FDA Approves New Treatment for Bipolar Depression


Caplyta is now FDA-approved for depressive episodes from bipolar I and II.

knlml/Adobe Stock

knlml/Adobe Stock

The US Food and Drug Administration (FDA) has approved Caplyta (lumateperone) for the treatment of bipolar depression in adults.

Caplyta, an atypical antipsychotic from biopharmaceutical company Intra-Cellular Therapies, is the only drug approved by the FDA for the treatment of depressive episodes stemming from bipolar I or bipolar II disorder in adults as monotherapy or adjunctive therapy with either valproate or lithium. The drug has shown a consistently favorable profile on weight, extrapyramidal symptoms, and cardiometabolic parameters, according to Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies.1

The drug was previously approved by the FDA for the treatment of schizophrenia in adults in 20192 following favorable safety and tolerability as well as demonstrated efficiency among patients with schizophrenia in prior studies. With this expansion of indications, Intra-Cellular Therapies announced that plans to launch its Caplyta treatment for bipolar depression will begin immediately.1

This approval is important for individuals living with bipolar depression and their providers, given the limited treatment options for depressive symptoms specifically associated with bipolar disorder. Bipolar depression is the most common and the most significant clinical presentation in individuals with bipolar disorder, which currently affects 11 million adults in the United States.1

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients. Caplyta is approved for a broad range of adult patients, including those patients with bipolar II depression who have been underserved with limited treatment options,” said Roger McIntyre, MD, FRCPC, professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada, in a press release.

“We are excited to offer Caplyta to the millions of patients living with bipolar depression,” Mates said in a press release. “We thank the patients, health care professionals, and our Intra-Cellular team for all their contributions that led to this approval.”


1. Intra-Cellular Therapies announces U.S. FDA approval of CAPLYTA (lumateperone) for the treatment of bipolar depression in adults. News Release. Intra-Cellular Therapies. December 20, 2021. Accessed December 20, 2021.

2. FDA approves Intra-Cellular Therapies’ novel antipsychotic, CAPLYTA (lumateperone) for the treatment of schizophrenia in adults. News Release. Intra-Cellular Therapies. December 23, 2019. Accessed December 20, 2021.

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