VistaGen获FDA批准开展Refisolone新药临床研究,推进更年期血管舒缩症状(潮热)二期临床试验

美股速递
Apr 22

VistaGen Therapeutics宣布,美国食品药品监督管理局(FDA)已就其Refisolone新药临床申请发出“研究可继续进行”许可函,这意味着公司可进一步开展针对更年期引发的血管舒缩症状(即潮热)的二期临床开发计划。

此次监管绿灯为Refisolone的临床推进扫清了关键障碍,标志着该创新疗法在解决更年期女性潮热问题方面迈出实质性一步。公司计划基于这一许可加速推进二期临床试验,探索Refisolone在缓解更年期相关症状方面的潜力与安全性。

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