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Pipeline

Phase 3 ORCA-3 Trial

ORCA-3

Ongoing Research of Cytisinicline for Addiction

A Second Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial of Cytisinicline in Adult Smokers

JAMA Internal Medicine | April 2025

ORCA-3 was designed to evaluate the efficacy and safety of 3 mg cytisinicline dosed 3 times daily for a period of 6 weeks or 12 weeks compared to placebo. ORCA-3 randomized 792 adult smokers at 20 clinical trial sites in the United States. All participants received standard behavioral support for the duration of the trial. The primary endpoint for ORCA-3 was biochemically-verified continuous smoking abstinence during the last 4 weeks of treatment.