Cytisinicline
Cytisinicline is a plant-based medication that has been used for over 60 years in other countries to help people quit smoking. The US Food and Drug Administration (FDA) is reviewing cytisinicline now and could approve it by mid-2026.
You may have heard about a medicine for quitting smoking that could soon be available in the United States. It is called cytisinicline.
Cytisinicline has been helping people quit smoking in other countries for over 60 years.
The US Food and Drug Administration (FDA) is reviewing cytisinicline now and could approve it by mid-2026. This would make it the first new quit-smoking medicine in the US in nearly 20 years.
Early research also suggests cytisinicline may help people quit vaping. This is important because there are no FDA-approved medicines for vaping cessation right now.
If cytisinicline is approved, it will give people who want to quit smoking and vaping another tool to help them succeed.
What is cytisinicline?
Cytisinicline (pronounced sigh-tis-IN-ih-kleen) is a plant-based medicine that has helped millions of people quit smoking in Europe for over 60 years. It comes from the seeds of the laburnum plant, a shrub commonly called "golden rain" that grows in Europe.
Scientists call this active ingredient cytisine. You may also see it called cytisinicline, which is the newer name for the same thing.
How does cytisinicline work?
When you smoke, nicotine attaches to nicotine receptors in the brain, which is what makes smoking feel good. Over time, your brain wants more nicotine. This is why quitting is so hard.
Cytisinicline attaches to the same spots in your brain that nicotine does. But it only partly activates them. This does two important things:
- Cytisinicline reduces your cravings. Because cytisinicline partly turns on these brain spots, you feel less urge to smoke.
- Cytisinicline blocks the good feelings from smoking. If you do smoke while taking the medicine, you will not enjoy it as much. This is because cytisinicline is already sitting in those brain spots, so nicotine cannot attach as well.
Doctors call this type of medicine a "partial agonist." It is like having a key that only partly opens a lock. The medicine opens the lock enough to calm your cravings but blocks nicotine from fully opening it.
Cytisinicline has been used for a long time in other countries
Bulgarian scientists first studied it in the 1950s. They noticed it worked on the same brain receptors as nicotine.
In 1964, Bulgaria released it as a stop-smoking medicine called Tabex. It quickly became popular across Eastern Europe and the Soviet Union. For over 60 years, people in these countries have used it to quit smoking.
The World Health Organization recently added it to their list of essential medicines.
Why has it taken so long for cytisinicline to reach the United States?
The medicine stayed mostly unknown in the US for decades. There are several reasons for this:
- Early research was published in languages other than English.
- It was made during the Cold War, when communication between Eastern Europe and the US was limited.
- Large drug companies in the US had little financial incentive to get FDA approval.
Because it comes from a plant and cannot be patented, large drug companies had little financial reason to pay for the expensive studies needed for FDA approval.
This changed when a smaller company, Achieve Life Sciences, invested in running clinical trials that meet US standards. They found that it works well and is safe.
FDA review status
FDA review of cytisinicline for quitting smoking
The US Food and Drug Administration is currently reviewing cytisinicline.
- June 2025: Achieve Life Sciences submitted an application asking the FDA to approve cytisinicline for smoking cessation.
- September 2025: The FDA accepted the application for review.
- June 20, 2026: The FDA aims to make a decision by this date.
If approved, cytisinicline would be the first new prescription medicine for quitting smoking in nearly 20 years.
If cytisinicline is approved for smoking cessation in June 2026, Achieve Life Sciences expects it would be available by prescription later in 2026.
FDA review of cytisinicline for quitting vaping
The FDA is also planning to review cytisinicline for vaping cessation. Achieve Life Sciences plans to submit the vaping cessation application after the smoking cessation decision.
If cytisinicline is approved for smoking in mid-2026 and the vaping application follows shortly after, approval for vaping cessation could come before the end of 2026.
This is important because there are no FDA-approved medicines for vaping cessation right now.
Cytisinicline is safe and effective
Scientists have done many studies on cytisinicline. When researchers combine the results from multiple studies, they can get a clearer picture of how well a medicine works. Several major reviews have now analyzed all the available evidence.
The evidence shows that cytisinicline is safe. It is effective for quitting smoking. It may also be effective for quitting vaping.
Learn more about the studies on cytisinicline
Cytisinicline and quitting smoking
Cytisinicline is effective for quitting smoking
A 2023 review combined data from 14 clinical trials involving nearly 10,000 adults who smoke. This analysis found:
- People taking cytisinicline were more than twice as likely to quit smoking compared to those taking a placebo. A placebo is a harmless, inactive substance that looks like the drug being tested but has no effect.
- Cytisinicline worked better than nicotine patches and gums for helping people quit.
- Cytisinicline worked about as well as varenicline (Chantix), the most effective quit-smoking medicine currently available.
Another recent analysis confirmed these findings. They concluded that cytisinicline provides clear health benefits compared to behavioral support alone and has similar effectiveness to varenicline.
Cytisinicline and quitting vaping
Cytisinicline may be effective for quitting vaping
Right now, there is no FDA-approved medicine specifically for quitting e-cigarettes or vapes. Early research suggests cytisinicline may help.
In a clinical trial of 160 adults who vaped nicotine every day, people taking cytisinicline were 2.6 times more likely to quit vaping than those taking a placebo.
The FDA has recognized this as an important area. They gave cytisinicline a "Breakthrough Therapy" status for vaping cessation. This means the FDA sees it as a potential answer to a critical need.
How is cytisinicline taken?
In Europe, people start by taking one 1.5 mg tablet every 2 hours (6 tablets per day). They gradually reduce the dose over 25 days.
In the recent US studies, people took 3 mg of cytisinicline three times a day for 6 or 12 weeks. The 12-week treatment worked better than the 6-week treatment.
All participants in the studies also received behavioral support to help them quit. This included counseling and encouragement. The combination of medicine plus support works best.
People should not use cytisinicline if they are pregnant or breastfeeding. People with certain medical conditions should talk to their doctor first.
Side effects of cytisinicline
Cytisinicline has been used safely by millions of people for over 60 years.
Researchers have found that people taking cytisinicline reported fewer side effects overall, compared to varenicline. Studies also suggest cytisinicline may cause fewer stomach problems than varenicline.
Like all medicines, cytisinicline can cause side effects. But most are mild and go away on their own.
The most common side effects include:
- Nausea (feeling sick to your stomach)
- Trouble sleeping
- Unusual dreams
- Headache
- Dry mouth
Serious side effects are rare. In studies involving thousands of people, no serious safety concerns were found.
Reviewed by Amanda Graham, PhD
Chief Health Officer, Truth Initiative
Updated March 30, 2026