A large-scale clinical trial designed to confirm efficacy and monitor adverse events in the target population, typically the last step before regulatory submission.
Phase 3 trials enroll hundreds to thousands of participants over months to years. Successful Phase 3 results are the standard threshold for regulatory authorisation. Phase 1 tests safety in healthy volunteers; Phase 2 tests efficacy in a small target population; Phase 4 is post-marketing surveillance.
Compounds where this term is relevant
- Semaglutide · GLP-1 receptor agonist · once-weekly subcutaneous
- Tirzepatide · Dual GIP / GLP-1 receptor agonist · once-weekly subcutaneous
- Tesamorelin · Synthetic GHRH analogue · stimulates pituitary GH release · daily subcutaneous
- Bremelanotide · Melanocortin (MC1R/MC3R/MC4R) receptor agonist · on-demand subcutaneous
Related terms
- RCT · Randomized Controlled Trial — a study design that randomly assigns participants …
- Primary endpoint · The principal outcome measure used to evaluate whether a clinical trial succeede…
- Sample size · The number of participants in a study, denoted n.