# US 12,178,848 B2 · Methods and compositions for the treatment of exocrine pancreatic insufficiency > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,848 B2 - Document ID: US12178848B2 - Status: Granted - Kind: B2 - Application number: 17/693,057 - Filed: 2022-03-11 - Published: 2022-08-18 - Granted: 2024-12-31 - Earliest claimed: 2016-05-25 - Assignees: Board of Regents, The University of Texas System - Applicants: Board of Regents, The University of Texas System - Inventors: David J. Mangelsdorf; Steven A. Kliewer; Katie C. Coate; Genaro Hernandez - Web page: https://patentgrep.com/patent/US12178848B2 ## CPC - A61K 38/1825: {Fibroblast growth factor [FGF]} - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes - C07K 14/50: Fibroblast growth factor [FGF] - 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 - 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) ## Abstract The present invention relates to the treatment of secretory disorders, and provides novel methods of treatment of these disorders comprising the administration of fibroblast growth factor 21 (FGF21) or derivatives thereof. The methods of the invention are useful in conditions including exocrine pancreatic insufficiency (EPI), for example EPI resulting from cystic fibrosis, alcoholism, pancreatitis, pancreatic cancer, gallstones, celiac disease, high triglycerides, or lupus. The methods of the present invention find further utility in the treatment of salivary flow disorders, for example Sjorgen's syndrome, and the treatment of EPI or pancreatitis resulting from surgical procedures. ## Claims ### Claim 1 A method of reducing endoplasmic reticulum (ER) stress in the exocrine pancreas of a human subject suffering from exocrine pancreatic insufficiency (EPI), comprising administering to said subject a therapeutically sufficient amount of fibroblast growth factor 21 (FGF21). ### Claim 2 (depends on 1) The method of claim 1, wherein the exocrine pancreatic insufficiency is comorbid with a disorder selected from the group consisting of: cystic fibrosis, alcoholism, pancreatitis, pancreatic cancer, gallstones, celiac disease, high triglycerides, and lupus. ### Claim 3 (depends on 1) The method of claim 1, wherein the exocrine pancreatic insufficiency results from a surgical procedure. ### Claim 4 (depends on 3) The method of claim 3, wherein the surgical procedure is endoscopic retrograde cholangiopancreatography (ERCP). ### Claim 5 (depends on 1) The method of claim 1, wherein administering comprises local, regional, or systemic administration. ### Claim 6 (depends on 5) The method of claim 5, wherein administering comprises providing a single dose. ### Claim 7 (depends on 5) The method of claim 5, wherein administering comprises oral, intravenous or intramuscular administration. ### Claim 8 (depends on 1) The method of claim 1, wherein the FGF21 is administered at a dosage of between 0.1 mg and 300 mg. ### Claim 9 (depends on 8) The method of claim 8, wherein the FGF21 is administered at a dosage of between 1 mg and 200 mg. ### Claim 10 (depends on 1) The method of claim 1, wherein the administering comprises providing a pharmaceutical composition comprising FGF21, dispersed in a pharmaceutically acceptable carrier, buffer or diluent. ### Claim 11 (depends on 1) The method of claim 1, further comprising providing to the subject a second therapy. ### Claim 12 (depends on 11) The method of claim 11, wherein the second therapy is provided prior to administering the FGF21. ### Claim 13 (depends on 11) The method of claim 11, wherein the second therapy is provided after administering the FGF21. ### Claim 14 (depends on 11) The method of claim 11, wherein the second therapy is provided at the same time as the FGF21. ### Claim 15 (depends on 1) The method of claim 1, wherein the exocrine pancreatic insufficiency results from pancreatitis. ### Claim 16 (depends on 1) The method of claim 1, wherein the exocrine pancreatic insufficiency results from cystic fibrosis.