Expanded Access Policy

Expanded Access Policy

Navigator Medicines, Inc. is developing therapies that have the potential to transform the lives of patients suffering from inflammatory disorders and autoimmune diseases. We are committed to bringing these important and innovative therapies to patients, while collaborating with patients, families, patient advocacy organizations, physicians, researchers, and regulatory authorities to accomplish this goal.

We understand that patients and families may be interested in accessing Navigator Medicines’ investigational therapies prior to regulatory approval and outside of the clinical trial setting through an expanded access program (sometimes referred to as “compassionate use” or “early access”). At this time, we do not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval.

Navigator Medicines believes that participation in robust, thoughtfully designed clinical trials is the most effective way for an individual patient to access investigational products. Clinical trials are conducted to gain an understanding of the safety and efficacy of an investigational product, collecting data that may support the approval of a new therapy. We encourage awareness of and participation in our clinical trials. Information regarding our clinical trials may be found on www.clinicaltrials.gov.

Treating physicians, patients, and/or caregivers interested in learning more about Navigator Medicines’ investigational therapies should contact Navigator Medicines at info@NavigatorMeds.com. We anticipate acknowledging receipt of inquiries sent to this email within five business days.