Key takeaways:
Cytisine is an herbal compound that’s been used to help people quit smoking in Europe for more than 50 years.
Achieve Life Sciences is seeking FDA approval for cytisine as a smoking cessation medication. The company is also planning to ask the FDA to approve it for vaping cessation.
Most research shows cytisine works as well as or better than other smoking cessation methods. Side effects are generally mild and can include stomach upset, trouble sleeping, and constipation.
Smoking cessation medications treat nicotine dependence to help you quit. FDA-approved options include over-the-counter nicotine patches, lozenges, and gum. There are also prescription-only options like Chantix (varenicline). And soon, there may be another. Cytisine is an herbal product that’s long been used in other countries to help people quit smoking.
Below is what you need to know about cytisine for smoking cessation. This includes how it works, how it compares with other options, and when it might be available in the U.S.
What is cytisine?
Cytisine (also called cytisinicline) is a naturally occurring chemical found in certain plants. It has a chemical structure that’s similar to nicotine. For more than 50 years, cytisine has been sold in Central and Eastern Europe as a smoking cessation treatment under the brand name Tabex.
In recent years, cytisine has become more widely available. It’s approved for smoking cessation in Canada and the U.K.
Now, the manufacturer Achieve Life Sciences is looking to bring cytisine to the U.S. Researchers have completed two phase 3 clinical trials of cytisine for smoking cessation with positive results. And the company plans to apply for FDA approval.
How does cytisine work for smoking cessation?
Cytisine is a nicotine receptor partial agonist. This means it selectively attaches to nicotine receptors (binding sites) in the body — but not as strongly as nicotine.
Cytisine works by blocking nicotine from attaching to these binding sites. This prevents nicotine from providing a pleasurable feeling, which helps reduce cravings. And because cytisine attaches where nicotine does, it also helps manage nicotine withdrawal symptoms. These symptoms happen when the body suddenly has nothing attached to nicotine binding sites. And they are a common reason why people have trouble quitting smoking.
How well does cytisine work for quitting smoking?
Two clinical trials found cystine is more likely to help people quit smoking than a placebo (a pill with no medication in it). Participants took either a placebo or cytisine for 6 or 12 weeks. Key results from these studies include:
The first study showed people taking cytisine were six to eight times more likely to quit.
The second study showed people taking cytisine were three to six times more likely to quit.
In both studies, people were five to six times more likely to stay nicotine-free after they stopped taking cytisine.
How to quit smoking: There are several ways to quit smoking, but some strategies — like avoiding triggers — can benefit anyone.
Prescription smoking cessation medications: Wellbutrin and Chantix are prescription-only pills that help people quit smoking. Find out if one of these medications may be a good option for you.
Free nicotine patches: Find out ways to get low-cost or free nicotine patches to help you quit smoking.
Keep in mind that all participants received smoking cessation counseling. It’s possible that real-world rates of quitting may be lower without this type of support.
Cytisine was found to be similarly effective in a 2024 review that combined results from six clinical trials. This review found that people taking cytisine were almost three times more likely to quit smoking than those taking a placebo.
How does cytisine compare to other smoking cessation methods?
The available research shows that cytisine may work well for smoking cessation. But it’s also good to know how it compares to treatments that are already available.
- NicoretteNicotine
- ChantixVarenicline
- ZybanBuproban and Bupropion (Zyban)
Cytisine vs. nicotine replacement therapy
Nicotine replacement treatment (NRT) reduces the urge to smoke by giving your body “clean nicotine,” or nicotine without the other harmful chemicals in tobacco products. NRT comes in several forms, such as patches, lozenges, or gum. Over a period of several weeks, you’ll slowly lower your dosage of nicotine. This helps your body gradually adjust to less nicotine.
One study found cytisine worked better than NRT at helping people quit smoking. It also had a higher likelihood of helping people stay nicotine-free after treatment ended. But people receiving cytisine reported more side effects overall than those using NRT.
