April 29, 2026
2 min read
Key takeaways:
- Risk for relapse fell by 63% with Caplyta compared with placebo.
- There were no relapses over 6 months for 84% of patients.
- No new safety signals emerged, compared with previous data.
The FDA has approved Johnson & Johnson’s supplemental new drug application for Caplyta among patients with schizophrenia at risk for relapse, according to a press release from the company.
Noting that schizophrenia affects approximately 2.8 million adults in the United States, with a total cost of $366.8 billion in 2024, Johnson & Johnson said approximately 40% of patients do not receive adequate care.
The approval targets relapses in schizophrenia, which can lead to worse symptoms, cognition, quality of life and life expectancy.
Relapse remains “one of the most critical challenges” for patients with schizophrenia, Leighann Forbes, MS, PhD, vice president, U.S. neuroscience medical affairs, Johnson & Johnson, told Healio.
Leighann Forbes
“Relapses can disrupt stability, undermine functioning, and often trigger disruptive episodes such as psychosis or hallucinations that can derail daily life for patients and their loved ones,” she said.
Adults with schizophrenia experience an average of nine relapse episodes per 6-year period, according to the release.
“Each relapse can contribute to deterioration in symptoms, cognition, functioning, quality of life and life expectancy,” Forbes said. “That’s why managing relapse risk is a critical goal in long-term disease management.”
However, physicians often focus on symptoms to reduce risks for relapse instead of treating the relapse itself, Forbes said.
“A comprehensive treatment plan, which could include medication and psychosocial services, can help reduce the risk of relapse for adults with schizophrenia,” she said. “Addressing this risk can help patients maintain functioning, reduce caregiver and societal strain and break the cycle of repeated hospitalizations.”
In a phase 3, double-blind, randomized withdrawal trial, Johnson & Johnson said that daily oral 42 mg doses of Caplyta (lumateperone) significantly extended time to relapse compared with placebo over 26 weeks, with risks for relapse falling by 63%.
Also, 84% of patients on Caplyta did not experience a relapse for 6 months, with significant delays in time to treatment discontinuation due to relapse and all other causes.
Johnson & Johnson further said no new safety concerns were identified during this trial and that its safety profile was consistent with previous data. Headache was the most common adverse event related to treatment.
“Together, these data reinforce Caplyta as a safe and effective treatment option for adults living with schizophrenia,” Forbes told Healio. “Caplyta can be taken at any time of day and does not require titration, meaning patients can start treatment at the effective dose for them.”
Caplyta was previously approved for adults with major depressive disorder, schizophrenia and depressive episodes associated with bipolar I or II disorder in conjunction with antidepressants, lithium or valproate or as a monotherapy.
“Caplyta can be prescribed to patients who have experienced relapse,” Forbes said.
For more information:
Leighann Forbes, MS, PhD, can be reached at neurology@healio.com.
Sources/Disclosures
Source:
Press Release
Disclosures:
Forbes reports employment with Johnson & Johnson.
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