ring substituted with one or two substituents, each independently selected from the group consisting of C 1 -C 3  alkyl, halo-C 1 -C 3  alkoxy, halo-C 1 -C 3  alkyl, (C 1 -C 3  alkoxy)-C 1 -C 3  alkyl, C 1 -C 3  alkoxy, phenyl, and 4- to 6-membered heterocyclyl. 
     
     
         19 . The compound of  claim 18 , or a pharmaceutically acceptable salt thereof, wherein R b  is a thiazol-2(3H)-one or a 5-membered heteroaryl ring substituted with one or two substituents, each independently selected from the group consisting of —CH 3 , —CH 2 CH 3 , —CH 2 CH 2 CH 3 , —CH(CH 3 ) 2 , fluoro-C 1 -C 3  alkyl, fluoro-C 1 -C 3  alkoxy, phenyl, 5-membered heterocyclyl, methoxy-C 1 -C 3  alkyl, —OCH 2 CH 3 , and —OCH 3 . 
     
     
         20 . The compound of  claim 19 , or a pharmaceutically acceptable salt thereof, wherein R b  is a thiazol-2(3H)-one or a 5-membered heteroaryl ring substituted with one or two substituents, each independently selected from the group consisting of —CH 3 , —CH 2 CH 3 , —CF 3 , —CH 2 CHF 2 , —CH 2 CH 2 CF 3 , —CHF 2 , —OCH 2 CHF 2 , phenyl, —OCH 2 CF 3 , —CH 2 CF 3 , —CH 2 CH 2 F, —CH 2 CH 2 OCH 3 , —OCH 2 CH 3 , —OCH 3 , and tetrahydrofuranyl. 
     
     
         21 . The compound of  claim 18 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring substituted with one halo-C 1 -C 3  alkyl and optionally further substituted with one C 1 -C 3  alkyl. 
     
     
         22 . The compound of  claim 18 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring substituted with one substituent selected from the group consisting of C 1 -C 3  alkyl and halo-C 1 -C 3  alkyl. 
     
     
         23 . The compound of  claim 22 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring substituted with one halo-C 1 -C 3  alkyl. 
     
     
         24 . The compound of  claim 18 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring substituted with two substituents, each independently selected from the group consisting of C 1 -C 3  alkyl and halo-C 1 -C 3  alkyl. 
     
     
         25 . The compound of  claim 24 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring substituted with one C 1 -C 3  alkyl and one halo-C 1 -C 3  alkyl. 
     
     
         26 . The compound of any one of  claims 1 - 25 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring comprising one, two, or three nitrogen ring atoms. 
     
     
         27 . The compound of  claim 26 , wherein the 5-membered heteroaryl ring of R b  is pyrazolyl, imidazolyl, pyrrolyl, oxazolyl, triazolyl, or thiazolyl. 
     
     
         28 . The compound of  claim 27 , or a pharmaceutically acceptable salt thereof, wherein the 5-membered heteroaryl ring of R b  is pyrazolyl. 
     
     
         29 . The compound of any one of  claims 1 - 28 , or a pharmaceutically acceptable salt thereof, wherein R b  is 
       
         
           
           
               
               
           
         
         wherein, R b1  is halo-C 1 -C 3  alkyl, methoxy-C 1 -C 3  alkyl, C 1 -C 3  alkyl, hydrogen, or tetrahydrofuranyl; and 
         R b2  is hydrogen, halo-C 1 -C 3  alkyl, or C 1 -C 3  alkyl. 
       
     
     
         30 . The compound of any one of  claims 1 - 29 , or a pharmaceutically acceptable salt thereof, wherein R b  is 
       
         
           
           
               
               
           
         
       
     
     
         31 . The compound of  claim 29  or  30 , or a pharmaceutically acceptable salt thereof, wherein R b1  is halo-C 1 -C 3  alkyl; and R b2  is hydrogen or C 1 -C 3  alkyl. 
     
     
         32 . The compound of any one of  claims 29 - 31 , or a pharmaceutically acceptable salt thereof, wherein R b2  is hydrogen. 
     
     
         33 . The compound of any one of  claims 29 - 31 , or a pharmaceutically acceptable salt thereof, wherein R b2  is C 1 -C 3  alkyl. 
     
     
         34 . The compound of  claim 33 , or a pharmaceutically acceptable salt thereof, wherein R b2  is —CH 3 . 
     
     
         35 . The compound of any one of  claims 29 - 34 , or a pharmaceutically acceptable salt thereof, wherein R b1  is fluoro-C 1 -C 3  alkyl. 
     
