This section highlights FDA-related milestones and regulatory updates for drugs developed by Lexaria Bioscience (LEXX).
Over the past two years, Lexaria Bioscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DehydraTECH-CBD, DehydraTECH-GLP-1, Semaglutide, and WEIGHT-A24-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DehydraTECH-CBD - FDA Regulatory Timeline and Events
DehydraTECH-CBD is a drug developed by Lexaria Bioscience for the following indication: Hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DehydraTECH-CBD
- Announced Date:
- November 20, 2024
- Indication:
- Hypertension
Announcement
Lexaria Bioscience Corp. announces that it has received final 12-week body weight and blood sugar results from all 12 study groups of the recently completed diabetes animal study WEIGHT-A24-1 (the "Study").
AI Summary
Lexaria Bioscience Corp. has announced that it received the final 12‐week body weight and blood sugar results from all 12 study groups in its recently completed diabetes animal study, WEIGHT-A24-1. The study, which used diabetic Zucker rats given unlimited food and water, compared several formulations utilizing Lexaria’s proprietary DehydraTECH technology against the approved Rybelsus® control group. Notably, the DehydraTECH-liraglutide and DehydraTECH-CBD formulations outperformed Rybelsus® by showing superior improvements in body weight loss and blood sugar control. Specifically, these top groups achieved body weight improvements of 11.53% and 10.65%, and blood sugar improvements of 11.13% and 3.35%, respectively. The positive trends observed from this animal study support Lexaria’s plans to advance into a Phase 1b human study in Australia, aiming to further evaluate the safety, tolerability, and effectiveness of their innovative formulations.
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DehydraTECH-GLP-1 - FDA Regulatory Timeline and Events
DehydraTECH-GLP-1 is a drug developed by Lexaria Bioscience for the following indication: Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DehydraTECH-GLP-1
- Announced Date:
- October 9, 2024
- Indication:
- Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Announcement
Lexaria Bioscience Corp. announce that dosing has begun, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) Zepbound® (tirzepatide) in an oral dose format.
AI Summary
Lexaria Bioscience Corp. has started dosing for its human pilot study #3, which tests an oral capsule version of DehydraTECH-processed tirzepatide from Zepbound®. The study involves up to 10 healthy volunteers and compares two treatment methods. In the first phase, subjects receive either the oral capsule or a single injection of tirzepatide. After a washout period, they switch to the alternate treatment during a second seven-day phase.
The study will check how well the drug is tolerated, measure blood levels, and monitor blood sugar control. Using the innovative DehydraTECH platform, Lexaria aims to improve absorption of tirzepatide, an important drug used for managing blood sugar levels. Early results are promising, as no serious adverse events have been seen so far, suggesting that the oral formulation could offer a safe and effective alternative to injections.
Read Announcement- Drug:
- DehydraTECH-GLP-1
- Announced Date:
- September 27, 2024
- Indication:
- Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Announcement
Lexaria Bioscience Corp announce that approval has been received from an independent review board, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action GLP-1 (glucagon-like peptide) + GIP (glucose-dependent insulinotropic peptide) tirzepatide in an oral dose format..
AI Summary
Lexaria Bioscience Corp. has announced that an independent review board has approved human pilot study #3. This study will test a DehydraTECH-processed version of tirzepatide—a dual action GLP-1 and GIP therapy—delivered in a swallowed oral format. The study aims to determine if this new oral formulation, created using the commercially available Zepbound® injectable product, can provide effective drug absorption and stable blood sugar control while reducing side effects, compared to traditional injectable dosing.
Up to 10 healthy volunteers will participate in this week-long pilot study. Researchers will evaluate blood absorption levels, tolerability, and blood sugar regulation with regular blood samples taken over a 10-hour period plus a final sample at 24 hours after the dose. Subject recruitment will begin soon, with first dosing expected in late October and final doses administered in late November.
Read Announcement- Drug:
- DehydraTECH-GLP-1
- Announced Date:
- August 29, 2024
- Indication:
- Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Announcement
Lexaria Bioscience Corp. announces that tolerability and additional pharmacokinetic ("PK") results from human pilot study #2, GLP-1-H24-2, (the "Study") have been received. Lexaria's DehydraTECH-processed Rybelsus® capsules demonstrated superior tolerability in delivering the GLP-1 drug semaglutide versus commercially available Rybelsus®.
