Japan-based Otsuka Pharmaceutical and Danish firm Lundbeck have started patient enrolment in two Phase III clinical trials of brexpiprazole to treat manic episodes in patients with bipolar I disorder.

While the mechanism of action is unknown, brexpiprazole’s efficacy is thought to be mediated with partial agonist activity at serotonin 5-HT1A and dopamine D2, and antagonist activity at serotonin 5-HT2A receptors.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Additionally, brexpiprazole is said to have high affinity for noradrenaline alpha1B/2C receptors.

The multi-centre, randomised, double-blind Phase III trials will investigate the safety, efficacy and tolerability of brexpiprazole in patients having an acute manic episode, with or without mixed features, requiring hospitalisation.

“Brexpiprazole is said to have a high-affinity for noradrenaline alpha1B/2C receptors.”

The trial’s primary endpoint is mean change from baseline to day 21 in the Young-Mania Rating Scale (YMRS) total score, while the key secondary endpoint is similar change in Clinical Global Impression – Bipolar (CGI BP) severity-of-illness score in mania during the double-blind treatment period.

YMRS score is a clinician rating scale used to evaluate mania symptoms based on subjective reports and clinical observations of a patient’s condition.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Otsuka discovered the investigational candidate and is developing it in alliance with Lundbeck.

In July 2015, the US Food and Drug Administration (FDA) approved brexpiprazole for the treatment of schizophrenia and as a combination therapy to treat major depressive disorder (MDD).

Health Canada approved brexpiprazole for schizophrenia in February this year, while the Australian Department of Health granted approval for the same indication in May.

Bexpiprazole is distributed and marketed under the brand name Rexulti in the US, Canada and Australia.