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 FDA approved BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia in adults, and accepted Vanda's BLA filing for imsidolimab to treat Generalized Pustular Psoriasis with a target action date of December 12, 2026.
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07569198 |
Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07422519 |
Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression |
RECRUITING | NA |
| NCT07373535 |
Understanding Music and Mindfulness Preferences in Psilocybin-Assisted Psychotherapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07112261 |
Avatar Therapy in Virtual Reality for Treatment-Resistant Major Depressive Disorder: A Pilot Study |
ACTIVE_NOT_RECRUITING | NA |
| NCT07052058 |
Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to Standard Treatment for Treatment-Resistant Major Depression in the Brazilian Public Health System (SUS) |
NOT_YET_RECRUITING | PHASE2 |
| NCT06902298 |
Personalized Ultrasonic Brain Stimulation for Depression (R61) |
RECRUITING | PHASE1/PHASE2 |
| NCT06732089 |
Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study |
RECRUITING | |
| NCT05381974 |
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD |
WITHDRAWN | PHASE2 |
