Expanded access

Dren Bio is committed to developing therapies for patients with serious diseases and to being transparent about how those therapies can be accessed.

Our current position

Expanded access, sometimes called compassionate use, is the use of an investigational medicine outside of a clinical trial by a patient with a serious or immediately life-threatening disease who has no comparable alternatives.

Dren Bio's investigational medicines are in early stages of development, and the information needed to evaluate their benefits and risks is still being gathered. At this time, the most appropriate way for a patient to receive one of our investigational medicines is through participation in a clinical trial, where safety can be monitored closely and the resulting data can support review by regulatory authorities.

We keep this position under continuous review as our programs advance, and we evaluate any change in the context of clinical trial enrollment, available supply and regulatory guidance.

Finding a clinical trial

Information about ongoing studies, including eligibility criteria and participating sites, is listed on ClinicalTrials.gov. We encourage patients to discuss trial participation with their treating physician, who can assess whether a study is appropriate.

Submitting an inquiry

Requests for expanded access are accepted from a licensed physician. Each inquiry is acknowledged and reviewed by our medical team, who will respond directly to the requesting physician. Please do not include patient-identifying information in an initial inquiry.