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A randomised, placebo controlled phase 3 trial of Cannabidiol soft gel capsules in insomnia-related indications

Trial Profile

A randomised, placebo controlled phase 3 trial of Cannabidiol soft gel capsules in insomnia-related indications

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2025

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Sponsors Avecho Biotechnology

Most Recent Events

  • 03 Mar 2025 According to an Avecho Biotechnology media release, the company announced it has signed an exclusive ten-year development and licensing agreement with Sandoz Group AG for the commercial rights to Avecho's Phase III cannabidiol capsule for insomnia in Australia. Sandoz has agreed to an upfront licensing fee of US$3M (approx. A$4.8M[1]) for the exclusive commercial rights to the CBD product for insomnia in Australia. company will continue to fund and oversee the ongoing Phase III trial.
  • 22 Dec 2022 According to an Avecho Biotechnology media release, company has received ethics approval for this trial.
  • 04 Aug 2022 New trial record

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