BOTHELL, WA
Cytisinicline NDA receives CRL over third-party manufacturer inspection
- Sponsor
- Achieve Life Sciences, Inc. $ACHV
- Drug
- cytisinicline
- Indication
- nicotine dependence (smoking cessation)
FDA issued a Complete Response Letter to Achieve Life Sciences for the cytisinicline NDA. The sponsor plans a Q4 2026 resubmission.
What this means
Cytisinicline is a plant-derived pill that helps smokers quit by partially blocking the brain's nicotine receptors — a milder version of how nicotine itself acts. The FDA delayed approval after inspecting a third-party manufacturer the company uses, but it did not raise concerns about whether the drug is safe or works. Achieve Life Sciences plans to address the manufacturing concerns and resubmit later in 2026; if approved, cytisinicline would be the first new prescription smoking cessation medication in 20 years.