Tarpeyo (budesonide (delayed-release))
An approved treatment for IgA Nephropathy.
The same compound appears under different names depending on the context. Here is how to identify Budesonide (delayed-release) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Budesonide (delayed-release)
- Brand name
- Tarpeyo
- International name
- Kinpeygo (Europe)
- Drug class
- Targeted-release corticosteroid
- Manufacturer
- Calliditas Therapeutics
- How it's taken
- The usual dose is 16 mg (four 4 mg capsules) by mouth once daily in the morning, at least 1 hour before a meal, for 9 months, with the dose lowered to 8 mg a day for the last 2 weeks.
A steroid pill engineered to release in the lower small intestine where it reduces production of the defective IgA antibodies that damage kidneys. It was the first drug the FDA approved for IgA nephropathy, and its label says it reduces the loss of kidney function. It is approved for adults with primary IgA nephropathy who are at risk of their disease getting worse, and it has not been shown to be safe and effective in children.
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Where Budesonide (delayed-release) fits
First FDA-approved therapy specifically targeting IgA nephropathy's disease mechanism. Designed to reduce aberrant IgA production at its source in the gut-associated lymphoid tissue.
How Budesonide (delayed-release) works
Tarpeyo is a special delayed-release form of budesonide, a steroid medicine that targets the immune system in a very specific location. The capsule stays intact until it reaches the small intestine, where it reduces inflammation and suppresses B cells producing the harmful antibodies causing IgA nephropathy. This targeted approach acts on where the harmful antibodies are made, though the FDA label says it is not established how much of the benefit comes from this local effect and how much from budesonide absorbed into the body.
Mechanism: Targeted-release corticosteroid that delivers medication to ileal Peyer's patches, reducing mucosal B cell production of galactose-deficient IgA1
Side effects and safety
Common side effects include swelling of the legs, ankles or face, high blood pressure, muscle spasms, acne, headache, upper respiratory infection, weight gain, indigestion, skin inflammation, and joint pain. It is still a steroid, so it can suppress the adrenal glands, raise the risk of infection, and worsen high blood pressure or diabetes. Tell your doctor about signs of infection, new swelling, or if you have liver problems.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Budesonide (delayed-release)
The usual dose is 16 mg (four 4 mg capsules) by mouth once daily in the morning, at least 1 hour before a meal, for 9 months, with the dose lowered to 8 mg a day for the last 2 weeks. Swallow it whole without chewing or crushing, since the delayed-release coating is important. Continue taking any other kidney medicines your doctor recommended.
Availability and cost
Only available as the brand-name product.
Targeted-release formulation of budesonide designed to deliver corticosteroid directly to the ileum where IgA is produced. The specialized delivery technology distinguishes it from standard generic budesonide.
Help paying for Tarpeyo
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured US patients may pay as little as $0 for their Tarpeyo prescription.
For: private insurance · source - Insurance and case manager help
Care Navigators help with financial support options, refills and home delivery; pharmacists check in during the 9-month course.
The official page does not say who qualifies. Ask the program. · source
Good to know: Tarpeyo is dispensed only through PANTHERx Rare Pharmacy.
- From a charity · NORD RareCareIgA Nephropathy Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCareIgA Nephropathy Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · The Assistance FundImmunoglobulin A Nephropathy (IgAN) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.” - From a charity · IgA Nephropathy FoundationIgA Nephropathy Foundation Patient Aid Grant fundApply directly
Pays for: Out-of-pocket medical costs and non-medical costs of treatment such as childcare or transportation (Foundation membership required).
The foundation says: “Status not shown on page”
How IgA nephropathy treatments compare
As of 2026, five FDA-approved medicines are available for IgA nephropathy, plus active investigational programs. The right choice depends on your proteinuria level, kidney function (eGFR), prior treatments, biopsy findings, and personal preferences around oral pills versus injections. Your nephrologist will help match a treatment to your specific situation. This chart compares the practical differences between options.
