U.S. veterinary programme for CannEpil® begins under FDA pathway
Argent BioPharma Ltd (ASX: RGT) has advised shareholders that Splash Beverage Group (NYSE American: SBEV), the company’s exclusive global licensing partner for CannEpil®, has commenced its U.S. veterinary pharmaceutical development programme through a strategic collaboration with Lupvindol Biosciences Ltd.
The appointment represents the first operational milestone following Argent’s recently announced expansion of CannEpil® into veterinary healthcare, establishing a defined regulatory development pathway within the United States animal health market.
The programme will initially focus on companion-animal oncology and chronic pain management, with canine applications expected to form the first stage of development.
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The FDA regulatory pathway explained
Development activities will progress through the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA CVM), the division responsible for regulating drugs used in animals. Rather than beginning at the point of commercial sale, the programme starts with an investigational phase that must satisfy defined regulatory checkpoints before a product can reach the market.
For investors, this matters because a defined regulatory pathway converts a licensing concept into an executable development plan, adding structure to the veterinary opportunity.
The pathway is expected to proceed as follows:
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Commence via the Investigational New Animal Drug (INAD) process through FDA CVM
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Progress toward potential Conditional Approval
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Initial indications targeting companion-animal oncology and chronic pain, with canine applications first
Industry-leading cannabinoid development team leads programme
The veterinary programme will be led by Dr. Hunter Land, Chief Executive Officer of Lupvindol Biosciences, alongside an experienced cannabinoid pharmaceutical development team.
Dr. Land was the first full-time U.S. research and development employee of GW Pharmaceuticals and played an important role in the development of Epidiolex®, described as “the world’s first FDA-approved plant-derived cannabinoid medicine,” as well as Sativex®.
The broader Lupvindol team brings extensive experience across FDA regulatory strategy, pre-clinical and clinical study design, product development and commercialisation. Argent believes the appointment of such an experienced team strengthens the execution capability of the veterinary programme and supports the long-term commercial opportunity for CannEpil®.
Why Argent retains the value
A central feature of the arrangement is its capital-efficient structure. Argent BioPharma continues to retain ownership of all existing and future CannEpil® intellectual property, manufacturing know-how and regulatory assets, while participating in the product’s long-term commercial success through royalties.
The company participates in “long-term commercial success… through royalties across both the human and veterinary healthcare markets.” In practice, this gives Argent a second addressable market in animal health without funding the development itself, as the licensing partner carries the execution cost.
| Element | Detail |
|---|---|
| Licensing partner | Splash Beverage Group (NYSE American: SBEV) |
| Development lead | Lupvindol Biosciences (Dr. Hunter Land) |
| Argent’s retained assets | IP, manufacturing know-how, regulatory assets |
| Argent’s revenue model | Royalties across human and veterinary markets |
| Initial focus | Canine oncology & chronic pain via FDA CVM |
Roby Zomer, Chairman
“We are extremely pleased to see the rapid execution of the strategy following the recent expansion of CannEpil® into veterinary healthcare.
The appointment of Dr. Hunter Land and the Lupvindol Biosciences team brings one of the industry’s most experienced cannabinoid pharmaceutical development groups to the programme. Their involvement, including direct experience with the development of Epidiolex® and Sativex®, provides significant scientific and regulatory expertise as CannEpil® advances through the FDA veterinary pathway.
Importantly, this milestone demonstrates that the global licensing strategy is already translating into tangible operational progress. While Argent retains ownership of the CannEpil® intellectual property, manufacturing capabilities and long-term royalty participation, our licensing partner is actively executing the next phase of development, creating additional opportunities to expand the value of the CannEpil® platform for shareholders.”
The CannEpil® platform and what’s next
CannEpil® is a pharmaceutical-grade cannabinoid combination therapy formulated as a standardised 20:1 CBD:THC oral solution, developed for the management of drug-resistant epilepsy, also referred to as refractory epilepsy. This is a condition where standard treatments fail to control seizures, affecting approximately one-third of all epilepsy patients worldwide.
The veterinary expansion builds on an already commercial-stage human product, extending rather than replacing the core platform. The existing human-market foundation includes:
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20:1 CBD:THC standardised oral solution
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Regulatory and commercial access across Ireland, the UK, Germany and Australia
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Full reimbursement in Ireland under the Medicinal Cannabis Access Programme
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1,000 units delivered into the Irish market, the largest commercial shipment in the product’s history
That largest commercial shipment, 1,000 units valued at approximately A$783,000, was delivered into the Irish market under full government reimbursement at roughly 467 euros per unit, demonstrating that the human-market supply chain is operating at scale ahead of the veterinary programme’s development phase.
- An active FDA IND programme in the United States
The next step for the veterinary programme is progression through the INAD process toward potential Conditional Approval. No specific timelines, trial dates, royalty percentages or development budgets have been disclosed for the veterinary programme at this stage.
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