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Last Updated: December 12, 2025

Claims for Patent: 12,427,162

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Summary for Patent: 12,427,162

Title:	Pharmaceutical composition, methods for treating and uses thereof
Abstract:	The present invention relates to certain SGLT-2 inhibitors for treating, preventing, protecting against and/or delaying the progression of chronic kidney disease in patients, for example patients with prediabetes, type 1 or type 2 diabetes mellitus.
Inventor(s):	Uli Christian BROEDL, Odd-Erik JOHANSEN, Eric Williams Mayoux, Nima Soleymanlou, Maximilian von EYNATTEN, Hans-Juergen Woerle, David Z. I. Cherney, Bruce A. PERKINS
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US18/515,359
Patent Claims:	1. A method for delaying loss of eGFR and/or for delaying the progression to end stage renal disease/kidney failure, or renal death in a patient with chronic kidney disease, said method comprising administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient, wherein the chronic kidney disease is stage 2 chronic kidney disease, stage 3 chronic kidney disease, stage 4 chronic kidney disease, or stage 5 chronic kidney disease. 2. The method according to claim 1, wherein the patient with chronic kidney disease is a patient with albuminuria. 3. The method according to claim 2, wherein the patient with chronic kidney disease is a patient with microalbuminuria or with macroalbuminuria. 4. The method according to claim 1, wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus. 5. The method according to claim 1, wherein the patient has or is at risk of a cardiovascular disease. 6. The method according to claim 1, wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus and with or at risk of a cardiovascular disease. 7. The method according to claim 1, wherein the patient is a patient with stage 2 chronic kidney disease, stage 3 chronic kidney disease or stage 4 chronic kidney disease. 8. The method according to claim 1, wherein the patient is a patient with one or more cardiovascular risk factors selected from A), B), C) and D): A) previous or existing vascular disease selected from myocardial infarction, coronary artery disease, percutaneous coronary intervention, coronary artery by-pass grafting, ischemic or hemorrhagic stroke, congestive heart failure, and peripheral occlusive arterial disease, B) advanced age>/=60-70 years, and C) one or more cardiovascular risk factors selected from advanced type 1 or type 2 diabetes mellitus>10 years duration, hypertension, current daily cigarette smoking, dyslipidemia, obesity, age>/=40, metabolic syndrome, hyperinsulinemia or insulin resistance, and hyperuricemia, erectile dysfunction, polycystic ovary syndrome, sleep apnea, or family history of vascular disease or cardiomyopathy in first-degree relative; D) one or more of the following: confirmed history of myocardial infarction, unstable angina with documented multivessel coronary disease or positive stress test, multivessel Percutaneous Coronary Intervention, multivessel Coronary Artery By-pass Grafting (CABG), history of ischemic or hemorrhagic stroke, or peripheral occlusive arterial disease. 9. The method according to claim 1, wherein the one or more other therapeutic substances are selected from other antidiabetic substances. 10. The method according to claim 1, comprising administering empagliflozin in combination with metformin, with linagliptin or with metformin and linagliptin. 11. The method according to claim 1, wherein the one or more other therapeutic substances is a RAAS inhibitor. 12. The method according to claim 1, wherein the one or more other therapeutic substances is a direct renin inhibitor, an Angiotensin-Converting Enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB). 13. The method according to claim 1, comprising administering empagliflozin in combination with a RAAS inhibitor. 14. The method according to claim 1, comprising administering empagliflozin in combination with a direct renin inhibitor, an Angiotensin-Converting Enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB). 15. The method according to claim 1, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg. 16. The method according to claim 1, wherein empagliflozin is administered as a pharmaceutical composition comprising 10 mg or 25 mg of empagliflozin.

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