NanO₂ is an investigational drug being studied by NuvOx Therapeutics. It has not been approved by the U.S. Food and Drug Administration (FDA) for any use. This record describes a way for a patient's own doctor to request NanO₂ for that patient outside of a clinical trial, through a pathway called "expanded access" (sometimes called "compassionate use").
This option may be considered for patients who have a serious or life-threatening illness, who have already tried other available treatments, and who cannot join an ongoing NanO₂ clinical trial. NuvOx's RESTORE study in glioblastoma has finished enrolling patients, and NuvOx does not currently have any other NanO₂ study open for enrollment in the United States.
Under this pathway, the patient's treating physician - not NuvOx - applies to the FDA and manages the patient's care. NuvOx's role is to review each request, and if approved, provide the drug and the regulatory information the FDA needs to evaluate it. Each request is reviewed individually, and approval is not guaranteed.
Inclusion Criteria:
Exclusion criteria:
Providing NanO₂ for the requested use will interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the use.
A request will be evaluated against the criteria of 21 CFR 312.305(a) and 312.310(a).
expanded.access@nuvoxpharma.com
A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM
Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas
Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas