Investigational New Drug (IND)

An Investigational New Drug (IND) application is a regulatory submission to authorities such as the US FDA that allows a new pharmaceutical compound to be tested in humans, representing the formal transition of a drug candidate from preclinical research to clinical evaluation. An IND includes data on pharmacology, toxicology, manufacturing quality, and proposed clinical trial protocols, ensuring patient safety while enabling scientific innovation.

Without IND approval, clinical trials cannot legally begin. Different IND types include commercial INDs, investigator INDs, and emergency INDs, each serving distinct development or clinical purposes while maintaining regulatory oversight. The IND pathway is a critical milestone in drug discovery, signalling that a compound shows sufficient promise for human evaluation. A biotech company developing a novel oncology therapy must submit an IND demonstrating acceptable animal safety data before enrolling patients, bridging laboratory discovery with real-world therapeutic testing.