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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

What Is Nikitabs (Cytisine)? What Is It Used For?

What Is Nikitabs (Cytisine)? What Is It Used For?
In this article

What is Nikitabs (cytisine)? What is it used for?

Nikitabsis a prescription smoking-cessation medicine containing cytisine . By binding to nicotine receptors in the brain, it reduces withdrawal symptoms and cigarette cravings and blunts the "pleasure" of smoking. It is taken as a short, gradually tapered 25-day course. Cytisine is one of the oldest smoking-cessation medicines used worldwide; large randomized trials, World Health Organization recommendations, and the approval process in the United States have brought renewed attention to it in recent years. This article explains how the medicine works, how to use it, current scientific evidence, its comparison with varenicline, and its status in Türkiye.

At a glance
  • Active ingredient and action: Cytisine acts at the brain's α4β2 nicotinic acetylcholine receptors as a partial agonist. The mechanism is the same as varenicline's.
  • Use: 1.5 mg tablets, on a tapered 25-day schedule; one pack (100 tablets) provides a complete course. Smoking must be stopped completely no later than day 5 .
  • Evidence: According to the Cochrane review, it is superior to placebo; no clear difference from varenicline was demonstrated. In two large US phase 3 trials (ORCA-2, ORCA-3), abstinence rates with 12 weeks of treatment were 3-5 times those with placebo.
  • Side effects: Mostly mild: insomnia, abnormal dreams, nausea, and dry mouth. Comparative studies found fewer side effects than with varenicline.
  • International status: Among the medicines recommended in the WHO's 2024 smoking-cessation guideline; added to the WHO Essential Medicines List in 2025. Not yet approved in the United States.
  • Türkiye: Licensed since December 2022; pharmacy price 5,643.64 TL (100 tablets). SGK does not reimburse it at pharmacies, but Ministry of Health smoking-cessation clinics provide it free of charge .
What is new in this update? (September 2026)
  • US approval delayed: In June 2026, the FDA issued a complete response letter (CRL) for cytisinicline concerning the manufacturing facility and labeling, rather than efficacy or safety. The company will resubmit in the final quarter of 2026, with approval expected in the first half of 2027.
  • Long-term safety data: The ORCA-OL study, which examined continuous use for up to 52 weeks, identified no new safety signal (May 2026).
  • First evidence for quitting e-cigarettes: In the ORCA-V1 study, cytisine approximately doubled the rate of quitting e-cigarette use; the FDA granted "breakthrough therapy" designation and a priority review voucher for this use.
  • Decision to provide free medicines in Türkiye: Under a decision published in the Official Gazette on July 4, 2026, cytisine, varenicline, bupropion, and nicotine patches and gum will be provided free of charge to up to 1 million people annually, regardless of social insurance coverage.
  • Comparative evidence and special groups: Two large head-to-head studies against varenicline and the negative result in patients with tuberculosis have been added to the article.

Smoking is the leading cause of preventable cancers. It increases the risk of many cancers, particularly lung, mouth, laryngeal, esophageal, stomach, pancreatic, kidney, and bladder cancer. We explained this relationship in detail in our article on the relationship between smoking and cancer . According to TÜİK's Türkiye Health Survey 2025, among people aged 15 and over in Türkiye, 30.1% use tobacco every day (42.9% of men and 17.5% of women), exceeding the 28.3% recorded in 2022.

Cytisine is not a cancer medicine. However, quitting smoking is one of the most powerful known interventions for preventing cancer and improving survival, whether or not a person has been diagnosed with cancer. Smoking-cessation treatment is therefore directly part of oncology practice. We discussed evidence that quitting smoking prolongs survival even in advanced cancer in this article .

What is cytisine? Its origins

Cytisine is a plant-derived alkaloid. It is found in the seeds of certain plants in the legume family (Fabaceae), particularly Laburnum anagyroides (the golden chain tree). Medicinal cytisine is extracted from these plants and purified. Its use as a medicine in Eastern Europe goes back decades; in Bulgaria, it has been used for smoking cessation under the name Tabex since the 1960s. Long known in only a few Eastern European countries, it has attracted international research attention over the past 15 years because of its low cost and favorable side-effect profile.

