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ITI-007 (Lumateperone)
Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders.
Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders. Used for Schizophrenia (acute and maintenance treatment), Bipolar disorder (in development).
At a glance
| Generic name | ITI-007 (Lumateperone) |
|---|---|
| Sponsor | Intra-Cellular Therapies, Inc. |
| Drug class | Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor |
| Target | 5-HT7 receptor, PDE1 |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
ITI-007 works through a dual mechanism: it antagonizes 5-HT7 receptors and inhibits phosphodiesterase 1 (PDE1), leading to modulation of intracellular cAMP signaling. This mechanism is proposed to address both positive and negative symptoms of schizophrenia while potentially reducing extrapyramidal side effects associated with dopamine antagonism, as it does not directly block dopamine D2 receptors at therapeutic doses.
Approved indications
- Schizophrenia (acute and maintenance treatment)
- Bipolar disorder (in development)
Common side effects
- Somnolence
- Nausea
- Headache
- Dizziness
- Akathisia
- Weight gain
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:
- ITI-007 (Lumateperone) CI brief — competitive landscape report
- ITI-007 (Lumateperone) updates RSS · CI watch RSS
- Intra-Cellular Therapies, Inc. portfolio CI