Investigational New Drug (IND)
A regulatory designation allowing a new compound to be tested in human clinical trials. An IND application must demonstrate the compound is safe enough for initial human testing based on preclinical data. Active IND status is a significant milestone in any peptide compound's development.
Technical Context
IND application components: (1) Animal pharmacology and toxicology — enough to support initial human dose and identify target organs of toxicity; (2) Manufacturing information — sufficient to ensure consistent product quality for the proposed trial; (3) Clinical protocol — detailed plan for the proposed study including objectives, design, endpoints, statistical plan, and monitoring. FDA review: 30-day safety review — the IND is effective 30 days after receipt unless FDA issues a clinical hold (preventing study initiation until concerns are resolved). INDs are maintained as active throughout clinical development with annual reports, protocol amendments, safety reports, and IND serial submissions. For peptide compounds, IND-enabling studies typically include: GLP toxicology (2-4 weeks in two species), safety pharmacology (CV, respiratory, CNS), and genotoxicity battery. This preclinical package typically takes 12-18 months and costs $2-5M.