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About a week ago, on August 8th, fell International Cat Day. Even if you are a cat person like I am, you might have missed the event. Don’t worry, your feline probably didn’t know about it either. In this article, we will take a look at what biotech is doing in cat health.
While the cat isn’t officially man’s best friend, it’s definitely a solid contender to the slightly noisier dog. In the U.S., 32% of households share their home with a cat, and pet-care spend keeps climbing. Indeed, a Morgan Stanley survey indicates roughly 7% annual growth through 2030 (versus 2.5% in 2024), with spend per pet reaching about $1,733. Pets are not just animals; to many, they are family members.
In cats, the most frequent medical conditions are well known: chronic kidney disease (CKD) rises sharply with age, common after 10 and very frequent in the oldest cats, dental disease affects the majority by mid-life, and osteoarthritis is widespread but often missed. Obesity is also a risk for cats, while in seniors, hyperthyroidism is the leading endocrine issue, and diabetes still carries a high day-to-day burden, although it is less common. Add frequent lower urinary tract disorders and heart disease, and you have the short list that drives most veterinary visits and where biotech advances can most visibly shift both quality and length of life.
Table of contents
Why cat biotech is unique
Cats aren’t small dogs; their livers process drugs differently, they’re poor at a pathway called glucuronidation, so medicines that are fine in people or dogs can behave very differently in cats. That’s why simple copy-paste from human or canine drugs isn’t a durable option.
If you give a cat a human or dog-like antibody, the cat’s immune system may attack it. So, companies build the antibody to look feline, so it’s tolerated and keeps working, an approach known as “felinization”. A good example is Zoetis’s Solensia (frunevetmab). It blocks nerve growth factor (NGF) to reduce osteoarthritis pain.
Format and delivery have to be part of the strategy from the get-go, too. Many cats fight pills, so delivery matters as much as the molecule. You see transdermal gels like Mirataz (mirtazapine) that you rub on the ear to stimulate appetite, or easy-to-dose liquids like Elura (capromorelin) for weight loss in CKD. It also has to be simple for owners to administer, or adherence will drop.
Regarding clinical trials, feline studies are tiny by human standards, so regulators lean on practical endpoints like owner-reported pain and mobility, and vet exams. The routes to market have to be more flexible, too – in the U.S., the FDA’s “expanded conditional approval” lets important cat drugs reach clinics while confirmatory data is still being gathered. That’s how the first CKD-anemia pill for cats got out of the gate. The agency now allows vet-prescribed compounding under defined conditions, still unapproved, but a legal way to treat.
Cats visit vets less often than dogs, and owners are more price-sensitive. That pushes developers toward low-friction, high-impact products that deliver a clear benefit.
Chronic kidney disease (CKD): From management to molecular medicine
CKD is the defining chronic disease of older cats and a leading driver of morbidity; because signs take time to creep up, many cases are picked up late, when weight loss and anemia are already in play. The first real molecular advance for the anemia piece is Varenzin-CA1 (molidustat), a hypoxia-inducible factor–prolyl-hydroxylase (HIF-PH) inhibitor that nudges the kidney to make more of its own erythropoietin. The FDA granted conditional approval in May 2023, the first time a product has been cleared specifically to control non-regenerative anemia in cats with CKD. That pathway lets vets use the drug while confirmatory effectiveness data continues to be measured.
Because many cats won’t take pills reliably, delivery formats that fit feline behavior have also moved the needle on CKD-linked weight loss and appetite. Mirataz (mirtazapine) transdermal ointment, the first FDA-approved transdermal for cats, delivers an appetite stimulant through the ear for two weeks, avoiding oral dosing altogether. Elura (capromorelin) oral solution, a ghrelin receptor agonist, is the first drug specifically approved for weight loss in CKD cats and is now standard in many CKD management plans.
A bolder approach is gene therapy. Scout Bio’s SB-001 uses an AAV vector to express feline erythropoietin after a single injection, aiming to correct the anemia driver rather than top it up intermittently. A 2023 study concluded the single-dose strategy represents a suitable treatment concept for CKD-associated anemia, while noting the need to watch for hypertension and other class effects.
Historically, internists managed CKD-related anemia with human erythropoiesis-stimulating agents (epoetin, later darbepoetin). They raise hematocrit, but a significant minority of cats develop antibodies against the drug that wipe out red-cell production. That safety concern explains the pivot to treatments that are specifically designed for cats.
Feline infectious peritonitis (FIP): A biotech breakthrough wrapped in regulatory knots
For decades, a diagnosis of FIP, caused by mutation of a feline coronavirus, was a near-certain death sentence within months. The narrative flipped when nucleoside antivirals hit the clinic: GS-441524, the parent nucleoside of remdesivir, has produced 80 to 90% remission/survival across real-world and academic cohorts, with studies indicating some cats can complete therapy in six weeks rather than the classic 12. It works by blocking the viral RNA polymerase with outcomes that owners and vets can see within days to weeks.
