Clinical Trials

//Clinical Trials
Clinical Trials2019-06-11T07:55:39-05:00

Achieve is advancing the clinical development of cytisinicline in the United States and recently completed the Phase 2b ORCA-1 trial.

Achieve Life Sciences Announces Statistically Significant Improvement in Quit Rates for Simplified Cytisinicline Dosing Schedule in Phase 2b ORCA-1 Dose-Selection Trial

ORCA Program


This Phase 2b trial was conducted in the US to assess various dosing schedules of cytisinicline in approximately 254 smokers. It evaluated efficacy based on the overall reduction in the number of cigarettes smoked during the various study treatment doses and schedules. It also evaluated compliance and safety profiles, compared to the respective placebo arms. This dose-finding study resulted in identification of the 3 mg, 3 times daily dosing regimen to be used in future cytisinicline Phase 3 trials.

Study Design

This six-arm, multi-center, double-blind, randomized, placebo-controlled, Phase 2b study was conducted in the US. The study was double-blinded to dose but not to the administration schedule. Subjects provided a quit date 5-7 days from randomization. Study treatment started the day after randomization such that study treatment was initiated prior to the quit date.

Demographics were similar between schedules and for treatment arms in gender, age, years of prior smoking, and number of previous quit attempts. At baseline, subjects in the study reported smoking a median of 20 cigarettes per day. ORCA-1 was initiated in October 2018 and enrolled 254 smokers at eight centers across the United States.

ORCA-1 Study Design

ORCA-1 Program Study Design. Click image to enlarge.

ORCA-1 Trial Locations

ORCA-1 was conducted in the following states in the US.

ORCA-1 Trial Locations

To learn more about the ORCA-1 trial, please visit www.OrcaProgram.com

Phase 3 trials

It is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction, including approximately 2,000 patients in Phase 3 clinical trials conducted in Europe and New Zealand and published in the New England Journal of Medicine. The United States cytisinicline Phase 3 development program is expected to initiate in late-2019.