Innervate Radiopharmaceuticals LLC

Innervate Radiopharmaceuticals is dedicated to advancing an innovative imaging agent, 18F-mFBG, for patients with neuroblastoma.

Expanded access, also referred to as compassionate use, is a regulatory pathway that allows patients with serious or immediately life-threatening conditions to access investigational drugs outside of clinical trials when no comparable or satisfactory options are available. The U.S. Food and Drug Administration (FDA) outlines key criteria for expanded access, including
that the patient’s condition must be serious or life-threatening, with no approved alternatives.

Potential benefits of the investigational drug must outweigh foreseeable risks, based on available safety and efficacy data and granting expanded access must not compromise ongoing clinical trials, regulatory submissions, or the ability to develop therapies for broader patient populations.

Innervate Radiopharmaceuticals understands and appreciates this pathway and these key criteria. However, at this time, Innervate Radiopharmaceuticals is not offering expanded access to our investigational imaging agent in the US.

We recognize the urgency faced by patients with limited options and the need to balance that with safety and efficacy. We will regularly reassess this policy as clinical development progresses and regulatory landscapes evolve. 
As authorized by the 21st Century Cures Act, Innervate Radiopharmaceuticals reserves the right to revise this policy at any time.