Shots:
- The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040s
- NDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1 in bipolar I with manic or mixed episodes, & 1 relapse prevention study in schizophrenia, along with RWE data. Bioequivalence data for Bysanti & iloperidone from single & multiple dose studies will be presented at ASCP 2025
- Also, Bysanti (QD) is being assessed as adjunctive therapy for MDD pts who had an inadequate response to current treatment; data expected in 2026
Ref: PRNewswire | Image: Vanda Pharmaceuticals
Related News:- Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click Here for Full Press Release
