Expanded Access Policy

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NOUS-209 for the prevention Lynch Syndrome-associated defective mismatch repair (dMMR) neoplasia in genetically confirmed mismatch repair (MMR) mutation Lynch Syndrome carriers.

Nouscom is committed to the responsible development of NOUS-209 through rigorously controlled clinical trials to establish its safety and efficacy and to support regulatory approval.

At this time, Nouscom does not offer expanded access (compassionate use) to NOUS-209 outside of ongoing clinical trials. This decision reflects the current stage of clinical development, limitations in investigational drug supply, and the need to protect the integrity of ongoing studies.

Patients who may be eligible for participation in a clinical trial with NOUS-209 are encouraged to monitor Nouscom’s news releases as to the potential start of new clinical trials: https://nouscom.com/category/press-releases

Healthcare providers or patients wishing to submit an inquiry regarding expanded access may contact: Sven Gogov, M.D., Chief Medical Officer –  Email: info@nouscom.com –  Phone: +41-61 201 1831

We will acknowledge receipt of any such inquiry within 15 working days. All requests are evaluated on a case-by-case basis, and we will communicate our determination in writing.