Intra-Cellular Therapies, Inc. (ICT) is a biopharmaceutical company headquartered in New York, NY, focused on the development and commercialization of therapeutics for neuropsychiatric and neurological disorders. The company was founded in 2003 by Dr. Sharon M. W. Rosenberg and Dr. Robert L. B. Nahas, with a focus on intracellular signaling pathways.
Intra-Cellular Therapies is dedicated to developing novel treatments for CNS disorders by targeting intracellular signaling pathways within neurons. The company's scientific platform integrates expertise in receptor pharmacology, intracellular signaling, and medicinal chemistry to develop compounds with improved efficacy and safety profiles[1].
Intra-Cellular Therapies was founded in 2003 with a unique approach to CNS drug development: targeting intracellular signaling pathways rather than just cell surface receptors. This approach aimed to develop more effective treatments with fewer side effects.
CAPLYTA is the company's flagship product, representing a novel approach to treating schizophrenia and bipolar depression[2]:
Key Features:
Clinical Trial Results:
ZTALMY represents a breakthrough in rare disease treatment[3]:
| Drug Candidate | Indication | Mechanism | Stage |
|---|---|---|---|
| Lumateperone | Bipolar depression | D2/5-HT2A partial agonist | Phase 3[4] |
| Lumateperone | Alzheimer's disease psychosis | D2/5-HT2A partial agonist | Phase 2 |
| Lumateperone | Major depressive disorder | D2/5-HT2A partial agonist | Phase 2 |
| ITI-333 | Opioid use disorder | Mu opioid receptor antagonist | Phase 1 |
| ITI-1284 | Neurological disorders | PDE4 modulator | Preclinical |
Unlike traditional antipsychotics that target single receptors, lumateperone acts on multiple receptor types:
This multimodal approach may explain the favorable side effect profile compared to traditional antipsychotics.
Ganaxolone (ZTALMY) is a synthetic analog of allopregnanolone, a neurosteroid that potentiates GABA-A receptors. This mechanism is distinct from benzodiazepines and may offer benefits for treatment-resistant seizures.
Intra-Cellular's pipeline addresses significant unmet needs in neuropsychiatry[5]:
Lumateperone's multimodal mechanism offers potential advantages over existing antipsychotics:
Approximately 40-50% of Alzheimer's patients develop psychosis, representing a major unmet need:
This rare genetic epilepsy:
With approximately 30% of patients not responding to SSRIs, new mechanisms are needed:
Lumateperone's novel mechanism may offer benefits
Phase 2 trials showed antidepressant effects
Major Depressive Disorder
CAPLYTA
ZTALMY
Lumateperone Science. Molecular Psychiatry. ↩︎
CAPLYTA FDA Approval. FDA Press Release. ↩︎
ZTALMY FDA Approval. FDA Press Release. ↩︎
Lumateperone Bipolar Depression. JAMA Psychiatry. 2021. ↩︎
Alzheimer's Disease Psychosis. Alzheimer's & Dementia. ↩︎
Lumateperone in AD Psychosis. Journal of Alzheimer's Disease. ↩︎