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Achieve Life Sciences, Inc
Achieve Life Sciences is developing cytisinicline for use as a smoking cessation treatment in the United States and rest of world. Topline results from ORCA-2 were reported in April 2022 and for ORCA-3 in May 2023. Results exceeded expectations on safety & efficacy parameters. Achieve is conducting the ORCA-OL safety trial and has submitted its NDA as of June 2025. Both Phase III trials compare cytisinicline with placebo combined with counseling. The primary endpoint is abstinence at 6 & 12 weeks for the last 4 weeks of treatment. A Phase III trial in vaping cessation (ORCAV1) reported topline in April 2023.