Ironwood Pharmaceuticals has commenced a Phase I trial investigating IW-6463 for the treatment of central nervous system (CNS) disorders.

IW-6463 is an orally administered CNS-penetrant soluble guanylate cyclase (sGC) stimulator that is currently under development for use in the treatment of serious and orphan CNS disorders.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The solution is being developed by Cyclerion Therapeutics, which is expected to be separated from Ironwood in the first half of this year.

The placebo-controlled, double-blind trial is designed to evaluate the safety, tolerability, and pharmacokinetics of oral IW-6463 in healthy participants.

“We believe IW-6463 may represent an important option for the treatment of serious neurodegenerative diseases.”

Both the single-ascending and multiple-ascending doses of IW-6463 are expected to be studies as part of the randomised Phase I trial.

Data from the trial is expected to be available in the second half of this year.

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.

Cyclerion Therapeutics development head and Ironwood Pharmaceuticals incoming chief medical officer Chris Wright said: “With its ability to cross the blood-brain barrier, we believe IW-6463 may represent an important option for the treatment of serious neurodegenerative diseases, where there is a high unmet medical need.

“Our Phase I study is designed to provide safety, tolerability and pharmacokinetic data on single and multiple-ascending doses of IW-6463, as well as to explore evidence of translation of some of our pre-clinical results on CNS activity in this first-in-human study.”

CNS disorders are a set of neurological diseases that affect the structure or function of the brain or spinal cord, all of which form the CNS.