5 FDA-approved iga nephropathy treatments are available: Tarpeyo (budesonide (delayed release), approved 2021); Filspari (sparsentan, approved 2023); Fabhalta (iptacopan, approved 2024); Vanrafia (atrasentan, approved 2025); Voyxact (sibeprenlimab, approved 2025); BHV-1400 (BHV-1400, Phase 1). Tarpeyo is typically used as standard corticosteroid considerations apply (immunosuppression, infection risk, glucose changes); first disease-modifying therapy approved specifically for igan.
| Drug | What makes it different | How it works | How it’s given | How often | Where you get it | Safety highlights | FDA approved |
|---|---|---|---|---|---|---|---|
Tarpeyo budesonide (delayed release) You are here | Targets the disease at its source in the gut | Targeted-release corticosteroid that suppresses Gd-IgA1 antibody production in gut-associated lymphoid tissue (Peyer’s patches) | Oral capsule (taken on an empty stomach) | Once daily | Home (specialty pharmacy delivery) | Standard corticosteroid considerations apply (immunosuppression, infection risk, glucose changes); first disease-modifying therapy approved specifically for IgAN | 2021 |
Filspari sparsentan | Dual ETA + AT1 receptor block in one pill (non-immunosuppressive) | Dual endothelin-A and angiotensin-II AT1 receptor antagonist that reduces glomerular pressure and proteinuria | Oral tablet (REMS program) | Once daily | Home (REMS-certified specialty pharmacy) | Boxed warnings for hepatotoxicity and major birth defects; monthly liver enzyme monitoring; confirmed contraception required (pregnancy contraindicated) | 2023 |
Fabhalta iptacopan | First oral complement inhibitor for IgAN | Selective oral inhibitor of complement factor B that blocks alternative-pathway activation driving kidney inflammation | Oral capsule (REMS program) | Twice daily | Home (REMS-certified specialty pharmacy) | Boxed warning for serious encapsulated-bacteria infections; meningococcal, pneumococcal, and Hib vaccinations required at least 2 weeks before starting | 2024 |
Vanrafia atrasentan | Selective ETA blocker, no REMS or routine liver monitoring required | Selective endothelin-A receptor antagonist that reduces glomerular hypertension and fibrosis | Oral tablet (no REMS required) | Once daily | Home (specialty pharmacy delivery) | Boxed warning for major birth defects (pregnancy contraindicated); contraception required during and for 2 weeks after treatment; warnings include hepatotoxicity, fluid retention, and decreased sperm counts | 2025 |
Voyxact sibeprenlimab | First APRIL antagonist; self-injected at home once a month | Monoclonal antibody that blocks APRIL signaling, reducing B-cell production of pathogenic Gd-IgA1 antibodies | Subcutaneous injection (self-administered, no REMS required) | Every 4 weeks | Home (after training from care team) | Routine vaccinations should be up-to-date before starting; live vaccines avoided during treatment; immunoglobulin levels are monitored periodically | 2025 |
BHV-1400 BHV-1400 | Selectively removes only the disease-driving antibody; spares normal immunity | TRAP degrader that selectively binds Gd-IgA1 and routes it to the liver for clearance, sparing normal antibodies | Subcutaneous injection | Phase 1 expansion cohort enrolling IgAN patients; pivotal regimen TBD | Clinical trial site only (not commercially available) | Investigational — Phase 1 healthy-volunteer single-dose data showed up to 81% Gd-IgA1 reduction; spares normal IgA, IgG, IgE, and IgM; pivotal trial planned for 2026 | Phase 1 |
This chart compares FDA-approved IgA nephropathy treatments and one advanced investigational program (BHV-1400). It is not medical advice. All approved IgAN therapies require background renin-angiotensin system (RAS) blockade with an ACE inhibitor or ARB, and many patients also take an SGLT2 inhibitor. Treatment selection should be made with your nephrologist based on your kidney function, biopsy results, proteinuria level, comorbidities, and prior therapies.
Clinical trial results
The NefIgArd Phase 3 trial of 364 patients showed kidney function (eGFR) was 5.9 mL/min/1.73 m² higher with Tarpeyo than with placebo at 2 years. The benefit appeared by month 3 and did not grow after the 9-month course ended. FDA gave accelerated approval in December 2021 and full approval in December 2023.
