Caplyta Shows Strong Remission Gains in Phase III Depression Study

Caplyta Shows Strong Remission Gains in Phase III Depression Study

As reported by the European Pharmacy Review, a combination approach using Johnson & Johnson’s small‑molecule therapy Caplyta (lumateperone) alongside standard antidepressants continues to show promising results for adults with major depressive disorder (MDD), according to new Phase III analyses shared at the 2026 Annual Meeting of the American College of Neuropsychopharmacology (ACNP).

Higher and More Durable Remission Rates

Newly released data from a six‑month open‑label extension study suggest that adjunctive lumateperone may significantly enhance the likelihood of remission in patients who have not achieved adequate relief with antidepressants alone.

Investigators reported that:

  • 65% of participants reached remission,
  • 43% maintained sustained symptomatic improvement,
  • 44.1% achieved complete remission, and
  • 42.8% sustained remission through Week 24, with steady improvement throughout treatment.

These results indicate not only a greater probability of symptom reduction early in treatment, but also continued therapeutic benefit over time.

Clinical Experts Highlight the Significance

Dr. Michael Thase, Professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania, noted that the findings underscore both the depth and durability of the treatment response—two critical factors for individuals seeking long‑term relief from major depression. He emphasized that adjunctive lumateperone appeared to nearly double remission rates compared with placebo in earlier analyses.

Dr. Bill Martin, Global Therapeutic Area Head of Neuroscience at Johnson & Johnson Innovative Medicine, added that many patients with depression cycle through treatment options without ever experiencing full remission. The new data, he said, reinforce that complete symptom relief should be viewed as an achievable goal rather than an uncommon outcome.

Caplyta’s Expanding Role in Mood Disorders

Caplyta received U.S. approval in November 2025 as an adjunctive treatment for major depressive disorder, adding to its existing indications for schizophrenia and depressive episodes associated with bipolar I or II disorder. The latest Phase III findings strengthen its potential role in combination therapy for patients with persistent MDD symptoms.

As research continues, lumateperone may become a key option for clinicians aiming to bridge the gap between partial improvement and true remission in major depression.