索维尔泰德:第一次批准
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|July 24, 2023
概括
索维泰德 (Sovateltide) 是一种内甲素-B受体激动剂,是一种新的神经前体细胞疗法. 它在印度获得批准,用于治疗急性脑缺血性中风 (ACIS) 在发病后24小时内.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 再生医学是一种再生医学.
背景情况:
- 急性脑缺血性中风 (ACIS) 带来了重大的神经挑战.
- 目前针对ACIS的治疗方法在疗效和治疗窗口方面存在局限性.
- 内末林-B受体激应是一种神经保护的潜在治疗途径.
研究的目的:
- 总结一下sovateltide的发展里程碑.
- 要突出监管途径导致其批准ACIS治疗.
- 为了提供一个概述的sovateltide作为神经原始细胞治疗.
主要方法:
- 对sovateltide的临床前和临床发展数据的审查.
- 对监管提交和审批流程的分析.
- 索维泰德作为内甲素-B受体激动剂的药理学表征.
主要成果:
- 索维泰德在神经损伤的临床前模型中显示出有效性.
- 该药物成功完成了急性脑缺血性中风的临床试验.
- 在2023年5月,sovateltide在印度获得了ACIS的营销许可.
结论:
- 索维泰德代表了急性脑缺血性中风的新型治疗剂.
- 批准标志着神经前体细胞疗法的临床应用的一个重要里程碑.
- 进一步的研究可能会探索sovateltide在其他神经疾病的潜力,如HIE和阿尔茨海默病.
相关概念视频
Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists
201
Endothelins (ETs) are potent vasoactive peptides critical in the human body's various physiological and pathological processes. One of the most promising therapeutic strategies for treating pulmonary arterial hypertension (PAH) involves counteracting the effects of these endothelins using a class of drugs known as endothelin receptor antagonists.
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
201
Prescription, Nonprescription and Orphan Drugs
765
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
765
Drug Administration and Therapy Phases: Overview
545
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
545
Pharmacovigilance
891
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
891
Antiasthma Drugs: Leukotriene Modifiers
365
Leukotriene modifiers, or cysteinyl leukotriene receptor antagonists, are medications used to manage chronic asthma. These agents target specific inflammatory mediators produced during arachidonic acid metabolism, an essential process in generating inflammation in the body.
Leukotriene modifiers work through two distinct mechanisms:
Leukotriene modifiers work through two distinct mechanisms:
365
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
174
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
174