Development history
Calliditas Therapeutics developed this targeted-release formulation specifically for IgA nephropathy, working for years to deliver the medicine to the part of the gut where it needs to work. It became the first FDA-approved medicine for IgA nephropathy.
Explore IgA Nephropathy trials
Other IgA Nephropathy treatments
Budesonide (delayed-release) in Trial Friend News and Guides
Common questions about Budesonide (delayed-release)
▸What is Budesonide (delayed-release) (Tarpeyo)?
A steroid pill engineered to release in the lower small intestine where it reduces production of the defective IgA antibodies that damage kidneys. It was the first drug the FDA approved for IgA nephropathy, and its label says it reduces the loss of kidney function. It is approved for adults with primary IgA nephropathy who are at risk of their disease getting worse, and it has not been shown to be safe and effective in children.
▸How does Budesonide (delayed-release) work?
Tarpeyo is a special delayed-release form of budesonide, a steroid medicine that targets the immune system in a very specific location. The capsule stays intact until it reaches the small intestine, where it reduces inflammation and suppresses B cells producing the harmful antibodies causing IgA nephropathy. This targeted approach acts on where the harmful antibodies are made, though the FDA label says it is not established how much of the benefit comes from this local effect and how much from budesonide absorbed into the body.
▸What are the side effects of Budesonide (delayed-release)?
Common side effects include swelling of the legs, ankles or face, high blood pressure, muscle spasms, acne, headache, upper respiratory infection, weight gain, indigestion, skin inflammation, and joint pain. It is still a steroid, so it can suppress the adrenal glands, raise the risk of infection, and worsen high blood pressure or diabetes. Tell your doctor about signs of infection, new swelling, or if you have liver problems.
▸How is Budesonide (delayed-release) taken?
The usual dose is 16 mg (four 4 mg capsules) by mouth once daily in the morning, at least 1 hour before a meal, for 9 months, with the dose lowered to 8 mg a day for the last 2 weeks. Swallow it whole without chewing or crushing, since the delayed-release coating is important. Continue taking any other kidney medicines your doctor recommended.
▸Is Budesonide (delayed-release) FDA approved?
Yes, Budesonide (delayed-release) (Tarpeyo) is FDA approved (2021) for the treatment of IgA Nephropathy.
▸How is Tarpeyo different from regular budesonide?
Tarpeyo uses a delayed-release formulation engineered to release medication specifically in the lower small intestine (ileum), where it targets the immune cells producing harmful IgA antibodies. Other budesonide products, such as inhalers and capsules for Crohn's disease, are approved for other conditions and are not substitutes for Tarpeyo in IgA nephropathy.
▸What did the NefIgArd trial show?
The NefIgArd Phase 3 trial of 364 patients showed kidney function (eGFR) was 5.9 mL/min/1.73 m² higher with Tarpeyo than with placebo at 2 years. The benefit appeared by month 3 and did not grow after the 9-month course ended. FDA granted accelerated approval in December 2021 and full approval in December 2023.
▸Does Tarpeyo have fewer steroid side effects than systemic steroids?
The FDA label does not compare Tarpeyo with prednisone or other oral steroids, so that has not been shown.
What the label says: Tarpeyo is a systemically available corticosteroid and is expected to cause steroid side effects, even though the liver breaks down much of each dose on its first pass.
In the trial: swelling, high blood pressure, muscle spasms and acne were more common than with placebo.
Source: Tarpeyo prescribing information
▸How should Tarpeyo be taken?
Tarpeyo is taken as 16 mg (four 4 mg capsules) once daily in the morning, at least 1 hour before a meal, for 9 months, with a lower 8 mg dose for the last 2 weeks. The capsule must be swallowed whole without chewing or crushing, since the delayed-release coating is essential for delivering the medication to the correct location.
▸Is Tarpeyo available in Europe?
Yes. Tarpeyo is marketed as Kinpeygo in Europe, where it has also received regulatory approval for IgA nephropathy.
▸What patient support is available for Tarpeyo?
TARPEYO Touchpoints (1-833-444-8277) offers copay help for eligible commercially insured patients, who may pay as little as $0, and Care Navigators who help with financial support options, refills and home delivery.