Lumateperone

Generic Name: Lumateperone

Brand Names: Caplyta

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈FN_₃O

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.

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

Associated Therapies: -

Clinical Trials

Lumateperone Demonstrates Efficacy in Reducing Symptomatic Relapse Risk in Schizophrenia

Intra-Cellular Therapies reports positive results from a study on 42 mg lumateperone (Caplyta) for relapse prevention in schizophrenia. The study showed significant reduction in relapse risk (HR, 0.37; 95% CI, 0.22-0.65) and better safety compared to placebo. Lumateperone is FDA-approved for schizophrenia and bipolar depression.

morningstar.com

2 months ago

Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for Schizophrenia Maintenance Treatment

CAPLYTA (lumateperone) demonstrated efficacy and safety as a maintenance treatment for schizophrenia in a randomized withdrawal trial, showing a statistically significant longer time to relapse compared to placebo (p=0.0002).

stocktitan.net

2 months ago

CAPLYTA Shows Breakthrough 63% Reduction in Schizophrenia Relapse Risk

Intra-Cellular Therapies announced positive Phase 3 results for CAPLYTA (lumateperone) in preventing schizophrenia relapse, showing a 63% reduction in relapse risk vs. placebo (p=0.0002), with 16.4% of lumateperone patients relapsing vs. 38.6% in the placebo group. The drug was generally well-tolerated, with headache as the most common adverse event.

medpagetoday.com

2 months ago

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.

globenewswire.com

3 months ago

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.

Lumateperone

Lumateperone Demonstrates Efficacy in Reducing Symptomatic Relapse Risk in Schizophrenia

Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for Schizophrenia Maintenance Treatment

CAPLYTA Shows Breakthrough 63% Reduction in Schizophrenia Relapse Risk

Adjunctive Antipsychotic Helps Ease Symptoms of Depression

Schizophrenia Clinical Trial Pipeline Insights Featuring 55+ Companies

Drug Development Updates