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A Phase 2b double-blind, randomized, low-dose comparator-controlled clinical trial to assess the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis

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Trial Profile

A Phase 2b double-blind, randomized, low-dose comparator-controlled clinical trial to assess the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jan 2026

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At a glance

  • Drugs Psilocybin (Primary)
  • Indications Adjustment disorders
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Psyence Group

Most Recent Events

  • 19 Dec 2025 According to a Psyence Biomed media release, Bellberry Human Research Ethics Committee (HREC) authorization applies to all participating study sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne
  • 19 Dec 2025 According to a Psyence Biomed media release, Company has also begun planning the activation of additional clinical sites to further accelerate patient recruitment and advance the Phase IIb program.
  • 19 Dec 2025 According to a Psyence Biomed media release, the company announced that the Bellberry Human Research Ethics Committee (HREC) has formally approved the use of NPX5 in the ongoing Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer.

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