Phase 3 ORCA-2 Trial

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

Journal of the American Medical Association | July 2023

ORCA-2 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 in 810 adult smokers (randomized 1:1:1). Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial. The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment.