# US 2018/0022776 A1 · Ibat inhibitors for the treatment of liver diseases > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0022776 A1 - Document ID: US20180022776A1 - Status: Published application - Kind: A1 - Application number: 15/722,110 - Filed: 2017-10-02 - Published: 2018-01-25 - Earliest claimed: 2010-11-08 - Assignees: Albireo AB - Applicants: Albireo AB - Inventors: Per-Göran Gillberg; Hans Graffner; Ingemar Starke - Web page: https://patentgrep.com/patent/US20180022776A1 ## CPC - C07K 5/06078: {and aromatic or cycloaliphatic} - A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole - A61K 31/554: having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem - A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol - A61K 38/05: Dipeptides - A61P 35/00: Antineoplastic agents - C07K 5/06026: {the side chain containing 0 or 1 carbon atom, i.e. Gly or Ala} - C07K 5/0606: {the side chain containing heteroatoms not provided for by C07K5/06086 - C07K5/06139, e.g. Ser, Met, Cys, Thr} - A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) - A61K 2121/00: Preparations for use in therapy - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions. ## Claims ### Claim 1 (canceled) ### Claim 2 A method for the treatment of non-alcoholic steatohepatitis (NASH), comprising orally administering to a subject in need of such treatment a therapeutically effective amount of an IBAT inhibitor, wherein the IBAT inhibitor is 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio -8-(N-{(R)-1′-phenyl-1′-[N′-(carboxymethyl)carbamoyl]methyl}carbamoylmethoxy)-2,3 ,4, 5-tetrahydro-1,5-benzothiazepine, or a pharmaceutically acceptable salt thereof. ### Claim 3 (depends on 2) The method according to claim 2, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises decreasing the level of serum bile acids in the subject. ### Claim 4 (depends on 2) The method according to claim 2, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises decreasing the level of liver bile acids in the subject. ### Claim 5 (depends on 2) The method according to claim 2, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises treatment of liver fibrosis. ### Claim 6 (depends on 2) The method according to claim 2, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises treatment of hepatic cirrhosis. ### Claim 7 (depends on 2) The method according to claim 2, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises treatment of pruritus. ### Claim 8 A method for the treatment of a non-alcoholic steatohepatitis (NASH), comprising orally administering to a subject in need of such treatment a therapeutically effective amount of an IBAT inhibitor, wherein the IBAT inhibitor is 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-1′-phenyl-1′[N′-(carboxymethyl)carbamoyl]methyl}carbamoylmethoxy) -2,3,4,5-tetrahydro-1,5-benzothiazepine, or a pharmaceutically acceptable salt thereof, and ursodeoxycholic acid or nor-ursodeoxycholic acid. ### Claim 9 (depends on 8) The method according to claim 8, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises decreasing the level of serum bile acids in the subject. ### Claim 10 (depends on 8) The method according to claim 8, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises decreasing the level of liver bile acids in the subject. ### Claim 11 (depends on 8) The method according to claim 8, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises treatment of liver fibrosis. ### Claim 12 (depends on 8) The method according to claim 8, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises treatment of hepatic cirrhosis. ### Claim 13 (depends on 8) The method according to claim 8, wherein treatment of non-alcoholic steatohepatitis (NASH) comprises treatment of pruritus. ### Claim 14 A method for the treatment of non-alcoholic fatty liver disease (NAFLD), comprising orally administering to a subject in need of such treatment a therapeutically effective amount of an IBAT inhibitor, wherein the IBAT inhibitor is 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-1′-phenyl-1′[N′-(carboxymethyl)carbamoyl]methyl}carbamoylmethoxy) -2,3,4,5-tetrahydro-1,5-benzothiazepine, or a pharmaceutically acceptable salt thereof ### Claim 15 (depends on 14) The method according to claim 14, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises decreasing the level of serum bile acids in the subject. ### Claim 16 (depends on 14) The method according to claim 14, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises decreasing the level of liver bile acids in the subject. ### Claim 17 (depends on 14) The method according to claim 14, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises treatment of liver fibrosis. ### Claim 18 (depends on 14) The method according to claim 14, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises treatment of hepatic cirrhosis. ### Claim 19 (depends on 14) The method according to claim 14, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises treatment of pruritus. ### Claim 20 A method for the treatment of a non-alcoholic fatty liver disease (NAFLD), comprising orally administering to a subject in need of such treatment a therapeutically effective amount of an IBAT inhibitor, wherein the IBAT inhibitor is 1,1-dioxo-3,3-dibutyl-5-phenyl-7-methylthio-8-(N-{(R)-1′-phenyl-1′[N′-(carboxymethyl)carbamoyl]methyl}carbamoylmethoxy) -2,3,4,5-tetrahydro-1,5-benzothiazepine, or a pharmaceutically acceptable salt thereof, and ursodeoxycholic acid or nor-ursodeoxycholic acid. ### Claim 21 (depends on 20) The method according to claim 20, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises decreasing the level of serum bile acids in the subject. ### Claim 22 (depends on 20) The method according to claim 20, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises decreasing the level of liver bile acids in the subject. ### Claim 23 (depends on 20) The method according to claim 20, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises treatment of liver fibrosis. ### Claim 24 (depends on 20) The method according to claim 20, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises treatment of hepatic cirrhosis. ### Claim 25 (depends on 20) The method according to claim 20, wherein treatment of non-alcoholic fatty liver disease (NAFLD) comprises treatment of pruritus.