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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: 02 Dec 2025

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At a glance

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

Most Recent Events

  • 06 Nov 2025 According to a Psyence Biomed media release, patients have now been dosed across two active clinical sites - the Empax Center in Perth and the Mind Medicine Australia Clinic in Melbourne.
  • 06 Nov 2025 According to a Psyence Biomed media release, company has also activated Paratus Clinical Research in Melbourne to expand the study to three actively enrolling sites and accelerate data collection toward topline results anticipated by year-end 2026.
  • 06 Nov 2025 According to a Psyence Biomed media release, today announced multiple patients successfully dosed in ongoing phase IIb clinical trial evaluating nature-derived psilocybin, in combination with psychotherapy.

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