IP Library › Granted Patent US 12,427,162
Granted Patent B2
US 12,427,162 · App. 18/515,359 · Granted Sep 30, 2025

Pharmaceutical composition, methods for treating and uses thereof

Inventors: Uli Christian Broedl (Mainz, DE); Odd-Erik Johansen (Hoevik, NO); Eric Williams Mayoux (Gambais, FR); Nima Soleymanlou (Grand Island, NY); Maximilian von Eynatten (Erding, DE); Hans-Juergen Woerle (Cully, CH); David Z. I. Cherney (Toronto, CA); Bruce A. Perkins (Toronto, CA)
Assignee: Boehringer Ingelheim International GmbH
A61K31/7048A61K9/2018A61K9/2866A61K31/155A61K31/522A61K38/28A61K45/06
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Quick Facts
Patent No.
US 12,427,162
App. No.
18/515,359
Granted
Sep 30, 2025
Kind
B2
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.

Claims (34)

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.

Continuity (11)
Continuation 17715113 · Apr 7, 2022
Continuation 17094037 · Nov 10, 2020
Continuation 16738112 · Jan 9, 2020
Continuation 16131165 · Sep 14, 2018
Continuation 15899499 · Feb 20, 2018
Continuation 15672517 · Aug 9, 2017
Continuation 14918818 · Oct 21, 2015
Continuation 14253935 · Apr 16, 2014
Provisional Application 61823045 · May 14, 2013
Provisional Application 61813223 · Apr 18, 2013
Related Publication 20240091245A1 · Mar 21, 2024
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