- Laverdia-CA1 is the first small-molecule SINE (selective inhibitor of nuclear export) drug developed specifically for dogs.
- The oral tablet is conditionally approved by the FDA for treatment of B-cell and T-cell canine lymphoma, including naïve and relapsed cases.
- The therapy enables at-home administration, potentially increasing access for owners who decline traditional chemotherapy.
- Clinical studies demonstrated a reasonable expectation of efficacy without bone marrow suppression typical of cytotoxic chemotherapy.
- Anivive used its AI-powered AniviveSELECT platform to identify verdinexor as a veterinary oncology candidate.
Anivive has received FDA conditional approval for Laverdia-CA1 (verdinexor), marking the company’s first commercial product and a notable milestone in canine oncology. The oral therapy is approved for the treatment of both B-cell and T-cell lymphoma in dogs under FDA application number 141-526, with full approval pending confirmation of effectiveness through continued clinical trials.
“This conditional approval provides a much-needed option to treat dogs with lymphoma,” said Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine.
Laverdia-CA1 represents a new class of targeted cancer therapeutics for veterinary medicine. As a selective inhibitor of nuclear export (SINE), verdinexor blocks Exportin-1 (XPO1), a transport protein that is overexpressed in certain cancers. By preventing the export of tumor suppressor proteins from the cell nucleus, the drug promotes programmed cell death in lymphoma cells while largely sparing healthy tissue.
Unlike traditional chemotherapy protocols, Laverdia-CA1 is administered orally in tablet form, allowing dogs to be treated at home. This approach addresses several barriers that contribute to low treatment rates in canine lymphoma, including limited access to veterinary oncologists, quality-of-life concerns, and cost. Anivive estimates that while more than 700,000 dogs are diagnosed with lymphoma annually, nearly 80% of owners decline treatment.
Peer-reviewed clinical studies showed a reasonable expectation of efficacy across lymphoma subtypes, including in both treatment-naïve and relapsed patients. The drug’s mechanism differs from cytotoxic therapies and is not associated with bone marrow suppression. The most commonly reported side effects include anorexia, vomiting, diarrhea, weight loss, and lethargy.
“This presents a paradigm shift in the treatment of lymphoma and has the potential to become routine, standard-of-care treatment for dogs,” said Cheryl London, DVM, PhD, DACVIM, professor at Tufts University.
According to Anivive, verdinexor was identified using AniviveSELECT, the company’s proprietary AI-driven drug discovery platform, which analyzes data from more than 300 sources to accelerate therapeutic development. The company positions Laverdia-CA1 as the first in a pipeline of first-in-class veterinary therapeutics developed using this approach.
“We’re a different kind of pharmaceutical company, dedicated to dramatically accelerating time to market of new drugs at significantly reduced cost to veterinarians and pet owners,” said Anivive CEO Dylan Balsz.
Laverdia-CA1 is now available to veterinarians under FDA conditional approval as Anivive continues studies to support full approval.
Information sourced from the company’s press release.
