Lumateperone
- Generic Name
- Lumateperone
- Brand Names
- Caplyta
- Drug Type
- Small Molecule
- Chemical Formula
- C24H28FN3O
- CAS Number
- 313368-91-1
- Unique Ingredient Identifier
- 70BSQ12069
- 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.
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- 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
- Associated Therapies
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Adjunctive Antipsychotic Helps Ease Symptoms of Depression
Lumateperone (Caplyta) added to existing antidepressants significantly improved depression symptoms in a phase III trial, with significant MADRS score improvement by day 43. Lumateperone, already approved for schizophrenia and bipolar depression, showed efficacy as early as day 8. The study involved 484 patients with major depressive disorder who had inadequate response to prior antidepressant therapy. Lumateperone also improved CGI-S and QIDS-SR-16 scores, with stable weight and BMI, and no notable changes in extrapyramidal symptoms. A supplemental new drug application for adjunctive treatment of major depressive disorder is expected by end of 2024.
Schizophrenia Clinical Trial Pipeline Insights Featuring 55+ Companies
Schizophrenia clinical trial pipeline features 55+ companies and 60+ drugs, with key players like Sumitomo Pharma America, Boehringer Ingelheim, and Reviva Pharmaceuticals advancing novel therapies. Recent milestones include Reviva's Phase III RECOVER trial data, Luye Pharma Group's IND approval for LY03020, and Teva's positive SOLARIS trial results. DelveInsight's report provides comprehensive global coverage and insights into the schizophrenia pipeline.
Drug Development Updates
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