Lumateperone
- Generic Name
- Lumateperone
- Brand Names
- Caplyta
- Drug Type
- Small Molecule
- Chemical Formula
- C24H28FN3O
- CAS Number
- 313368-91-1
- Unique Ingredient Identifier
- 70BSQ12069
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
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 Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
CAPLYTA | ORAL | 10.5 mg in 1 1 | 2022/09/22 | 72060-110 | |
CAPLYTA | ORAL | 42 mg in 1 1 | 2022/09/22 | 72060-142 | |
CAPLYTA | ORAL | 21 mg in 1 1 | 2022/09/22 | 72060-121 | |
CAPLYTA | ORAL | 42 mg in 1 1 | 2024/01/12 | 70518-3497 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
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No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No China products found
No China products found for this drug
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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No Australia products found
No Australia products found for this drug