Overview
Schizophrenia is a complex mental illness and impacts approximately 1% of the population. Although there are several antipsychotics including aripiprazole, paliperidone and clozapine available for clinical use, they are generally accompanied by significant metabolic and/or neurological adverse effects. Lumateperone is a newly approved 2nd generation antipsychotic currently indicated for the treatment of schizophrenia. It has a unique receptor binding profile and differs from other antipsychotics in that it modulates glutamate, serotonin and dopamine, which are all neurotransmitters that contribute to the pathophysiology of schizophrenia. The data so far indicates that lumateperone can alleviate both positive and negative symptoms of schizophrenia. Further, not only is the new antipsychotic selective for dopamine (D2) receptors in the mesolimbic and mesocortical brain regions, but it also has minimal off-target activity. Both characteristics lend to a more favourable adverse effect profile and ultimately safer drug.
Background
Schizophrenia is a complex mental illness and impacts approximately 1% of the population. Although there are several antipsychotics including aripiprazole, paliperidone and clozapine available for clinical use, they are generally accompanied by significant metabolic and/or neurological adverse effects. Lumateperone is a newly approved 2nd generation antipsychotic currently indicated for the treatment of schizophrenia. It has a unique receptor binding profile and differs from other antipsychotics in that it modulates glutamate, serotonin and dopamine, which are all neurotransmitters that contribute to the pathophysiology of schizophrenia. The data so far indicates that lumateperone can alleviate both positive and negative symptoms of schizophrenia. Further, not only is the new antipsychotic selective for dopamine (D2) receptors in the mesolimbic and mesocortical brain regions, but it also has minimal off-target activity. Both characteristics lend to a more favourable adverse effect profile and ultimately safer drug.
Indication
Lumateperone is approved for the treatment of schizophrenia in adults. It is also approved for the treatment of depressive episodes associated with bipolar disorder (i.e. bipolar depression) in adults, as monotherapy and/or adjunctive therapy with lithium or valproate.
Associated Conditions
- Depressive Episodes
- Schizophrenia
Research Report
Comprehensive Report on Lumateperone (Caplyta)
1. Introduction to Lumateperone (Caplyta)
1.1 Overview
Lumateperone, marketed under the brand name Caplyta®, is a novel second-generation (atypical) antipsychotic agent developed for the treatment of serious central nervous system (CNS) disorders.[1] It is specifically approved for schizophrenia and bipolar depression in adults.[1] Lumateperone is distinguished by a unique receptor binding profile, which contributes to its mechanism of action and a generally favorable tolerability profile, particularly concerning metabolic disturbances and extrapyramidal symptoms (EPS), when compared to some other antipsychotic medications.[1]
Schizophrenia, a complex mental illness affecting approximately 1% of the population, presents a significant treatment challenge [User Query]. While several antipsychotics, including aripiprazole, paliperidone, and clozapine, are available, their use is often accompanied by significant metabolic and/or neurological adverse effects [User Query]. Lumateperone's development appears to be a direct response to these limitations. The emphasis on its "novel" mechanism involving the modulation of glutamate, serotonin, and dopamine, coupled with "minimal off-target activity" and a "more favourable adverse effect profile," suggests a targeted drug design strategy aimed at improving upon existing therapies [User Query]. This approach seeks to provide efficacy in managing both positive and negative symptoms of schizophrenia with enhanced safety and tolerability [User Query].
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/26 | Phase 3 | Recruiting | |||
2024/11/15 | Phase 3 | Recruiting | |||
2024/10/04 | Phase 1 | Recruiting | |||
2024/08/16 | Phase 1 | Recruiting | |||
2024/07/01 | Phase 3 | Recruiting | Louisiana State University Health Sciences Center Shreveport | ||
2024/06/17 | Phase 3 | Recruiting | |||
2024/06/17 | Phase 3 | Recruiting | |||
2024/04/18 | Phase 3 | Recruiting | |||
2024/01/29 | Phase 3 | Recruiting | |||
2023/12/18 | Phase 4 | Recruiting | University of Massachusetts, Worcester |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
REMEDYREPACK INC. | 70518-3497 | ORAL | 42 mg in 1 1 | 1/12/2024 | |
Intra-Cellular Therapies, Inc | 72060-142 | ORAL | 42 mg in 1 1 | 9/22/2022 | |
Intra-Cellular Therapies, Inc | 72060-121 | ORAL | 21 mg in 1 1 | 9/22/2022 | |
Intra-Cellular Therapies, Inc | 72060-110 | ORAL | 10.5 mg in 1 1 | 9/22/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |