IP Library › Granted Patent US 12,252,482
Granted Patent B2
US 12,252,482 · App. 18/826,887 · Granted Mar 18, 2025

Pyrazolopyridine derivatives and uses thereof

Inventors: Simone Bonazzi (Cambridge, MA); Jennifer Stroka Cobb (Stow, MA); Natalie Alysia Dales (Arlington, MA); Matthew James Hesse (Pittsburgh, PA); Rama Jain (Danville, CA); John Ryan Kerrigan (Wakefield, MA); Hasnain Ahmed Malik (Boston, MA); James R Manning (Emeryville, CA); Pamela Yf Ting (Somerville, MA)
Assignee: Novartis AG
C07D403/14A61P7/00C07D405/14C07D417/14
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Quick Facts
Patent No.
US 12,252,482
App. No.
18/826,887
Granted
Mar 18, 2025
Kind
B2
Abstract

The present disclosure relates to compounds of formula (I) and pharmaceutical compositions and their use in reducing Widely Interspaced Zinc Finger Motifs (WIZ) expression levels, or inducing fetal hemoglobin (HbF) expression, and in the treatment of inherited blood disorders (e.g., hemoglobinopathies, e.g., beta-hemoglobinopathies), such as sickle cell disease and beta-thalassemia.

Claims (77)

1. A compound of Formula (Ic):

or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof, wherein:

X is selected from CH and N;

each of R 2b , R 2c , R 2d and R 2e is independently selected from hydrogen and unsubstituted C 1 -C 3 alkyl;

R 2f is hydrogen;

or R 2b and R 2e or R 2b and R 2f together with the carbon atoms to which they are attached form a C 1 -C 3 alkylene bridging ring;

R 3 is selected from C 1 -C 8 alkyl, C 2 -C 6 alkenyl, —SO 2 R 4 , and C 1 -C 6 haloalkyl, wherein the C 1 -C 8 alkyl and C 1 -C 6 haloalkyl are independently substituted with 0-3 occurrences of R 3a ;

each R 3a is independently selected from C 3 -C 10 cycloalkyl, a 4- to 6-membered heterocyclyl comprising 1-2 heteroatoms independently selected from N, O and S, a 5- to 10-membered heteroaryl comprising 1-4 heteroatoms independently selected from N, O, and S, C 6 -C 10 aryl, C 1 -C 6 alkoxyl, hydroxyl, and —C(═O)—NR 7 R 8 , wherein the C 3 -C 10 cycloalkyl, 4- to 6-membered heterocyclyl, 5- to 10-membered heteroaryl and C 6 -C 10 aryl are substituted with 0-4 occurrences of R 3b ;

each R 3b is independently selected from C 1 -C 6 alkoxyl, halo, C 1 -C 6 haloalkyl, C 1 -C 6 haloalkoxyl, C 1 -C 6 alkyl, —CN, —SO 2 NR 7 R 8 , —SO 2 R 4 , and hydroxyl;

R 4 is selected from C 3 -C 8 cycloalkyl, C 1 -C 6 alkyl, a 4- to 6-membered heterocyclyl comprising 1-2 heteroatoms independently selected from N, O and S, and C 6 -C 10 aryl, wherein the C 1 -C 6 alkyl is substituted with 0-1 occurrence of R 4a ;

R 4a is selected from C 3 -C 8 cycloalkyl, C 6 -C 10 aryl, and C 1 -C 6 alkoxyl;

R 7 is selected from hydrogen and C 1 -C 6 alkyl;

R 8 is selected from hydrogen and C 1 -C 6 alkyl;

or

R 7 and R 8 together with the nitrogen atom to which they are attached form a 5- or 6-membered heterocyclyl comprising 0-1 additional heteroatom selected from N, O, and S; and

m is 1 or 2.

