NuvOx Expanded Access

August 3, 2026 updated by: NuvOx LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This expanded access record is published by NuvOx Pharma to satisfy the public-availability requirement of Section 561A of the Federal Food, Drug, and Cosmetic Act, in accordance with Subpart I of 21 CFR Part 312 (§§ 312.300-312.320). Publication of this record does not obligate NuvOx to grant access to any individual patient, nor guarantee that a request will be approved.

NanO₂ is an investigational systemic oxygen therapeutic under evaluation across multiple indications. It is not approved by the FDA for any use. NuvOx's Phase 2b glioblastoma study (RESTORE, NCT03862430) has reached its enrollment target and is closed to new participants, and NuvOx currently has no other NanO₂ clinical study enrolling patients in the United States. For patients who are not eligible for or able to participate in an ongoing trial, individual-patient expanded access may be a route to receive NanO₂ outside of an approved indication.

Mechanism: Access is structured as individual-patient expanded access under 21 CFR 312.310. The patient's licensed treating physician - not NuvOx - serves as the sponsor of the individual-patient IND, submits the request to the FDA, and holds ongoing sponsor responsibilities, including preparing the treatment plan (dose, route, schedule, duration, monitoring, and toxicity management), obtaining IRB review and approval, obtaining informed consent under 21 CFR Part 50, and meeting IND safety reporting obligations to both the FDA and NuvOx.

NuvOx's role, if a request is granted, is limited to (a) evaluating the request, (b) supplying NanO₂ in a quantity sufficient for the authorized treatment, and (c) providing a Letter of Authorization permitting the FDA to cross-reference NuvOx's existing IND for the chemistry, manufacturing, controls, and nonclinical/clinical information supporting use of the drug, regardless of the specific condition for which access is sought.

Requesting access: Requests must come from the patient's treating physician and be submitted to expanded.access@nuvoxpharma.com, including the physician's name and address, institution/clinic name, an explanation of how the patient meets the criteria above, and the expected IRB submission date with IRB contact information. Patient-identifiable information should not be included. NuvOx acknowledges each request within 72 hours of receipt and evaluates requests on a case-by-case basis; approval of one request does not guarantee approval of future requests.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

  • Inclusion Criteria:

    1. Patients must have a condition that is serious or immediately life-threatening.
    2. Patients must have exhausted other treatment options or are ineligible to participate in ongoing clinical trials.
    3. The potential benefits of treatment with NanO₂ must outweigh the potential risks, as determined at the discretion of the treating physician and NuvOx.

  • Exclusion criteria:

    1. 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).

        • NuvOx will consider the totality of available information, including applicable nonclinical and clinical experience, the patient's condition, and the treating physician's rationale for use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NuvOx LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NuvOx Expanded Access

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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