Medicinal composition for preventing or treating secondary hyperparathyroidism under maintenance dialysis
Inventors
Kataoka, Daisuke • Kuyama, Kazuo • Asano, Kenji • WAGATSUMA, Hirotaka • Tsuruta, Atsushi • Takanohashi, Toshiyuki
Assignees
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Publication Number
US-11311508-B2
Publication Date
2022-04-26
Expiration Date
Abstract
A medicinal composition for preventing or treating secondary hyperparathyroidism under maintenance dialysis, said medicinal composition comprising 3-{[(2S)-2-amino-2-carboxyethyl]carmaboylamino}-5-chloro-4-methylbenzenesulfonic acid or a pharmaceutically acceptable salt thereof, or a solvate of the same which is to be administered by a predefined route in a predefined dosage. According to the present invention, it is possible to provide a prophylactic or therapeutic agent for secondary hyperparathyroidism under maintenance dialysis, said agent showing reduced side effects or no significant accumulation. This medicinal agent allows easy administration management and has a high safety compared with conventional products.
Core Innovation
The invention relates to a medicinal composition and a method for preventing or treating secondary hyperparathyroidism under maintenance dialysis. The composition comprises 3-{[(2S)-2-amino-2-carboxyethyl]carbamoylamino}-5-chloro-4-methylbenzenesulfonic acid together with a pharmaceutically acceptable salt thereof or a solvate thereof.
The composition is administered intravenously to an adult at the end of dialysis at a daily dose of 0.025 mg to 0.8 mg. The timing is defined as the end of dialysis, including administration at the end of each dialysis session within a schedule of 3 to 5 sessions per week.
The invention further addresses reduced side effects and avoidance of significant accumulating property in the prevention or treatment. The document characterizes the composition in relation to serum iPTH and serum Ca, including observations that trough levels remain stable.
Claims Coverage
The independent claims are clm-00001, clm-00006, and clm-00011. Across these independent claims, the core inventive coverage centers on preventing or treating secondary hyperparathyroidism in maintenance dialysis using a specific benzenesulfonic acid composition given intravenously at the end of dialysis at a defined adult daily dose range, with independent-claim emphasis on reduced side effects or avoidance of significant accumulation.
Intravenous end-of-dialysis dosing of substituted benzenesulfonic acid for SHPT
Administering to a subject in need thereof a composition comprising 3-{[(2S)-2-amino-2-carboxyethyl]carbamoylamino}-5-chloro-4-methylbenzenesulfonic acid, a pharmaceutically acceptable salt thereof or a solvate thereof, wherein said composition is intravenously administered at the end of dialysis at a daily dose of 0.025 mg to 0.8 mg for an adult.
Reduced side effects with intravenous end-of-dialysis dosing of substituted benzenesulfonic acid
Preventing or treating secondary hyperparathyroidism under maintenance dialysis with reduced side effects by administering to a subject in need thereof a composition comprising 3-{[(2S)-2-amino-2-carboxyethyl]-carbamoylamino}-5-chloro-4-methylbenzenesulfonic acid, a pharmaceutically acceptable salt thereof or a solvate thereof, wherein said composition is intravenously administered at the end of dialysis at a daily dose of 0.025 mg to 0.8 mg for an adult.
No significant accumulation with intravenous end-of-dialysis dosing of substituted benzenesulfonic acid
Preventing or treating secondary hyperparathyroidism under maintenance dialysis without manifesting significant accumulating property by administering to a subject in need thereof a composition comprising 3-{[(2S)-2-amino-2-carboxyethyl]carbamoylamino}-5-chloro-4-methylbenzenesulfonic acid, a pharmaceutically acceptable salt thereof or a solvate thereof, wherein said composition is intravenously administered at the end of dialysis at a daily dose of 0.025 mg to 0.8 mg for an adult.
The claim set covers SHPT prevention or treatment in maintenance dialysis using 3-{[(2S)-2-amino-2-carboxyethyl]carbamoylamino}-5-chloro-4-methylbenzenesulfonic acid (or pharmaceutically acceptable salts/solvates) administered intravenously at the end of dialysis within an adult daily dose range of 0.025 mg to 0.8 mg, with independent-claim variations emphasizing reduced side effects or absence of significant accumulating property.
Stated Advantages
Reduced side effects.
Avoidance of significant accumulating property.
Documented Applications
Preventing or treating secondary hyperparathyroidism in adults under maintenance dialysis using intravenous administration of the specified composition at the end of dialysis.
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