Because no sponsor filed a conventional U.S. veterinary application, there is still no FDA-approved GS-441524 product; for years, owners turned to gray-market supply chains to save their cats. In May 2024, the FDA clarified it would exercise enforcement discretion under Guidance For Industry (GFI) 256, allowing vet-prescribed compounding of GS-441524 under defined conditions.
That policy shift was followed by a Stokes Pharmacy and Bova Group partnership that made U.S.-made compounded oral GS-441524 available to veterinarians in most states, bringing treatment out of the shadows without changing the “unapproved” legal status. It’s a rare case where owner demand, clinical evidence, and regulatory pragmatism converged to normalize an effective but unlicensed therapy.
Other fronts moving fast: What else is in the feline pipeline?
While CDK and FIP are the most serious conditions that cats suffer from, biotech innovation has not stopped there. Solensia (frunevetmab), a felinized anti-NGF monoclonal antibody from Zoetis, is the first FDA-approved monoclonal antibody for any animal species and controls osteoarthritis pain with a once-monthly injection.
Metabolic disease is also getting cat-specific options. Bexacat (bexagliflozin) became the first U.S. oral treatment for feline diabetes in 2022, avoiding insulin in a subset of newly diagnosed, non-insulin-dependent cats under strict safety screening. However, in early 2024, the FDA issued a letter indicating Bexacat may cause an increased risk of diabetic ketoacidosis (DKA) or euglycemic DKA in cats, a life-threatening condition.
The most-watched kidney project right now is the AIM program out of Japan. Basic research over the past decade suggests that cats are unusually prone to kidney disease because their apoptosis inhibitor of macrophage – AIM – protein can’t “switch on” to help clear tubular debris during injury. In mice, freeing or supplying AIM sped kidney recovery.
Building on that mechanism, the Institute for AIM Medicine announced in June 2025 that a multi-center clinical trial had begun across 26 veterinary hospitals in Japan to test an injectable AIM-based treatment for cats. It’s early, and efficacy in pet cats still has to be proven, but this is the first formal clinical study aimed at turning the AIM hypothesis into a therapy.
Alongside disease-modifying ideas, there’s parallel work on adjunctive CKD care that could realistically reach practices sooner. Porus One (Renaltec), an oral adsorbent mixed with food, lowered the toxins indoxyl sulfate and p-cresyl sulfate in a 2024 study, with larger drops on twice-daily dosing. For now, it’s still sold in the U.S. as a non-prescription renal support, with practice-level outcome data pending.
Outside the kidney, cardiology is finally moving. In March 2025, Irish company TriviumVet received FDA conditional approval for felycin-CA1, a once-weekly delayed-release sirolimus tablet to manage ventricular hypertrophy in subclinical hypertrophic cardiomyopathy (HCM). A 12-month pivotal study is in progress to convert to full approval.
For infectious diseases, Anivive Lifesciences is advancing GC376, a 3CL protease inhibitor for FIP. The company says it’s pursuing FDA approval, and in February 2025, GC376 was nominated by the AVMA and Feline VMA for inclusion on the FDA’s bulk compounding list, a signal that U.S. stakeholders want more regulated options alongside GS-441524. If successful, veterinarians could have two mechanistically distinct antivirals to tailor treatment or combine in refractory cases.
What could hold feline biotech back, and what’s coming next
The science is moving, but two practical frictions still shape how fast innovations reach cats: regulation and economics.
On the regulatory side, feline trials are small and often rely on owner-reported measures, which is one reason the U.S. FDA uses conditional approval to bridge important drugs into clinics while confirmatory effectiveness data are gathered. That’s how Varenzin-CA1 (molidustat) reached CKD-anemia cats in May 2023, and how the first cardiology product for cats, felycin-CA1 (sirolimus), entered practice in March 2025 for subclinical HCM.
In Europe, Regulation (EU) 2019/6 is meant to improve the availability of veterinary medicines and reduce administrative drag across member states, though companies still face some national-level implementation differences.
Access to FIP antivirals shows the other side of the coin. There is still no FDA-approved GS-441524 product; for years, owners have relied on gray-market sourcing.
Costs and logistics are the other brake. Biologics that must be shipped and administered in-clinic, gene therapies, and compounded antivirals all sit at the pricier end of care. That reality meets a market where owners are spending more on veterinary care but also feeling the pinch.
Despite those constraints, the near-term horizon is tangible with more and more cat-specific biotech solutions being advanced as well as disease-modifying approaches. The bottom line is: cat biotech isn’t niche anymore, but realistically, it is still facing unique challenges.