Caplyta (lumateperone) has scored a label extension into the depression setting, underscoring the belief Johnson & Johnson (J&J) saw in the drug when it acquired original developer Intra-Cellular Therapies in a $14.6bn deal earlier this year.
The US Food and Drug Administration (FDA) has approved Caplyta as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
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Already armed with approvals in schizophrenia and bipolar depression, the MDD label extension represents the largest market the medication now has approval to treat. MDD, or clinical depression, is one of the most common psychiatric disorders that affects approximately 22 million American adults.
J&J anticipates that Caplyta, an oral atypical antipsychotic taken once daily, will eventually generate $5bn in annual sales, according to remarks made by CEO Joaquin Duato on a recent Q3 earnings call.
Analysts at GlobalData forecast annual sales of $2.7bn by 2031, the furthest year in its revenue model. It is likely the drug鈥檚 peak sales will extend beyond that figure.
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By GlobalDataCaplyta has already produced commercial success for Intra-Cellular Therapies. The drug brought in $680m in sales in 2024, though the coveted MDD approval will propel sales even further under J&J鈥檚 ownership.
Analysts at Leerink Partners estimated that an entry into the MDD market could add at least $1bn to sales, according to a note in January 2025, when J&J agreed to acquire Intra-Cellular. At the time, the deal was the biggest in the biopharma industry since Novo Nordisk acquired Catalent in February 2024.
The FDA approval is based on data from two Phase III studies 鈥� 501 and 502 鈥� that both met their primary and secondary endpoints. Caplyta improved depression symptoms compared to an oral antidepressant plus placebo, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression Scale-Severity index (CGI-S) total scores.
Although its exact mechanism of action is unknown, Caplyta acts on dopamine and serotonin receptors.
Roger McIntyre, professor of psychiatry and pharmacology at the University of Toronto, said: 鈥淔or people who are still experiencing lingering depressive symptoms while on an antidepressant, adding Caplyta to a patient鈥檚 treatment regimen may offer early improvement, with the potential for remission鈥攖he ultimate goal of treatment.鈥�
Caplyta鈥檚 approval in MDD represents the latest push by J&J into the market beyond traditional serotonin selective reuptake inhibitors聽(SSRIs). The company also offers ketamine-based nasal spray Spravato (esketamine), which is approved for MDD in adults who have not responded to two oral antidepressants. In 2024, total annual sales for the drug reached $1bn, with sales rising to $1.19bn in the first nine months of 2025. An annual sales forecast of $3.8bn in 2031 is ascribed to Spravato, according to GlobalData.
