Swiss biopharmaceutical firm Idorsia has reported positive results from a Phase II programme of ACT-541468 to treat patients suffering from insomnia.

ACT-541468 is a dual orexin receptor antagonist (DORA) designed to target the orexin system for maintaining natural sleep pattern.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The results showed that the Phase II programme has met its primary endpoint with a desired effect on sleep onset and maintenance, indicating a significant dose-response relationship.

The programme includes two placebo-controlled dose-response trials and assessed the safety and efficacy of ACT-541468 in a total of 418 adults and elderly subjects.

Idorsia managing director and chief scientific officer Martine Clozel said: “Its discovery is the result of an extensive effort to combine two important characteristics of a sleep medication: maintaining efficacy throughout the night, and a low potential for a next-day residual effect.

"Its discovery is the result of an extensive effort to combine two important characteristics of a sleep medication: maintaining efficacy throughout the night, and a low potential for a next-day residual effect."

“I am delighted to see that the positive readouts from this comprehensive Phase II programme are consistent with our preclinical predictive models, for both adult and elderly patients with insomnia."

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.

The programme’s first trial was conducted in 360 patients aged between 18 and 64 and demonstrated significant dose-dependent reduction of wake time after sleep onset (WASO) at days one and two, along with a dose-dependent decrease in latency to persistent sleep (LPS).

ACT-541468’s efficacy and safety profile, as well as its ability to significantly decrease WASO and LPS at days one and two, were validated in a second trial with 58 subjects aged 65-85.

During the programme, ACT-541468 was found to be well-tolerated without any serious adverse events.