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FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder


Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.

Futuristic bipolar disorder concept with glowing low polygonal light and dark human heads. Image Credit: Adobe Stock Images/Inna

Image Credit: Adobe Stock Images/Inna

The FDA has approved Vanda Pharmaceuticals’ Fanapt (iloperidone) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The approval was based on the results of a Phase III clinical study, which enrolled 400 patients. After four weeks, the primary endpoint of a bigger success rate than placebo was achieved, with major improvements already being displayed after two weeks of treatment. First approved in 2009 to treat patients with schizophrenia, Vanda stated that the expanded indication for Fanapt will provide patients with flexible dosing and a well-known safety profile.1,2

"Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder," said Mihael H. Polymeropoulos MD, president, CEO, chairman, Vanda Pharmaceuticals, in a press release.

According to the Depression and Bipolar Support Alliance, bipolar disorder affects close to 5.7 million adults in the United States, with the average starting age being around 25 years. A majority of people diagnosed with bipolar disorder have a family member who also struggles with the condition or with major depression, suggesting that it can be hereditary.3

"Today's announcement marks a significant step forward for one of Vanda's leading franchises and underscores the effectiveness of our strategy in pursuing innovative therapies that address high unmet medical needs to improve the lives of patients. With this as our foundation, we have established a resilient business, with a diverse product pipeline, a history of revenue growth and strong financial position. We remain focused on providing critical medicines to patients across the world while creating sustainable, long-term value,” continued Polymeropoulos, in the press release.

The 2009 approval of Fanapt for the treatment of schizophrenia was based on promising results from two placebo-controlled Phase III clinical studies comparing the drug to placebo and active control in patients with schizophrenia. The study found that doses of 12 mg and 24 mg of the treatment daily were significantly more effective than the placebo. Almost a year earlier, the FDA rejected Vanda’s New Drug Application for Fanapt before reversing the decision.4,5

"Many patients today are still unable to find suitable treatment options for effectively managing bipolar disorder,” said Stephen Stahl, MD, PhD, professor, psychiatry, University of California San Diego, in the press release. “Tailoring the right treatment for the right patient is critical for effective care, and the approval of Fanapt represents an important milestone. Fanapt possesses a well-studied safety profile, and its approval will provide patients with a new and effective option for treating a highly complex disorder."


1. Vanda Pharmaceuticals' Fanapt® (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder. Vanda Pharmaceuticals. April 2, 2024. Accessed April 3, 2024. https://vandapharmaceuticalsinc.gcs-web.com/node/15856/pdf

2. Fanapt® Shown to be Effective in Bipolar I Disorder in Phase III Clinical Study. Vanda Pharmaceuticals. December 19, 2022. Accessed April 3, 2024. https://vandapharmaceuticalsinc.gcs-web.com/node/15146/pdf

3. Bipolar Disorder Statistics. DBSA. Accessed April 3, 2024. https://www.dbsalliance.org/education/bipolar-disorder/bipolar-disorder-statistics/

4. FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia. Vanda Pharmaceuticals. May 6, 2009. Accessed April 3, 2024. https://vandapharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/fda-approves-vanda-pharmaceuticals-fanapttm-treatment

5. FDA Reverses Earlier Decision, Approves Schizophrenia Drug. Psychiatric News. June 5, 2009. Accessed April 3, 2024. https://psychnews.psychiatryonline.org/doi/full/10.1176/pn.44.11.0002

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