FDA Approves Risperidone Extended-Release Injectable for Bipolar I Disorder

The US Food & Drug Administration (FDA) approved the risperidone (UZEDY) once-monthly extended-release injectable suspension for the treatment of adults with bipolar I disorder.1

Announced by Teva Pharmaceuticals on October 10, 2025, this approval expands risperidone’s use to include bipolar I disorder—specifically as a maintenance treatment, either as a monotherapy or an adjunctive therapy to lithium or valproate. This follows FDA’s approval of risperidone-extended-release injectable suspension for adult schizophrenia in 2023.2

“The FDA’s decision to expand the indication for UZEDY may help those living with BD-I,” said Craig Chepke, MD, medical director at Excel Psychiatric Associates and scientific director at HMP Global’s Psych Congress® events and programs, in a statement.1 “As a clinician, I am excited to now have a new treatment option for this complex disease.”

Risperidone, approved for bipolar I disorder at doses of 50 mg, 75 mg, and 100 mg, may help the millions (~3,400,000) of individuals who develop bipolar I disorder in their lifetime.1 This psychiatric disorder is associated with poor long-term outcomes and a greater mortality risk, due to suicide and cardiovascular disease, compared to the general population.

UZEDY is the first subcutaneous, long-acting formulation of risperidone that uses SteadyTeq™, a copolymer technology that controls the steady release of risperidone. Patients reach therapeutic blood concentrations within 6 to 24 hours of a single dose.1

This decision draws on existing clinical data for UZEDY and Model-Informed Drug Development (MIDD) approaches that incorporate prior evidence on the safety and efficacy of risperidone formulations previously approved for bipolar I disorder. In the application, Teva Pharmaceuticals included the 2 phase 3 pivotal studies examining UZEDY for schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – Safety in Humans of TV-46000 sc INjection Evaluation).

“Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps,” said Chris Fox, executive vice president, U.S. commercial at Teva, in a statement.1 “This expanded indication for UZEDY builds on its success in adults living with schizophrenia.”

References

1. FDA Approves Expanded Indication for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder. Tevapharm.com. Published October 10, 2025. Accessed October 10, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-uzedy-risperidone-extended-release-injectable-suspension-as-a-tre/

2. Walter K. FDA Approves Risperidone for Adults With Schizophrenia. Hcplive.com. Published May 2023. Accessed October 10, 2025. https://www.hcplive.com/view/fda-approves-risperidone-adults-schizophrenia

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