Lumateperone - Intra-Cellular Therapies
Alternative Names: CAPLYTA; ITI-007; ITI-722; Lumateperone tosylateLatest Information Update: 29 Feb 2024
At a glance
- Originator Bristol-Myers Squibb
- Developer Intra-Cellular Therapies
- Class Antidementias; Antidepressants; Antipsychotics; Behavioural disorder therapies; Fluorobenzenes; Piperidines; Pyrroles; Quinoxalines; Sleep disorder therapies; Small molecules; Tosyl compounds
- Mechanism of Action Dopamine D2 receptor modulators; Glutamate modulators; Serotonin 2A receptor antagonists; Serotonin uptake inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Bipolar depression; Schizophrenia
- Phase III Behavioural disorders; Bipolar disorders; Major depressive disorder
- Phase II Sleep maintenance insomnia
Most Recent Events
- 22 Feb 2024 Intra-Cellular Therapies announces intention to submit sNDA to US FDA for Major depressive disorder in the second half of 2024
- 22 Feb 2024 Intra-Cellular Therapies completes enrollment in the phase-III trial in Major depressive disorder (Adjunctive treatment) in USA, Bulgaria, Czech Republic, Hungary, India and Slovakia (PO) (NCT04985942)
- 28 Jan 2024 No recent reports of development identified for phase-I development in Schizophrenia(In adults) in USA (SC, Injection)