So you want to build a dog drug?
Five differences between human and veterinary medicine.
31 August 2026
Loyal’s strategy is “save the dogs, save the world” - I regularly get reached out to by human biotech founders who are curious whether they should take a similar strategy to Loyal and first commercialize
Note - veterinary medicines have split regulatory oversight: FDA Center for Veterinary Medicine (CVM) oversees drugs (think, pharmacological drugs like pain medicines) while USDA oversees immune modulators (think vaccines, some monoclonal antibodies, etc). All of Loyal’s drugs are regulated by FDA and this focuses on that regulatory body.
(1) The regulatory bar is not lower, but it is accelerated
If you want to irritate the FDA, the most efficient way is to proclaim you are developing dog drugs because it is easier than human drugs! Do not do this :)
However, the regulatory path for a dog drug is streamlined in certain ways that are especially meaningful for a startup.
In both dogs and humans, you must prove efficacy (the drug does what it says it does), safety (the drug is safe for intended use, acutely and over time), and manufacturing (you can repeatedly manufacture the drug at a high quality at scale).
In human medicine, you get the formal regulatory approval at the very end of the 7-9+ year process. While clinical trials are of course massively derisking, there isn’t a formal sign off until you receive the NDA (new drug approval) from the FDA.
In veterinary medicine, the dossiers are each approved separately. You earn efficacy, safety, and manufacturing approval one-by-one. This
b) there is an accelerated approval pathway for drugs that serve an unmet medical need.
c)
(2) Safety is paramount