塞拉德尔帕:第一次批准
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|November 21, 2024
概括
赛拉德尔帕是一种选择性PPARδ激动剂,在美国获得了用于初级胆道胆炎 (PBC) 的加速批准. 这种口服治疗为对ursodeoxycholic acid有不充分反应或不耐受的患者提供了一个新的选择.
科学领域:
- 药理学 药理学是指药理学的学科.
- 肝病学 肝病学是一种肝病学.
- 药物开发 药物开发
背景情况:
- 原发性胆道胆炎 (PBC) 是一种慢性肝病.
- 对于PBC的现有治疗方法包括ursodeoxycholic acid (UDCA). 对于PBC的现有治疗方法包括ursodeoxycholic acid (UDCA).
- 一些患者对UDCA表现出不充分的反应或不耐受.
研究的目的:
- 为了总结seladelpar的发展里程碑.
- 为了突出seladelpar用于PBC治疗的监管批准.
主要方法:
- 审查seladelpar的发展路径.
- 对PBC的监管提交数据的分析.
主要成果:
- 塞拉德尔帕是一种选择性氧酶增殖器激活受体 (PPAR) δ激动因子,证明了有效性.
- 在美国于2024年8月14日授予加速批准,基于性酸酶 (ALP) 减少.
- 指示包括UDCA的联合治疗或不耐受患者的单一治疗.
结论:
- 塞拉德尔帕代表了PBC治疗的重大进步.
- 继续批准取决于验证临床益处的确认性研究.
- 欧盟和英国正在进行监管评估.
相关概念视频
Drugs Affecting GI Tract Motility: Serotonin Receptor Agonists
212
Serotonin, a crucial neurotransmitter synthesized by enterochromaffin cells, plays a cardinal role in regulating gastrointestinal (GI) motility. With over 90% of the body's total serotonin in the GI tract, its influence on digestive processes is profound. Serotonin is swiftly released upon various stimuli, such as food boluses or certain drugs, triggering intrinsic sensory neurons in the myenteric plexus and extrinsic vagal and spinal sensory neurons. This leads to the activation of the...
212
Pharmacovigilance
773
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...
773
Drugs for Treatment of Diarrhea-Predominant IBS
147
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
147
Structure-Activity Relationships and Drug Design
595
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
595


