Expanded Access Policy

IntraBio is dedicated to finding and developing groundbreaking therapies for rare and common neurodegenerative diseases. Our approach is rooted in an unwavering dedication to patients and families affected by these devastating diseases, and to address the huge unmet medical needs of the patient communities. 


Our Commitment to Clinical Research
IntraBio is committed to delivering innovative novel treatments to patients as quickly as possible. To do this, we collaborate extensively with scientists, physicians, patients, and health authorities globally to conduct comprehensive clinical trials. We firmly believe that through these trials and subsequent regulatory approval, we can provide timely access to our medicines for as many patients as possible suffering these devastating neurodegenerative diseases.

For information regarding our ongoing clinical trials, please visit https://clinicaltrials.gov/. You can also contact our Patient Services team, or have a member of your medical care team reach out to us at info@intrabio.com.


Expanded Access
Clinical trials are the primary pathway for accessing investigational therapies. These trials are critical in rigorously evaluating the safety and effectiveness of our investigational treatments before submission for regulatory review and potential approval. 

Expanded access is a potential pathway that allows people with a serious or immediately life-threatening disease to obtain an investigational medical product when they are ineligible for a clinical trial and no comparable or satisfactory alternative therapies are available, as determined by their treating physician.

IntraBio currently operates an Expanded Access Program in the United States for levacetylleucine for people living with Ataxia-Telangiectasia who meet program eligibility criteria.

Participation in the Expanded Access Program is subject to physician request, medical review, and applicable regulatory requirements and is evaluated on a case-by-case basis, as required by applicable law.

More information about the U.S. Expanded Access Program for levacetylleucine can be found on ClinicalTrials.gov, study IB1001-EA3, NCT07380165 or contact ibmedical@intrabio.com.

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