Achieve Life Sciences publishes cytisinicline receptor study findings

Achieve Life Sciences (NASDAQ: ACHV) announced the publication of research in Nicotine & Tobacco Research examining the receptor selectivity profile of cytisinicline, its experimental smoking cessation treatment.

The study found that cytisinicline demonstrated strong binding at the α4β2 nicotinic receptor, displacing 99% of a comparison compound in laboratory testing. At the same concentration, cytisinicline showed minimal displacement at the 5-HT3 receptor, with only -8% displacement under assay conditions.

The 5-HT3 receptor is associated with nausea when activated. The research suggests this minimal interaction may explain cytisinicline's tolerability profile observed in clinical trials, according to the company's statement.

"These findings from our preclinical program provide additional insights regarding cytisinicline's pharmacologic profile and support observations from clinical studies," said Mark Rubinstein, the company's chief medical officer.

The company submitted a New Drug Application to the FDA in June 2025, which was accepted for review in September 2025. The FDA assigned a Prescription Drug User Fee Act date of June 20, 2026, for the smoking cessation indication based on two completed Phase 3 studies and an open-label safety study.

Achieve Life Sciences has also completed a Phase 2 study examining cytisinicline for vaping cessation and conducted an end-of-Phase 2 meeting with the FDA regarding a potential vaping indication.

The publication complements survey data from the company's ORCA-OL open-label safety study, which followed participants for up to one year of cytisinicline treatment.

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