AI Summary
Lexaria Bioscience Corp. recently announced key results from its human pilot study #2, GLP-1-H24-2, which evaluated their DehydraTECH-processed Rybelsus® capsules. The study found that the DehydraTECH capsules, designed to deliver the GLP-1 drug semaglutide, showed superior tolerability compared to the commercially available Rybelsus® tablets. Notably, none of the nine participants who took the DehydraTECH capsules experienced any adverse events, whereas six out of nine who received the standard tablet encountered mild side effects. The capsules also demonstrated promising pharmacokinetic properties, matching or exceeding the blood concentration levels achieved by the regular tablets. These findings support Lexaria’s goal to enhance drug absorption and tolerability, potentially leading to more effective oral delivery of GLP-1 drugs in the future.
Read Announcement- Drug:
- DehydraTECH-GLP-1
- Announced Date:
- August 27, 2024
- Indication:
- Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Announcement
Lexaria Bioscience Corp. announces that the first results from human pilot study #2, GLP-1-H24-2 (the "Study"), have been received. Lexaria's DehydraTECH®-processed Rybelsus® evidenced a trend toward higher overall absorption compared to Rybelsus® that was not processed with DehydraTECH.
AI Summary
Lexaria Bioscience Corp. announced the first results from its human pilot study #2, GLP-1-H24-2. The study compared equal 7 mg semaglutide doses in two forms: a standard Rybelsus® swallowed tablet and a DehydraTECH®-processed Rybelsus® swallowed capsule, with the medications taken under fed conditions. The DehydraTECH®-processed version showed a trend toward higher overall absorption, with an average of 18.8% higher semaglutide levels observed over 24 hours. Although the differences in absorption were not statistically significant due to a small sample size, the trend suggests that the DehydraTECH® process may enhance the drug's bioavailability even when food is present.
These results build on earlier findings under fasted conditions, highlighting continued pharmacokinetic improvements. Lexaria plans to further develop its GLP-1 experimental program by finalizing ongoing animal studies and preparing for a 12-week chronic human study under fasted dosing. The achievements support continued research into improving oral drug delivery systems.
Read Announcement- Drug:
- DehydraTECH-GLP-1
- Announced Date:
- August 19, 2024
- Indication:
- Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Announcement
Lexaria Bioscience Corp. announces positive findings from its applied research program together with the National Research Council of Canada ("NRC") that evaluated important mode of action facets of DehydraTECH processed with the glucagon-peptide 1 ("GLP-1") drug, semaglutide.
AI Summary
Lexaria Bioscience Corp. announced positive research findings in collaboration with the National Research Council of Canada. The study focused on key mode of action features of their DehydraTECH technology when used with the GLP-1 drug semaglutide. Researchers compared DehydraTECH-processed semaglutide to the commercial product Rybelsus® by testing them in simulated gastric fluid to mimic conditions in the human gut.
Using methods such as PAGE and SEC, the study showed that semaglutide was efficiently released and maintained its monomeric form—an important property that allows the drug to cross the gastric barrier and be absorbed into the bloodstream. This positive outcome is notable because it demonstrates that Lexaria’s DehydraTECH can achieve the desired monomeric state without the SNAC ingredient found in Rybelsus®. These promising results support further research into improving oral delivery of GLP-1 drugs.
Read Announcement- Drug:
- DehydraTECH-GLP-1
- Announced Date:
- June 18, 2024
- Indication:
- Formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
Announcement
Lexaria Bioscience Corp. announces it has now hired a contract research organization ("CRO") to oversee execution of the Company's 12-week chronic study GLP-1-H24-4, (the "Study") which will evaluate various DehydraTECH-GLP-1 (glucagon-like peptide) formulations and other treatments with efficacy objectives of weight loss, blood sugar reduction, and more.
AI Summary
Lexaria Bioscience Corp. has announced that it has hired a contract research organization (CRO) to manage its upcoming 12-week chronic study called GLP-1-H24-4. This study will test several DehydraTECH-GLP-1 formulations along with other treatments. The main goals are to investigate how these treatments can help with weight loss and lower blood sugar levels. The study’s design includes multiple treatment arms and will involve diabetic patients who will receive a daily oral dose over the study period.
