FDA清除了Pentixapharm第3阶段对新的成像剂的试验,以更好地诊断可治疗的高血压。 FDA clears Pentixapharm’s Phase 3 trial for new imaging agent to better diagnose treatable hypertension.

蒂沙法已获得FDA的确认,对其计划的第3期PANDA研究,对68GaGa-PentixaFor,一种针对CXCR4的PET/ CT成像剂,在患有原发性阿尔多斯特和耐治疗高血压的患者中没有重大担忧. Pentixapharm has received FDA confirmation with no major concerns for its planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor, a PET/CT imaging agent targeting CXCR4 in patients with primary aldosteronism and treatment-resistant hypertension. 美国食品和药物管理局在IND会议前的非约束性反支持了研究设计,并概述了可能获得批准所需的证据. The FDA’s non-binding feedback from a pre-IND meeting supports the study design and outlines evidence needed for potential approval. 该药物旨在改善原发性阿尔多斯类型的分类,将手术可治疗的单边病例与需要药物治疗的双边病例区分开来,解决一个常见但经常被误诊的疾病的关键诊断挑战. The agent aims to improve subtyping of primary aldosteronism—distinguishing surgically treatable unilateral cases from bilateral ones requiring medication—addressing a key diagnostic challenge in a common but often underdiagnosed condition. 多项研究的2 600多名病人提供的数据显示,成像一致,安全情况良好。 Data from over 2,600 patients across multiple studies show consistent imaging and a favorable safety profile. 该公司计划提交IND应用程序,并继续推进CXCR4和CD24心脏病学和肿瘤学定向方案。 The company plans to submit an IND application and continues advancing CXCR4- and CD24-targeted programs in cardiology and oncology.