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