Johnson & Johnson’s (J&J) Caplyta (lumateperone) plus antidepressants nearly doubled the likelihood of remission after six weeks, with benefit remaining for more than six months in patients with major depressive disorder (MDD).
In new analysis from three Phase III trials (NCT04985942, NCT05061706 and NCT05061719), Caplyta showed meaningful remission in three different measures. These were the Montgomery-Asberg Depression Rating Scale (MADRS): remission (defined as MADRS ≤10), complete remission (defined as MADRS ≤5), and sustained remission (defined as MADRS ≤10 maintained at each assessment).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
In the pooled pivotal data, 25.6% of patients reached MADRS ≤10 at six weeks when treated with adjunctive Caplyta compared to 13.6% on placebo.
In the Caplyta cohort, 10.6% of patients achieved complete remission compared to 5.6% with placebo plus an antidepressant.
In the long-term extension trial, which was a six-month open-label extension safety study, efficacy was maintained with long-term Caplyta treatment, with nearly two out of three patients reaching MADRS ≤10, and 44.1% reaching complete remission. Notably, 42.8% of patients experienced sustained remission by the end of treatment.
Dr Michael Thase, chief of the Division of Mood and Anxiety Disorders Treatment & Research Program at Perelman School of Medicine at the University of Pennsylvania, said: “Today, remission is out of reach for the majority of patients with depression, which means they continue to struggle with persistent symptoms that negatively impact their daily lives. These data capture not only symptom reduction, but also the durability and depth of treatment response, which are critical benchmarks for patients and clinicians striving for lasting relief.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe data were presented at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held from January 12 to 15, in Nassau, Bahamas.
J&J acquired Caplyta as part of its $14.6bn takeover of Intra-Cellular Therapies in April 2025. The deal was announced during the J.P. Morgan Healthcare Conference in January 2025. The deal was the largest M&A pharma transaction of the year.
Just a few months later, in November 2025, the drug was approved by the US Food and Drug Administration (FDA) as an adjunctive therapy for MDD. It had previously been approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder.
A supplemental New Drug Application (sNDA) for Caplyta has been submitted to the FDA for the prevention of relapse in schizophrenia.
The MDD approval is notable to J&J, which is already a dominant player in the market with its nasal spray Spravato (esketamine). GlobalData predicts sales of the spray to reach $1.87bn in 2029.
Meanwhile, sales of Caplyta are expected to reach $995m in the same year.
GlobalData anticipates that the MDD market will grow to be worth approximately $9.55bn by 2029, at a compound annual growth rate (CAGR) of 7.3%.
GlobalData is the parent company of Clinical Trials Arena.
