Exploring the five phases of drug development

Drug development is undeniably complex.

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From the discovery of molecules to FDA review, safety monitoring, and commercialization, there are numerous opportunities for both success and failure. In 2022, the FDA approved 37 new 'novel' drugs. However, this figure does not account for the many others that did not make the cut. In fact, the overall probability of success for new molecular entities is only 12%.

To be considered a 'success,' a new drug must navigate through five specific phases: 1) discovery and development, 2) preclinical research, 3) clinical research, 4) FDA review, and 5) safety monitoring.

Below, we explore each step in more detail.

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In the discovery stage—the initial step in bringing a new drug to market—researchers assess various compounds to determine which ones could be suitable candidates for development as medical treatments.

The process commences with the identification of a new target molecule, which may be a protein or another molecule involved in the disease process. Once a target molecule is identified, scientists must design and synthesize a new compound that can interact with the target and influence or inhibit its function.

Researchers utilize several methods during the discovery process to identify and evaluate potential treatments. These include:

• Testing numerous molecular compounds to discover possible benefits against diseases.
• Re-evaluating existing treatments for potential benefits against other diseases.
• Using updated knowledge about diseases to design products that could halt or reverse disease effects.
• Employing new technologies capable of targeting specific sites within the body or manipulating genetic material.

Throughout the discovery stage, researchers may examine thousands of compounds to identify viable candidates for therapeutic development. Generally, only a handful of these compounds will show promise and warrant further study. The Pharmaceutical Journal, a research publication based in the United Kingdom, estimates that for every 10,000 compounds tested in the discovery phase, only 10-20 will progress to the development phase. Furthermore, roughly half of those that enter the development phase ultimately advance to preclinical trials.