Are Nikitabs and cytisinicline the same?

The active ingredient is the same: cytisine. Nikitabsis a 1.5 mg tablet licensed in Türkiye and used on the traditional 25-day schedule. Cytisinicline is the name of the product developed by the US company Achieve Life Sciences for FDA approval. The US studies used a different schedule: for 6 or 12 weeks, 3 mg three times daily. Thus, the ORCA studies demonstrate cytisine's efficacy, but their dosing schedule differs from Nikitabs'.

How does it work?

When a cigarette is smoked, nicotine reaches the brain within seconds and fully stimulates nicotinic acetylcholine receptors, particularly the α4β2 subtype. This causes a sudden, large release of dopamine in the brain's reward center; this release produces the feeling of "pleasure" that sustains addiction. As nicotine levels fall, irritability, restlessness, poor concentration, and intense cigarette cravings develop.

Cytisine binds to the same receptor but stimulates it less strongly than nicotine; this is called partial agonist activity. This has two effects. First, mild stimulation of the receptor partly maintains dopamine levels and eases withdrawal symptoms. Second, by occupying the receptor, it prevents nicotine from exerting its full effect even if the person smokes, reducing the satisfaction obtained from cigarettes. We explained the reasons for irritability and restlessness after quitting smoking in this article .

Figure 1 · Nicotine and cytisine: the same receptor, different effects

By partially stimulating the receptor, cytisine eases withdrawal while also blunting nicotine's effect.

nicotine (cigarette) cytisine α4β2 receptorfully stimulated α4β2 receptorpartially stimulated dopaminesudden, large increase dopaminemoderate, balanced increase feeling of rewardaddiction continues withdrawal decreasescigarette cravings decrease if a cigarette is smoked while taking cytisinethe receptor isoccupied by cytisine nicotine cannot exertits full effect the "pleasure" obtained from smoking is bluntedvarenicline works on the same principle(partial agonist at the α4β2 receptor)
How to read it: In the left column, nicotine fully stimulates the α4β2 receptor; a sudden, large dopamine increase creates a feeling of reward and sustains addiction. In the right column, cytisine only partially stimulates the same receptor; dopamine remains at a moderate level, reducing withdrawal symptoms and cigarette cravings. The bottom panel shows what happens if someone smokes while taking cytisine: because the receptor is occupied by cytisine, nicotine cannot exert its full effect and the "pleasure" of smoking is blunted. Varenicline works on the same principle.
Feature Nicotine Cytisine Varenicline
Target Nicotinic receptors, particularly α4β2 α4β2 nicotinic receptor α4β2 nicotinic receptor
Effect on the receptor Full agonist Partial agonist Partial agonist
Dopamine Sudden, large increase Moderate increase Moderate increase
Does it blunt nicotine's effect? — Yes, partly Yes, partly
Source Tobacco Plant-derived alkaloid Synthetic molecule developed using cytisine as a model
Standard treatment duration — 25 days (Nikitabs) 12 weeks

How is it used? The 25-day schedule

Nikitabs is taken on a 25-day schedule in which the dose is gradually reduced after a short initial period. One pack (100 tablets) is sufficient for a complete course. The tablets are swallowed with water without chewing. Smoking is not stopped immediately when treatment begins; it is reduced during the first few days and stopped completely no later than day 5. Taking the medicine while continuing to smoke can increase nicotine-related side effects.

Figure 2 · Nikitabs dosing calendar

The daily tablet count gradually decreases; smoking is stopped completely on day 5.

