FDA label
What is Caplyta used for?
Caplyta contains lumateperone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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.”
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Caplyta, capsule
Indications and Usage, quoted from the label by Intra-Cellular Therapies, Inc (NDA209500). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id db730b06-6351-47fd-8183-e61e61bbead5, version 27, effective June 20, 2025. NDC 72060-110, one of 3 listings for this product.
Questions
What is Caplyta used for?
The FDA label says: “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.”
What drug class is Caplyta?
FDA lists lumateperone in the Atypical Antipsychotic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.