Johnson & Johnson’s Caplyta demonstrates phase III promise for depression

Combining an antipsychotic therapy with an antidepressant has shown clinical promise for enabling remission in adults with major depressive disorder.

Findings from the six-month open-label extension safety study found that using Johnson & Johnson’s Caplyta (lumateperone) alongside an antidepressant nearly doubled the likelihood of remission at six weeks compared to placebo, according to new analysis of phase III data.

Data presented at the 2026 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) showed that 65 percent of patients achieved remission and 43 percent attained sustained symptomatic relief.

A total of 44.1 percent experienced complete remission. Notably, 42.8 percent experienced sustained remission by the end of treatment at Week 24, with rates increasing steadily throughout the study.

Dr Michael Thase, Professor of Psychiatry, Perelman School of Medicine at University of Pennsylvania, said: “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.

“The findings demonstrate that adjunctive lumateperone may almost double the likelihood of remission, with benefits sustained over six months, offering renewed hope to millions of adults seeking recovery from this disease.”

Dr Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, added: “Too many patients spend years cycling through treatments, settling for ‘good enough’ because they don’t realise complete relief is possible. These data demonstrate that remission is within reach and should be the expectation, not the exception.”

Small molecule drug Caplyta was approved in the US in November 2025 as an adjunctive therapy for major depressive disorder. The therapy is also indicated for schizophrenia and bipolar I or II disorder-associated depressive episodes.