Qnovia’s Heat-Free Inhalable Nicotine Replacement Therapy Posts Positive First-in-Human Data, Advances FDA and MHRA Filings as Funding Expands

Key Points

•  Qnovia reports positive Phase 1 results for inhalable NRT device.

•  RespiRx delivers cigarette-like nicotine uptake within seven minutes.

•  Trial included 25 healthy adults in 2025.

•  Company plans FDA NDA and UK MHRA submissions.

•  Startup has raised $50 million and prepares for next funding round.

2Firsts, February 24, 2026

According to Orange County Business Journa,  Medical technology startup Qnovia Inc. has announced positive results from its first-in-human Phase 1 clinical trial of RespiRx, a handheld inhalable nicotine replacement therapy (NRT) device designed to help smokers quit.

The 2025 trial enrolled 25 healthy adult participants and evaluated key pharmacokinetic measures, including peak nicotine concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and participants’ self-reported urge to smoke.

According to the company, RespiRx delivered peak blood nicotine levels in approximately seven minutes following 10 inhalations. Qnovia stated that this uptake profile resembles that of combustible cigarettes and was faster than traditional nicotine replacement products such as gum or patches.

The device consists of a handheld unit containing a nebule of pharmaceutical-grade nicotine, which is converted into a fine mist without the use of heat. The company said the absence of combustion eliminates exposure to additional harmful chemicals. The dosage is designed to taper over a 12-week cessation program.

Qnovia plans to pursue regulatory approval in both the United States and the United Kingdom. The company is preparing a New Drug Application (NDA) submission to the U.S. Food and Drug Administration and intends to submit to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) later this year.

The Irvine, California-based company has raised approximately $50 million to date and is preparing for an additional funding round. Founder and CEO Mario Danek stated that the clinical milestone supports the company’s commercialization plans.

In addition to the device, Qnovia is developing a behavioral health platform intended to track patient progress during cessation therapy.

(Cover Image: Qnovia’s handheld inhalable nicotine replacement therapy (NRT) device, RespiRx|Source: Orange County Business Journal )