New treatments — molidustat, AIM, and where things actually stand

New treatments — molidustat, AIM, and where things actually stand

Not long after a CKD diagnosis you start hearing things. "A new drug is coming." "They're developing a cure in Japan." "Stem cells can fix it."

Hope matters. But if you can't tell what you can use today from what you are still waiting for, you end up neglecting the care that actually works right now. This chapter is here to draw that line.

1. Three questions to ask about any new treatment

  • Is it approved? — in which country, for what exactly, fully or conditionally
  • How far does the evidence go? — cell studies, lab animals, or real patients
  • Can you actually get it? — is it available where you live, and at what cost

If any of the three is blank, it belongs in the "still waiting" column. Waiting is fine — just don't stop the care you can do meanwhile.

2. Molidustat — the most practical new drug right now

As CKD progresses, anemia follows. Failing kidneys make less of the hormone (EPO) that tells the body to produce red blood cells. Anemic cats lose energy, appetite and quality of life.

Until now the answer was EPO or darbepoetin (DPO) injections. Molidustat takes a different route.

EPO · DPO injectionsMolidustat
ApproachHormone given from outsidePrompts the body to make its own
RouteInjection — clinic visitsOral — at home
Antibody riskYes. Antibodies against the foreign hormone can leave the body unable to make red cells at allMinimal — it is the cat's own hormone
IronNeeds separate attentionHelps the body use its own iron more efficiently

How it works — it makes the body think it is short of oxygen

When oxygen runs low the body produces HIF, which signals the kidney to make more red blood cells. When oxygen is sufficient, HIF is broken down immediately.

Molidustat blocks that breakdown. The body reads this as "we are short of oxygen" and the kidney starts producing EPO on its own. Drugs in this class are called HIF-PH inhibitors.

How well does it work

Time pointCats with a meaningful rise in HCT
Day 28about 50%
Day 56about 75%

For comparison, response rates around 56% have been reported for darbepoetin. Owners also report better appetite and energy, not just a better number — which follows naturally once anemia lifts.

How it is given

  • A cycle of 28 days on, 7 days off
  • An oral suspension, so it can be given at home
  • Usually considered once HCT falls below roughly 20–25%. Your vet decides when to start
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Side effects and monitoring
Vomiting is the most common.
Raised blood pressure and clot risk have been reported, so blood pressure monitoring is essential — CKD cats are prone to hypertension to begin with.
Raising HCT too fast is not desirable either. The goal is relief of symptoms, not a normal number.

Where you can get it

RegionStatus
United StatesFDA conditional approval — brand name Varenzin-CA1
EuropeAuthorised by the EMA, in distribution
KoreaNo confirmed timeline. Ask your vet or an importer
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What does "conditional approval" mean?
It means safety has been established and effectiveness is reasonably expected, while more data is still being collected. Not that it cannot be used — just that the evidence base is thinner than for a full approval. The drug was originally developed for anemia in human CKD; cats got there first.

3. About using human drugs off-label

There are human drugs in the same class — roxadustat, daprodustat. Which leads to "if you can't get the cat one, use the human one."

  • The doses are nothing alike. A single human tablet can be many times a cat's dose. This is not a splitting problem
  • There is no feline safety data for those specific drugs. Same class does not mean same metabolism or same side effects
  • Only with your vet, and with blood pressure and HCT checked on a set schedule
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Do not start on a dose you found online. Drugs that stimulate red cell production thicken the blood if overdone, and cause clots. That outcome is worse than the anemia.

4. AIM — between hope and reality

The AIM protein research from Japan is probably the story you have heard most. The hypothesis:

  • Debris accumulating in the kidney tubules damages the kidney
  • A protein called AIM acts as the signal to clear that debris
  • In cats, AIM stays tightly bound to another protein and fails to do its job
  • This may be why cats are so uniquely prone to kidney disease

For years the honest answer was "interesting hypothesis, but not yet." That changed in 2026.

January 2026 — improved survival in advanced CKD

Results were published in The Veterinary Journal.

AIM groupControl
Cats11 (mouse AIM 6 · feline AIM 5)15
Dosing2 mg every 2 weeks, up to 12 doses
1-year survivalabout 82% (9 of 11)20%
Uremic crisisNone12 cats died

Blood indoxyl sulfate (IS) also fell significantly. Notably, IS is the same uremic toxin that intestinal adsorbents (AST-120 / Porus One) aim to capture in the gut — a different route to an overlapping target.

It also matters that the cats were in advanced disease. The intuitive guess — that this would only help early cases — did not hold.

April 2026 — approval application filed

  • February — the product name was finalised as FeliAIM
  • 24 April — IAM CAT Inc. (CEO Toru Miyazaki) filed for veterinary marketing approval with Japan's Ministry of Agriculture, Forestry and Fisheries
  • June — reports suggested approval could come within the year, with early human trials also planned
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It is under review, not approved. The application has been filed; marketing authorisation has not been granted, and dosing experience so far comes from the trial stage. No timeline exists for other countries.
This moves fast — check the notices at iamaim.jp and iamcat.co.jp for the current position.

The open questions are worth stating plainly. 26 cats is a small study. Whether the result holds at scale, whether 12 doses at two-week intervals is practical, and what it will cost — all of that comes after approval.

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Cat food marketed with "AIM" is not a drug. The name is the same; the substance in the study above is not what you are feeding, and no such product has been shown to treat CKD or slow it down. Choose food on food criteria — phosphorus, protein, moisture.

Why do feline kidney drugs appear in Japan first?

This is not the first time. Rapros (beraprost sodium) was approved in Japan in 2017 for feline CKD, indicated for slowing loss of kidney function and improving clinical signs in IRIS stages 2–3. It is a tablet given twice daily. It has never been approved in the US or the EU.

Approval status differs by country, and Japan is consistently ahead on feline kidney drugs. When you hear about something new, ask first: approved where?

5. Stem cells

The idea of regenerating damaged kidney tissue has been tried in several small studies, with mixed results — some showed modest improvement, others no meaningful difference.

It is not standard care today. You may choose to try it, knowing the cost is high and the outcome uncertain.

6. Kidney transplant

Technically possible, and performed at a handful of university hospitals in the US. The practical barriers are steep.

  • Cost — tens of thousands of dollars for surgery alone
  • Lifelong immunosuppression — with its own infection risk
  • A donor cat is required. Most programmes require the family to adopt the donor
  • The patient must qualify — heart disease, infection or cancer usually rules it out

7. So what do you do today?

Known to work, right nowWorth watching
Phosphorus control (diet + binders)
Blood pressure
Proteinuria
Hydration
Acidosis and electrolytes
Adequate protein and stable weight
Molidustat — worth raising now if there is anemia
AIM / FeliAIM (under review in Japan)
Stem cells
Transplant
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The left column is unglamorous. It is also what has actually extended lives so far. The best way to wait for a new drug is to keep your cat in the condition to receive it when it arrives.

8. What to ask your vet

  • "What is my cat's HCT right now? Are we at the point of treating the anemia?"
  • "Can we get molidustat here? If not, what is the alternative?"
  • "If we start it, how often should blood pressure be checked?"
  • "Compared with darbepoetin, which suits my cat better?"

9. Related

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This is the chapter that dates fastest. Approval status and availability keep changing. We update it as they do, but confirm current availability and prescribing with your own vet.