NuvOx Expanded Access Program for NanO₂

Sponsor: NuvOx LLC

Expanded Access
Sponsor score: 0

ClinicalTrials ID:NCT07748299

Provider View

This program allows doctors to request the investigational drug NanO₂ for patients with serious illnesses who have no other treatment options and cannot join a clinical trial. The drug is not yet approved by the FDA, and each request is reviewed individually.

Patient Parameters

Program Overview

NanO₂ is an experimental drug being studied by NuvOx Therapeutics. It is not yet approved by the FDA for any use. This program, called 'expanded access' or 'compassionate use,' allows a patient's doctor to request NanO₂ for patients with serious or life-threatening conditions who have tried other treatments and cannot join a clinical trial. The doctor, not NuvOx, applies to the FDA and manages the patient's care. NuvOx reviews each request and, if approved, provides the drug and necessary information to the FDA. Approval is not guaranteed.

Description

NuvOx Therapeutics offers an expanded access program for the investigational drug NanO₂, which is not yet FDA-approved. This program allows doctors to request the drug for patients with serious illnesses who have no other treatment options and cannot participate in a clinical trial. The patient's doctor is responsible for applying to the FDA and managing the treatment, including planning the dosage and monitoring the patient. NuvOx reviews each request and, if approved, supplies the drug and provides necessary information to the FDA. Requests must be submitted by the patient's doctor and include specific information about the patient's condition and treatment plan. Approval is not guaranteed, and each request is evaluated individually.

Eligibility Criteria

Inclusion Criteria

  • Have a serious or life-threatening condition.
  • Have tried all other available treatments or cannot join a clinical trial.
  • The potential benefits of NanO₂ must outweigh the risks, as determined by the doctor and NuvOx.

Exclusion Criteria

  • Providing NanO₂ must not interfere with clinical trials that could lead to FDA approval.
  • Each request is evaluated based on available information, including the patient's condition and the doctor's reasons for requesting the drug.

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