Achieve Life Sciences, Inc. (ACHV) published a peer‑reviewed study in Nicotine & Tobacco Research that details the receptor selectivity of its lead candidate cytisinicline. The paper, titled “Receptor Selectivity of Cytisinicline: Minimal 5‑HT3 Binding May Explain Lower Incidence of Nausea in Smoking Cessation Therapy,” shows that cytisinicline binds strongly to nicotinic acetylcholine receptors while showing minimal interaction with the serotonin 5‑HT3 receptor, a key driver of nausea.
The study provides a mechanistic explanation for the low nausea rates observed in clinical trials. Cytisinicline displaced 99 % of a comparison compound at the α4β2 nicotinic receptor and only displaced –8 % at the 5‑HT3 receptor, supporting the hypothesis that reduced 5‑HT3 engagement translates into fewer nausea events.
The publication comes as Achieve’s regulatory journey continues. The company submitted a New Drug Application for cytisinicline in June 2025, received FDA acceptance for review in September 2025, and has a PDUFA action date of June 20 2026. In addition, the company secured a National Priority Voucher for e‑cigarette or vaping cessation and has partnered with Adare Pharma Solutions to establish U.S. manufacturing, positioning it to meet demand if the drug is approved.
Chief Medical Officer Mark Rubinstein said the preclinical data “lend further biological basis for why cytisinicline has such low rates of adverse events like nausea, which is thought to be linked to binding at the 5‑HT3 receptor.” CEO Rick Stewart added that the U.S. manufacturing partnership “increases our confidence in our supply chain and continues our strong progress toward launch.”
The company has faced headwinds in recent months, but the study reinforces the therapeutic advantage of cytisinicline and supports the upcoming FDA decision that could open a new treatment option for smoking and vaping cessation.
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