Acadia Pharmaceuticals has commenced the Phase III CLARITY programme of pimavanserin with the initiation of the CLARITY-2 clinical trial.

Intended for major depressive disorder (MDD) patients, the programme also includes the CLARITY-3 trial, which will be launched in the coming months.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Pimavanserin is a selective serotonin inverse agonist that targets 5-HT2A receptors, which are believed to be involved in depression.

The Phase III trials are designed to assess the safety and efficacy of the therapeutic as adjunctive treatment in patients who did not achieve an adequate response to standard antidepressant therapy.

“If we’re successful in the Phase III programme, we plan to use the Phase II CLARITY study and positive study results from at least one of these two studies.”

Both the six-week, randomised, double-blind, placebo-controlled, multi-centre trials will enrol around 280 patients each. CLARITY-2 will be conducted in the US, while CLARITY-3 will involve international sites.

The primary endpoint of the trials is a change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.

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.

Participants completing the studies can choose to enrol into a 52-week open-label extension study that will track pimavanserin’s long-term safety and tolerability.

Acadia Pharmaceuticals president Serge Stankovic said: “We believe pimavanserin has the potential to be a very important treatment option for the millions of MDD patients where there remains unmet medical need.

“Based on feedback we received from the US FDA, if we’re successful in the Phase III programme, we plan to use the Phase II CLARITY study and positive study results from at least one of these two Phase III studies to support a supplemental NDA submission.”

The company is further studying the therapeutic in a variety of indications, including dementia-related psychosis, schizophrenia inadequate response and schizophrenia-negative symptoms.

In 2016, the US Food and Drug Administration (FDA) approved pimavanserin to treat hallucinations and delusions linked to Parkinson’s disease psychosis.