2. The compound according to claim 1 , or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof, wherein:

X is selected from CH and N;

each of R 2b , R 2c , R 2d and R 2e is independently selected from hydrogen and unsubstituted C 1 -C 3 alkyl;

R 2f is hydrogen;

R 3 is selected from C 1 -C 8 alkyl, C 2 -C 6 alkenyl, —SO 2 R 4 , and C 1 -C 6 haloalkyl, wherein the C 1 -C 8 alkyl and C 1 -C 6 haloalkyl are independently substituted with 0-3 occurrences of R 3a ;

each R 3a is independently selected from C 3 -C 10 cycloalkyl, a 4- to 6-membered heterocyclyl comprising 1-2 heteroatoms independently selected from N, O and S, a 5- to 10-membered heteroaryl comprising 1-4 heteroatoms independently selected from N, O, and S and phenyl, wherein the C 3 -C 10 cycloalkyl, 4- to 6-membered heterocyclyl, 5- to 10-membered heteroaryl and phenyl are substituted with 0-4 occurrences of R 3b ;

each R 3b is independently selected from C 1 -C 6 alkoxyl, halo, C 1 -C 6 haloalkyl, C 1 -C 6 haloalkoxyl, C 1 -C 6 alkyl, and hydroxyl;

R 4 is selected from C 3 -C 8 cycloalkyl, C 1 -C 6 alkyl, a 4- to 6-membered heterocyclyl comprising 1-2 heteroatoms independently selected from N, O and S, and C 6 -C 10 aryl, wherein the C 1 -C 6 alkyl is substituted with 1 occurrence of R 4a ;

R 4a is selected from C 3 -C 8 cycloalkyl, C 6 -C 10 aryl, and C 1 -C 6 alkoxyl; and

m is 1.

3. The compound according to claim 1 or a pharmaceutically acceptable salt thereof, wherein said compound is of Formula (1d):

4. The compound according to claim 1 or a pharmaceutically acceptable salt thereof, wherein said compound is of Formula (Id-1), wherein:

wherein R 2b is selected from hydrogen and C 1 -C 4 alkyl.

5. The compound according to claim 4 , or a pharmaceutically acceptable salt thereof, wherein

R 3 is selected from C 1 -C 8 alkyl, —SO 2 R 4 , and —C(═O)—(R 6 ), wherein the C 1 -C 8 alkyl is independently substituted with 0-3 occurrences of R 3a ;

each R 3a is independently selected from C 3 -C 10 cycloalkyl, a 4- to 6-membered heterocyclyl comprising 1-2 heteroatoms independently selected from N, O and S, C 1 -C 6 alkoxyl, and hydroxyl, wherein the C 3 -C 10 cycloalkyl and 4- to 6-membered heterocyclyl are substituted with 0-2 occurrences of R 3b ;

each R 3b is independently selected from C 1 -C 6 alkoxyl, halo, C 1 -C 6 haloalkyl, C 1 -C 6 haloalkoxyl, C 1 -C 6 alkyl, —CN, —SO 2 R 4 , and hydroxyl.

6. The compound according to claim 5 or a pharmaceutically acceptable salt thereof, wherein said compound is of Formula (Id-2) or Formula (Id-3):

7. The compound according to claim 1 , or a pharmaceutically acceptable salt thereof, wherein R 3 is selected from methyl, ethyl, n-propyl, i-propyl, 2-propanyl, butyl, i-butyl, 2-butanyl, 3-methyl-2-butanyl, i-pentyl, 3-pentanyl, neopentyl, 2,4-dimethylpentanyl, and —CH 2 —(CH 2 ) 0-1 —R 3a .

8. The compound according to claim 1 , wherein said compound is selected from:

1-(5-(((2S,4R)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2R,4S)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2S,4S)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2R,4R)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-((1-(2,4-dimethylpentan-2-yl)piperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-((1-(2-(4,4-difluorocyclohexyl)propan-2-yl)piperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2S,4R)-1-((4,4-dimethylcyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2S,4R)-2-methyl-1-(pyridin-3-ylmethyl)piperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

(S)-1-(5-((4-isobutyl-3-methylpiperazin-1-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione; and

(R)-1-(5-((4-isobutyl-3-methylpiperazin-1-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

or a pharmaceutically acceptable salt thereof.

9. The compound according to claim 1 , wherein said compound is selected from:

or a pharmaceutically acceptable salt thereof.

10. The compound according to claim 1 , wherein said compound is

or a pharmaceutically acceptable salt thereof.

11. The compound according to claim 1 , wherein said compound is

or a pharmaceutically acceptable salt thereof.

