Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.
- New clinical trial sites launched in Sydney and Gold Coast
- Targeting completion of ~210 patients before interim analysis in early 2026
- Sandoz partnership provides funding and recruitment support
- Regulatory planning underway for TGA registration and commercialization
- Trial designed to meet Australian and international regulatory standards
Expanding the Clinical Footprint
Avecho Biotechnology Limited has taken a significant step forward in its development of a cannabidiol (CBD) treatment for insomnia by activating three new clinical trial sites across Sydney and the Gold Coast. This expansion follows the company’s recent licensing agreement with Sandoz AG, a global leader in generic and biosimilar medicines, which has brought both capital and operational expertise to the project.
These new sites tap into independent databases of insomnia patients, providing a fresh and valuable pool of potential participants. Recruitment, which had paused over the summer months, has now resumed with renewed momentum, aiming to complete dosing for approximately 210 subjects ahead of a planned interim analysis in early 2026.
Strategic Partnership with Sandoz
The collaboration with Sandoz, formalized in March 2025, is more than a financial boost. Avecho’s CEO, Dr Paul Gavin, highlights that Sandoz’s deep regulatory and operational experience is already enhancing trial execution and patient recruitment efforts. The partnership also includes joint planning for regulatory submissions to the Australian Therapeutic Goods Administration (TGA) and strategies for commercial launch, positioning Avecho’s CBD product for a potentially expedited path to market.
Sandoz’s involvement is particularly timely given recent regulatory changes in Australia that allow over-the-counter sales of approved CBD products without a prescription. Avecho’s Phase III trial is designed to meet stringent requirements not only from the TGA but also from international bodies such as the US Food and Drug Administration and the European Medicines Agency, underscoring the global ambitions of the program.
The Trial and Market Potential
The Phase III trial is the largest of its kind in Australia testing cannabidiol for insomnia. Participants are randomized to receive either 75mg or 150mg doses of the CBD TPM-enhanced soft-gel capsule or a placebo over eight weeks, with sleep quality and duration tracked through validated questionnaires and diaries. The trial’s success could pave the way for the first pharmaceutical-grade CBD insomnia treatment available over the counter in Australia.
Insomnia affects a significant portion of the population, with estimates suggesting up to 60% of Australians experience symptoms, and the global sleep aids market projected to reach nearly US$1 trillion by 2032. Avecho’s product, leveraging its proprietary Tocopheryl Phosphate Mixture (TPM) technology to enhance CBD absorption, aims to capture a meaningful share of this expanding market.
Looking Ahead
With recruitment accelerating and regulatory planning well underway, Avecho is positioning itself at a critical inflection point. The interim analysis expected in early 2026 will be a key milestone, potentially unlocking further value and commercial opportunities. The collaboration with Sandoz not only strengthens Avecho’s operational capabilities but also signals confidence from a major pharmaceutical player in the company’s innovative approach to insomnia treatment.
Bottom Line?
Avecho’s expanded trial and Sandoz partnership set the stage for a pivotal moment in Australia’s CBD insomnia market.
Questions in the middle?
- Will the interim analysis confirm the efficacy needed for TGA approval?
- How quickly can Avecho and Sandoz translate trial success into commercial sales?
- What impact will regulatory changes have on competitive dynamics in the Australian CBD market?