Qnovia's Inhaled Nicotine Replacement Therapy Delivers Positive Results in First Human Study

RespiRx ™ achieves cigarette-comparable nicotine delivery with favorable safety profile,
marking first major advancement in smoking cessation in decades

IRVINE, Calif., Feb. 10, 2026 /PRNewswire/ -- Qnovia, Inc., a pharmaceutical and medtech company revolutionizing inhaled therapeutics, today announced positive results from its Phase 1 clinical trial evaluating the safety and efficacy of RespiRx™, a handheld inhalable nicotine replacement therapy (NRT). With this milestone, Qnovia's ultraportable vibrating mesh nebulizer is poised to be the first safe and effective NRT innovation introduced to the market in over 20 years.

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.

"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." ‑

Smoking remains the world's leading cause of preventable death. The World Health Organization estimates about 8 million deaths annually among roughly 1.2 billion smokers across the globe. And yet, quit rates remain in the single digits, with most going "cold turkey." In fact, 70% of worldwide smokers want to quit, but relapse rates sit between 60% to 90% within the year. While several nicotine replacement therapies (patches, gums, lozenges, legacy devices, etc.) exist, they typically have low success rate due to slow onset, sensory mismatch and poor adherence.

"Most current FDA-approved therapies were designed decades ago and fail to reflect the neurobiology, pharmacokinetics, and behavioral drivers of addiction," Danek added. "The consequence is staggering: smoking-related disease is projected to generate trillions of dollars in direct and indirect healthcare burden over the coming decade, spanning respiratory disease, cardiovascular morbidity, cancer, and premature mortality."

Robert West, Chairman of Qnovia's Scientific Advisory Board, Professor Emeritus of Health Psychology at University College London, and one of the world's most influential behavioral scientists in smoking cessation commented:

"From the very early days of development of nicotine replacement therapy to help smokers quit, the challenge was to find a way to give smokers the nicotine they crave in a way that eases their transition to becoming non-smokers. Medicinal nicotine products, such as skin patches and gum, have lacked the speed of nicotine delivery needed for many smokers, while, more recently, e-cigarettes, as mass-market products, have raised concerns about creating or sustaining nicotine addiction in people who would otherwise not have smoked. Qnovia's nicotine device offers the prospect of a medicinal nicotine product that is effective at controlling cigarette cravings and easing the transition to smoking cessation for millions of smokers."

Qnovia's RespiRx™ platform represents a category-defining shift, engineered to deliver controlled, pharmaceutical-grade nicotine directly to the lung — without combustion, smoke, or carcinogens — while preserving the rapid onset and sensory cues that reinforce smoking behavior. By restoring pulmonary delivery and clinically relevant pharmacokinetics, RespiRx addresses the primary reasons conventional NRTs underperform in real-world settings. 

About Qnovia, Inc.
Qnovia, Inc. is a pharmaceutical and medtech company focused on developing and commercializing proprietary inhalation device technologies to improve patient outcomes. The company's drug delivery platform, the RespiRx™, is the first cartridge-based, ultra-portable vibrating mesh nebulizer. Qnovia sees significant opportunity to utilize its drug delivery technologies to improve the treatment of several indication areas with several generic as well as select investigational new drugs. The company was founded by Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies. Learn more at www.qnovia.com.

SOURCE Qnovia, Inc.