J&J's Caplyta Eases Bipolar Mania Within Three Days in Second Pivotal Trial, Clearing Way for FDA Filing
NEW BRUNSWICK — Johnson & Johnson announced on Tuesday 10 November 2026 that a second pivotal Phase 3 trial of CAPLYTA (lumateperone) for manic episodes in adults with bipolar I disorder had met its primary and key secondary endpoints, with symptom improvement appearing as early as the third day of treatment. The result, reported by the company in a press release the same day and corroborated by Fierce Pharma and Psychiatric Times, means the medicine has now succeeded in two late-stage trials in acute mania, and Johnson & Johnson plans to use the combined evidence to support a future submission to the United States Food and Drug Administration (FDA) seeking approval for this use. CAPLYTA is not currently approved to treat manic episodes, and the planned submission has not yet been filed, so approval is not guaranteed. But for people living with bipolar I disorder, the announcement is a notable step toward a treatment that may act within days rather than weeks. The new trial, k...