Methods of treatment for gastrointestinal motility disorders
Inventors
Pulley, Jill M. • Jerome, Rebecca N. • Beaulieu, Dawn B. • Shirey-Rice, Jana K. • Zaleski, Nicole M.
Assignees
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Publication Number
US-12569481-B2
Publication Date
2026-03-10
Expiration Date
Abstract
Disclosed herein are methods for treating or reducing symptoms of a gastrointestinal motility disorder in a subject. The methods include administering to the subject a therapeutically effective amount of a sodium channel blocker compound.
Core Innovation
The invention describes methods for treating a gastrointestinal motility disorder or reducing symptoms thereof in a subject in need thereof. The method comprises administering a therapeutically effective amount of a compound of Formula I, including a pharmaceutically acceptable ester or salt thereof. The claimed compound structure includes defined substitutions for R1–R5, R6–R10, R11–R12, and W being oxygen or sulfur.
A key functional feature is that the administered compound decreases contractility of gastrointestinal tract muscles. In the described target biology, Nav1.5 (SCN5A) and late sodium current are discussed in relation to gastrointestinal system cells, including intestinal smooth muscle cells and interstitial cells of Cajal (ICC). The described pharmacology includes decreased late sodium current, reduced intracellular Na+ and Ca2+, and restored ion homeostasis.
The disclosure links these effects to therapeutic outcomes in gastrointestinal disorders, including dysmotility/hypermotility and treatment contexts that include Crohn’s disease. It also discusses potential broader biological connections such as motility coordination, inflammation, and endothelial dysfunction. Documented symptom endpoints include abdominal pain and Crohn’s symptoms such as diarrhea/loose stools.
Claims Coverage
The only independent claim explicitly provided is clm-00001, which covers a method for treating gastrointestinal motility disorders or reducing their symptoms by administering a Formula I compound. The described claim set includes dependent refinements involving mechanistic and symptom-outcome limitations, compound embodiment selection, and constrained clinical context.
Administering a Formula I compound to decrease gastrointestinal muscle contractility
A method for treating a gastrointestinal motility disorder or reducing symptoms thereof in a subject in need thereof by administering a therapeutically effective amount of a compound of Formula I, or a pharmaceutically acceptable ester or salt, wherein the compound decreases contractility of gastrointestinal tract muscles.
Inhibiting late sodium current in gastrointestinal system cells
The method in which the administered compound decreases contractility of gastrointestinal tract muscles by inhibiting the late sodium current of an action potential in gastrointestinal system cells.
Reducing Crohn’s disease symptoms after administration
The method in which Crohn’s disease symptoms are reduced after administering the compound, including gastrointestinal and systemic symptom effects.
Treating Crohn’s disease with a quantified baseline of loose stools
The method in which, prior to administering the compound, the subject averages at least 3 loose stools per day.
Using ranolazine as the Formula I compound embodiment
The method in which the compound is ranolazine.
Claim coverage centers on a Formula I therapeutic administration method for gastrointestinal motility disorders, with the central inventive function being decreased contractility of gastrointestinal tract muscles. Dependent limitations further narrow to inhibition of late sodium current in gastrointestinal system cells, Crohn’s symptom reduction, quantified baseline loose stool frequency, and a named embodiment in which the compound is ranolazine.
Stated Advantages
Decreases contractility of gastrointestinal tract muscles.
Reduces gastrointestinal motility disorder symptoms.
Reduces abdominal pain.
Reduces Crohn’s disease symptoms, including diarrhea/loose stools.
Documented Applications
Treating a gastrointestinal motility disorder or reducing symptoms thereof in a subject in need thereof.
Reducing symptoms in Crohn’s disease, with symptom sets including diarrhea/loose stools and abdominal pain.
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