Argent starts EU-GMP cannabinoid supply for drug resistant epilepsy at Slovenia’s largest hospital

• Argent BioPharma has commenced supply of EU-GMP Cannabinoid API for epilepsy treatment at Slovenia’s largest hospital, the University Medical Centre Ljubljana
• API supply to UKC commenced following completion of successful pilot program
• Prescriptions follow dosing guidelines co-developed under Argent’s epilepsy program platform
• Argent collaborated with Slovenia medical regulators, providing data and validation that shaped hospital compounding regulations
• Argent now exploring further EU and USA commercial expansion opportunities

Special Report: Argent BioPharma has started formal clinical supply of its EU-GMP cannabinoid-based active pharmaceutical ingredient (API) for epilepsy treatment at a leading EU hospital, the University Medical Centre Ljubljana (UKC Ljubljana).

Following a successful pilot program, neurologists at the paediatric clinic are now prescribing Argent BioPharma’s (ASX:RGT) cannabinoid API under protocol-driven guidelines, providing a new evidence-based option for patients with drug-resistant epilepsy.

The API is produced by PHCANN International, Argent’s EU-GMP-certified manufacturing partner, ensuring consistent, high-quality supply in line with European regulatory standards.

Transitioning from a structured pilot to routine hospital use, the API enables neurologists to dispense recommended, protocol-aligned formulations for patients with drug-resistant epilepsy.

This milestone is the culmination of a multi-year collaboration between Argent and UKC Ljubljana.

In close collaboration with Slovenia’s Ministry of Health (MoH) and Agency for Medicinal Products and Medical Devices (JAZMP), Argent is providing pre-clinical data, GMP validation, and clinical experience with CannEpil, helping shape the national framework now governing hospital compounding of cannabinoid treatments for neurological conditions.

CannEpil is Argent’s cannabinoid therapy for refractory epilepsy, which has been used clinically in Ireland and other European markets.

Argent said lessons learned in dosing, safety monitoring and supply logistics directly informed both the MoH pathway and new collaboration, accelerating physician uptake and regulatory alignment.

Core activities of Argent’s epilepsy program platform

Argent has identified five pillars on which its epilepsy program platform (EPP) rests, including:

1. EU-GMP manufacturing – to secure consistent, high-quality production of APIs and finished-dose products, with EU-GMP partners PHCANN International.
2. Clinical research – to span investigator-initiated and company-sponsored trials in refractory epilepsy.
3. Regulatory engagement – exemplified by Argent’s hands-on work with the Slovenian MoH, Medical Cannabis Access Programme (MCAP) listing in Ireland, and orphan-drug-pathway initiatives elsewhere.
4. Physician education and protocol development – to provide neurologists with compounding guidelines, dosing algorithms and real-world data capture.
5. Commercial roll-out – leveraging CannEpil’s success, expanding EU distribution and hospital collaborations.

Supports EU and US expansion 

Argent believes formal supply at UKC Ljubljana validates its capability to convert pilot projects into full hospital programs and highlights its leadership in shaping cannabinoid regulations alongside national health authorities.

The initiative further strengthens the EPP pipeline and supports upcoming EU and US expansion milestones.

“Launching full clinical supply in Slovenia is a testament to our team’s regulatory expertise and our longstanding commitment to patients with refractory epilepsy,” chairman Roby Zomer said.

“By partnering with the UKC and leading clinicians, we are setting a new standard for cannabinoid-based neuroimmune therapies across Europe.”

UKC Ljubljana senior consultant neurologist Dr David Neubauer highlighted the significance of the new therapy.

“Integrating a GMP-certified cannabinoid formulation – supported by detailed protocols and framework co-developed with Argent BioPharma – gives us an evidence-based option for the most complex epilepsy cases,” he said.

“Early results were encouraging, and we have developed strategies how to use the cannabinoid formulation for treatment of the most resistant epilepsies and encephalopathies for children and adolescents.”

This article was developed in collaboration with Argent BioPharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.