The first longevity
drugs for your dog
aging.
Our other drugs in development are for large and giant dogs. Large body size in dogs is correlated with shortened lifespan, so the larger a dog is, the shorter average lifespan that dog will have. LOY-001 and LOY-003 are intended for dogs weighing 40 lb or more, and target the over-expression of IGF-1, a growth hormone that we believe is associated with large dogs’ shorter lifespan relative to small dogs.
LOY-001 is a prescription long-acting injection, while LOY-003 is a prescription daily pill. LOY-001 received a Reasonable Expectation for Effectiveness (RXE) technical section complete letter in 2023 — the FDA’s first-ever formal acceptance that a drug can be developed and approved to extend lifespan, and a historic milestone for Loyal.
We anticipate LOY-001 and LOY-003 will be available under FDA conditional approval* in 2027.
A “longevity drug” is a new concept. Currently, medicines on the market target disease after symptoms have already appeared. Our approach is preventive — we aim to address the underlying causes of disease before they even start to appear.
For example, when a dog gets old, they may be diagnosed with arthritis. We call this the binary, 0 to 1, approach. The reality is, the dog’s health was likely already declining before the point that the disease started to show and present itself as arthritis. This is the aim of a “longevity drug”: to target the cause of the diseases before they get severe enough to diagnose.
Quality of life as a dog ages is just as important as the amount of time they have. Our goal is to increase the amount of healthy years your dog lives.
We expect to support the following populations with our drugs:
For LOY-002, dogs 10 years and older and between 14 and 179 pounds
For LOY-001 and LOY-003, dogs 7 years and older and at least 40 pounds
When we designed our four-year clinical study for LOY-002 (which is already longer than typical), we chose to target 10+ year dogs to balance comprehensive research with speed. If we included younger dogs in the study, we would have had to run the study for longer than four years to show lifespan extension, delaying the full approval for more years. We hope to demonstrate our drugs' efficacy on younger dogs in additional studies to expand eligibility.
We gather a large amount of safety data throughout numerous studies. We believe strongly that if our product is unsafe, it shouldn’t go to market.
Throughout the approval process, all safety data is submitted to the FDA for review, which has supported continued development of our product. We’ll be able to share this data as we get closer to launch, and we’ll disclose any side effects seen in any of our studies that are associated with our drugs.
See our safety section for more information.
Supplements are not held to the same standard of rigorous safety and effectiveness screening, independent analysis, and regulation as drugs approved by the FDA.
Unlike drugs, supplements are often not monitored and their manufacturers are not required to run studies to show that their products work. If they do run safety studies, the research may not be independently verified.
On the FDA website, they write “The benefit of the FDA’s drug approval process is the assurance that an approved animal drug is safe, effective, and high-quality.”
