Cytisine included in the WHO list of essential medicines

The World Health Organization (WHO) has decided to include cytisine, a smoking cessation treatment, on the Model list of essential medicines (EML). This decision, adopted by the Expert Committee at its 25th meeting, marks a major step forward in the global fight against tobacco use. It paves the way for greater access to this effective, affordable, and safe medicine, particularly in low- and middle-income countries, where cessation options remain limited.

A new treatment recognized by the WHO

Cytisine (or cytisinicline) is a natural alkaloid extracted from certain plants of the Fabaceae family, notably the Cytisus laburnumIt is a partial agonist of nicotinic receptors, acting as a "pharmacological substitute" for nicotine: it alleviates withdrawal symptoms and reduces the effects of smoked tobacco, without producing the same effects as nicotine. Its mode of action is similar to that of varenicline, another reference partial agonist.

Used for over half a century in Eastern Europe and Central Asia, cytisine has until now had only limited international recognition. Its inclusion in the WHO Model List of Essential Medicines is a decisive step in its recognition as a standard treatment for smoking cessation.

The assessment conducted by the WHO Expert Committee was based on a robust body of clinical data. Several randomized trials have shown that cytisine increases the chances of long-term abstinence by two to three times compared to a placebo. The results indicate an efficacy comparable to that of varenicline, with a safety profile considered favorable. Adverse effects, generally mild and transient, mainly concern mild digestive disorders or nausea, which are significantly less marked than with other treatments for tobacco dependence.

The standard dosage, in the form of a 25-day course, offers additional advantages in terms of simplicity and compliance. New protocols, tested over 6 to 12 weeks, have also demonstrated enhanced efficacy and excellent tolerance, offering greater flexibility depending on addiction profiles.

Several systematic reviews, including Cochrane 2023, confirm that cytisine is now among the most effective treatments available, with comparable efficacy to varenicline and often a more favorable safety profile. By including it on its Model List, the WHO officially recognizes its strategic role in tobacco control and includes it alongside nicotine replacement therapy, bupropion, and varenicline, thus expanding the range of validated and accessible therapies.

A response to a major public health issue and a lever for accessibility

Tobacco use remains one of the world's leading health scourges, responsible for more than 8 million premature deaths each year. It also places a heavy economic burden on healthcare systems due to the chronic diseases it causes (cancers, cardiovascular diseases, respiratory conditions, and diabetes). In this context, increasing access to effective smoking cessation treatments is a major public health priority.

The WHO emphasizes that a diversity of treatment options is essential to meet patients' needs. Some patients tolerate nicotine replacement therapy better, others bupropion or varenicline; the addition of cytisine broadens the range of solutions, allowing for more personalized approaches and increasing the chances of successful cessation.

The expected impact goes far beyond scientific recognition. Inclusion of a medicine in the WHO Model List sends a strong signal to countries, encouraging them to include it in their own national lists of essential medicines. This inclusion paves the way for wider dissemination, particularly in low- and middle-income countries, where access to cessation treatments is often limited by cost or availability. The low production cost of cytisine represents a major asset, offering the potential to reduce inequalities in access and stimulate market competition, which could lead to an overall reduction in the price of other cessation treatments.

Beyond the therapeutic and economic aspects, this decision is part of a global political and normative dynamic. It strengthens the implementation of the WHO Framework Convention on Tobacco Control (FCTC), in particular its Article 14, which calls on Parties to promote access to effective treatments for smoking cessation and nicotine dependence. The inclusion of cytisine thus provides an additional tool for States to meet their international commitments and strengthen their public health policies.[1].

By making smoking cessation more accessible, regardless of income or country of residence, the WHO is sending a clear message: quitting smoking must become a universal right. This progress could make a decisive contribution to accelerating the decline in tobacco use worldwide and bringing closer the health goals set by the 2030 Agenda for Sustainable Development.

©Generation Without Tobacco

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[1] Press release, Powerful New Tobacco Cessation Drug Added to WHO Essential Medicines List – Cytisine, Action on Smoking and Health, published September 5, 2025, accessed September 8, 2025