Entropy secures South African patent for psilocybin fibromyalgia treatment
Entropy Neurodynamics (ASX: ENP) has been granted a South African patent covering methods of treating fibromyalgia using psilocybin and psilocin-based treatments, a development the clinical-stage biotechnology company says strengthens its global intellectual property estate.
The patent has been granted under South African Patent No. 2025/01722, entitled “Methods of Treating Fibromyalgia with Compositions Comprising Psilocybin.”
Its term extends to 11 September 2043, subject to the payment of annual renewal fees. According to the Company, the grant expands a growing global IP portfolio supporting the development of its lead program, TRP-8803.
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What the patent actually protects
The protection secured is broader than a simple claim over the use of psilocybin. It covers a full therapeutic framework spanning the clinical development, delivery and manufacture of psychedelic-based fibromyalgia therapies.
According to the announcement, the granted patent covers:
- Therapeutic methods
- Dosing regimens
- Patient selection criteria
- Clinical assessment protocols
- Biomarkers
- Treatment outcome measures
- Integration therapy
- Manufacture
Collectively, the claims establish a comprehensive intellectual property position designed to provide meaningful commercial exclusivity as Entropy advances its psychedelic development programs. The Company noted the claims were devised to be difficult for competitors to design around, creating what it describes as indication-level protection within the jurisdiction.
CEO Commentary — Jason Carroll
“Importantly, the claims extend well beyond simply protecting the use of psilocybin and related therapies. They encompass the broader therapeutic framework, including dosing protocols, patient selection, clinical assessments and treatment methodology, creating comprehensive, indication-level intellectual property protection that we believe will be difficult for competitors to replicate.”
Understanding fibromyalgia and the psychedelic treatment opportunity
Fibromyalgia is a chronic pain disorder characterised by widespread musculoskeletal pain, fatigue, sleep disturbance and cognitive impairment. The condition affects millions of people globally and remains an area of significant unmet medical need.
Currently available therapies provide limited efficacy for many patients.
The scale of the opportunity is notable. The South African fibromyalgia treatment market was valued at US$1.9Bn in 2025, according to third-party data cited by the Company from Mobility Foresights. A sizeable addressable market combined with defined IP protection creates long-term commercial optionality.
Why the patent matters for the investment case
The grant complements Entropy’s broader IP strategy, which is focused on securing protection across key therapeutic indications and jurisdictions to maximise the long-term commercial value of its psychedelic medicine platform.
Strong intellectual property can enhance the value of development programs, support future partnering opportunities and reinforce commercial positioning. For a pre-revenue biotech, a defensible IP estate is a core component of the investment case.
The patent adds to a growing portfolio supporting TRP-8803, a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin). Development of TRP-8803 follows a number of Phase 2a clinical trials using oral psilocybin for the treatment of Binge Eating Disorder, Irritable Bowel Syndrome and Fibromyalgia.
The South African grant follows a similar trajectory to the Australian psilocin patent secured in mid-2026, which established composition-of-matter protection over novel psilocin salt and cocrystal forms at the molecular core of the TRP-8803 platform, providing a complementary layer of exclusivity across two distinct jurisdictions.
| Fact | Detail | Investor Impact |
|---|---|---|
| Patent jurisdiction | South Africa (Patent No. 2025/01722) | Commercial exclusivity in a defined market |
| Patent term | To 11 September 2043 | Long runway for commercialisation & partnering |
| South African market size | US$1.9Bn (2025) | Sizeable addressable opportunity |
| Scope | Methods, dosing, biomarkers, manufacture | Broad, harder to design around |
What’s next for Entropy
Management has stated that building a robust global patent estate remains a key strategic priority as the Company continues to generate clinical evidence across its precision-controlled psychedelic platform.
According to Entropy, the South African patent supports its long-term commercialisation and partnering strategy. The Company continues to position TRP-8803 for large indications with substantial unmet clinical need, with the expanding IP portfolio intended to underpin the commercial value of that program over time.
For readers interested in the clinical trial progress running alongside this IP development, our detailed coverage of the DSMB safety clearance walks through the independent safety review that cleared Cohort 2 progression without protocol changes, including the selection of the 60-minute infusion regimen and the timeline for upcoming efficacy readouts.
Ready to Explore Entropy Neurodynamics’ Growing IP Portfolio?
Entropy Neurodynamics has secured broad, indication-level patent protection in South Africa for its psilocybin-based fibromyalgia treatment, extending to 2043 and covering everything from dosing regimens to biomarkers and manufacture. With the South African fibromyalgia market valued at US$1.9Bn, the grant adds meaningful commercial exclusivity to the TRP-8803 development program.
Investors seeking a deeper understanding of the company’s psychedelic medicine platform and long-term partnering strategy can explore the Entropy Neurodynamics investor centre for the latest updates on its clinical pipeline and global IP estate.