A Phase 1 clinical trial of Qnovia’s RespiRx handheld inhalable nicotine replacement therapy (NRT) revealed cigarette-comparable nicotine delivery with favorable safety profile.


Qnovia Inc reported positive results from its Phase 1 clinical trial evaluating the safety and efficacy of RespiRx, a handheld inhalable nicotine replacement therapy (NRT) designed to help smokers quit.

The clinical trial was conducted in 2025 on 25 healthy adults and aimed to identify the pharmacokinetic profile of RespiRx in relation to cigarettes and Nicotrol Inhaler, a buccal NRT whose production was discontinued in 2023.

Key findings include:

  • A lower plasma nicotine exposure than cigarettes, while maintaining effective craving relief without excessive dosing
  • Delivers cigarette-like nicotine uptake, an essential factor for effective craving control and smoking cessation. Reaching peak blood levels in 7 minutes with just 10 puffs (Cmax 8.7 ng/mL), demonstrating a Tmax comparable to combustible cigarettes of ~6 minutes, significantly outperforming authorized legacy nicotine replacement therapies
  • Meaningful reduction in urge-to-smoke scores, suggesting effective satiation
  • No serious side effects or adverse events; only a moderate cough was reported

The study employed a randomized, open-label, three-way crossover design for adult smokers. Participants received single doses of RespiRx, a traditional cigarette and Nicotrol Inhaler in a randomized fashion. This allowed researchers to effectively evaluate and compare peak nicotine levels (Cmax), nicotine exposure over time (Tmax), the rate at which nicotine reached the bloodstream (AUC), and participants’ urge to smoke score.

The company says its ultraportable vibrating mesh nebulizer is poised to be the first safe and effective NRT innovation introduced to the market in over 20 years.

“We are very encouraged by the results of the first-in-human FDA trial of RespiRx,” said Mario Danek, founder and CEO of Qnovia. “The findings show that our novel nicotine delivery method — via a cool mist, without any heating or combustion — matches the speed and habit-loop of smoking and vaping without the carcinogens. As the first major NRT innovation in two decades, and first-ever truly inhaled Investigational New Drug-cleared NRT, RespiRx is uniquely positioned to globally drive towards a smoke-free generation and meaningfully reduce the burden of smoking-related disease.”