Also known as: Fanapt, FANAPT
Iloperidone is an atypical antipsychotic and 5HT2/D2 antagonist marketed as Fanapt. It is used for schizophrenia and for acute manic or mixed episodes associated with bipolar I disorder in adults. The FDA first approved Fanapt in 2009, with a later bipolar I approval in 2024.
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 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.
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.
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 |
|---|---|---|---|
| NCT07090161 |
Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension |
RECRUITING | PHASE2 |
| NCT06961968 |
Randomized Withdrawal Study in Patients With Schizophrenia |
RECRUITING | PHASE3 |
| NCT05648591 |
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents |
RECRUITING | PHASE4 |
| NCT05344365 |
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis |
WITHDRAWN | PHASE2 |
| NCT04819776 |
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder |
COMPLETED | PHASE3 |
| NCT04712734 |
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia |
COMPLETED | PHASE1 |
| NCT04127058 |
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia |
COMPLETED | PHASE1 |
| NCT02600741 |
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) |
COMPLETED | |
| NCT02453893 |
Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia |
UNKNOWN | PHASE3 |
| NCT02413918 |
Iloperidone in Mixed States of Bipolar Disorder |
COMPLETED | PHASE4 |
