Patients Dosed With Psilocybin in Phase 2b Trial for Adjustment Disorder in Palliative Care

Psyence BioMed announced multiple patients have been dosed in their phase 2b clinical trial of nature-derived psilocybin.¹ The trial is evaluating nature-derived psilocybin in combination with psychotherapy as a treatment for adjustment disorder for patients in palliative care.

The phase 2b study is multi-site (currently across 2 sites) and has a large sample size. With a double-blind and placebo-controlled design, investigators plan to enroll 87 participants across Australia, who will be randomly assigned into a therapeutic dose group for psilocybin (10 mg or 25 mg) or a low dose comparator (1 mg) for placebo. All groups will receive the assigned dosage or placebo along with structured psychotherapy. The study intends to investigate the efficacy, safety, and durability of patient response to psilocybin in combination with psychotherapy. Psyence noted that the goal of the study is to advance psilocybin as a first-in-class treatment for adjustment disorder in palliative care settings.

Jody Aufrichtig, chief executive officer of Psyence Biomed, said in a press release, “It demonstrates not only our team’s operational excellence but also the maturity of our clinical infrastructure. With a trial design that meets rigorous regulatory standards, Psyence BioMed is generating high-quality data to support future approvals, commercial readiness, and the advancement of a nature-derived psilocybin therapy for patients facing adjustment disorder in palliative care.”¹

Previous studies have found that psilocybin may reduce anxiety and depression related to life-threatening illness when combined with psychotherapy.² Patients in palliative care may not respond consistently to antidepressants or anxiolytics, and psilocybin may relieve end-of-life distress.³ Psilocybin is thought to alter activity and connectivity across the default-mode network (including the prefrontal cortex, the cingulate, and parietal and temporal association cortices).³ The drug is metabolized into psilocin, which is similar in structure to serotonin, and was shown to act primarily on 5HT receptors.⁴

“The randomization and dosing of these patients across multiple independent trial sites marks an exciting and validating milestone for Psyence BioMed,” added Clive Ward-Able, MD, medical director of Psyence, in a press release. “With multiple sites now operational and patients progressing through screening, we are seeing strong interest and momentum. This level of engagement reinforces the importance of our work in developing psilocybin-based therapies for palliative care.”¹

The company plans to expand the study to 3 actively enrolling sites in Australia to continue data collection, with topline results anticipated by the end of 2026.

References

1. Psyence Biomed doses multiple patients and expands clinical sites in phase IIb study for adjustment disorder in palliative care. Press release. November 6, 2025. Accessed November 7, 2025. https://www.biospace.com/press-releases/psyence-biomed-doses-multiple-patients-and-expands-clinical-sites-in-phase-iib-study-for-adjustment-disorder-in-palliative-care

2. Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181-1197.

3. Dorval M, Chang SL, Farzin H, et al. Roadmap for equitable access and responsible use of psilocybin-assisted psychotherapy in palliative care. Pall Med Rep. 2025;6(1):153-160.

4. Halberstadt AL, Geyer MA. Multiple receptors contribute to the behavioral effects of indoleamine hallucinogens. Neuropharmacology. 2011;61(3): 364–381.