林业发展局批准了BYSANTI,这是针对两极狂躁症和精神分裂症的新抗精神病药,预计美国将在Q3 2026发射。 The FDA approved BYSANTI, a new antipsychotic for bipolar mania and schizophrenia, with a U.S. launch expected in Q3 2026.

美国食品和药物管理局批准了BYSANTI (米尔萨佩里),一种新的非典型抗精神病药物,用于治疗双极性I型疾病和精神分裂症的成年人急性躁狂或混合发作. The FDA has approved BYSANTI (milsaperidone), a new atypical antipsychotic, for acute treatment of manic or mixed episodes in adults with Bipolar I Disorder and for schizophrenia. 由Vanda制药公司开发,它是第一个新的化学实体,根据实际使用活代谢物Iloperidone这一活性代谢物的情况,具有公认的安全性特征。 Developed by Vanda Pharmaceuticals, it is a first new chemical entity with a well-established safety profile based on real-world use of its active metabolite, iloperidone. 该药物预计将在2026年第三季度在美国推出,并受到专利和数据专属保护,直至2044年。 The drug is expected to launch in the U.S. third quarter of 2026 and is protected by patents and data exclusivity through 2044. 它还正在作为一种抗治疗性抑郁症的治疗方法进行研究,预计到2026年底将取得结果。 It is also being studied as a treatment for treatment-resistant depression, with results expected by end of 2026. 在Vanda早些时候于2025年12月为NEREUS点头后获得批准。 The approval follows Vanda’s earlier FDA nod for NEREUS in December 2025.