Company Overview of Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc., a biopharmaceutical company, discovers and develops small molecule drugs for the treatment of neuropsychiatric and neurologic disorders within the central nervous system (CNS). Its lead drug candidate is ITI-007, which is in phase III clinical development for the treatment of schizophrenia, behavioral disturbances in dementia, bipolar disorder, depression, and other neuropsychiatric and neurological disorders. The company also develops ITI-002 program that is in phase 1 development for the treatment of central nervous system, cardiovascular, and other disorders. Intra-Cellular Therapies, Inc. has a license and collaboration agreement with Takeda Pharmaceutical...
430 East 29th Street
New York, NY 10016
Key Executives for Intra-Cellular Therapies, Inc.
Co-Founder, Chairman, Chief Executive Officer and President
Total Annual Compensation: $954.0K
Co-Founder and Vice President of Business Development
Total Annual Compensation: $283.7K
Chief Financial Officer, Vice President of Finance, Treasurer and Assistant Secretary
Total Annual Compensation: $386.3K
Senior Vice President, General Counsel and Secretary
Total Annual Compensation: $207.5K
Vice President of Corporate Communications & Investor Relations
Total Annual Compensation: $294.4K
Compensation as of Fiscal Year 2014.
Intra-Cellular Therapies, Inc. Key Developments
Intra-Cellular Therapies Announces Completion of Phase 1 Studies for ITI-214, a Phosphodiesterase Type 1 Inhibitor, and Assumes IND Sponsorship for ITI-214
Sep 21 15
Intra-Cellular Therapies, Inc. announced that it is assuming sponsorship of the Investigational New Drug Application (IND) for studies related to ITI-214. ITI-214 is a novel, potent phosphodiesterase type 1 (PDE1) inhibitor. Multiple human clinical Phase 1 studies have been completed. In these studies, ITI-214 demonstrated a favorable safety profile and was generally well-tolerated across a broad range of doses both in healthy volunteers and in patients with schizophrenia with a pharmacokinetic profile that supports once daily dosing. Under a license agreement, Takeda conducted four Phase 1 studies. A single rising dose study was conducted in the US in healthy male and female, Japanese and non-Japanese volunteers. In a second US study ITI-214 was administered once daily over 14 days to healthy volunteers and patients with stable schizophrenia. In a third study, conducted in Japan, ITI-214 was administered for 7 days at multiple rising oral doses in both male and female healthy volunteers. A fourth study compared the relative bioavailability of oral formulations of ITI-214 used in all previous studies to an immediate-release tablet, either with or without food in healthy volunteers. The company is currently evaluating ITI-214 for several indications including cognition in patients with Parkinson's disease, dementia, schizophrenia and other CNS and non-CNS disorders.
Intra-Cellular Therapies, Inc. - Special Call
Sep 16 15
To discuss the top-line results of Phase 3 trial and PET study
Intra-Cellular Therapies, Inc. Announces Positive Results from the First Phase 3 Clinical Trial of ITI-007 for the Treatment of Patients with Schizophrenia
Sep 16 15
Intra-Cellular Therapies, Inc. announced positive results from the first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia. In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4 (study endpoint) as measured by the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score (p=0.022). Moreover, ITI-007 60 mg showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the entire study. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for Severity of Illness (CGI-S; p=0.003). These findings confirm the positive results demonstrated by ITI-007 60 mg in the company's Phase 2 study. Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile as evidenced by motoric, metabolic, and cardiovascular characteristics similar to placebo, and no clinically significant changes in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin, or lipids.
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