Investigational New Drug application (IND)

An Investigational New Drug application (IND) is the submission a sponsor files with the FDA to get permission to begin clinical trials of an unapproved drug or biologic in humans. It is the regulatory gateway from lab and animal research into the clinic.

How it works

The IND contains three main sections:

• Preclinical data from animal pharmacology and toxicology studies supporting that the drug is reasonably safe to test in people.
• Manufacturing information on the drug's composition, stability and quality controls.
• Clinical protocols describing the proposed studies, along with investigator information.

Once submitted, the FDA has 30 days to review it. If the agency does not impose a clinical hold within that window, the IND goes into effect and the sponsor can start dosing, usually in a Phase 1 trial. The FDA can place a full or partial clinical hold at any point if it sees safety risks, and the sponsor must address the issues before trials resume.

INDs stay open through all phases of development, with amendments for new protocols and annual safety reports.

Why it matters for traders

For early-stage biotechs, "IND clearance" headlines mark the move from preclinical to clinical-stage, which can broaden the investor base. More market-moving are clinical holds: a hold on a lead program, especially after a patient safety event, can send shares sharply lower, and the lifting of a hold can produce a strong rebound. Companies often pair IND news with fast track or orphan designation requests.

Example

A hypothetical biotech, Northwind Therapeutics (NWTX), submits an IND for its lead antibody on June 2. With no clinical hold by the 30-day mark, the IND takes effect around July 2, and NWTX announces plans to dose the first Phase 1 patient in the third quarter.

FAQ

Does IND clearance mean the FDA approved the drug?

No. It only allows clinical testing to begin. Approval requires an NDA or BLA backed by trial results.

What is a clinical hold?

An FDA order to delay or suspend clinical studies under an IND, usually for safety or protocol concerns. Trials cannot proceed until the FDA lifts it.