Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing and commercializing therapies for high unmet medical needs. It applies genetics and genomics in discovery and clinical development and has operated as a NASDAQ-traded company since 2006.
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 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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07446439 |
A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use |
RECRUITING | PHASE3 |
| NCT07362017 |
Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis |
NOT_YET_RECRUITING | PHASE3 |
| NCT07223632 |
Treatment of Charcot-Marie-Tooth Disease, Axonal, Type 2S (CMT2S) in an Individual Patient |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT07221578 |
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder |
RECRUITING | PHASE3 |
| NCT07179055 |
An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye |
RECRUITING | PHASE2 |
| NCT07090161 |
Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension |
RECRUITING | PHASE2 |
| NCT07065773 |
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06961968 |
Randomized Withdrawal Study in Patients With Schizophrenia |
RECRUITING | PHASE3 |
| NCT06953869 |
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia |
RECRUITING | PHASE3 |
| NCT06836557 |
Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis |
RECRUITING | PHASE3 |
