NuvOx Expanded Access
NCT07748299 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-08-05
Summary
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.
Conditions
- Glioblastoma
- Respiratory Distress Syndrom
- Ischemic Stroke
- Hypoxic Conditions
Interventions
- DRUG
-
NanO₂
NanO₂ is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) for any use. The primary goal is to provide patients with access to potentially beneficial treatments that are still under investigation, especially when they have exhausted other treatment options.
Sponsors & Collaborators
-
NuvOx LLC
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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