Laguna and Neurocrine advance schizophrenia diagnostic and treatment programs
Laguna won FDA Breakthrough Device Designation for a blood-based schizophrenia test, while Neurocrine dosed the first patient in a Phase 2 trial of NBI-1117570.
Bipolar I Disorder
DiseaseDisease Profile
Bipolar I disorder is a mood disorder characterized by episodes of mania and often major depression, with major shifts in mood, energy, and activity that impair daily functioning. The illness is persistent and associated with substantial disability.
- Category
- Mood disorder (psychiatric)
- Prevalence
- DSM-5 Bipolar I disorder prevalence: 1.5% (12-month) and 2.1% (lifetime) in U.S. adults
- F31.9
Related News
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.
Bipolar Depression Pipeline Expands With 10+ Therapies in Development Across 8+ Companies
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
Vanda Pharmaceuticals Receives FDA Approval for BYSANTI and BLA Acceptance for Imsidolimab
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.
FDA Approves Vanda's BYSANTI for Bipolar I Disorder and Schizophrenia
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.
FDA Approves Vanda's Bysanti for Schizophrenia and Bipolar I Disorder
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.
FDA Approves Vanda's Bysanti for Schizophrenia and Bipolar I Disorder
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone), an atypical antipsychotic for schizophrenia and manic or mixed episodes in bipolar I disorder. The drug will be available by the third quarter of 2026.
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