investigational new drug

A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational new drugs work and whether they are safe to use. An investigational new drug may be approved by the FDA for use in one disease or condition but still be considered investigational in other diseases or conditions. Also called experimental drug, IND, investigational agent, and investigational drug.