6Days 1-31 every 2 hours 5Days 4-121 every 2.5 hours 4Days 13-161 every 3 hours 3Days 17-201 every 5 hours 1-2Days 21-251-2 daily tablets/dayDay 5: stop smoking completely25 days in total · 100 tablets · 1 packswallow tablets with water without chewing
How to read it: The bars show the daily tablet count for each period: on days 1-3, every 2 hours (6 daily); on days 4-12, every 2.5 hours (5 daily); on days 13-16, every 3 hours (4 daily); on days 17-20, every 5 hours (3 daily); and on days 21-25, 1-2 tablets daily. The red dashed line indicates that smoking must be stopped completely no later than day 5. The complete course lasts 25 days and contains 100 tablets.
Period Dosing frequency Tablets daily
Days 1-3 1 tablet every 2 hours 6
Days 4-12 1 tablet every 2.5 hours 5
Days 13-16 1 tablet every 3 hours 4
Days 17-20 1 tablet every 5 hours 3
Days 21-25 1-2 tablets daily 1-2
Practical tips
  • Set your quit date at the outset: Mark day 5 on the calendar and reduce smoking until that date.
  • Get behavioral support: A smoking-cessation clinic, the ALO 171 counseling line, or mobile apps can improve the chances of success. We compiled other methods in our article on effective ways to quit smoking .
  • The first 3 days are an assessment period: According to the summary of product characteristics, treatment should be stopped if there is no noticeable effect during this period; another attempt can be made after 2-3 months.
  • Take the tablets on time: Because its action is short-lived (half-life approximately 4 hours), following the dosing intervals is important during the initial period.

Pharmacokinetics: what happens in the body?

Feature Information
Absorption After a single 1.5 mg dose, the highest blood concentration (approximately 15.5 ng/mL) is reached in about 1 hour
Metabolism Very limited; no substantial transformation by liver enzymes
Elimination Approximately 64% of the dose is excreted unchanged in urine within 24 hours
Half-life Approximately 4 hours

Source: UK summary of product characteristics. Because the medicine is largely eliminated through the kidneys, caution is needed in severe kidney impairment; data in these patients are limited.

Scientific evidence: the current picture

Systematic review: Cochrane 2023

The 2023 update from Cochrane, one of the most reliable sources of evidence on smoking cessation, brought together 75 randomized trials (45,049 participants) of nicotine receptor partial agonists:

Comparison Smoking abstinence at 6 months or longer (relative rate) Certainty of evidence
Cytisine versus placebo (4 studies, 4,623 people) 1.30 (1.15-1.47) moderate
Varenicline versus placebo (41 studies, 17,395 people) 2.32 (2.15-2.51) high
Cytisine versus varenicline (2 studies, 2,131 people) 1.00 (0.79-1.26) low

In other words, cytisine significantly increases the likelihood of quitting smoking compared with placebo; no clear difference from varenicline was demonstrated, although the certainty of this comparison is low. The same review found no increase in serious side effects with cytisine. In Cochrane's network meta-analysis, cytisine ranked as the third most effective option, with approximately twice the effect of placebo (odds ratio 2.21). Substantial variation (heterogeneity) between the studies comparing cytisine with placebo should also be noted.

US phase 3 trials: ORCA-2 and ORCA-3

In two large US phase 3 trials, cytisine (cytisinicline) 3 mg three times daily, together with behavioral support, was compared with placebo for 6 or 12 weeks. Abstinence was confirmed by biochemical tests.

Study Treatment arm Continuous abstinence at the end of treatment Continuous abstinence through week 24
ORCA-2
JAMA, 2023
810 people
6 weeks of cytisine 25.3% - 4.4%
OR 8.0
8.9% - 2.6%
OR 3.7
12 weeks of cytisine 32.6% - 7.0%
OR 6.3
21.1% - 4.8%
OR 5.3
ORCA-3
JAMA Intern Med, 2025
792 people
6 weeks of cytisine 14.8% - 6.0%
OR 2.9
6.8% - 1.1%
OR 6.3
12 weeks of cytisine 30.3% - 9.4%
OR 4.4
20.5% - 4.2%
OR 5.8

The figures refer to the cytisine and placebo arms. End of treatment covers weeks 3-6 in the 6-week arm and weeks 9-12 in the 12-week arm. The two studies consistently confirmed each other: 12 weeks of treatment produced a stronger and more lasting effect than 6 weeks. In absolute terms, with 12 weeks of treatment, approximately 16 additional people out of every 100 remained continuously abstinent from week 9 to week 24 compared with placebo.

