Denali Therapeutics believes that the goal of making life-changing medicines available to the patient community is achieved through well-designed clinical studies followed by regulatory approval. The best way to access a medicine that has not yet received regulatory marketing approval, i.e., an investigational medicine, is through participation in a clinical study. Denali Therapeutics understands that not all patients are able to participate in a clinical study, and other treatment options may have been exhausted. In those cases, the individual’s treating physician may choose to request access to an investigational medicine outside of a clinical study via what is called an early access program.

If you are a healthcare professional and would like to inquire about potential availability of a Denali Early Access Program for such an individual patient, please reach out through our contact page. Denali will review all requests according to our internal guidelines.