Johnson & Johnson (J&J) has announced its $14.6 billion acquisition of Intra-Cellular Therapies, which brings Caplyta (lumateperone) to its growing portfolio of mental health treatments.
The deal also includes a cash payment of $132 per share for all outstanding shares of Intra-Cellular Therapies.
Caplyta is an oral medication that was first approved in 2019 for the treatment of schizophrenia in adults, followed by a 2021 approval for depressive episodes associated with bipolar I and II disorders, both as monotherapy and as adjunctive therapy with lithium or valproate.
Related: Intra-Cellular’s Schizophrenia Drug Caplyta Shows Promising Trial Results for Relapse Prevention
Offered as a simplified once-daily dosing regimen, patients can begin treatment at the effective dose without the need for gradual escalation. Caplyta’s ease of use for both patients and healthcare providers, and versatility in addressing complex mental health conditions, highlights its potential.
While the exact mechanism of action for lumateperone remains unclear, it is known to act as an antagonist of serotonin 5-HT₂A receptors and dopamine D₂ receptors, which are associated with its antipsychotic effects.
Caplyta has also demonstrated a favorable safety profile in clinical studies, with lower risks of weight gain, metabolic disturbances and motor side effects often linked to treatment discontinuation.
In December 2024, Intra-Cellular Therapies submitted a supplemental NDA to the FDA for Caplyta’s use as an adjunctive treatment for major depressive disorder.
In two global, double-blind, placebo-controlled Phase III trials, participants receiving Caplyta alongside standard antidepressants reported meaningful improvements in depressive symptoms, as measured by both clinician-rated and patient-reported outcomes. Caplyta’s safety profile is consistent with existing clinical data.
Additional research is underway to explore other uses for Caplyta, including managing bipolar mania and preventing relapse in schizophrenia. Phase III trials are currently evaluating its efficacy in treating bipolar I disorder with manic or mixed episodes.
Positive topline results from a Phase III study, shared in November 2024, highlighted Caplyta’s effectiveness in reducing relapse rates among adult patients with schizophrenia.
Beyond Caplyta, Intra-Cellular Therapies brings a pipeline of innovative therapies, such as ITI-1284, which is currently in Phase II trials for generalized anxiety disorder and Alzheimer’s-related psychosis.
J&J continues to advance a growing pipeline of mental health therapies. This includes seltorexant, an investigational orexin-2 receptor antagonist currently advancing towards regulatory submission after meeting all primary and secondary endpoints in a pivotal Phase III trial; and Spravato (esketamine), which is approved for treatment-resistant depression and undergoing further studies to expand its applications.
The acquisition of Intra-Cellular Therapies represents a strategic move for J&J. While the deal is expected to have a dilutive effect on earnings per share in the short term, projections indicate it will become accretive by 2030, driven by Caplyta’s strong commercial potential, with peak sales estimated to exceed $5 billion.
Join or login to leave a comment
JOIN LOGIN