Regulatory Milestone: Argent BioPharma’s Cannabinoid API Gains Hospital Approval in Slovenia

Clinical Supply Transition Marks New Chapter

Argent BioPharma (ASX:RGT) has officially commenced the supply of its EU-GMP-certified cannabinoid active pharmaceutical ingredient (API) to the University Medical Centre Ljubljana (UKC), Slovenia’s largest hospital. This transition from a successful pilot program to routine clinical use represents a significant milestone for the company, enabling neurologists to prescribe cannabinoid-based formulations aligned with established dosing protocols for patients with drug-resistant epilepsy.

The move underscores Argent’s growing influence in the European cannabinoid therapy landscape, building on the commercial and clinical foundation laid by its flagship product, CannEpil®. The supply arrangement is supported by a multi-year collaboration with UKC Ljubljana and regulatory engagement with Slovenian health authorities, including the Ministry of Health and the Agency for Medicinal Products and Medical Devices (JAZMP).

Regulatory Leadership and Protocol-Driven Care

Argent’s role in shaping the regulatory framework for cannabinoid therapies in Slovenia is notable. The company provided critical technical data, GMP validation, and clinical evidence that informed national guidelines permitting hospital compounding of cannabinoid formulations. This regulatory leadership ensures that the API meets EU Pharmacopoeia standards, supporting consistent, high-quality production and safe administration in clinical settings.

Neurologists at UKC Ljubljana now follow dosing guidelines co-developed under Argent’s Epilepsy Program Platform (EPP), which integrates clinical research, physician education, and real-world data capture. Dr. David Neubauer, Senior Consultant Neurologist at UKC, highlighted the value of this approach, noting that the GMP-certified cannabinoid formulation offers an evidence-based option for some of the most complex pediatric epilepsy cases.

Building on CannEpil® and Expanding Horizons

Argent’s expertise with CannEpil®, already established in Ireland and other European markets, has informed the Slovenian pathway, accelerating physician uptake and regulatory alignment. The company’s integrated EU-GMP manufacturing partnerships, notably with PHCANN International and NYSK Holdings, ensure reliable API supply to meet clinical demand.

This milestone not only validates Argent’s ability to convert pilot projects into full hospital programs but also strengthens its broader Epilepsy Program Platform. It sets the stage for further expansion across Europe and into the United States, where regulatory and commercial opportunities for cannabinoid therapies continue to evolve.

Chairman Roby Zomer emphasized the strategic importance of this development, framing it as a new standard for cannabinoid-based neuroimmune therapies in Europe and a testament to Argent’s commitment to patients with refractory epilepsy.