- CAPLYTA® nearly doubled remission rates at six weeks compared to placebo in Phase 3 studies.
- 65% of patients reached remission in a six-month open-label extension study.
- CAPLYTA® was approved by the FDA in November 2025 as an adjunctive therapy for MDD.
Study Findings
CAPLYTA® (lumateperone), when used with an antidepressant, significantly increased remission rates in adults with major depressive disorder (MDD) compared to placebo. In pooled data from two Phase 3 studies, nearly twice as many patients achieved remission at six weeks with CAPLYTA®.
Long-term Benefits
A six-month open-label extension study showed sustained benefits, with 65% of patients reaching remission. The study also reported that 43% of patients experienced sustained relief from symptoms.
Clinical Implications
CAPLYTA® was approved by the FDA in November 2025 as an adjunctive therapy for MDD. The drug is characterized by high serotonin 5-HT2A receptor occupancy and moderate dopamine D2 receptor occupancy, and does not require dose titration, allowing patients to start treatment at 42 mg.
Challenges in MDD Treatment
MDD affects about 22 million American adults, with remission being the ultimate treatment goal. However, nearly two-thirds of patients do not achieve remission with current therapies, leading to prolonged psychosocial impairment and increased relapse risk.
