Snakebite Treatment Is Getting a Glow Up: Why Varespladib Could Change Emergency Care for Pets and People
Snakebite envenomation is one of those clinical scenarios veterinarians dread. It is unpredictable, time sensitive, and often dependent on geography, venom type, and access to antivenom. After more than a century with little therapeutic innovation, a potential shift may finally be underway. Ophirex, Inc., a Public Benefit Corporation focused on snakebite treatment, has announced major regulatory and business milestones as it advances varespladib, a novel oral rescue therapy designed to be administered immediately after a snakebite. The update includes progress toward FDA approval for human use under the Animal Rule, new momentum in veterinary drug development, and leadership additions that signal long term commitment to animal health.
Varespladib is being developed as the first oral rescue treatment for snakebite envenomation. Unlike antivenom, which requires refrigeration, intravenous administration, and clinical infrastructure, varespladib is intended for rapid use at the time of the bite. That timing advantage could be critical. According to Ophirex CEO Jeremy Gowler, the goal is to allow treatment to begin within minutes rather than hours. For both human and veterinary patients, especially those in rural or wilderness settings, that difference could translate to reduced tissue damage, improved outcomes, and fewer complications before definitive care is reached.
FDA Animal Rule and What It Signals
Ophirex has reached agreement with the FDA that varespladib is appropriate for development under the FDA’s Animal Rule. This pathway allows approval of human drugs based on efficacy data from well controlled animal studies when human trials are not ethical or feasible, paired with safety data from humans. Since 2002, more than 15 drugs have been approved under the Animal Rule, many of them for emergency or biodefense indications. For veterinary professionals, this pathway is notable because it emphasizes translational animal models that closely mimic real world envenomation scenarios. Animal studies are currently underway to help define effective dosing and evaluate the breadth of protection across different venom types.
Two Phase 2 human studies, BRAVO and BRAVIO, have already been completed. Both enrolled emergency department patients who had received standard of care, including antivenom. While the BRAVO study did not meet its primary endpoint, a pre-specified subgroup analysis showed signals of benefit in patients who received varespladib within five hours of the bite. This timing insight reinforces the core concept behind an oral rescue therapy. Results from the BRAVIO trial and additional mouse studies evaluating varespladib against major U.S. venomous snake species are expected to be published in the coming months.
For veterinarians, the most immediate headline is that varespladib has received FDA MUMS designation for treatment of snakebite envenomation in dogs. MUMS, or Minor Use in a Major Species, designation comes from the FDA Center for Veterinary Medicine and provides meaningful development incentives. These include eligibility for seven years of marketing exclusivity, user fee waivers, and access to FDA grant funding. This designation highlights a reality most small animal clinicians know well. Snakebite remains a common emergency in many regions, yet treatment options have barely evolved. An oral, shelf stable, species agnostic therapy could dramatically change how snakebite is managed in general practice, emergency clinics, and field settings.
Development of varespladib has also been supported by the Defense Health Agency through its Small Business Innovation Research program and the Broad-Spectrum Snakebite Antidote initiative. That program aims to create a treatment that is lightweight, cost effective, easy to use, and effective across snake species while reducing the logistical challenges of antivenom. These goals align closely with veterinary needs, particularly for working dogs, rural patients, and practices far from referral centers.
Ophirex also announced the appointment of Aaron Schacht to its Board of Directors. Schacht brings extensive animal health experience, including leadership roles at BiomEdit, Elanco, and Eli Lilly, as well as a track record in R and D, regulatory strategy, and business development. The company has also launched a new corporate brand identity and website, signaling confidence and forward momentum as it works to address a long neglected medical need.
What Veterinarians Should Watch Next
For veterinary professionals, varespladib represents more than a new drug candidate. It reflects a broader shift toward faster, more accessible emergency interventions that can be deployed before patients reach advanced care. As additional data is published and regulatory pathways progress, veterinarians may soon find themselves at the forefront of a new era in snakebite management, one where early intervention is no longer limited by geography, refrigeration, or IV access.
