US FDA declines to approve Achieve Life Sciences' smoking-cessation drug

The U.S. Food and Drug Administration has declined to approve Achieve Life Sciences' drug to treat nicotine dependence in adults, citing unresolved issues found at a third-party manufacturing facility and final product labeling that was not completed by the agency's action date.

The FDA did not identify any deficiencies related to the drug's clinical efficacy or safety, Achieve added in its statement on Monday.

The rejection delays Achieve's bid to introduce another non-nicotine prescription option for adults trying to quit smoking, with FDA-approved choices still largely limited to Pfizer's Chantix and GSK's Zyban, apart from nicotine replacement products.

The experimental drug, called cytisinicline, is a plant-derived compound aimed at helping adults quit smoking by targeting nicotine receptors in the brain to reduce nicotine cravings and withdrawal symptoms, including irritability and sleep problems. Unlike nicotine replacement products such as patches, gums and lozenges, it does not deliver nicotine.

Achieve said late-stage trials and safety studies involving more than 1,500 participants showed cytisinicline helped more adults quit smoking than placebo, with benefits lasting through 24 weeks and no new safety concerns identified in longer-term data.

The company had previously said it expected a complete response letter after its former third-party manufacturer received an FDA inspection classification requiring corrective action. The issues were general manufacturing matters and not specific to cytisinicline, Achieve added.

The company has since moved its manufacturing to U.S.-based Adare Pharma Solutions and plans to resubmit its application for cytisinicline in the fourth quarter of 2026, with potential FDA approval in the first half of 2027.

Last year, cytisinicline received the FDA Commissioner's National Priority Voucher for nicotine dependence related to e-cigarette use, or vaping, under the agency's new pilot program to speed up reviews of selected drugs.

Achieve's shares were up more than 6% in early trading.

(Reporting by Kunal Das and Kamal Choudhury in Bengaluru; Editing by Diti Pujara and Jonathan Ananda)

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This story was originally published June 22, 2026 at 9:40 AM.