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Pipeline

Phase 2 ORCA-V1 Trial

ORCA-V1

Ongoing Research of Cytisinicline for Addiction

A randomized placebo-controlled clinical trial of cytisinicline for nicotine e-cigarette cessation

JAMA Internal Medicine | May 2024

ORCA-V1 was a Phase 2 trial designed to evaluate the efficacy and safety of 3 mg cytisinicline dosed 3 times daily for a period of 12-weeks compared to placebo in 160 adult users of nicotine e-cigarettes or vapes. All subjects received behavioral support for the duration of the trial. The primary endpoint for ORCA-V1 was biochemically verified continuous abstinence measured during the last 4 weeks of treatment.