Bioxyne Lands Initial Orders for GMP-Compliant Psilocybin Capsules

SYDNEY – Bioxyne Limited, an Australian life sciences and wellness products company, has received its first commercial orders for GMP-manufactured psilocybin capsules through its subsidiary Breathe Life Sciences (BLS). The capsules, branded BLSPSIL25, are intended for investigational use in addressing treatment-resistant depression, as well as exploratory research into other mental health conditions like anxiety and substance use disorders, and PTSD.

The initial orders cover 250 doses, sufficient to support treatment for about 60 patients over the next 12 months. Supplies are going to authorized prescribers in Queensland and Western Australia under Australia’s Therapeutic Goods Administration (TGA) Authorised Prescriber pathway. This follows the company’s 2024 achievement as the first [and for a time the only] entity in Australia to secure a GMP license for manufacturing psilocybin and MDMA.

The development marks a step from investment in psychedelic production capabilities to actual revenue generation in a market still bound by strict regulations. Australia became one of the first countries to permit psilocybin and MDMA prescriptions outside clinical trials in 2023, but access remains limited to authorized medical professionals for specific indications. Treatment-resistant depression affects an estimated 300,000 Australians though the current order volume reflects a modest initial rollout.

Bioxyne CEO Sam Watson described the orders as translating manufacturing expertise into “early commercial results and positive patient outcomes,” without providing further financial details in public releases.

This move positions Bioxyne among early participants in Australia’s regulated psychedelic therapy sector, where demand could grow as evidence from clinical studies accumulates. However, broader adoption depends on prescriber confidence, reimbursement pathways and ongoing safety data.