sNDA Submitted: Lumateperone for the Prevention of Relapse in Schizophrenia
Psychiatric Times
JULY 8, 2025
The safety profile of Caplyta remains consistent, with headache as the most common adverse event. An sNDA for Caplyta as adjunctive therapy in major depressive disorder is under FDA review, showing robust efficacy in phase 3 studies. Caplyta’s safety profile was consistent with the existing body of clinical data.
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