Caplyta FDA Approval History
Last updated by Judith Stewart, BPharm on April 29, 2022.
FDA Approved: Yes (First approved December 20, 2019)
Brand name: Caplyta
Generic name: lumateperone
Dosage form: Capsules
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia, Bipolar Disorder
Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.
- Caplyta is indicated for the treatment of:
- Schizophrenia in adults.
- Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
- The Caplyta product label carries a Boxed Warning for increased risk of mortality in elderly patients with dementia-related psychosis, and the increased risk of suicidal thoughts and behaviors.
- Caplyta capsules are taken orally once daily.
- Common side effects include sleepiness, dizziness, nausea, and dry mouth.
Development Timeline for Caplyta
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