Shots:
- FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26
- In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full therapeutic dose range, allowing it to rely on the established efficacy & safety profile from extensive development data & 100,000+ patient-years of RWE with Fanapt
- Also, Bysanti (QD) is being assessed as adjunctive therapy for treatment-resistant major depressive disorder, with the trial expected to be completed by the end of 2026
Ref: PRnewswire | Image: Vanda | Press Release
Related News: Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion
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