FDA Approves Uzedy Once-Monthly Extended Release Injectable Suspension for Bipolar I Disorder

Teva Pharmaceuticals recently announced that the US Food and Drug Administration (FDA) has approved Uzedy (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of adults with bipolar I disorder (BD-I).¹

Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq technology, a copolymer technology proprietary to Medincell that controls the steady release of risperidone. Utilizing this technology, therapeutic blood concentrations are reached within 6 to 24 hours of just a single dose. For the BD-I indication, Uzedy is now approved with 3 once-monthly dosing options: 50 mg, 75 mg, and 100 mg.

“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, the executive vice president of US Commercial at Teva. “This expanded indication for UZEDY builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.”

Uzedy extended-release injectable suspension for subcutaneous use was first approved in the US in May 2023 for the treatment of adults with schizophrenia.² This latest approval is based on existing clinical data for Uzedy, and Model-Informed Drug Development methodologies that leverage previous findings on the safety and efficacy of risperidone formulations already approved for BD-I.

“Bipolar I disorder carries profound implications for a person’s life and is linked to suboptimal long-term outcomes, with treatment adherence to daily oral options frequently presenting as a major impediment to effective care,” said Craig Chepke, MD, DFAPA, the medical director of Excel Psychiatric Associates and scientific director at HMP Global’s Psych Congress events and programs. “The FDA’s decision to expand the indication for Uzedy may help those living with BD-I. As a clinician, I am excited to now have a new treatment option for this complex disease.”

The data reviewed by the FDA to support Uzedy’s approval for the treatment of BD-I includes previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BD-I, in addition to the efficacy and long-term safety and tolerability of Uzedy for the treatment of schizophrenia established in 2 phase 3 pivotal studies: the RISE Study (Risperidone Subcutaneous Extended-Release Study) and the SHINE Study (Safety in Humans of TV-46000 sc INjection Evaluation).

The RISE study, was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment in patients (aged 13 to 65 years) with schizophrenia. Approximately 544 patients were randomized to receive a subcutaneous injection of Uzedy once monthly, once every 2 months, or placebo in a 1:1:1 ratio. The primary endpoint was time to impending relapse.³

The SHINE study was designed to evaluate the long-term safety, tolerability and efficacy of Uzedy subcutaneously administered once monthly or once every 2 months for up to 56 weeks in 331 patients (aged 13 to 65 years) with schizophrenia. The primary endpoint was the frequency of all adverse events, including serious adverse events.⁴

“Long-acting injectables are increasingly recognized as key drivers of innovation in CNS therapeutics,” said Christophe Douat, the CEO of Medincell. “We are proud that Uzedy is now available to support patients living with bipolar I disorder. This milestone highlights the exceptional regulatory and commercial execution of our partner, Teva.”

References

1. FDA approves expanded indication for UZEDY® (risperidone) extended-release injectable suspension as a treatment for adults living with bipolar I disorder. News release. October 10, 2025. Accessed October 16, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/FDA-Approves-Expanded-Indication-for-UZEDY-risperidone-Extended-Release-Injectable-Suspension-as-a-Treatment-for-Adults-Living-with-Bipolar-I-Disorder/default.aspx

2. O’Brien E. FDA approves long-acting treatment for schizophrenia in adults. Psychiatric Times. May 1, 2023. https://www.psychiatrictimes.com/view/fda-approves-long-acting-treatment-for-schizophrenia-in-adults

3. Kane JM, Harary E, Eshet R, et al. Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria. Lancet Psychiatry. 2023;10(12):934-943.

4. Kane JM, Eshet R, Harary E, et al. A long-term safety and tolerability study of TV-46000 for subcutaneous use in patients with schizophrenia: a phase 3, randomized, double-blinded clinical trial. CNS Drugs. 2024;38(8):625-636.