Continuous abstinence through week 24 with 12 weeks of cytisine (%)
Dark: cytisine. Light: placebo. Both arms received behavioral support. Bar lengths use a 25% scale.
Cytisine (12 weeks)Placebo
ORCA-2
21.1
 
4.8
ORCA-3
20.5
 
4.2
How to interpret this: Although the placebo arm also received behavioral support, the abstinence rate without active medication remained around 5%; cytisine approximately quadrupled that rate. These figures relate to the US 12-week schedule; the effect of the 25-day schedule used in Türkiye may be closer to the more modest results in the Cochrane review.

Direct comparisons with varenicline

  • Australia (JAMA, 2021; 1,452 people): A 25-day course of cytisine was compared with 12 weeks of varenicline. Continuous abstinence at 6 months was 11.7% versus 13.3%; cytisine was not shown to be "no worse than varenicline." However, side effects were significantly less frequent with cytisine (approximately 12% fewer).
  • New Zealand, RAUORA (Addiction, 2021; 679 Māori participants and family members): Verified abstinence at 6 months was 12.1% with cytisine and 7.9% with varenicline (a borderline statistical difference). Side effects were approximately 44% less frequent with cytisine.

Taken together, the two studies suggest that cytisine and varenicline are probably similarly effective; cytisine can be used for a shorter period, with fewer side effects and, in many countries, at a lower cost.

A negative result: patients with tuberculosis

In a study of 2,472 smokers receiving tuberculosis treatment in Pakistan and Bangladesh, published in 2020 in Lancet Global Health, adding cytisine to behavioral support did not significantly increase abstinence at 6 months (32.4% versus 29.7%). The authors stated that they did not support adding cytisine for this patient group. Interestingly, quit rates were high in both groups, suggesting that a tuberculosis diagnosis itself and behavioral support may be powerful sources of motivation.

Quitting e-cigarettes: ORCA-V1

No medicine is yet approved for quitting e-cigarette use. In the ORCA-V1 study of 160 US adults who used e-cigarettes daily, the continuous abstinence rate during weeks 9-12 after 12 weeks of cytisine was 31.8% versus 15.1% . The effect persisted through week 16, but the difference was no longer statistically significant at that point (23.4% versus 13.2%). For this use, the FDA granted "breakthrough therapy" designation in July 2024 and a priority review voucher in October 2025; a phase 3 study (ORCA-V2) is planned. We discussed the role of e-cigarettes as a smoking-cessation method in this article .

Long-term use: ORCA-OL

In the ORCA-OL study presented in May 2026, 475 people took cytisine continuously for up to 52 weeks (median 361 days). Of the side effects, 95% were mild or moderate; the most common were abnormal dreams (8.4%) and insomnia (8.4%). Treatment discontinuation due to drug-related side effects was 5.7%, and no new safety signal was detected.

Our assessment: how should the evidence be interpreted?
  • Robust efficacy: Cytisine's superiority to placebo is consistent across the Cochrane review and the US phase 3 trials.
  • Dose and duration matter: The strongest results were obtained with a fixed dose of 9 mg daily for 12 weeks. No large trial has directly compared Türkiye's 25-day schedule with 12 weeks of treatment. For people who relapse soon after the 25-day course, extending treatment is a question to discuss with a physician.
  • Varenicline or cytisine? Efficacy appears similar; cytisine's advantages are fewer side effects and a short course. However, the certainty of comparative evidence is low.
  • The ORCA studies were company-sponsored: The results were published in peer-reviewed journals and are consistent with independent studies, but some figures were taken from company announcements.
  • The same effect should not be expected in every patient group: The negative result in patients with tuberculosis shows that the medicine's additional contribution may be limited in the presence of comorbidities and intensive behavioral support.

