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Random freezes, missing sound and display glitches usually trace back to one bad driver. Find and replace yours safely.Free scan · under a minuteSirolimus for cats is sold in the United States as felycin-CA1, a prescription sirolimus delayed-release tablet that the FDA conditionally approved on March 14, 2025 for managing ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM). The labeled target dose is 0.3 mg/kg by mouth once weekly. Sirolimus and rapamycin are two names for the same compound, but the approval covers only felycin-CA1 in that labeled population. It is not a general approval of sirolimus or rapamycin for feline heart disease.
The sections below explain who the label applies to, what FDA publishes about dosing and strengths, what the small pilot study did and did not show, and the side effects and exclusions your veterinarian will weigh before any prescription.
Who felycin-CA1 is labeled for
FDA’s definition narrows the approval to a specific clinical picture. As FDA defines subclinical HCM, a cat must show:
- Left-ventricular hypertrophy, meaning a left-ventricular wall thickness of at least 6 mm at end diastole, measured by 2D or M-mode assessment.
- No systemic hypertension.
- No other cause of compensatory myocardial hypertrophy.
- No current or historic signs of congestive heart failure.
- No arterial thromboembolism.
- No severe left-ventricular outflow tract obstruction.
These criteria describe the population FDA studied and labeled. They are not a home screening rule. A cat that appears to have a thickened heart wall still needs a veterinary workup, and a cat that does not fit this definition falls outside the labeled use.
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FDA describes HCM as progressive. Cats can remain subclinical for years, or they can progress to heart failure, arterial thromboembolism, or sudden death. Individual courses vary, so the label should not be read as predicting how any one cat will fare.
Dosage and formulation
The FDA-recorded target is the once-weekly oral dose of 0.3 mg/kg described above. Because the dose is set per kilogram of body weight, the number of tablets for a given cat depends on a weight-based prescription from the veterinarian. This article does not calculate an individual dose.
Tablet strengths and packaging
- 0.4 mg delayed-release tablet
- 1.2 mg delayed-release tablet
- 2.4 mg delayed-release tablet
- Cartons of 12 tablets, according to FDA’s Freedom of Information summary for application 141-604
What the prescription status means for dosing
FDA states: “Felycin-CA1 is only available by prescription from a licensed veterinarian.” Three practical consequences follow:
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- Human sirolimus tablets and compounded sirolimus preparations are different products. Neither is covered by felycin-CA1’s labeling or by the pilot results, so they are not interchangeable with it.
- Administration instructions and the follow-up schedule come from the current label and the prescribing veterinarian. They should not be reconstructed from memory or from online summaries, including this one.
- Any dose or product other than the labeled felycin-CA1 regimen is outside the approval. Section on conditional approval explains why extra-label use is not an option.
What the pilot study showed
The main effectiveness evidence is a two-center pilot field study of 43 client-owned cats, described in FDA’s Freedom of Information summary for application 141-604. Cats received placebo, the labeled 0.3 mg/kg weekly dose, or twice that dose (0.6 mg/kg weekly) for 180 ± 10 days. The table shows the day-180 results, reported as mean changes in maximum left-ventricular wall thickness from baseline.
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1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minute| Group | Cats | Weekly oral dose | Mean change in maximum wall thickness at day 180 |
|---|---|---|---|
| Placebo | 13 | None | Increased 0.94 mm |
| Labeled dose (1×) | 15 | 0.3 mg/kg | Decreased 0.17 mm |
| Double dose (2×) | 15 | 0.6 mg/kg | Increased 0.50 mm |
These are exploratory pilot results from groups of 13 to 15 cats, not a head-to-head dosing recommendation. The 0.6 mg/kg arm was a study comparison; it is not an alternative regimen. FDA presented the same three figures again in a July 2026 presentation summarizing this pilot.
Two qualifications matter as much as the numbers. First, the sponsor did not set its effectiveness criteria before the study began. After exploratory analyses, it selected maximum left-ventricular wall thickness at day 180 as the endpoint. Second, the study was small, so the group differences should be read as signals that justified further study rather than as settled proof of benefit.
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What conditional approval means
FDA’s veterinarian resource, “Conditional Approval Explained,” separates conditional approval from full approval:
“For conditional approval, the drug company must show that the drug has a ‘reasonable expectation of effectiveness,’ but has not yet proven that it meets the ‘substantial evidence’ standard of effectiveness for full approval.”
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In practice, the framework works like this:
- Both conditional and full approval require safety when the drug is used according to the label.
- Conditional approval requires a reasonable expectation of effectiveness. Full approval requires substantial evidence of effectiveness.
- The initial conditional approval lasts one year and may be renewed annually for up to four more years, subject to progress requirements.
- During the conditional period, the sponsor may sell the product for the labeled use while it collects further effectiveness data.
- Extra-label use of conditionally approved animal drugs is not allowed.
FDA described felycin-CA1 as the first product approved for use in cats with HCM for any indication. That makes it the first option in its category, but it does not turn the pilot into a full efficacy trial.
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The initial one-year term runs from the March 2025 approval, so renewal status is a current question. Check the FDA record or the current label rather than assuming the 2025 status still applies.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Safety and side effects
In the pilot, the most common adverse reactions were cardiac, and many were linked to the natural variability of HCM progression. Causation for the serious cardiac outcomes was not established.
Cardiac events
- Arrhythmia, congestive heart failure, syncope, and pericardial effusion were recorded in cats receiving felycin-CA1.
- In the 2× group, three of 15 cats progressed to congestive heart failure or presumed cardiac sudden death. All three had progression risk factors at enrollment.
- FDA said it is unknown whether these events were associated with treatment. With 43 cats and variable disease progression, the pilot cannot answer that question.
Non-cardiac events
Lethargy, vomiting, diarrhea, and inappetence were also reported. These are the signs a veterinarian will want to hear about promptly after any change in medication.
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Diabetes mellitus
One cat in the 1× group developed diabetes that went untreated. It presented in diabetic ketoacidosis and died of acute cardiac arrest. FDA concluded that felycin-CA1 should not be used in cats with pre-existing diabetes mellitus. This cat developed diabetes during the study, so the exclusion is not limited to cases where the disease was already diagnosed at enrollment; a veterinarian should check for diabetes before starting treatment.
Liver disease
FDA says cats should be screened for pre-existing liver disease before treatment starts. The product should not be used in cats with pre-existing liver disease.
Immune effects and vaccination
FDA’s announcement says the target feline dose is not expected to be immunosuppressive. It cites a vaccine-response study indicating the dose should not affect the rabies vaccine response. These are stated expectations from FDA, not guarantees that no immune-related effects will occur.
Quick Recap
Questions to settle with your veterinarian
- Confirm the diagnosis with echocardiography, recording left-ventricular wall thickness at end diastole by 2D or M-mode and whether it reaches 6 mm.
- Rule out the conditions that fall outside the label: systemic hypertension, another cause of hypertrophy, current or past heart failure signs, arterial thromboembolism, and severe outflow tract obstruction.
- Screen for pre-existing liver disease and check for diabetes mellitus before the first dose.
- Confirm the weight-based tablet count and the strength on the prescription, and ask which label instructions apply.
- Ask what follow-up examinations and cardiac checks are planned, and which signs should prompt an urgent call. The pilot recorded syncope, congestive heart failure, and lethargy as adverse events, so those are the first changes to report.
- If the diagnosis is uncertain or the heart findings are complex, ask whether a veterinary cardiologist should review the case.
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