Molecule
Milsaperidone is a prescription medicine indicated for the treatment of schizophrenia in adults. It is available as tablets and kits for oral use. MedsAcross supplies Milsaperidone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults.
Source: US FDA prescribing information
The mechanism of action of milsaperidone in the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults is unknown. However, the efficacy of milsaperidone in these conditions could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Milsaperidone and iloperidone rapidly interconvert in vivo. Milsaperidone has an in vitro receptor binding profile similar to iloperidone.
Source: US FDA prescribing information
Administer BYSANTI orally twice daily with or without food. Titrate BYSANTI to reduce the risk of orthostatic hypotension. See Full Prescribing Information for titration schedule. After the titration, recommended maintenance dosage for: Schizophrenia is 6 to 12 mg twice daily. Bipolar mania is 12 mg twice daily,. CYP2D6 Poor Metabolizers: See Full Prescribing Information for titration schedule and recommended dosage. See Full Prescribing Information for the recommended dosage in patients with hepatic impairment and dosage modifications for drug interactions
Source: US FDA prescribing information
BYSANTI is contraindicated in individuals with a known hypersensitivity reaction to milsaperidone or the inactive ingredients in BYSANTI. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported. Known hypersensitivity to milsaperidone or the inactive ingredients in BYSANTI.
Source: US FDA prescribing information
Boxed warning (increased mortality in elderly patients with dementia-related psychosis): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. BYSANTI is not approved for the treatment of patients with dementia-related psychosis. BYSANTI is not approved for use in patients with dementia-related psychosis. Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). QTc Interval Prolongation: may be associated with torsade de pointes and sudden death.
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis QT Prolongation Neuroleptic Malignant Syndrome (NMS) Tardive Dyskinesia Metabolic Changes Orthostatic Hypotension and Syncope Falls Seizures Leukopenia, Neutropenia and Agranulocytosis Hyperprolactinemia Body Temperature Regulation Dysphagia Priapism Potential for Cognitive and Motor Impairment Intraoperative Floppy Iris Syndrome Commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) were: Schizophrenia: dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
Source: US FDA prescribing information
Strong CYP2D6 Inhibitors: Reduce the dosage of BYSANTI when administered with a strong CYP2D6 inhibitor. Strong CYP3A4 Inhibitors: Reduce the dosage of BYSANTI when administered with a strong CYP3A4 inhibitor. Strong CYP2D6 and Strong CYP3A4 Inhibitors: Reduce the dosage of BYSANTI if administered concomitantly with both a CYP2D6 and a CYP3A4 inhibitor. Drugs that Lower Blood Pressure: Avoid concomitant administration of BYSANTI with alpha-adrenergic blocking agents and consider lowering the dosage of other drugs that lower blood pressure
Source: US FDA prescribing information
Storage Store the tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15° to 30 °C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Milsaperidone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Bysanti kitOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 1 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 10 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 12 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 2 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 4 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 6 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
| Bysanti 8 mg tabletOral | Vanda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 February 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 8 presentations of Milsaperidone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Milsaperidone, including Bysanti.
Yes. The US FDA first approved Milsaperidone on 20 February 2026, according to Drugs@FDA.
No listed presentation of Milsaperidone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.