Ambros Therapeutics

Expanded Access Policy

Ambros Therapeutics is committed to developing promising new therapies for seriously debilitating diseases. Our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population. We currently have a late-stage clinical trial planned for the treatment of Complex Regional Pain Syndrome Type 1 (CRPS-1) for the investigational product neridronate (CRPS-RISE).

We understand patient interest in accessing neridronate outside of clinical trials and prior to regulatory approval. However, enrollment in our clinical trials is the most appropriate way to access neridronate, as we seek regulatory approvals to make neridronate available broadly to patients as quickly as possible. We may offer an initial expanded access protocol to provide open-label treatment with neridronate to eligible participants who complete CRPS-RISE.

At this time, Ambrosis not offering expanded access to its investigational product for patients who have not participated in a previous clinical trial with neridronate. As such, Ambros is currently not accepting expanded access or compassionate use requests.

We encourage all patients and physicians who are interested in accessing our investigational medicine to visit the clinical trial section below to find out about enrolling in the clinical trial. For more information please visit clinicaltrials.gov.

We will re-evaluate this policy periodically and may revise it at any time. If you have any questions about the Ambros Expanded Access Policy, please contact us at clinicaltrials@ambrostx.com.Ambros expects to acknowledge receipt of any questions within ten business days of receipt.

Please do not send any personal or private health information to this email address.