Chronic kidney disease treatment or prevention method
Inventors
SANO, Ryuhei • Yamanaka, Masao • Ohta, Takeshi
Assignees
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Publication Number
US-12721844-B2
Publication Date
2026-09-01
Expiration Date
Abstract
One aim of the present invention is to treat or prevent chronic kidney disease. Provided is a treatment or prophylactic pharmaceutical composition for chronic kidney disease, that contains an SGLT1-inhibiting compound or a pharmaceutically acceptable salt thereof.
Core Innovation
The invention relates to SGLT1-inhibiting pharmaceutical compositions and methods for treating or preventing chronic kidney disease (CKD). The disclosed approach administers a therapeutically effective amount of a compound of Formula [II] or a pharmaceutically acceptable salt to provide a renal-protecting agent for CKD.
The methods cover CKD treatment while excluding a disease selected from diabetic kidney disease and diabetic nephropathy in one embodiment. In another embodiment, the methods treat CKD unaccompanied by hyperglycemia by administering the same Formula [II] compound or pharmaceutically acceptable salt.
The document also describes combination therapy including an SGLT2 inhibitor together with the SGLT1 inhibitor, and it states potential additive or synergistic effects and possible reduction in side effects and/or dose.
Claims Coverage
The consolidated dataset provides two independent claims. Both claims are directed to treating chronic kidney disease by administering a therapeutically effective amount of a compound of Formula [II] or a pharmaceutically acceptable salt, with differing patient-condition limitations.
Treating chronic kidney disease excluding diabetic kidney disease and diabetic nephropathy
A method of treating chronic kidney disease, except for a disease selected from the group consisting of diabetic kidney disease and diabetic nephropathy, comprising administering a therapeutically effective amount of a compound of Formula [II] or a pharmaceutically acceptable salt thereof.
Treating chronic kidney disease unaccompanied by hyperglycemia
A method of treating chronic kidney disease unaccompanied by hyperglycemia, comprising administering a therapeutically effective amount of a compound of Formula [II] or a pharmaceutically acceptable salt thereof.
The claim coverage is centered on administering a therapeutically effective amount of a Formula [II] compound or salt to treat CKD. One independent claim excludes diabetic kidney disease and diabetic nephropathy, while the other focuses on CKD unaccompanied by hyperglycemia.
Stated Advantages
Renal-protecting effect by reducing or inhibiting GFR decline.
Potential additive or synergistic effects when combined with an SGLT2 inhibitor.
Possible reduction in side effects and/or dose in combination therapy.
Expected to treat or prevent chronic kidney disease via renal protection.
Renal protective effect in 5/6-nephrectomy and fatty rat models.
Compound 1 lowers blood glucose in OGTT outcomes.
SGLT1 inhibition supported by hSGLT1 IC50 values, including confirmation for Compound 1.
Documented Applications
Treatment of chronic kidney disease (CKD).
Treatment of CKD unaccompanied by hyperglycemia, including cases associated with hypertension, obesity, hyperlipidemia, hyperuricemia, and immunological or inflammatory disease etiologies such as IgA nephropathy and anti-GBM disease.
Combination therapy for CKD using an SGLT1 inhibitor with an SGLT2 inhibitor selected from dapagliflozin, ipragliflozin, tofogliflozin, empagliflozin, canagliflozin, and luseogliflozin.
Preclinical evaluation described via figure descriptions using rat models, with improved renal parameters including GFR, urinary protein, creatinine clearance, and urea nitrogen.
OGTT-related assessment showing Compound 1 lowers blood glucose.
SGLT1 inhibition assessment based on hSGLT1 IC50 values, including confirmation for Compound 1.
Ames reverse-mutation testing conclusions for metabolites, including results indicating some metabolites positive and Metabolites 1/3/5 negative.
Renal protective effect evaluation in a 5/6-nephrectomy model and a fatty rat model.
Capsule and tablet formulation examples.
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