Clinical Trials

Veloxis is committed to improving the lives of transplant patients by developing innovative therapeutics. We are currently evaluating VEL-101 (anti-CD28 pegylated monoclonal antibody fragment) as a medication to help prevent organ rejection in people who have had a kidney transplant.

Visit clinicaltrials.gov for clinical study information on VEL-101.

Interested in being involved?

If you are interested in getting involved in a clinical study, please talk to your physician. They will be able to advise you on whether you would be eligible to enroll into a study and if participation could be right for you.

For new medicines, companies like Veloxis are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain study eligibility criteria.

Veloxis Expanded Access Policy

Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.

In cases where a clinical trial isn’t an option, and the patient has exhausted all available treatment options, regulators/health authorities may grant permission for us to provide a treating physician with an investigational drug pre-approval. Such individual use of an investigational drug pre-approval is often called “expanded access” or “compassionate use” but may go by other names.

It’s important to remember that investigational drugs have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an investigational drug.

At this time, participation in one of our clinical trials is the only way to access our investigational therapies. We arrived at our position after reviewing the following considerations, all of which must be met for an expanded access program to be appropriate*:

  • Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

In the event that we decide to consider expanded access requests for our investigational drugs, we will evaluate and respond to each expanded access request objectively and on a case-by-case basis. This policy will be updated with a hyperlink to the relevant expanded access record(s) on clinicaltrials.gov after such record(s) becomes active.

As authorized by the 21st Century Cures Act, Veloxis may revise this expanded access policy at any time. Additionally, the posting of this policy by Veloxis shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

If you have additional questions, please speak with your physician or contact us at medinfo@veloxis.com.


*FDA Guidance for Industry: Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers.