美国FDA已授予其口服抗真菌产品(http://www.maoyihang.com/invest/)oteseconazole(VT-1161)的新药申请(NDA)优先审评资格,用于治疗复发性外阴阴道念珠菌病(RVVC)。 该项申请基于3项3期临床试验的积极结果的支持,包括2项全球性的VIOLET试验和1项在美国进行的ultraVIOLET试验,一共入组870多例患者。两项VIOLET试验均达...
FDA UNIIVHH774W97N SAFETY Risk and Safety Statements Symbol(GHS) GHS08 Signal wordWarning Hazard statementsH373 Precautionary statementsP260-P314-P501 VT-1161 price ManufacturerProduct numberProduct descriptionCAS numberPackagingPriceUpdatedBuy ChemSceneCS-0016914Oteseconazole 99.56%1340593-59-05mg$3502021-...
Oteseconazole (VT-1161) is a novel, investigational oral therapy that is currently under FDA review for the treatment of recurrent vulvovaginal candidiasis (RVVC). Susceptibility testing was performed on all viable clinical isolates collected from three Phase 3 studies to determine the susceptibility ...
“This is a significant milestone for the VT-1161 clinical program, which has the potential to be the first FDA-approved therapy for RVVC. Each day, we are reminded of the significant unmet need, and w...
Mycovia临床开发高级副总裁Stephen Brand博士说:“VT - 1161对广泛的真菌种类具有很强的抗力,这是导致RVVC的主要真菌病原体,在最近完成的第二阶段研究中,临床证明对再感染有持久的反应。”。“VT - 1161有潜力成为RVVC患者的最佳治疗选择,也是FDA批准的这种常见疾病的首个治疗方案。" ...