Avecho Nears Key Milestone in CBD Insomnia Trial Recruitment
Avecho Biotechnology is close to completing recruitment for the interim analysis cohort of its pivotal Phase III trial testing a CBD capsule for insomnia, with results expected in the first half of 2026.
- 190 of 210 patients dosed in Phase III CBD insomnia trial
- Recruitment extended due to strict participant criteria
- Interim analysis timeline to be confirmed post-recruitment
- Trial designed to meet Australian, US, and European regulatory standards
- Potential for first over-the-counter CBD insomnia product in Australia
Progressing Toward a Critical Clinical Milestone
Avecho Biotechnology Limited (ASX, AVE) has announced significant progress in its Phase III clinical trial evaluating its proprietary cannabidiol (CBD) TPM-enhanced soft-gel capsule for the treatment of insomnia. As of mid-December 2025, 190 participants have been dosed, nearing the 210-patient target required for the interim analysis cohort. This marks a pivotal moment for the company as it edges closer to a major inflection point in its clinical development program.
The trial, which is the largest of its kind testing CBD for insomnia in Australia, has experienced an extended recruitment timeline. This delay is attributed to the stringent inclusion and exclusion criteria designed to enroll a highly specific patient population. While this has slowed progress, Avecho’s leadership emphasizes that such precision is essential to maximize the likelihood of demonstrating the product’s efficacy and safety.
Design and Regulatory Ambitions
The Phase III trial is a multi-centre, randomized, double-blind, placebo-controlled study involving three groups receiving either 75mg or 150mg of CBD or a placebo nightly over eight weeks. Participants track their sleep quality and duration using validated questionnaires and sleep diaries, providing robust data on the product’s impact.
Importantly, the trial is structured to satisfy regulatory requirements not only in Australia but also in the United States and Europe. This strategic design reflects Avecho’s ambition to secure pharmaceutical registration and potentially pioneer the first over-the-counter CBD insomnia treatment in Australia. Regulatory changes in 2020 have opened the door for such products to be sold directly from pharmacies without prescriptions, provided they receive appropriate approvals.
Market Potential and Next Steps
Insomnia affects a significant portion of the global population, with estimates suggesting up to 237 million people worldwide suffer from symptoms. The sleep aids market is projected to reach nearly US$1 trillion by 2032, underscoring the commercial opportunity for effective treatments. In Australia alone, insomnia-related costs to the economy are estimated at A$19.1 billion annually.
Avecho expects to complete recruitment in early 2026 and subsequently announce the timeline for the interim analysis, targeted for the first half of 2026. The results of this analysis will be critical in determining the path forward for regulatory submissions and commercialisation strategies.
CEO Dr Paul Gavin highlighted the company’s focus on completing recruitment with the appropriate patient population to maximize success chances. He described reaching the interim analysis as a significant milestone, signaling a transition from patient enrolment to data evaluation.
Bottom Line?
With recruitment nearly complete, Avecho stands on the cusp of a defining moment that could reshape the Australian CBD insomnia market.
Questions in the middle?
- Will the interim analysis confirm the efficacy and safety needed for regulatory approval?
- How will Avecho navigate potential regulatory hurdles across multiple jurisdictions?
- What is the timeline for commercial launch if the trial results are positive?
