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 has always been committed to delivering safe and effective 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 ensure safe and 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 Statement
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.

We acknowledge that there may be circumstances in which patients or caregivers seek treatment with investigational therapies before regulatory approval through an expanded access program (also known as “compassionate use”) outside of clinical trials.

At this stage of development, IntraBio has concluded that our primary commitment is to expedite the development and swift approval of our investigational therapies. As a result, we are prioritizing patients’ access to these treatments only through their active engagement in clinical trials.

Any adjustments or updates to our expanded access policy will be promptly communicated and updated on our website.

IntraBio reserves the right to revise this policy in accordance with the 21st Century Cures Act.

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