Zatolmilast Phase 3 Clinical Trial in Fragile X Syndrome

Originally published June 2023, republished with minor edits.
Tetra Therapeutics, a Shionogi Group Company, is accepting males ages 9-45 with Fragile X syndrome for large scale clinical phase 3 trials of their phosphodiesterase (PDE) inhibitor
Individuals who complete the placebo-controlled trial are then eligible to continue taking the drug, as part of an open label continuation trial.
These trials mark a major milestone for community-based drug development. FRAXA-funded research pointed the way to phosphodiesterase inhibitors to treat Fragile X many years ago. However, finding a good phosphodiesterase (PDE) inhibitor was a challenge because there was so much interest in the pharmaceutical world in developing these drugs for Alzheimer's disease and other blockbuster indications.
Learn More about the clinical trial: www.fraxa.org/...
FRAXA’s mission is to find effective treatments and ultimately a cure for Fragile X syndrome. We directly fund research grants and fellowships at top universities around the world. We partner with biomedical and pharmaceutical companies, large and small, to bridge the gap between research discoveries and actual treatments.
Treatments for Fragile X are likely to help people affected by autism, Alzheimer’s, and other brain disorders.
To learn more about FRAXA's Fragile X syndrome research, to get involved with Fragile X awareness and events or to donate to FRAXA research, visit www.fraxa.org
Let's Connect
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LinkedIn: / fraxa-research-foundation
Reddit: / fragilexreseach
Website: www.fraxa.org

[@joseviesca2213]

Will this drug work on a non verbal teen with a mild form of ASD?

[@scentedgamer8676]

How long before this will hit the marked?

[@FRAXA]

The recent webinar linked below has more details about the this trial and the other late stage trial currently going on.
ruclips.net/video/hkAcrDD0Lyk/видео.htmlsi=WvUiy5aDxwZgWCI3

[@scentedgamer8676]

Have they started phase 3 or is it just in recruting phase?

[@FRAXA]

They are currently recruiting for their large scale phase 3 clinical trial.
www.fraxa.org/tetra-therapeutics-phase-3-clinical-trial-of-zatolmilast-in-fragile-x-syndrome/

[@scentedgamer8676]

@@FRAXA but havent they been recruiting for years?

[@FRAXA]

@@scentedgamer8676 phase 3 started recruiting late 2022. Typical phase 3 studies can last 1-4 years. It really depends on how quickly they can get all of the study participants enrolled.

[@scentedgamer8676]

@@FRAXA are they close to get enough participants?