Who should not use it? Precautions

Do not use

Hypersensitivity to the medicine; unstable angina; a recent heart attack or stroke; clinically significant rhythm disorders; pregnancy and breastfeeding.

Use with caution

Cardiovascular disease, heart failure, high blood pressure, pheochromocytoma, peripheral vascular disease, hyperthyroidism, stomach ulcers or reflux, diabetes, a history of psychiatric illness, and kidney or liver impairment.

Limited data

People under 18 or over 65. The summary of product characteristics requires an effective method of contraception for women of childbearing potential.

Drug interactions and the effects of quitting smoking

  • Quitting smoking changes the levels of other medicines: Cigarette smoke induces the liver enzyme CYP1A2. When smoking stops, this effect disappears, and blood levels of medicines such as theophylline, clozapine, olanzapine, and ropinirole may rise; dose adjustment may be necessary. This is a consequence of quitting smoking, not of cytisine, and applies to all smoking-cessation methods.
  • Oral contraceptives: It is not known whether cytisine reduces the effectiveness of hormonal contraception; an additional barrier method is recommended.
  • Use with nicotine patches or gum: This can increase nicotine-related side effects; they should not be combined without consulting a physician.
  • Alcohol: It can trigger cigarette cravings and increase side effects such as dizziness.

Side effects

Cytisine's side effects are mostly mild or moderate and usually occur during the first days of treatment. Side effects listed as "very common" in the summary of product characteristics include changes in appetite and weight gain, dizziness, mood changes, sleep disturbances (insomnia and abnormal dreams), palpitations, increased blood pressure, dry mouth, diarrhea, nausea, rash, and fatigue. Some of these symptoms can also be caused by nicotine withdrawal itself.

Side effect (ORCA-3) Placebo 6 weeks of cytisine 12 weeks of cytisine
Insomnia 7.6% 11.0% 11.9%
Abnormal dreams 5.7% 9.1% 7.7%
Nausea 7.3% 9.5% 6.9%
Headache 6.1% 7.6% 8.5%

The small differences in the table are notable: a substantial proportion of side effects also occurred in the placebo group. In ORCA-2, treatment discontinuation due to side effects was 2.9%; neither trial reported drug-related serious side effects. Raised liver enzymes were among the infrequently reported adverse effects; for interpretation of these tests, see our article on liver enzymes .

Seek medical attention immediately

If signs of a severe allergy develop, such as swelling of the face, lips, or tongue, shortness of breath, or widespread rash; chest pain or marked palpitations; severe mood changes; or thoughts of self-harm, stop the medicine and seek medical help immediately.

The history of varenicline (Champix) withdrawal and its current status

In 2021, Pfizer halted distribution worldwide and recalled products in some countries after a nitrosamine impurity called N-nitroso-varenicline was detected above the acceptable limit in varenicline tablets. Nitrosamines can pose a cancer risk with prolonged high exposure; the recall was precautionary. Varenicline became unavailable in many countries during this period, increasing interest in cytisine. Cytisine entered the UK market in January 2024; NICE decided to update its smoking-cessation guideline to include it.

As of September 2026, both Champix and the locally manufactured varenicline product Dupons appear as active products on medicine price lists in Türkiye. Being listed does not necessarily mean they are always available in pharmacies.

The situation in Türkiye

As of September 2026
  • License: Nikitabs 1.5 mg film-coated tablets were licensed by Nobel İlaç on December 22, 2022. A pack contains 100 tablets; it is sold on a standard white prescription.
  • Price: The retail pharmacy price is 5,643.64 TL (100 tablets, a complete course). SGK does not reimburse it at pharmacies.
  • Free treatment: Under a decision published in the Official Gazette on July 4, 2026, nicotine patches and gum, as well as medicines containing bupropion, varenicline, and cytisine will be provided free of charge to up to 1 million people annually, without requiring social insurance coverage. These medicines are available following a physician's assessment at smoking-cessation clinics.
  • Clinics and counseling line: According to the Ministry of Health, there are 1,678 smoking-cessation clinics nationwide; ALO 171 Smoking Cessation Counseling Line operates 24 hours a day, 7 days a week.
  • Varenicline: Champix and Dupons appear as active products on price lists.

