Lexaria Files IND Application for DehydraTECH-CBD Hypertension Trial

On January 29, 2024, Lexaria Bioscience Corp., a leading developer of drug delivery platforms, submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its upcoming clinical trial, HYPER-H23-1, which will focus on the use of DehydraTECH-CBD for hypertension. This submission came after a productive pre-IND meeting with the FDA, which provided Lexaria with valuable guidance on the IND development process.
Since 2018, Lexaria has sponsored five clinical studies involving DehydraTECH-CBD, involving a total of 134 participants. These studies have shown promising results, with significant reductions in resting blood pressure observed in both short-term and extended dosing periods, and in some cases, when used in conjunction with standard medications. This suggests that DehydraTECH-CBD could have a wide range of therapeutic applications.
According to the FDA's guidelines, once an IND application is submitted, there is a mandatory 30-day waiting period before any clinical trials can commence. This allows the FDA to review the application for safety and ensure that the research subjects are not exposed to unnecessary risks.
Lexaria is eager to start the HYPER-H23-1 clinical trial as soon as the IND becomes effective, subject to certain conditions, including securing necessary funding. The successful completion of the IND review process will be a significant milestone for the company, indicating that its DehydraTECH technology has passed rigorous regulatory scrutiny and is on track for potential future pharmaceutical commercialization.
The HYPER-H23-1 clinical trial is designed as a Phase 1b, randomized, double-blind, placebo-controlled study. It aims to assess the safety, pharmacokinetics, and pharmacodynamics of DehydraTECH-CBD in subjects with Stage 1 or Stage 2 hypertension. The primary goal is to evaluate the safety and tolerability of the treatment in hypertensive patients, with secondary objectives focusing on its efficacy in reducing blood pressure and conducting detailed pharmacokinetic assessments.
All procedures related to the HYPER-H23-1 study, including clinical, laboratory, and analysis tasks, will be carried out by independent U.S.-based contract service providers.
DehydraTECH™ is Lexaria's patented drug delivery technology that enhances the oral absorption of active pharmaceutical ingredients (APIs). Since 2016, Lexaria has been refining DehydraTECH for various beneficial molecules in oral and topical applications. The technology has shown the ability to increase bio-absorption and has demonstrated potential for more effective delivery of certain drugs across the blood-brain barrier, which is particularly significant for centrally acting drugs. Lexaria operates a licensed research lab and holds a strong intellectual property portfolio, with 38 patents granted and numerous pending worldwide.

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