GlioblastomaNCT07748299
NuvOx Expanded Access
A study testing NanO₂ in people with Glioblastoma and Respiratory Distress Syndrom, run by NuvOx LLC.
Trial 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"… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma, Respiratory Distress Syndrom, Ischemic Stroke
- What is being tested?
- NanO₂
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients must have a condition that is serious or immediately life-threatening.
- Patients must have exhausted other treatment options or are ineligible to participate in ongoing clinical trials.
- The potential benefits of treatment with NanO₂ must outweigh the potential risks, as determined at the discretion of the treating physician and NuvOx.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- NanO₂
- Medical subject headings
- Glioblastoma, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanO₂Drug
Also called NVX-108
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- NuvOx LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748299
- Sponsor's protocol ID
- NuvOx Expanded Access
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NuvOx Expanded Access
- ClinicalTrials.gov ID
- NCT07748299
- Acronym / sponsor ID
- NuvOx Expanded Access
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- NuvOx LLCIndustry (pharma, biotech, devices)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanO₂Also: NVX-108NanO₂ 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- NuvOx Expanded Access PolicyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing NanO₂ in people with Glioblastoma and Respiratory Distress Syndrom, run by NuvOx LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NuvOx (520-624-6688, expanded.access@nuvoxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.