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Caplyta Approval History

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

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia.

  • The Caplyta product label carries a Boxed Warning for increased risk of mortality in elderly patients with dementia-related psychosis.
  • The recommended dosage of Caplyta is one 42 mg capsule once daily with food.
  • Common side effects include sleepiness and dry mouth.

Development History and FDA Approval Process for Caplyta

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

Further information

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