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
| Date | Article |
|---|
| Apr 25, 2022 | Approval Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for Caplyta (lumateperone) for Specific Patient Populations |
| Dec 20, 2021 | Approval Intra-Cellular Therapies Announces U.S. FDA Approval of Caplyta (lumateperone) for the Treatment of Bipolar Depression in Adults |
| Dec 23, 2019 | Approval FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults |
| Sep 10, 2019 | Intra-Cellular Therapies Provides Lumateperone Regulatory Update |
| Jul 23, 2019 | Intra-Cellular Therapies Provides Update on FDA Advisory Committee Meeting for Lumateperone for the Treatment of Schizophrenia |
| Jul 8, 2019 | Intra-Cellular Therapies Announces Positive Top-line Results from a Phase 3 Trial of Lumateperone in Patients with Bipolar Depression |
| Jun 13, 2019 | Intra-Cellular Therapies Announces FDA Advisory Committee Meeting to Review the NDA for Lumateperone for the Treatment of Schizophrenia in Adults |
| Dec 11, 2018 | Intra-Cellular Therapies Announces FDA Acceptance of New Drug Application for Lumateperone for the Treatment of Schizophrenia |
| Sep 28, 2018 | Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia |
| Jun 6, 2018 | Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia |
| Nov 20, 2017 | Intra-Cellular Therapies Receives FDA Fast Track Designation for Lumateperone for the Treatment of Schizophrenia |
Further information
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