FDA Approves Fanapt for Mixed, Manic Episodes Associated With Bipolar I Disorder


The atypical antipsychotic was approved for the acute treatment of schizophrenia in 2009.



The US Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of mixed or manic episodes connected to bipolar I disorder in adults. Fanapt is a second-generation antipsychotic that was FDA-approved for the acute treatment of schizophrenia in 2009.1,2

“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, said Mihael H. Polymeropoulos, MD, president, CEO, and chairman of the board at Fanapt developer Vanda Pharmaceuticals Inc, in a press release.

“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.”

The FDA based this decision on the results of a phase 3 clinical trial assessing the efficacy of Fanapt in managing acute manic and mixed episodes linked with bipolar I disorder in adults.1 The clinical study (VP-VYV-683-3201) involved around 400 participants who had been diagnosed with bipolar I disorder and were experiencing a current manic episode. These participants were randomly assigned to receive either Fanapt or a placebo at a 1:1 ratio across clinical sites in the United States, Bulgaria, and Poland.3

The primary measurement at the end of week 4 was conducted using the Young Mania Rating Scale (YMRS), which evaluates the severity of manic symptoms. Results indicated that patients treated with Fanapt exhibited notably greater improvement compared with those receiving the placebo, with a highly statistically significant difference (p=0.000008) observed.3

Throughout the 4-week study period, YMRS assessments were conducted weekly. Significant improvement in the Fanapt group over the placebo group was evident as early as week 2. Various secondary outcome measures, including the Clinician Global Impression of Severity (CGI-S) and the Clinician Global Impression of Change (CGI-C), also achieved statistical significance (p=0.0005 and p=0.0002, respectively).3

Fanapt has also shown efficacy in reducing the symptoms of bipolar mania in a more recent study entitled, “Efficacy and safety of iloperidone in bipolar mania: a double-blind, placebo-controlled study,”1 the results of which Vanda submitted to the FDA in January 2024.4 This phase 3 study focused on patients who were exhibiting psychotic features, with half of the total 414 participants receiving a daily dose of 24 mg of Fanapt (206 participants) and the other half receiving a placebo (208 participants).2

The study protocol consisted of a screening period lasting up to 7 days prior to randomization, followed by a 1-day baseline evaluation period and a subsequent 28-day treatment phase.

The primary objective of the study was to assess the change in symptoms of mania from baseline to week 4, as measured by the YMRS, in comparison with the placebo group. Secondary efficacy measures included changes in scores on the CGI-S and CGI-C scales from baseline.2

Results indicated a notable improvement in mania symptoms among participants receiving Fanapt compared with those receiving the placebo at the 4-week mark. Specifically, Fanapt was associated with a mean reduction of -4.0 on the YMRS scale (P = .000008) and significant decreases in scores on the CGI-S (mean, -0.4; P = .0005) and CGI-C scales (mean, -0.5; P = .0002) when compared with the placebo group. Statistically significant differences favoring Fanapt were also observed as early as day 14 and continued through days 21 and 28 of the study.2

“Many patients today are still unable to find suitable treatment options for effectively managing bipolar disorder,” said Stephen Stahl, MD, PhD, professor of psychiatry at the University of California San Diego, in a 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.”

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.


1. Vanda Pharmaceuticals’ Fanapt® (iloperidone) receives US FDA approval for the acute treatment of bipolar I disorder. PR Newswire. News release. April 2, 2024. Accessed April 2, 2024. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-fanapt-iloperidone-receives-us-fda-approval-for-the-acute-treatment-of-bipolar-i-disorder-302106405.html

2. Yasgur BS. Schizophrenia med safe, effective for bipolar mania: phase 3 data. MedScape. February 1, 2024. Accessed April 1, 2024. https://www.medscape.com/viewarticle/schizophrenia-med-safe-effective-bipolar-mania-phase-3-data-2024a100029i?form=fpf

3. Fanapt® shown to be effective in bipolar I disorder in phase III clinical study. Vanda Pharmaceuticals Inc. News release. December 19, 2022. Accessed April 2, 2024. https://vandapharmaceuticalsinc.gcs-web.com/node/15146/pdf

4. Vanda Pharmaceuticals announces the publication of Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study in the Journal of Clinical Psychiatry. PR Newswire. News release. January 17, 2024. Accessed April 1, 2024. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-publication-of-efficacy-and-safety-of-iloperidone-in-bipolar-mania-a-double-blind-placebo-controlled-study-in-the-journal-of-clinical-psychiatry-302037494.html

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