Lexaria Bioscience Corp. announces that, on January 29, it submitted its much-anticipated Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD. This IND submission follows a successful pre-IND meeting with the FDA which provided Lexaria with guidance related to the development and filing of the IND.

From 2018 through 2023, Lexaria sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people, without recording a single serious adverse event (the "Studies"). These Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard of care medications; suggesting that DehydraTECH-CBD has the potential to have broad therapeutic utility. Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding.

The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.