12. The compound according to claim 1 , wherein said compound is

or a pharmaceutically acceptable salt thereof.

13. The compound according to claim 1 , wherein said compound is

or a pharmaceutically acceptable salt thereof.

14. A pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1 , or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof; and a pharmaceutically acceptable carrier or excipient.

15. A pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 8 or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier or excipient.

16. A pharmaceutical combination comprising a compound of claim 1 , or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof; and one or more additional therapeutic agent(s).

17. A pharmaceutical combination comprising a compound of claim 8 or a pharmaceutically acceptable salt thereof; and one or more additional therapeutic agent(s).

18. A method of treating a disease or disorder mediated by Widely Interspaced Zinc Finger Motifs (WIZ), comprising administering to a subject in need thereof a therapeutically effective amount of a compound according to claim 1 , or a pharmaceutically acceptable salt, stereoisomer or tautomer thereof.

19. The method according to claim 18 ; wherein said compound is selected from:

1-(5-(((2S,4R)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2R,4S)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2S,4S)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2R,4R)-1-((4,4-difluorocyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-((1-(2,4-dimethylpentan-2-yl)piperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-((1-(2-(4,4-difluorocyclohexyl)propan-2-yl)piperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2S,4R)-1-((4,4-dimethylcyclohexyl)methyl)-2-methylpiperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

1-(5-(((2S,4R)-2-methyl-1-(pyridin-3-ylmethyl)piperidin-4-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

(S)-1-(5-((4-isobutyl-3-methylpiperazin-1-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione; and

(R)-1-(5-((4-isobutyl-3-methylpiperazin-1-yl)methyl)pyrazolo[1,5-a]pyridin-3-yl)dihydropyrimidine-2,4(1H,3H)-dione;

or a pharmaceutically acceptable salt thereof.

20. The method according to claim 19 , where said disease or disorder is a hemoglobinopathy.

21. The method according to claim 19 , where said disease or disorder is a beta hemoglobinopathy.

22. The method according to claim 19 , where said disease or disorder is sickle cell disease or beta-thalassemia.

Assignments (10)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: DALES, NATALIE ALYSIA
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069162/0074 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
To: NOVARTIS AG
Reel/Frame 069162/0269 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: DALES, NATALIE ALYSIA
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069162/0398 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
To: NOVARTIS AG
Reel/Frame 069162/0427 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: BONAZZI, SIMONE; CERNIJENKO, ARTIOM; COBB, JENNIFER STROKA; DEWHURST, JANETTA; HESSE, MATTHEW JAMES; JAIN, RAMA; KERRIGAN, JOHN RYAN; MALIK, HASNAIN AHMED; MANNING, JAMES R.; O'BRIEN, GARY; PATTERSON, ANDREW W.; THOMSEN, NOEL MARIE-FRANCE
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069162/0517 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: DALES, NATALIE ALYSIA
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069162/0542 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: TING, PAMELA YF
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069162/0567 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
To: NOVARTIS AG
Reel/Frame 069162/0593 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: BONAZZI, SIMONE; CERNIJENKO, ARTIOM; COBB, JENNIFER STROKA; KERRIGAN, JOHN RYAN; MALIK, HASNAIN AHMED; O'BRIEN, GARY; PATTERSON, ANDREW W.; THOMSEN, NOEL MARIE-FRANCE; TING, PAMELA YF; HESSE, MATTHEW JAMES; JAIN, RAMA; MANNING, JAMES R.
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069292/0264 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2024
From: BONAZZI, SIMONE; CERNIJENKO, ARTIOM; COBB, JENNIFER STROKA; KERRIGAN, JOHN RYAN; MALIK, HASNAIN AHMED; PATTERSON, ANDREW W.; THOMSEN, NOEL MARIE-FRANCE; TING, PAMELA YF; HESSE, MATTHEW JAMES; JAIN, RAMA; MANNING, JAMES R.
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
Reel/Frame 069323/0428 →
Continuity (5)
Continuation 18460428 · Sep 1, 2023
Division 17693759 · Mar 14, 2022
Provisional Application 63164130 · Mar 22, 2021
Provisional Application 63161139 · Mar 15, 2021
Related Publication 20250002479A1 · Jan 2, 2025
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