PARTNERING AND INNOVATION

Expanded Access

How we approach expanded access and right-to-try

At Novo Nordisk, we’re committed to discovering and developing innovative medicines for diabetes and other serious chronic conditions. Sometimes, patients may wish to access investigational medicines that are not yet approved by the U.S. Food and Drug Administration (FDA). The most appropriate way patients could access these medications is through our clinical trials. Overseen by a team of medical experts, clinical trials are designed to determine whether an investigational medicine is safe and effective for patients.

In cases where enrolling in a clinical trial is not possible, there are options such as expanded access and right-to-try. The criteria for these options are based on regulations enabling this type of access. Novo Nordisk may consider such requests on a case-by-case basis when they meet the conditions below.

  • The investigational drug is under active clinical development but is not yet approved by the FDA
  • The patient is ineligible for or otherwise unable to participate in clinical trials
  • The potential benefit to the patient should outweigh potential risks
  • All other approved treatments did not help the patient, or there is no other approved treatment option available

Requesting access

To submit a request for an investigational medicine outside of a clinical trial, the treating physician can email Novo Nordisk here. We will respond within five (5) business days.