The Pathway to FDA Approval for Veterinary Stem Cell Therapies
How investigational treatments move from the lab to the veterinary clinic
Bringing a new veterinary therapy to market isn’t just about promising science—it’s about proving quality, safety, and effectiveness through a carefully regulated process. For veterinary stem cell therapies, this means years of research, rigorous testing, and close coordination with the U.S. Food and Drug Administration (FDA).
Gallant’s investigational regenerative therapies are following this pathway, with the goal of making ready-to-use, allogeneic stem cell treatments available to veterinarians and pets nationwide.
Note: Gallant’s therapies are investigational and not yet approved for commercial use. All studies are conducted under FDA oversight.
Why FDA Approval Matters
FDA approval isn’t just a milestone—it’s what ensures veterinary treatments meet the highest standards for safety, quality, and manufacturing. The FDA’s Center for Veterinary Medicine reviews every stage of development, from how the product is made to how it’s tested in clinical trials, to how it’s packaged and delivered.
For pet parents and veterinarians, FDA approval means:
- Confidence that the therapy has been thoroughly evaluated
- Clear, science-based labeling and usage guidelines
- Assurances about manufacturing consistency and quality control
The Steps in the Approval Process
1. Discovery & Preclinical Research
Before any product is tested in pets, scientists study it in the lab to understand how it works, ensure it meets safety requirements, and determine the conditions it may best address.
2. Clinical Trials
These carefully designed studies are conducted in veterinary clinics to evaluate safety and effectiveness in real-world settings. Gallant’s clinical trials are no-cost for pet parents and conducted under FDA authorization.
3. Manufacturing & Quality Control
Gallant produces its investigational therapies in a GMP-compliant (Good Manufacturing Practice) facility, ensuring that every dose meets strict quality standards.
4. FDA Review
Once the data from all required studies is complete, Gallant submits it to the FDA for review. If the product meets all requirements, it may be granted approval for veterinary use.
Where Gallant Is Today
Gallant has completed pivotal studies for certain indications, such as Feline Chronic Gingivostomatitis (FCGS), and continues to run clinical trials in additional conditions. Each step is guided by FDA-aligned protocols to ensure that, if approved, therapies can be integrated into everyday veterinary practice.
Still Under Investigation
While early results are encouraging, Gallant’s therapies are available only through FDA-authorized clinical trials at this time. Participation in these studies helps advance veterinary medicine and brings us closer to making regenerative therapies more widely available.
Learn about our clinical trials, find a participating clinic, and talk to your veterinarian about joining a study.
Disclaimer
Gallant’s investigational stem cell therapies are not commercially available. These veterinary products may be available through participation in a study at a qualified clinic under FDA-authorized protocols. This blog is intended for educational purposes only and does not constitute medical advice.
