Cytisinicline

May 19, 2026 — Achieve Life Sciences, Inc. (Nasdaq: ACHV) presented 52-week long-term safety results from ORCA-OL, an open-label exposure safety study of cytisinicline for nicotine dependence, at the American Thoracic Society (ATS) 2026 Annual Meeting. ORCA-OL enrolled 475 adults who smoke (84.6%), use e-cigarettes (12.8%), or both (2.5%) and dosed cytisinicline 3 mg three times daily for up to 52 weeks (median cumulative exposure 361 days).

Key safety findings: 66.3% reported ≥1 treatment-emergent adverse event; 94.8% were mild/moderate. Serious adverse events occurred in 6.5%. The most common adverse events were abnormal dreams (8.4%), insomnia (8.4%), and upper respiratory tract infection (6.7%). Nausea was reported in 2.5% over 52 weeks, and 5.7% discontinued due to treatment-related adverse events. An independent Data Safety Monitoring Committee identified no new safety signals.

Achieve said the ORCA-OL dataset completes its clinical evidence package supporting its cytisinicline New Drug Application for adult smoking cessation; the company cites an FDA PDUFA date of June 20, 2026.