Intra-Cellular Therapies Seeks FDA Approval for Caplyta in Major Depressive Disorder
• Intra-Cellular Therapies has submitted a supplemental New Drug Application to the FDA for Caplyta (lumateperone) as an adjunct treatment for Major Depressive Disorder (MDD).
• Caplyta, already approved for schizophrenia and bipolar disorder, demonstrated significant improvement in depression symptoms in Phase 3 trials when added to existing antidepressants.
• The application is supported by positive results from double-blind, placebo-controlled clinical trials in MDD patients who had an inadequate response to other antidepressants.
• If approved, Caplyta could become a first-choice add-on therapy for MDD, addressing a significant unmet need as over half of patients do not respond adequately to antidepressants alone.
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