Start of Main Content

Investigational New Drug

What is an investigational new drug (IND)?

An IND is a drug or biologic drug that the FDA has not yet approved for general use. INDs must undergo clinical trials to obtain information on their safety and efficacy, which the FDA will then review to approve or deny.

Before undergoing clinical trials, though, the drug’s manufacturer must complete an IND application to request authorization from the FDA to administer the IND to humans.

Before submitting an IND, the drug must undergo preclinical studies, including laboratory and animal testing, to determine the drug’s toxicity.

The following require an IND:

  • Substances intended for use in the diagnosis, mitigation, cure, treatment, or prevention of a disease
  • A substance (excluding foods) intended to affect the structure or function of the body
  • Biological products
  • Substances intended for use as a component of medicine
  • Live organisms
  • Dietary supplements (if used in a therapeutic context)

How do INDs improve healthcare?

INDs are one step in the drug development process. The IND ensures that a drug candidate has been shown to be safe and effective in preclinical studies and is ready to progress to human clinical trials.