Clinical

Phase 3 Trial

Pivotal efficacy and safety trial in large populations (300–3,000+) supporting drug approval.

Definition

Phase 3 trials are typically randomized, controlled, and designed to meet FDA-specified endpoints. Success here is the basis for an NDA. Obesity trials like SURMOUNT-1 (tirzepatide) and STEP (semaglutide) are Phase 3.

Related terms

Phase 2 TrialMid-stage efficacy and dose-ranging study, typically 100–300 patients with the target condition.
NDANew Drug Application — the FDA submission requesting approval to market a drug.

Compounds that reference Phase 3 Trial

RetatrutideA triple-acting GIP/GLP-1/glucagon receptor agonist in Phase 3 trials showing potentially the highest weight loss of any drug in development.

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