Cytisine's journey: from Eastern Europe to the WHO list

1960s
Tabex in Bulgaria
Cytisine began to be used as a smoking-cessation medicine in Eastern Europe.
2021
First large comparisons with varenicline
Australian and New Zealand studies: similar efficacy, fewer side effects. Varenicline was withdrawn from the market because of nitrosamines that same year.
December 22, 2022
License in Türkiye Nikitabs
Nobel İlaç, 1.5 mg tablets.
July 2023
ORCA-2 JAMA
Positive results from the first US phase 3 trial.
January 2024
Available in the United Kingdom
NICE decided to update its guideline to include cytisine.
July 2, 2024
The WHO's first guideline on smoking-cessation treatment
Varenicline, nicotine replacement, bupropion, and cytisine were recommended.
April 2025
ORCA-3 JAMA Intern Med
The ORCA-2 results were replicated.
September 2025
WHO Essential Medicines List
Cytisine was added to the list. In the same month, the FDA accepted the US application for review.
June 22, 2026
FDA complete response letter (CRL)
The reasons concerned the manufacturing facility and labeling, with no efficacy or safety issue.
July 4, 2026
Decision to provide free medicines in Türkiye
Smoking-cessation medicines, including cytisine, free for up to 1 million people annually.
Final quarter of 2026 → 2027
Planned US resubmission
With a new manufacturer (Adare Pharma Solutions); approval is expected in the first half of 2027.
What does an FDA complete response letter mean?

According to Achieve Life Sciences, the complete response letter concerned current good manufacturing practice (cGMP) deficiencies identified during an inspection of a third-party manufacturing facility, which were not specific to cytisine, and product labeling that could not be finalized by the FDA's decision date. According to the company, the FDA identified no deficiency relating to the medicine's clinical efficacy or safety. The company moved manufacturing to Adare Pharma Solutions; by August 2026, the first batch had been manufactured at the new facility and testing methods had been validated. Resubmission is planned for the final quarter of 2026; as of the end of September 2026, no announcement of resubmission had been made. This development does not affect the use of Nikitabs, which is licensed in Türkiye.

Why is this important in oncology?

Quitting smoking matters not only for cancer prevention but also after a cancer diagnosis. Continuing to smoke can make recovery after surgery and radiotherapy harder, increase treatment side effects, and raise the risk of a second cancer. We summarized why cancer patients should stop smoking in 10 points . You can find information on who should receive low-dose CT lung cancer screening after a long smoking history in our article on lung cancer screening , and information on lung cancer symptoms and treatment in our lung cancer guide .

We could not find data from a large trial specifically examining cytisine use in cancer patients. However, its simple interaction profile (very limited processing in the liver) and short treatment course suggest that it may also be considered under medical supervision in patients receiving chemotherapy. Heart disease, severe kidney impairment, and treatment-related nausea should be taken into account when making this decision.

Frequently asked questions

Can Nikitabs be obtained without a prescription?
No. Nikitabs is a medicine sold on a standard white prescription. It may also be provided free of charge at smoking-cessation clinics following a physician's assessment.
Which is more effective, Nikitabs or varenicline?
Head-to-head studies found similar efficacy; cytisine has fewer side effects and a shorter course. The choice should be made with your physician, considering your health and previous experience.
When should I stop smoking?
Reduce smoking after starting treatment and stop completely no later than day 5.
What if 25 days are not enough?
If no effect is seen in the first 3 days, treatment is stopped and another attempt can be made after 2-3 months. If the risk of restarting smoking after the course is high, it is important to continue behavioral support and discuss other options with your physician. US trials showed that longer treatment (12 weeks) was more effective, but that schedule is not the approved regimen in Türkiye.
Can it be used to quit e-cigarettes?
This use is not yet approved. In a small study, it approximately doubled the e-cigarette quit rate; a large phase 3 study is planned.
Will I gain weight?
Increased appetite and weight gain are both cytisine side effects and common consequences of quitting smoking. Regular walking and a balanced diet can limit this effect. The health benefits of quitting far outweigh the risk associated with gaining a few kilograms.
Can it be used during pregnancy?
No. It should not be used during pregnancy or breastfeeding. Discuss behavioral support and other options for quitting smoking during pregnancy with your physician.
How can I get the medicine free of charge?
You can contact your nearest smoking-cessation clinic. Call ALO 171 for clinic information and counseling.

