First new nicotine-free smoking-cessation therapy breaks 20-year gap

Marking the arrival of a new pharmacological option after two decades, Key Pharmaceuticals is launching Cyventine, a cytisine-based, nicotine-free treatment for smoking cessation. The privately owned Australian company is positioning the pharmacy-only medicine around evidence, education and broader consumer access.

Cytisine itself is far from new. Its modern clinical story stretches back decades, with researchers investigating a compound that had largely remained outside mainstream Western medicine. Dr Chris Bullen, Professor of Public Health and a leading smoking-cessation researcher in New Zealand, described its emergence as an example of an established molecule being revisited as researchers explored alternatives therapies.

“I’ve called it the smoking cessation medication that came from the cold. It literally did come from Eastern Europe around the time of the fall of the Soviet Union and the collapse of the Berlin Wall,” Dr Bullen told Health Industry Hub.

Cyventine represents a novel option at a time when Australia still has around 1.5 million people who smoke and many who have made repeated attempts to quit. The renewed interest in the therapy has been driven by a growing body of clinical evidence.

Leading the New Zealand trial comparing Cyventine with nicotine replacement therapy, Dr Bullen said Cyventine was more effective at helping participants quit smoking at six months, although it was associated with more side effects, which he characterised as “relatively uncommon and not serious”. He also pointed to the molecule’s subsequent comparison with Champix (varenicline), saying the study found no difference in efficacy, while reported nausea was lower in the Cyventine group.

The World Health Organization (WHO) added cytisine to its Model List of Essential Medicines in September 2025 to expand global access to affordable smoking cessation treatments, a development Dr Bullen said “carries a lot of weight with regulators”.

For Key Pharmaceuticals, the combination of clinical evidence, regulatory progress and the absence of a new smoking-cessation treatment for two decades created a rationale for bringing Cyventine to Australia.

The company’s proposition is shaped by its distribution model. Cyventine is available through pharmacists rather than requiring a GP prescription, giving consumers a familiar point of access to smoking-cessation support.

“Pharmacists are one of the most trusted professions in the country, and they are in every community,” said Trevor Juniper, COO of Key Pharmaceuticals.

The pharmacy-only model is particularly relevant where access to primary care is limited, especially across rural, remote and First Nations communities. Removing the need for a GP appointment reduces practical and financial barriers to accessing smoking-cessation treatment.

“It’s hugely helpful because accessibility is everything. It’s reducing the barriers to access for people who smoke to get what is essentially life-saving medication. It’s incredibly safe, and it should be widely available,” Dr Bullen emphasised.

He nevertheless identified circumstances where primary care involvement may be appropriate, particularly for people with severe chronic kidney disease, given Cyventine’s renal excretion, as well as pregnancy and breastfeeding where clinical studies are limited.

For Key Pharmaceuticals, the pharmacy channel is central to the launch strategy. The company said it is prioritising education before its broad consumer-facing launch in November, with training for pharmacists and pharmacy banner groups designed to help teams understand where Cyventine fits within the existing smoking-cessation toolkit.

“Nicotine addiction is really hard to break. That’s why so many people are still addicted to it,” said Meelian Hoh, CEO of Key Pharmaceuticals told Health Industry Hub. “Cyventine is giving Australians another choice in how they manage that quit attempt. It’s not a silver bullet, but it’s a real choice.”

The company is developing supporting tools around the treatment, including an app designed to assist consumers with the dosing schedule and broader resources intended to reinforce behavioural support. That emphasis on support extends to the company’s proactive engagement with pharmacists, GPs, NGOs and government programs like the Quit Line.

“There’s a whole ecosystem surrounding these people who want to quit smoking, including information and education. And then the product is made available after that,” explained Juniper.

Key Pharmaceuticals’ unique structure gives the company a longer investment horizon than a publicly listed pharmaceutical business.

“The beautiful thing about being Australian and privately owned is that we have a really long timeframe in terms of our investment,” stated Hoh. “We’re not here to make a quick buck. We’re not here for the quarter guidance earnings to stock market. We’re really invested in products that improve Australian consumers’ lives.”

The launch of Cyventine comes amid a broader debate around the importance of prevention in health spending which currently is around 2% in Australia, well below the OECD average.

Dr Bullen said investment in preventive health remained relatively limited compared with the burden of chronic disease, arguing that smoking cessation “should be embedded” more systematically into existing healthcare programs rather than treated as a standalone intervention. He pointed to opportunities across elective surgery delivery, lung cancer screening, diabetes vascular disease management, antenatal care and tuberculosis treatment, where identifying smokers and offering cessation support could make prevention part of routine clinical care.

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