The Drug Development Journey Explained

Before a drug reaches patients, it must survive this: every drug goes through clinical

trial phases, and most never make it to the end. It starts with preclinical testing,

where lab experiments and animal studies check basic safety and biological activity. Then comes Phase

1, a small group of healthy volunteers, where the goal isn’t curing disease but

answering one key question—is this drug safe for humans? Phase 2 expands to hundreds of patients

with the disease to test whether the drug actually works and what dose works best.

Phase 3 scales up to thousands of patients across multiple sites, where real-world

variability exposes weaknesses and most drugs fail. If Phase 3 succeeds, regulators review