The CRO will guide the full clinical protocol design, consult with medical experts, handle regulatory submissions, and plan data management. Lexaria believes that this expanded study will provide important information on the safety and effectiveness of its DehydraTECH-GLP-1 formulations. The company aims to better understand how these treatments can improve patient outcomes in the fields of weight loss and blood sugar control.
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Semaglutide - FDA Regulatory Timeline and Events
Semaglutide is a drug developed by Lexaria Bioscience for the following indication: To assess fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Semaglutide
- Announced Date:
- May 28, 2025
- Indication:
- To assess fibrosis.
Announcement
Veru Inc. announced positive topline safety results from the Phase 2b QUALITY clinical study, a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial, designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to enhance fat loss and to prevent muscle loss in older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management.
AI Summary
Veru Inc. announced positive topline safety results from its Phase 2b QUALITY clinical study. This trial, a multicenter, double-blind, placebo-controlled, randomized, dose-finding study, evaluated enobosarm 3mg and 6mg versus placebo in combination with semaglutide (Wegovy®) in patients aged 60 and older undergoing chronic weight management. The study was designed to determine whether enobosarm could enhance fat loss while preventing muscle loss.
Results show that the enobosarm 3mg plus semaglutide combination maintained a positive safety profile by avoiding increased gastrointestinal side effects compared to semaglutide alone. Notably, enobosarm 3mg promoted a highly selective fat loss while preserving lean muscle mass. Based on these promising findings, Veru Inc. will advance the enobosarm 3mg dose into its Phase 3 clinical program and has requested an End of Phase 2 meeting with the FDA to gain further regulatory clarity.
Read Announcement- Drug:
- Semaglutide
- Announced Date:
- February 27, 2025
- Indication:
- To assess fibrosis.
Announcement
Lexaria Bioscience , provides the following glucagon-like peptide-1 ("GLP-1") strategic update.
AI Summary
Lexaria Bioscience has announced a new strategic update focused on advancing glucagon-like peptide-1 (GLP-1) therapies using its patented DehydraTECH technology. The company is taking a three-part approach in this sector. The first part of the strategy is to attract pharmaceutical companies interested in integrating Lexaria’s drug delivery platform with their existing medications, as shown by a recent material transfer agreement and ongoing collaboration efforts.
The second element involves exploring the development and launch of a patented DehydraTECH-CBD product within the GLP-1 field, either through partnerships or internal development. The third part targets the creation of the world’s first oral version of liraglutide, a popular injectable GLP-1 drug. This innovative approach may help reduce side effects and eliminate the need for injections, providing a more patient-friendly option in the growing GLP-1 market.
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WEIGHT-A24-1 - FDA Regulatory Timeline and Events
WEIGHT-A24-1 is a drug developed by Lexaria Bioscience for the following indication: In GLP-1.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- WEIGHT-A24-1
- Announced Date:
- July 17, 2024
- Indication:
- In GLP-1
Announcement
Lexaria Bioscience Corp. announces that interim results from the first four weeks of dosing in its ongoing diabetes animal study WEIGHT-A24-1 (the "Study") have been received and have already produced several noteworthy findings.
AI Summary
Lexaria Bioscience Corp. has shared interim results from the first four weeks of dosing in its ongoing diabetes animal study, WEIGHT-A24-1. The study used diabetic, pre-conditioned Zucker rats, and the findings are already showing promising trends in body weight control. During a 34-day acclimation period, the rats gained about 10.9% in body weight on average. In the subsequent 28 days of treatment with various DehydraTECH-processed drug formulations, many groups experienced a marked decrease in the rate of weight gain. Notably, the DehydraTECH-CBD formulation 3 and the first oral version of DehydraTECH-liraglutide produced the largest weight losses of approximately -1.50% and -1.58%, respectively.
These early results are being used to select the best-performing formulations for the next phase of the study, as dosing continues for an additional 56 days. The ongoing research highlights the potential of DehydraTECH processing to enhance drug delivery in diabetes treatment.
Read Announcement
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