Glossary

Cytisine
An alkaloid found in certain plants of the legume family and used for smoking cessation.
Cytisinicline
The name of the cytisine product being developed for FDA approval in the United States.
Partial agonist
A medicine that binds to a receptor and stimulates it less strongly than the natural substance.
α4β2 nicotinic receptor
The receptor subtype most responsible for nicotine's addictive effects in the brain.
Continuous abstinence
Not smoking at all during a specified period; confirmed in trials by biochemical tests.
CRL (Complete Response Letter)
A letter in which the FDA states that an application cannot be approved in its current form and identifies deficiencies.
Nitrosamine
An impurity that can form during the manufacture of some medicines and may carry a cancer risk with prolonged high exposure.

DROZDOGAN Academy Commentary

Once an inexpensive, old medicine largely confined to Eastern Europe for decades, cytisine has become one of the main smoking-cessation options over the past five years through large randomized trials, WHO recommendations, and the US approval process.

⚡ Why it matters

Approximately one-third of adults in Türkiye use tobacco every day, and this proportion has increased in recent years. An effective, well-tolerated, short-course medicine now provided free at smoking-cessation clinics is an important opportunity for people who want to quit. Quitting smoking is one of the most effective ways to prevent cancer and improve the success of cancer treatment.

✅ Strengths

Superiority to placebo is consistent in both the Cochrane review and two US phase 3 trials. Similar efficacy to varenicline, with fewer side effects. No new safety signal with 52 weeks of use. A short course, low cost, a simple drug-interaction profile, and inclusion in both the WHO guideline and its Essential Medicines List.

⚠️ Limitations

The strongest results came from the 12-week schedule, which is not used in Türkiye; the effect of the 25-day course may be more modest. Certainty of the comparison with varenicline is low. No added benefit was demonstrated in patients with tuberculosis. Data are limited in cancer patients, young people, and people over 65. US approval was delayed by manufacturing issues.

🩺 What to do in practice
  1. If you want to stop smoking, use medication together with behavioral support ; the combination offers the highest chance of success.
  2. Contact your nearest smoking-cessation clinic or call ALO 171; medicines can now be provided free of charge.
  3. If you have heart disease, are pregnant, or have a serious chronic illness, talk to your physician before starting the medicine.
  4. Plan your quit date (day 5) at the outset and tell people around you.
  5. An unsuccessful attempt is not a reason to stop trying; most people quit smoking after several attempts .
❓ Open questions

Would 12 weeks of treatment be more effective than the 25-day course used in Türkiye? Will cytisine be approved for quitting e-cigarettes? How much could systematic use in cancer patients and lung cancer screening programs improve quit rates? Does combining cytisine with nicotine replacement provide additional benefit?

Our brief conclusion: Cytisine (Nikitabs) is a short-course medicine with proven smoking-cessation efficacy similar to varenicline and fewer side effects. The FDA's complete response letter concerns manufacturing, not efficacy or safety, and does not affect use in Türkiye. Now that it is provided free at smoking-cessation clinics in Türkiye, the medicine is accessible to anyone who wants to stop smoking.

