Irish veterinary pharmaceutical company achieves landmark regulatory milestone for a condition affecting hundreds of thousands of dogs worldwide, with full approval study now being advanced
MEDIA ENQUIRIES sarah.oconnor@triviumvet.com
STUDY INTEREST clinicalstudies@triviumvet.com
Waterford Ireland — May 2026 — TriviumVet, a subsidiary of PBI Gordon Companies, announced that the U.S. Food and Drug Administration (FDA) has conditionally approved Liavium-CA1 (pregabalin chewable tablets) for the management of pain and clinical signs associated with Chiari-like malformation (CM) and syringomyelia in dogs.
Since PBI’s acquisition in May 2025 this marks TriviumVet’s second approval in the past year and fourth overall. Felycin-CA1 for feline hypertrophic cardiomyopathy in the US, Zetbelis for canine gastroenterology in the EU and UK, and most recently, Liavium-CA1 for canine neuropathic pain in the US.
The Liavium-CA1 approval, granted through the FDA’s conditional approval pathway, marks a pivotal advance in veterinary neurology and represents the first dedicated pharmaceutical option for dogs suffering from these debilitating conditions.
Chiari-like malformation is a genetic condition in which a dog’s skull is too small to accommodate its brain, causing the cerebellum to herniate through the base of the skull. When this results in restricted cerebrospinal fluid flow, painful fluid-filled syrinxes can form along the spinal cord — a condition known as syringomyelia. Affected dogs may cry out when touched around the head, neck, or shoulders, exhibit phantom scratching with no apparent cause, or experience progressive difficulties with coordination and mobility. The conditions disproportionately affect small and brachycephalic breeds, including Cavalier King Charles Spaniels and Chihuahuas.
“This conditional approval is a defining moment for TriviumVet and, more importantly, for the thousands of dogs and their owners who have had very limited options for managing this painful and distressing condition. Liavium-CA1 represents years of scientific commitment and a genuine step forward for veterinary neurology.”
— Serenia Horgan, Managing Director - TriviumVet
Liavium-CA1 contains pregabalin as its active ingredient, a compound that acts on the nervous system to reduce the release of pain-transmitting neurotransmitters in the spinal cord. The product is administered orally twice daily with food and is available by veterinary prescription, ensuring that diagnosis, dosing, and monitoring are managed by a qualified veterinarian. The product will be distributed in the United States by Pegasus Laboratories, Inc. (Pegasus), under its registered trademark PRN® Pharmacal brand.
The FDA’s conditional approval confirms that Liavium-CA1 has been determined to be safe and to have a reasonable expectation of effectiveness. The product was granted eligibility for the conditional approval pathway on the basis that Chiari-like malformation (CM) and syringomyelia (SM) represent serious conditions with significant unmet need, and that demonstrating full effectiveness requires a particularly complex or difficult pivotal study. TriviumVet has up to five years to generate the additional effectiveness data required for full FDA approval.
Advancing Full Approval: The LUNA Study
In parallel with the commercial launch of Liavium-CA1, TriviumVet is advancing the LUNA Study — the pivotal effectiveness study that will form the cornerstone of the company’s application for full FDA approval of Liavium-CA1.
The LUNA Study will evaluate the effectiveness of Liavium-CA1 in a well-defined canine patient population diagnosed with CM and SM, utilising validated pain and quality-of-life outcome measures assessed by both veterinary clinicians and dog owners. The protocol is being designed to reflect the rigorous standards required by the FDA’s Center for Veterinary Medicine and the complex diagnostic and monitoring demands of this patient population.
TriviumVet is actively seeking expressions of interest from specialist veterinary neurology centres and referral hospitals across the United States to participate as investigator sites in the LUNA Study. Participating sites will play a critical role in delivering a study of significant scientific and clinical importance, working closely with the TriviumVet clinical team throughout the process.
“We are looking for neurology practices with expertise in CM and SM who share our ambition to minimise the suffering of dogs living with these conditions. The LUNA Study offers sites the opportunity to contribute to an important chapter in veterinary neurological medicine.”
— Gemma Kennedy, Senior Director of Clinical Operations - TriviumVet
Centers interested in participating in the LUNA Study are encouraged to contact TriviumVet’s clinical development team directly at clinicalstudies@triviumvet.com. TriviumVet will be presenting further details on the study design and site eligibility criteria to the veterinary neurology community in the coming months ahead of the planned commencement of enrolment in late 2026.
The FDA’s full announcement, including the Freedom of Information Summary for Liavium-CA1 (NADA 141-606), is available at fda.gov/animal-veterinary.