Molecule
Lumateperone is an atypical antipsychotic indicated for treatment of schizophrenia in adults. It is available as capsules for oral use. MedsAcross supplies Lumateperone 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.
CAPLYTA is indicated for: Treatment of schizophrenia in adults. Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults.
Source: US FDA prescribing information
The mechanism of action of lumateperone for the treatment of schizophrenia in adults, for the treatment of depressive episodes associated with bipolar depression (as monotherapy or as adjunctive therapy with lithium or valproate), and as adjunctive therapy with antidepressants for the treatment of MDD is unknown. However, the mechanism of action of lumateperone for these uses could be mediated through a combination of antagonist activity at central serotonin 5-HT 2A receptors, and partial agonist activity at central dopamine D 2 receptors.
Source: US FDA prescribing information
Recommended oral dosage of CAPLYTA is 42 mg once daily with or without food. Moderate hepatic impairment or severe hepatic impairment: Recommended dosage is 21 mg once daily.
Source: US FDA prescribing information
CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.
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. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke and transient ischemic attack). Neuroleptic Malignant Syndrome: If NMS is suspected, immediately discontinue CAPLYTA and provide intensive symptomatic treatment and monitoring. Tardive Dyskinesia: If signs and symptoms of TD occur consider discontinuing CAPLYTA treatment.
Source: US FDA prescribing information
The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Suicidal Thoughts and Behaviors Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis Neuroleptic Malignant Syndrome Tardive Dyskinesia Metabolic Changes Leukopenia, Neutropenia, and Agranulocytosis Orthostatic Hypotension and Syncope Falls Seizures Potential for Cognitive and Motor Impairment Body Temperature Dysregulation Dysphagia Most common adverse reactions in clinical trials (incidence ≥ 5% and greater than twice placebo) were: Schizophrenia: somnolence/sedation and dry mouth. Bipolar depression: somnolence/sedation, dizziness, nausea, dry mouth. MDD: dizziness, dry mouth, somnolence/sedation, nausea, fatigue, diarrhea.
Source: US FDA prescribing information
CYP3A4 inducers: Avoid concomitant use with CAPLYTA. Strong CYP3A4 inhibitors: Recommended dosage is 10.5 mg once daily. Moderate CYP3A4 inhibitors: Recommended dosage is 21 mg once daily.
Source: US FDA prescribing information
Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C 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.
3 presentations of Lumateperone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Caplyta 10.5 mg capsuleOral | Intra-Cellular Therapies | US FDA | Available on request |
| Caplyta 21 mg capsuleOral | Intra-Cellular Therapies | US FDA | Available on request |
| Caplyta 42 mg capsuleOral | Intra-Cellular Therapies | 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 December 2019 | 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 3 presentations of Lumateperone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lumateperone, including Caplyta.
Yes. The US FDA first approved Lumateperone on 20 December 2019, according to Drugs@FDA.
No listed presentation of Lumateperone 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.