Transparency note
  • This article is the September 2026 update of our website's Nikitabs article. It was prepared using public sources (the Cochrane review, WHO announcements, the UK summary of product characteristics, NICE, Achieve Life Sciences press releases, professional publications, medicine price websites in Türkiye, and news sources). JAMA and JAMA Internal Medicine full texts could not be accessed; ORCA results were taken from company announcements and professional news reports.
  • Corrections and additions to the previous version: Numerical results from the ORCA trials, ORCA-OL and ORCA-V1 data, Cochrane 2023 findings, comparative studies against varenicline, the tuberculosis trial result (replacing the previous general statement), the WHO 2024 guideline, the free-medicine decision of July 4, 2026, and TÜİK 2025 data were added; the Nikitabs licensing date and SGK coverage status were clarified.
  • Based on secondary sources: Cytisine's addition to the WHO Essential Medicines List is supported by the WHO application page and an ASH announcement; the WHO news report on the list update did not specifically mention cytisine. The free-medicine decision and TÜİK data were taken from news sources; the Official Gazette text was not examined directly.
  • Not verified: The exact date of the FDA complete response letter (the company announcement is dated June 22, 2026); the precise wording in the current summary of product characteristics of the recommendation to "stop treatment if there is no effect during the first 3 days" and of the "use with caution" list; the year of first UK licensing (sources vary between 2019 and 2022); and varenicline availability in pharmacies.
  • Based on general knowledge: Cytisine's use in Bulgaria since the 1960s, varenicline's development using cytisine as a model, CYP1A2 interactions, and smoking's effects on cancer treatment were presented as established medical knowledge.
  • "Our assessment," the commentary on use in cancer patients, and the Academy commentary are our own.
  • The diagrams were derived from the verified statements in the article; they contain no new data.
  • This article is not personal medical advice. Decide whether to use the medicine together with your physician.

References

  1. Livingstone-Banks J ve ark. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 (CD006103.pub9). AAFP summary, September 2023.
  2. NICE. NG209 2024 exceptional surveillance: tobacco – preventing uptake, promoting quitting and treating dependence.
  3. World Health Organization. WHO releases first-ever clinical treatment guideline for tobacco cessation in adults. July 2, 2024.
  4. World Health Organization. 25th Expert Committee on Selection and Use of Essential Medicines: A.8 Cytisine – smoking cessation; WHO updates list of essential medicines, September 5, 2025. ASH: New tobacco cessation drug added to WHO EML.
  5. Rigotti NA ve ark. ORCA-2. JAMA. July 11, 2023. Achieve Life Sciences press release.
  6. Rigotti NA ve ark. ORCA-3. JAMA Intern Med. April 21, 2025. Achieve Life Sciences press release; CHEST Physician news report.
  7. ORCA-V1 (e-cigarette cessation). JAMA Intern Med. 2024. Achieve Life Sciences press release, May 6, 2024.
  8. Achieve Life Sciences. ORCA-OL 52-week safety data, ATS 2026. May 19, 2026.
  9. Achieve Life Sciences. NDA submission (June 26, 2025), NDA acceptance (September 3, 2025), FDA Complete Response Letter (June 22, 2026), second-quarter 2026 update (August 11, 2026).
  10. Achieve Life Sciences. Breakthrough Therapy designation for vaping cessation (July 31, 2024); Commissioner's National Priority Voucher (October 17, 2025).
  11. Courtney RJ ve ark. Effect of cytisine vs varenicline on smoking cessation. JAMA. 2021;326(1).
  12. Walker N ve ark. Cytisine versus varenicline for smoking cessation in New Zealand indigenous Māori (RAUORA). Addiction. 2021;116(10):2847-58.
  13. Dogar O ve ark. Cytisine for smoking cessation in patients with tuberculosis. Lancet Glob Health. November 2020.
  14. Cytisinicline 1.5 mg tablets, UK summary of product characteristics (SmPC), emc. Last updated October 31, 2025.
  15. NCSCT. Cytisine: summary and dosing guide.
  16. Nikitabs 1,5 mg film kaplı tablet kısa ürün bilgisi (KÜB); ilacabak.com and ilacfiyati.com, September 2026.
  17. Karar; TRT Haber. Sigarayı bırakmak isteyen 1 milyon kişiye ücretsiz ilaç desteği. July 4, 2026. Takvim, September 6, 2026.
  18. TÜİK Türkiye Sağlık Araştırması 2025 (news reports, September 2026).
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