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Dosing regimen of siponimod

A dose, stroke technology, applied in the dosing regimen of siponimod, that addresses incompletely understood limitations, unmet high needs, inflammatory and immune mechanisms that are not well understood

Inactive Publication Date: 2020-05-08
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] To date, the inflammatory and immune mechanisms involved in stroke are not well understood
Additionally, targeting the highly dynamic events that occur during inflammation in the relatively inaccessible brain microenvironment is challenging, and an incomplete understanding of the interaction between the immune system and the brain during stroke has limited progress
[0014] Therefore, there is a high unmet need for effective drugs for the treatment of stroke (especially ICH) with minimal or no side effects and good efficacy

Method used

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  • Dosing regimen of siponimod
  • Dosing regimen of siponimod
  • Dosing regimen of siponimod

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 11

[0091] Embodiment 1.1: A method of treating stroke in a human subject suffering from stroke, the method comprising:

[0092] (a) administering multiple consecutive doses of sinimod intravenously to the subject within a period of time equal to or at most 96 hours from the first intravenously administered dose, wherein

[0093] (i) the first administered dose is not less than 0.25 mg and not more than 1.25 mg;

[0094] and among them

[0095] (ii) each of one or more consecutive doses administered after said first dose is no less than the immediately preceding dose and no more than the subsequent directly administered dose;

[0096] and among them

[0097] (iii) the sum of said consecutive doses administered over a consecutive 24-hour period is less than the daily maintenance dose; and subsequently

[0098] (b) administering a daily maintenance dose of sinimod for a maintenance period of at least 2 days, wherein

[0099] (i) The daily maintenance dose is not less than 2 mg a...

Embodiment 12

[0100] Embodiment 1.2: The method of treating stroke in a human subject as defined in embodiment 1.1, wherein said subject is administered intravenously to said subject according to step (a) said multiple consecutive doses of sinimod after the within a period equal to or at most 72 hours from the start of the first intravenously administered dose.

Embodiment 13

[0101] Embodiment 1.3: A method of treating stroke in a human subject as defined in Embodiment 1.1 or 1.2, wherein said subject is administered intravenously to said subject according to step (a) said multiple consecutive doses of sinimod at within a period equal to or at most 48 hours from the first intravenously administered dose.

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Abstract

The present disclosure relates to a novel dosing regimen for the administration of siponimod or pharmaceutically acceptable co-crystals or salts thereof, in the treatment of stroke, in particular intracerebral hemorrhage (ICH).

Description

technical field [0001] The present disclosure relates to a safe and effective method of treating stroke with siponimod, or a pharmaceutically acceptable salt, co-crystal, hydrate, solvate, polymorph and / or mixture thereof. In particular, the present invention relates to methods of treating hemorrhagic stroke, and more particularly to the treatment of intracerebral hemorrhage (ICH). [0002] The present disclosure further relates to the administration of sinimod or a pharmaceutically acceptable salt, co-crystal, hydrate, solvate, polymorph and / or mixture thereof in the treatment of stroke, particularly in the treatment of ICH. drug regimen. Background technique [0003] Stroke remains one of the leading causes of adult death and disability worldwide. Stroke is a medical condition in which insufficient blood flow to the brain causes cell death, ie, the blood supply to the brain is interrupted or reduced. There are two main types of stroke: ischemic, eg, acute ischemic strok...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/397A61K9/00A61K9/08A61K47/40A61P9/10
CPCA61K9/0019A61K47/40A61K31/397A61P9/10A61K9/08
Inventor J-H·查F·达尔克A·嘉丁E·勒冈诺克斯C·J·马兰加三世K·沙克尔-内加德E·沃尔斯特罗姆C·沃尔夫
Owner NOVARTIS AG
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