Johnson & Johnson Completes Landmark Acquisition of Intra-Cellular Therapies, Gaining Innovative Drug Lumateperone (CAPLYTA®)

Johnson & Johnson (NYSE: JNJ) recently announced that it has completed the acquisition of Intra-Cellular Therapies. Intra-Cellular Therapies will become part of Johnson & Johnson and operate as a business unit within Johnson & Johnson's Innovative Medicine division.

Through this acquisition, Johnson & Johnson willCAPLYTA® (lumateperone)Included in its robust portfolio of differentiated medicines. CAPLYTA® is an oral, once-daily therapy approved for the treatment of adult schizophrenia and is also the first and only medication approved by the U.S. Food and Drug Administration (FDA) for monotherapy and as an adjunct to lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder.Quetiapine, olanzapine-fluoxetine combination, lurasidone, and cariprazine have previously been approved by the FDA for the treatment of bipolar depression, but the breadth of their indications does not match that of lumateperone (Table 1).

Table 1 Drugs Approved by the FDA for the Treatment of Bipolar Depression

Lumateperone is a novel antipsychotic with a unique mechanism of action, which can synergistically act on serotonin and dopamine.And the glutamatergic system, which not only improves positive symptoms in schizophrenia patients, but is also effective for negative symptoms and depressive symptoms.。2In February 2025, Intra-Cellular Therapies announced that the FDA had accepted the supplemental new drug application for CAPLYTA® as an adjunctive treatment for major depressive disorder (MDD) in adults.

This acquisition also includes ITI-1284, a deuterated form of lumateperone. Its efficacy for generalized anxiety disorder (GAD) and agitation and psychosis related to Alzheimer’s disease (AD) is currently under investigation, further enhancing Johnson & Johnson's clinical-stage pipeline in its current areas of focus.

FDA Approves Lumateperone for Bipolar Depression: "The Broadest Indication Ever" | Industry News

2021-12-22

Source：

1. Johnson & Johnson Innovative Pharmaceuticals. (April 9, 2025). Johnson & Johnson Completes Landmark Acquisition of Intra-Cellular Therapies, Strengthening Leadership in Neuroscience. WeChat Official Account Platform. https://mp.weixin.qq.com/s/-LjXZyTM6NN4iMbQKwV3Cw

2. Liu Xueying, Kong Qingmei, Si Tianmei, et al. New advances in the treatment of schizophrenia with the novel antipsychotic lumateperone[J]. Chinese Journal of Psychiatry, 2021, 54(1): 57-61. DOI: 10.3760/cma.j.cn113661-20200326-00144.

3. FDA Grants New Indication to Lumateperone (Caplyta) for Bipolar Depression - Medscape - Dec 20, 2021.

4. FDA approves Caplyta for depressive episodes in bipolar I, II disorders. Healio. December 21, 2021

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