Cytisine vs. Chantix
Cytisine and Chantix belong to the same medication class. Head-to-head studies comparing them found that they work similarly well to help people quit smoking. Cytisine and Chantix also have similar side effects. But some studies suggest cytisine may be slightly more likely to cause side effects.
Cytisine vs. bupropion SR
Bupropion sustained-release (SR) is an antidepressant that’s also FDA approved to help people quit smoking. There are no studies available that directly compare cytisine to bupropion SR.
Studies suggest Chantix results in a higher quit rate than bupropion SR. Since Chantix and cytisine work similarly well, it’s possible that cytisine may also work better than bupropion SR. But more studies are needed to say for sure.
What are the risks of cytisine?
Cytisine seems to be safe to take for smoking cessation. The most common side effects reported in clinical trials include:
Trouble sleeping
Unusual dreams
Constipation
Nausea
Headaches
Anxiety
Achieve Life Sciences conducted a long-term safety study to make sure that cytisine would be safe to take over a longer period of time. The manufacturer didn’t find any long-term safety risks during this study.
Is cytisine available in the U.S.?
No, cytisine is not available in the U.S. yet. Based on clinical trial results, Achieve Life Sciences plans to submit cytisine for FDA approval in mid-2025. If the FDA agrees to review it, they could potentially approve cytisine for smoking cessation in 2026.
Does cytisine work for vaping?
Vaping can also cause nicotine dependency. So it makes sense that smoking cessation medications might also help people quit vaping. But there’s not enough research on whether this is true. Currently, there are no medications specifically approved for vaping.
Early research suggests cytisine may also help people quit vaping. If approved, cytisine would become the first FDA-approved vaping cessation medication.
Due to the lack of treatment options, the FDA granted their breakthrough therapy designation to cytisine for vaping cessation. This designation provides benefits to manufacturers to help speed up the research and development process.
Frequently asked questions
Cytisine hasn’t been studied for safety or effectiveness during pregnancy. Ideally, it’s best to quit smoking before becoming pregnant. But if you’re pregnant and having trouble quitting, help is available. Your prenatal care team can give you support and suggest a plan to help you quit smoking.
Clinical trials found that people who took cytisine for 6 or 12 weeks were at least three times more likely to quit smoking than people taking a placebo. They were also six times more likely to stay nicotine-free after they stopped taking cytisine.
Cytisine hasn’t been studied for safety or effectiveness during pregnancy. Ideally, it’s best to quit smoking before becoming pregnant. But if you’re pregnant and having trouble quitting, help is available. Your prenatal care team can give you support and suggest a plan to help you quit smoking.
Clinical trials found that people who took cytisine for 6 or 12 weeks were at least three times more likely to quit smoking than people taking a placebo. They were also six times more likely to stay nicotine-free after they stopped taking cytisine.
The bottom line
Cytisine is a naturally occurring compound found in certain plants. For decades, people in other countries have used cytisine for smoking cessation. And soon, it may be available in the U.S.
In studies, people taking cytisine were at least three times more likely to quit smoking than those not taking it. People were also up to six times more likely to remain nicotine-free after they finished taking cytisine. This medication may also help people quit vaping.
Side effects are mild and can include sleep disturbances, nausea, and constipation. The manufacturer Achieve Life Sciences plans to apply for FDA approval of cytisine smoking and vaping cessation in 2025. If approved, it’ll be the first medication FDA approved to help people quit vaping.
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References
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Achieve Life Sciences. (2025). Achieve Life Sciences announces critical milestone successfully reached in ORCA-OL cytisinicline clinical trial required for NDA submission.
Achieve Life Sciences. (2025). Achieve Life Sciences announces cytisinicline phase 3 ORCA-3 trial publication on smoking cessation in JAMA Internal Medicine.
Achieve Life Sciences. (2025). Achieve Life Sciences reports first quarter 2025 financial results and highlights updates in cytisinicline program.
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