Enrollment Update

June 17, 2025

Dear Members of the Fragile X Community,

On behalf of our entire team at Shionogi and our research and advocacy partners, I’m excited to share an important update about EXPERIENCE (Evaluation of Fragile X Experience in Cognition Expression), our clinical trial program to further evaluate the safety and efficacy of our investigational drug on cognition and other aspects of Fragile X syndrome (FXS).

EXPERIENCE-204 (adolescent) and EXPERIENCE-301 (adult) clinical trials are now fully enrolled. We are incredibly grateful to the entire FXS community for helping us reach this important milestone.

 

We recognize the ongoing pursuit of new drugs for FXS has been challenging and we are grateful for the opportunity to be part of this journey with you.

Once all participants have completed the EXPERIENCE-204 and 301 studies, the results will take several months to be analyzed. We appreciate the urgency in sharing the initial results with study investigators and the FXS community quickly and will do so as they become available. 

Please know that completing enrollment in EXPERIENCE-204 and 301 does not affect EXPERIENCE-302 (our open-label study), through which participants will continue to receive the investigational study drug. EXPERIENCE-302 remains open for previously enrolled participants as well as participants who complete EXPERIENCE-204 or 301. 

We’re incredibly grateful for the warm welcome we’ve received from the FXS community, as we completed the integration of Tetra Therapeutics with Shionogi earlier this year. As you heard in March when we finalized screening for these studies, we are committed to standing side-by-side with the FXS community and ensuring transparency as we advance our clinical trial program.

We look forward to sharing the study findings later this year.

 

Warm regards,

Juan Carlos Gomez, MD, MBA
Chief Medical Officer
Shionogi & Co., Ltd.

If you have any questions about the EXPERIENCE clinical trials, please contact medinfo@shionogi.com or 1-800-849-9707.

 

You can also view additional information about EXPERIENCE here and sign up for updates from Shionogi here.