Achieve Life Sciences completed the final Data Safety Monitoring Committee review of its ORCA‑OL long‑term safety trial and filed a 120‑day safety update with the U.S. Food and Drug Administration on November 3, 2025. The update confirms the trial met the FDA’s cumulative safety data requirements for the upcoming NDA review.
The ORCA‑OL study enrolled 334 participants who completed one year of cumulative treatment with 3 mg of cytisinicline taken three times daily. Conducted at 29 U.S. sites, the open‑label trial satisfied the FDA’s mandate of at least 300 participants with six months of exposure and at least 100 participants with one year of exposure. The Data Safety Monitoring Committee found no drug‑related safety concerns during its final review.
The safety update and DSMC review strengthen cytisinicline’s safety profile and support the company’s plan to submit its NDA for smoking cessation in June 2025. The NDA was accepted for review by the FDA in September 2025, with a Prescription Drug User Fee Act review date of June 20, 2026. The company’s Phase 3 results and the safety data provide the regulatory foundation for a commercial launch in 2026.
Achieve Life Sciences also received FDA Breakthrough Therapy designation for cytisinicline for vaping cessation and a National Priority Voucher for nicotine dependence treatment. The company reported a net loss of $12.8 million for Q1 2025 and held $23.2 million in cash, cash equivalents, and marketable securities, positioning it to fund ongoing development and commercialization activities.
Cytisinicline is a plant‑derived alkaloid that targets nicotinic acetylcholine receptors, reducing cravings and withdrawal symptoms. With no new FDA‑approved smoking‑cessation therapy since varenicline in 2006, cytisinicline could become the first new treatment in nearly two decades, addressing a significant unmet medical need.
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