     
         36 . The compound of  claim 35 , or a pharmaceutically acceptable salt thereof, wherein R b1  is —CHF 2 , —CH 2 CH 2 CF 3 , —CH 2 CH 2 F, —CH 2 CHF 2 , or —CH 2 CF 3 . 
     
     
         37 . The compound of  claim 29  or  30 , or a pharmaceutically acceptable salt thereof, wherein R b1  is C 1 -C 3  alkyl; and R b2  is fluoro-C 1 -C 3  alkyl. 
     
     
         38 . The compound of  claim 37 , or a pharmaceutically acceptable salt thereof, wherein R b1  is —CH 2 CH 3 ; and R b2  is —CF 3 . 
     
     
         39 . The compound of  claim 29  or  30 , or a pharmaceutically acceptable salt thereof, wherein R b1  is —CH 2 CH 2 OCH 3  or tetrahydrofuranyl; and R b2  is hydrogen. 
     
     
         40 . The compound of  claim 27 , or a pharmaceutically acceptable salt thereof, wherein the 5-membered heteroaryl ring of R b  is thiazolyl. 
     
     
         41 . The compound of  claim 40 , or a pharmaceutically acceptable salt thereof, wherein R b  is 
       
         
           
           
               
               
           
         
         wherein, R b3  is halo-C 1 -C 3  alkoxy, C 1 -C 3  alkyl, halo-C 1 -C 3  alkyl, or C 1 -C 3  alkoxy; and 
         R b4  is hydrogen or C 1 -C 3  alkyl. 
       
     
     
         42 . The compound of  claim 41 , or a pharmaceutically acceptable salt thereof, wherein R b  is 
       
         
           
           
               
               
           
         
       
     
     
         43 . The compound of  claim 41  or  42 , or a pharmaceutically acceptable salt thereof, wherein R b3  is —CH 3 , —CH 2 CH 2 CF 3 , —OCH 2 CHF 2 , —OCH 2 CHF 3 , —OCH 3 , or —OCH 2 CH 3 ; and R b4  is —CH 3 . 
     
     
         44 . The compound of any one of  claims 1 - 25 , or a pharmaceutically acceptable salt thereof, wherein R b  is a 5-membered heteroaryl ring, wherein the 5-membered heteroaryl ring of R b  is thiophenyl. 
     
     
         45 . The compound of  claim 44 , or a pharmaceutically acceptable salt thereof, wherein R b  is 
       
         
           
           
               
               
           
         
         wherein, R b5  is halo, C 1 -C 3  alkyl, phenyl, or halo-C 1 -C 3  alkyl. 
       
     
     
         46 . The compound of  claim 45 , or a pharmaceutically acceptable salt thereof, wherein R b  is 
       
         
           
           
               
               
           
         
       
     
     
         47 . The compound of  claim 45  or  46 , or a pharmaceutically acceptable salt thereof, wherein R b5  is phenyl, —CH 2 CH 3 , —CF 3 , bromo, or —CH 2 CH 2 CF 3 . 
     
     
         48 . The compound of  claim 1 , selected from Table 1, or a pharmaceutically acceptable salt thereof. 
     
     
         49 . A pharmaceutical composition comprising a compound of any one of  claims 1 - 48 , or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient. 
     
     
         50 . A method of treating a disease or disorder associated with modulation of pyruvate kinase (PKR) and/or PKM2 in a subject, comprising administering to the subject an effective amount of a compound of any one of  claims 1 - 48 , or a pharmaceutically acceptable salt thereof, or the pharmaceutical composition of  claim 49 . 
     
     
         51 . A method of activating PKR and/or PKM2 in a subject, comprising administering to the subject an effective amount of a compound of any one of  claims 1 - 48 , or a pharmaceutically acceptable salt thereof, or the pharmaceutical composition of  claim 49 . 
     
     
         52 . A method of treating a subject afflicted with a disease associated with decreased activity of PKR and/or PKM2, comprising administering to the subject an effective amount of a compound of any one of  claims 1 - 48 , or a pharmaceutically acceptable salt thereof, or the pharmaceutical composition of  claim 49 . 
     
     
         53 . The method of  claim 52 , wherein the disease is selected from the group consisting of sickle cell disease, sickle cell anemia, thalassemia, hereditary non-spherocytic hemolytic anemia, hemolytic anemia, hereditary spherocytosis, hereditary elliptocytosis, abetalipoproteinemia, paroxysmal nocturnal hemoglobinuria, acquired hemolytic, cancer, and anemia of chronic diseases. 
     
     
         54 . The method of  claim 53 , wherein the disease is selected from the group consisting of sickle cell disease and thalassemia. 
     
     
         55 . The method of  claim 54 , wherein the thalassemia is beta-thalassemia.

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