What is Cytisinicline? … and Why the Push for FDA Approval: A New Hope in the Fight Against Nicotine

Smoking tobacco in its various forms remains the leading cause of preventable illness and death in the United States. Nearly half a million Americans die each year from tobacco-smoking-related disease, and millions more struggle with nicotine dependence while trying to quit.

For decades, the options available to help people quit smoking have been limited, and in some cases, fraught with side effects or mixed success rates. But a promising new treatment, oral cytisinicline, could soon offer a fresh and potentially effective option for those who want to break free from nicotine addiction.

What Is Cytisinicline?

Cytisinicline is a plant-derived compound being developed by Achieve Life Sciences as a treatment for nicotine dependence, with the goal of helping adults quit smoking. It works by interacting with the brain’s nicotine receptors to reduce cravings and lessen the reward response to nicotine, which can make quitting easier. Unlike older medications, cytisinicline may have a more tolerable side-effect profile plus increased effectivness of participants and has shown promising results in clinical trials.

A Major Milestone: FDA Review Underway

In June 2025, Achieve Life Sciences submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek approval for cytisinicline as a treatment for smoking cessation in adults. This submission was supported by data from large, controlled Phase 3 clinical trials, which demonstrated that people who used cytisinicline were more likely to remain smoke-free than those given a placebo.

By September 2025, the FDA formally accepted this application and set an action date of June 20, 2026, meaning that a decision on approval could come by then, barring any unexpected delays.

If approved, cytisinicline would be the first new FDA-approved pharmacotherapy in pill form for smoking cessation in nearly two decades, a milestone that could open doors to new treatment options for millions of adults.

Addressing Vaping Nicotine Dependence Too

In addition to smoking cessation, cytisinicline is being studied as a potential therapy to help people stop using e-cigarettes and vaping products, an area where no FDA-approved treatments currently exist.

Achieve Life Sciences has received special recognition from the FDA, a National Priority Voucher, to help expedite development for vaping cessation. This reflects the growing concern about nicotine addiction among underage youth and young adults who vape, and the now more urgent need for evidence-based, effective treatment options.

Why This Matters for Tobacco Prevention and Control

● Smoking still kills: Tobacco use is responsible for the major portion of preventable disease and death in the U.S., with smokers facing dramatically higher risks of various forms of cancer, heart disease, and respiratory illness.

● Limited options until now: Most available cessation medications are decades old or underused, and many people struggle to quit even with support. Cytisinicline could expand the toolbox for clinicians and patients alike.

● Vaping addiction needs solutions: With millions of adults and young people using e-cigarettes, evidence-based effective treatments for vaping cessation are long overdue.

Looking Ahead

Cytisinicline’s journey through the FDA approval process is a reminder of how science and regulation intersect to bring new health tools to the public. If approved, this drug could represent real progress in reducing nicotine dependence, improving health outcomes, and supporting people as they seek to quit smoking or vaping.

As TFYCC continues to support tobacco-free communities and evidence-based policy, we’ll be watching developments around cytisinicline closely and sharing updates as they emerge.