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Lumateperone Approval Status

FDA Approved: No
Generic name: lumateperone
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia

Lumateperone is first-in-class antipsychotic in development for the treatment of schizophrenia.

Development Status and FDA Approval Process for lumateperone

DateArticle
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
May  6, 2014Intra-Cellular Therapies Presents New Data from the Phase 2 Trial of ITI-007 in Schizophrenia
Mar  3, 2014Intra-Cellular Therapies Announces Initiation of Phase I/II Clinical Trial for ITI-007
Jul 29, 2010Intra-Cellular Therapies Announces the Successful Completion of a Phase Ib/II Study of ITI-007 in Patients with Schizophrenia
Dec 21, 2009Intra-Cellular Therapies Announces the Results of a Phase I PET Study for ITI-007 for the Treatment of Schizophrenia and Other Psychiatric Disorders
Mar 10, 2009Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Jan 13, 2009Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Apr  9, 2008Intra-Cellular Therapies Announces the Discovery of PotentAntidepressant Activity in ITI-007/ITI-722
Dec 19, 2007Intra-Cellular Therapies Presents Preclinical Data FromSchizophrenia and Sleep Maintenance Programs

Further information

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