Welcome to Novo Nordisk in the United States

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 & Drug Administration (FDA). The most appropriate way patients could access these medications is through our clinical trials. Clinical trials are designed to determine whether an investigational medicine is safe and effective for patients, and are overseen by a team of medical experts. In cases where enrolling in a clinical trial is not possible, there are options known as expanded access and right-to-try. Through these processes, access to an investigational medicine may be requested for individual patients on a case by case basis.

Expanded access or right-to-try may be appropriate for a patient confronting a serious or life threatening condition, who has no other available medical option and does not qualify for a clinical trial. Novo Nordisk may consider certain requests when they meet the conditions below. These criteria are derived from the requirements of the regulations enabling this type of access and form the basis for our approach.    

  • The patient has a serious or life-threatening illness
  • 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
  • The patient failed all approved treatments, 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 us here. We will respond within five (5) business days.