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Lumateperone (ITI-007)
Lumateperone is a serotonin-dopamine antagonist that modulates glutamatergic neurotransmission.
Lumateperone is a serotonin-dopamine antagonist that modulates glutamatergic neurotransmission. Used for Schizophrenia, Bipolar depression.
At a glance
| Generic name | Lumateperone (ITI-007) |
|---|---|
| Sponsor | Intra-Cellular Therapies, Inc. |
| Drug class | Serotonin-dopamine antagonist |
| Target | 5-HT2A receptor, D2 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Lumateperone acts as a partial agonist at the serotonin 5-HT2A receptor and a dopamine D2 receptor antagonist. This mechanism of action is thought to contribute to its therapeutic effects in treating schizophrenia and bipolar depression.
Approved indications
- Schizophrenia
- Bipolar depression
Common side effects
- Orthostatic hypotension
- Weight gain
- Dizziness
- Headache
- Nausea
Key clinical trials
- Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression (PHASE3)
- Study of a Novel Antipsychotic ITI-007 in Schizophrenia (PHASE2)
- A Trial to Assess the Antipsychotic Efficacy of ITI-007 (PHASE3)
- A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment (PHASE3)
- Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression (PHASE3)
- Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally (PHASE3)
- ITI-007 (Lumateperone Tosylate) for Schizophrenia (PHASE2)
- ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lumateperone (ITI-007) CI brief — competitive landscape report
- Lumateperone (ITI-007) updates RSS · CI watch RSS
- Intra-Cellular Therapies, Inc. portfolio CI