What is an investigational drug?

An investigational drug refers specifically to a drug compound that is undergoing clinical testing in humans. These drugs are not yet approved for general use and are still being evaluated for their safety, efficacy, and potential side effects through various phases of clinical trials. During these trials, researchers gather vital data that will inform regulatory agencies, such as the FDA, about whether the drug should be approved for widespread public use.

The definition aligns closely with the context of drug development, illustrating how investigational drugs play a critical role in advancing medical knowledge and providing potential new treatments. The process ensures that medications are thoroughly tested before being made available to the public, safeguarding patient health and well-being.

In contrast, over-the-counter drugs are readily available for consumer use without a prescription, emergency use drugs are specifically designated for urgent situations, and banned drugs are those that have been deemed unsafe or ineffective and are prohibited from use. These definitions highlight the unique status of investigational drugs within the broader spectrum of pharmaceuticals.