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Powerful New Tobacco Cessation Drug Added to WHO Essential Medicines List – Cytisine
GENEVA, SWITZERLAND – SEPTEMBER 5, 2025 – Today, the World Health Organization (WHO) released the 2025 version of the WHO Model List of Essential Medicines (EML) with a major addition to help people who have been addicted by commercial recreational nicotine products – cytisine.
“It has been years since a new tobacco cessation drug has been added to the EML. Cytisine has demonstrated its safety and efficacy for cessation for decades and to have it on the EML is a wonderful opportunity for it to be used in many more countries,” said Dr. Carolyn Dresler, ASH Board Trustee. “As we strive for a world where no one dies from their tobacco addiction, cytisine can be a useful addition to helping people quit.”
The Executive Summary of the Report of the 25th WHO Expert Committee on the Selection and Use of Essential Medicines noted:
Section 24.5.2 Medicines for nicotine use disorders
The Expert Committee recommended the inclusion of cytisine (INN cytisinicline) on the core list of the EML for use as an aid to stopping smoking and tobacco use, based on a favourable balance of benefits and harms, in an area of major public health need. The Committee considered that the availability of different smoking cessation treatments serves to provide valuable options and choice for patients and clinicians, could facilitate market competition, reduce costs and improve access to effective smoking and tobacco cessation treatments for national health systems.
Cytisine is a plant-derived alkaloid and structurally similar to nicotine. It is the oldest medicine used in smoking cessation, used in Central and Eastern Europe since the mid-1960s, is extremely effective with fewer side effects, and can be provided at a lower cost to patients.
“Including cytisine in the WHO Model List of Essential Medicines (EML) provides a new global standard for access to effective and affordable smoking cessation products,” said Laurent Huber, Executive Director of Action on Smoking and Health. “Increasing access to and quality of smoking cessation support is the life-or-death reality for 1.3 billion people around the world today. ASH welcomes the addition of cytisine to the EML and encourages all countries to facilitate access to nicotine cessation treatment programs.”
Smoking remains the leading cause of preventable death and disease worldwide. According to WHO estimates, there are 1.3 billion addicted tobacco users worldwide. The majority of people who smoke started as children, want to quit, and wish they had never started.
“Adding cytisine to the WHO list of essential medicines has the potential to promote its inclusion in national lists, which may increase the therapeutic arsenal for treating tobacco dependence,” wrote Dr. Miguel Asqueta Sóñora, Technical Director of the Center for International Cooperation on Tobacco Control, Ministerio de Salud Pública / Uruguay, in their letter of support to the WHO Expert Committee on the Selection and Use of Essential Medicines.
“Providing assistance to people who use tobacco is a humane and necessary part of ending the tobacco epidemic and avoiding the unnecessary pain and suffering caused by tobacco-related diseases by helping more people to stop tobacco use earlier than could be achieved without such support,” wrote Professor Coral Gartner, Director of NHMRC Centre of Research Excellence on Achieving the Tobacco Endgame at the University of Queensland in their letter of support to the WHO Expert Committee.
“Integrating cytisine into smoking cessation programs can save lives, alleviate healthcare costs, and reinforce existing tobacco control policies. By providing tobacco users with accessible and effective treatment options, we can make meaningful strides toward a healthier, tobacco-free future for Kenya and beyond,” wrote Joel Gitali, Chairman of the Kenya Tobacco Control and Health Promotion Alliance in their letter of support to the WHO Expert Committee.
“Cytisine has been used in many countries and has been proven to be at least as effective as NRT and significantly less likely to produce side effects compared to antidepressants. Coupled with behavioral support, cytisine’s inclusion in the WHO Model List of Essential Medicines will boost smoking cessation efforts globally… In time, with widespread use, research into cytisine could drive further innovation and improve access to lifesaving medications that help with quitting tobacco products,” wrote Dr. Ulysses Dorotheo, Executive Director of the Southeast Asia Tobacco Control Alliance in their letter of support to the WHO Expert Committee.
Robust smoking cessation support is one of the main strategies included in the WHO’s MPOWER package and is a specific article (14) in the global tobacco treaty – the WHO Framework Convention on Tobacco Control (FCTC).
However, the WHO Report on the Global Tobacco Epidemic 2025 shows that cessation policies are still among the least implemented of all WHO FCTC demand reduction measures, as “less than one third of high-income countries, 11% of middle-income countries and 4% of low-income countries offer comprehensive cessation support at best-practice level.”
Cytisine, called cytisinicline in the U.S, is currently being reviewed for potential approval by the FDA.
Adding cytisine to the WHO EML is a chance to enhance global tobacco cessation support – an opportunity every country must act on immediately to prioritize the health of their citizens over the financial interests of recreational tobacco and nicotine corporations.
ACTION ON SMOKING AND HEALTH
Founded in 1967, Action on Smoking and Health (ASH) is America’s oldest anti-tobacco organization, dedicated to a world with ZERO tobacco deaths. Because tobacco is the leading cause of preventable death worldwide, ASH supports bold solutions proportionate to the magnitude of the problem. https://ash.org