Achieve Life Sciences reports 52-week cytisinicline quit rates in smokers

Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced results from its long-term, open-label ORCA-OL clinical trial evaluating cytisinicline for cigarette smoking and e-cigarette cessation, presented at the CHEST 2026 Annual Meeting in Phoenix, Arizona.

The trial enrolled 479 adults, with 475 receiving at least one dose of cytisinicline 3 mg three times daily for up to 52 weeks. Of those, 84.6% smoked cigarettes, 12.8% vaped exclusively, and 2.5% did both. All participants had previously made a counseling-supported quit attempt in a prior ORCA trial and were still smoking or vaping.

Four-week sustained abstinence rates in the total study population rose from 25.5% at Weeks 9–12 to 31.2% during the final four weeks of treatment (Weeks 49–52). Among participants who had received placebo in their prior ORCA trial, 39.4% had quit at Weeks 49–52. Among those who had previously received cytisinicline, 27.8% had quit at that same point.

At the end of the year, 32.8% of participants who exclusively smoked and 24.6% of those who exclusively vaped had quit. The study included 73 vaping participants, each still vaping after a prior medically supported quit attempt.

Participants who smoked averaged 56 years of age, had smoked for an average of 37 years, and had made a median of five prior quit attempts. Many had a history of hypertension, depression, anxiety, cancer, or COPD, and 86% were taking other medications.

The median duration of cytisinicline exposure was 361 days, with 69.7% of enrolled participants completing the 52-week study. The most common treatment-related adverse events were abnormal dreams (7.8%), insomnia (6.5%), and headache (3.8%). Treatment-related nausea occurred in 1.5%, and 3.6% discontinued due to a treatment-related adverse event. The independent Data Safety Monitoring Committee identified no new safety signals.

"Most people need more than one attempt to quit, yet treatment beyond 12 weeks and retreatment had not previously been studied with cytisinicline," said Mark Rubinstein, MD, Chief Medical Officer at Achieve.

Achieve has completed two Phase 3 trials, ORCA-2 and ORCA-3, evaluating cytisinicline for smoking cessation, and a Phase 2 trial for vaping cessation. Cytisinicline remains an investigational compound and has not received FDA approval.

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