FDA Approves Milsaperidone for Bipolar I and Schizophrenia, Advances Psychedelic Therapies
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
The U.S. Food and Drug Administration approved milsaperidone (Bysanti) tablets as a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. In clinical studies, milsaperidone demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum, with commercial availability expected by the third quarter of 2026.
Meanwhile, investigational psychedelic therapies continued to generate momentum, with COMP360 psilocybin meeting the primary endpoint in a second phase 3 trial for treatment-resistant depression. In the COMP006 study, a pair of 25-mg doses administered 3 weeks apart yielded a statistically significant reduction in depressive symptom severity at week 6 compared with a 1-mg dose control, reinforcing findings from the companion COMP005 trial and advancing the program toward regulatory submission.
Early clinical data also suggested antidepressant effects from intravenous SPL026 in patients with major depressive disorder. Results from a phase 2a randomized, placebo-controlled clinical trial evaluating SPL026 in participants with moderate-to-severe major depressive disorder showed statistically significant and clinically meaningful reductions in depressive symptoms at 2 weeks, as measured by the Montgomery-Åsberg Depression Rating Scale in participants treated with SPL026 compared with placebo. The company does not plan to advance intravenous SPL026 in its current form but will use the mechanistic and clinical insights generated from the trial to continue to inform its HLP004 development program.
Beyond drug development, new research offered insights into clinical decision-making and emerging neuromodulation approaches. Studies examining predictors of relapse following antidepressant discontinuation and the age-related effects of magnetic seizure therapy in treatment-resistant depression underscore the ongoing effort to refine personalized care strategies for patients with difficult-to-treat psychiatric conditions.
Recent research shows delay discounting did not predict relapse after antidepressant discontinuation in patients with remitted major depressive disorder, despite a modest association with residual depressive symptoms. Findings from the multi-site longitudinal study suggest a lack of reliable tools for predicting relapse and emphasize the importance of individualized, shared decision-making when counseling patients.
New data suggest adolescents with treatment-resistant major depressive disorder receiving magnetic seizure therapy may experience faster symptom improvement, fewer cognitive adverse events, and better overall tolerability compared to adults.