IP Library Granted Patent US 11,807,659
Granted Patent B2
US 11,807,659 · App. 17/720,938 · Granted Nov 7, 2023

TGR5 modulators and methods of use thereof

Inventors: Roberto Pellicciari (Perugia, IT); Antimo Gioiello (Perugia, IT); Antonio Macchiarulo (Perugia, IT); Francoise Perron-Sierra (Paris, FR); Klaus Seedorf (Hamburg, DE)
Assignee: INTERCEPT PHARMACEUTICALS, INC.
C07J9/005A61P1/16A61P3/08C07J41/00C07J41/0061C07J43/003
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Quick Facts
Patent No.
US 11,807,659
App. No.
17/720,938
Granted
Nov 7, 2023
Kind
B2
Abstract

The application relates to compounds of formula A: or a salt, solvate, ester, tautomer, amino acide conjugate, or metabolite thereof. The compounds of formula A are TGR5 modulators useful for the treatment of various diseases, including metabolic disease, inflammatory disease, autoimmune disease, cardiac disease, kidney disease, cancer, and gastrointestinal disease.

Claims (56)

1. A method of treating a metabolic disease or disorder in a subject, comprising administering to the subject in need thereof a therapeutically effective amount of a compound of formula A:

or a pharmaceutically acceptable salt, solvate, ester, tautomer, amino acid conjugate, or metabolite thereof, wherein:

A is

 oxadiazolonyl, or isoxazolonyl, wherein the carbon atom marked with “*” is bonded to the carbon atom to which A is bonded;

n is 0, 1, or 2;

R 1 is H or OH;

R 2 is H or OH;

R 3 is CR 11 R 12 C(O)OH, C(O)NHR 31 , tetrazolyl, oxadiazolyl, oxadiazolonyl, or thiazolidine-dionyl optionally substituted with NHS(O) 2 —(C 1 -C 3 ) alkyl;

R 11 and R 12 are each independently H, F, OH, CH 2 OH, or CH 2 F, provided that Ru and R 12 are not both H;

R 31 OH, (CH 2 ) p OH, or (CH 2 ) p OSO 3 H; and

p is 1 or 2,

wherein the metabolic disease or disorder is selected from obesity, diabetes, diabesity, metabolic syndrome, insulin resistance, including pre-diabetic insulin resistance, hypertension, and dyslipidemia.

2. The method of claim 1 , wherein A is

3. The method of claim 1 , wherein R 1 and R 2 are each H.

4. The method of claim 1 , wherein R 1 is H, and R 2 is OH.

5. The method of claim 1 , wherein R 2 is H, and R 1 is OH.

6. The method of claim 1 , wherein R 1 and R 2 are each OH.

7. The method of claim 1 , wherein n is 1.

8. The method of claim 1 , wherein R 3 is tetrazolyl, oxadiazolyl, oxadiazolonyl, or thiazolidine-dionyl optionally substituted with NHS(O) 2 -(C 1 -C 3 ) alkyl.

9. The method of claim 1 , wherein the compound is of formula I:

or a pharmaceutically acceptable salt, solvate, ester, tautomer, amino acid conjugate, or metabolite thereof, wherein:

R 11 and R 12 are each independently H, F, OH, CH 2 OH, or CH 2 F, provided that Ru and R 12 are not both H; and

R 13 is H or OH.

10. The method of claim 1 , wherein the compound is of formula II:

or a pharmaceutically acceptable salt, solvate, ester, tautomer, amino acid conjugate, or metabolite thereof, wherein:

q is 0, 1, or 2;

R 21 and R 22 are each independently H or OH; and

R 23 is tetrazolyl, oxadiazolyl, oxadiazolonyl, or thiazolidine-dionyl optionally substituted with NHS(O) 2 -(C 1 -C 3 ) alkyl.

11. The method of claim 10 , wherein the compound of formula II is

12. The method of claim 11 , wherein the compound of formula II is

13. The method of claim 1 , wherein the compound is of formula III:

or a pharmaceutically acceptable salt, solvate, ester, tautomer, amino acid conjugate, or metabolite thereof, wherein:

R 31 is OH, (CH 2 ) p OH, or (CH 2 ) p OSO 3 H; and

p is 1 or 2.

14. A method of treating type II diabetes, comprising administering to a subject in need thereof a therapeutically effective amount of a compound of formula A:

or a pharmaceutically acceptable salt, solvate, ester, tautomer, amino acid conjugate, or metabolite thereof, wherein:

A is

 oxadiazolonyl, or isoxazolonyl, wherein the carbon atom marked with “*” is bonded to the carbon atom to which A is bonded;

n is 0, 1, or 2;

R 1 is H or OH;

R 2 is H or OH;

R 3 is CR 11 R 12 C(O)OH, C(O)NHR 31 , tetrazolyl, oxadiazolyl, oxadiazolonyl, or thiazolidine-dionyl optionally substituted with NHS(O) 2 -(C 1 -C 3 ) alkyl;

R 11 and R 12 are each independently H, F, OH, CH 2 OH, or CH 2 F, provided that Ru and R 12 are not both H;

R 31 is OH, (CH 2 ) p OH, or (CH 2 ) p OSO 3 H; and

p is 1 or 2.

15. A method of treating a TGR5-mediated disease, comprising administering to a subject in need thereof a therapeutically effective amount of a compound of formula A:

or a pharmaceutically acceptable salt, solvate, ester, tautomer, amino acid conjugate, or metabolite thereof, wherein:

A is

 oxadiazolonyl, or isoxazolonyl, wherein the carbon atom marked with “*” is bonded to the carbon atom to which A is bonded;

n is 0, 1, or 2;

R 1 is H or OH;

R 2 is H or OH;

R 3 is CR 11 R 12 C(O)OH, C(O)NHR 31 , tetrazolyl, oxadiazolyl, oxadiazolonyl, or thiazolidine-dionyl optionally substituted with NHS(O) 2 -(C 1 -C 3 ) alkyl;

R 11 and R 12 are each independently H, F, OH, CH 2 OH, or CH 2 F, provided that Ru and Rig are not both H;

R 31 is OH, (CH 2 ) p OH, or (CH 2 ) p OSO 3 H; and

p is 1 or 2.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Jan 4, 2024
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 066662/0210 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2023
From: LES LABORATOIRES SERVIER
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 065195/0749 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2023
From: PERRON-SIERRA, FRANCOISE; SEEDORF, KLAUS
To: LES LABORATOIRES SERVIER
Reel/Frame 065220/0441 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2023
From: PELLICCIARI, ROBERTO; GIOIELLO, ANTIMO; MACCHIARULO, ANTONIO
To: INTERCEPT PHARMACEUTICALS, INC.
Reel/Frame 065220/0511 →
SECURITY INTEREST Recorded May 4, 2023
From: INTERCEPT PHARMACEUTICALS, INC.
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 063541/0362 →
Priority Claims (1)
EP 15305976 · Jun 24, 2015 · regional
Continuity (4)
Continuation 17010505 · Sep 2, 2020
Continuation 15742595
Provisional Application 62182081 · Jun 19, 2015
Related Publication 20220380404A1 · Dec 1, 2022