Shaikh Firdous, Sharma Sanjay
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's, NMIMS, Deemed to be University, Vile Parle West, Mumbai, Maharashtra, 400056, India.
Curr Top Med Chem. 2025 Jul 22. doi: 10.2174/0115680266366384250716121432.
The goal of this study is to provide a comprehensive review of physicochemical and pharmacological properties, including pharmacokinetics and pharmacodynamics parameters, with an overview of preclinical and clinical trial data, chemistry, and multiple routes of synthesis, bioanalytical methods, and patents of the API: Vadadustat Methods: A review was conducted by compiling data from Science Direct, PubMed, Drug Bank, WIPO patent, Clinicaltrialgov, Wolters Kluwer, and many others to enhance understanding of the topic Results: The FDA approved Vadadustat on March 27, 2024, for treating anemia in adults with CKD on dialysis. Vadadustat effectively increased hemoglobin levels in both non-dialysis and dialysis- dependent CKD patients. It showed comparable efficacy to traditional erythropoiesisstimulating agents (ESAs) like darbepoetin alfa. Multiple clinical trials, including Phase 2 and Phase 3 studies, demonstrated Vadadustat's potential as an effective treatment for anemia in CKD patients.
Vadadustat, as an oral HIF-PH inhibitor, offers significant advantages in the treatment of anemia in CKD. Its oral route of administration improves patient compliance, and its efficacy is comparable to ESAs. Clinical and preclinical data support its safety and therapeutic potential, although long-term cardiovascular effects remain under observation.
This review examines therapeutic, pharmacological, analytical, and regulatory aspects related to Vadadustat.
本研究的目的是全面综述维达司他（Vadadustat）的物理化学和药理学特性，包括药代动力学和药效学参数，并概述临床前和临床试验数据、化学性质、多种合成途径、生物分析方法及该原料药的专利。
通过汇集来自科学Direct、PubMed、药物银行、世界知识产权组织（WIPO）专利、Clinicaltrialgov、威科集团等的数据进行综述，以增进对该主题的理解。
美国食品药品监督管理局（FDA）于2024年3月27日批准维达司他用于治疗接受透析的慢性肾脏病（CKD）成人患者的贫血。维达司他在非透析和依赖透析的CKD患者中均能有效提高血红蛋白水平。它与传统促红细胞生成剂（ESA）如阿法达贝泊汀显示出相当的疗效。多项临床试验，包括2期和3期研究，证明了维达司他作为CKD患者贫血有效治疗方法的潜力。
维达司他作为一种口服低氧诱导因子脯氨酰羟化酶（HIF-PH）抑制剂，在治疗CKD贫血方面具有显著优势。其口服给药途径提高了患者的依从性，且疗效与ESA相当。临床和临床前数据支持其安全性和治疗潜力，尽管长期心血管影响仍在观察中。
本综述探讨了与维达司他相关的治疗、药理、分析和监管方面的问题。
