Vanrafia (atrasentan)
An approved treatment for IgA Nephropathy.
The same compound appears under different names depending on the context. Here is how to identify Atrasentan wherever you encounter it, plus the key facts at a glance.
- Generic name
- Atrasentan
- Brand name
- Vanrafia
- Drug class
- Selective endothelin receptor antagonist
- Manufacturer
- Novartis
- How it's taken
- One tablet taken by mouth once per day with or without food.
An oral pill that blocks endothelin, a molecule narrowing blood vessels in the kidneys and driving scarring. It is approved for adults with primary IgA nephropathy who are at risk of their disease getting worse quickly, generally with a urine protein-to-creatinine ratio (UPCR) of 1.5 g/g or higher. It reduces protein leakage into urine. Received accelerated FDA approval in April 2025 based on this drop in urine protein; the label says it has not yet been shown to slow kidney function decline.
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Where Atrasentan fits
Selective endothelin receptor antagonist for IgA nephropathy, targeting kidney inflammation and fibrosis. Adds another mechanistic option for patients at risk of progressive kidney disease.
How Atrasentan works
Atrasentan blocks a protein called endothelin-A that causes inflammation and scarring in the kidneys. By blocking this protein, the drug helps reduce the amount of protein that leaks into your urine. It is meant to slow kidney damage, but the FDA label says this has not been proven yet.
Mechanism: Selective endothelin A (ETA) receptor antagonist that reduces glomerular hypertension, fibrosis, and proteinuria
Side effects and safety
Vanrafia has a boxed warning: it can cause serious birth defects and must not be taken during pregnancy. You need a pregnancy test before starting, and anyone who can become pregnant must use effective birth control before, during, and for 2 weeks after treatment. The most common side effects are swelling in the legs and arms and low red blood cell count (anemia). Vanrafia can also affect the liver, so your doctor will check liver blood tests before you start. It may lower sperm count in men. Tell your doctor right away if you gain weight quickly, feel short of breath, have swollen ankles, or have signs of liver problems such as yellow skin, dark urine, or pain in the upper right belly.
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 Atrasentan
One tablet taken by mouth once per day with or without food. The standard dose is 0.75 mg daily. Swallow the tablet whole.
Availability and cost
Only available as the brand-name product.
Selective endothelin A receptor antagonist repurposed from oncology development for IgA nephropathy. Orphan drug pricing in a rare kidney disease.
Help paying for Vanrafia
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
Co-Pay Plus: eligible privately insured patients may pay as little as $0; combined annual limit up to $15,000. Not for Medicare, Medicaid, TRICARE, VA or DoD.
For: private insurance · source - Bridge or quick-start supply
Bridge Program: privately insured patients with a prior authorization or initial denial may get Vanrafia free for up to 12 months or until coverage is approved.
For: private insurance · source - Insurance and case manager help
Novartis Patient Support answers insurance coverage questions and gives ongoing support. Mon-Fri 8 AM-8 PM ET.
The official page does not say who qualifies. Ask the program. · source - Free medicine program
Novartis Patient Assistance Foundation provides Vanrafia free to eligible patients who are uninsured or have government insurance and meet income limits.
For: no insurance, Medicare, Medicaid · source
Good to know: Free drug is through the separate Novartis Patient Assistance Foundation (1-800-277-2254); income limits apply. The Bridge Program requires a prior authorization or appeal to be filed within 45 days.
- 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) | 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 You are here | 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 ALIGN trial showed atrasentan reduced protein in urine by 38% at week 36, compared to a 3% reduction with placebo. Accelerated FDA approval was granted April 2, 2025. In February 2026, Novartis reported final ALIGN results: after about 2.5 years, kidney function (eGFR) was 2.39 points better with Vanrafia than placebo, a result that favored Vanrafia but just missed statistical significance (p = 0.057). The full results, published in The Lancet in June 2026, showed kidney function declined 1.4 points a year more slowly with Vanrafia than with placebo[1]. Novartis said in July 2026 that it had submitted these results to the FDA for traditional (full) approval[2]. Until the FDA acts, Vanrafia stays on accelerated approval.
Development history
Atrasentan was first developed by AbbVie. Chinook Therapeutics licensed it from AbbVie in December 2019 to develop it for kidney disease, and Novartis acquired Chinook in August 2023. The FDA granted accelerated approval on April 2, 2025, making Vanrafia the first selective endothelin receptor antagonist approved for IgA nephropathy and a new mechanistic option for the disease.
Explore IgA Nephropathy trials
Other IgA Nephropathy treatments
Atrasentan in Trial Friend News and Guides
Common questions about Atrasentan
▸What is Atrasentan (Vanrafia)?
An oral pill that blocks endothelin, a molecule narrowing blood vessels in the kidneys and driving scarring. It is approved for adults with primary IgA nephropathy who are at risk of their disease getting worse quickly, generally with a urine protein-to-creatinine ratio (UPCR) of 1.5 g/g or higher. It reduces protein leakage into urine. Received accelerated FDA approval in April 2025 based on this drop in urine protein; the label says it has not yet been shown to slow kidney function decline.
▸How does Atrasentan work?
Atrasentan blocks a protein called endothelin-A that causes inflammation and scarring in the kidneys. By blocking this protein, the drug helps reduce the amount of protein that leaks into your urine. It is meant to slow kidney damage, but the FDA label says this has not been proven yet.
▸What are the side effects of Atrasentan?
Vanrafia has a boxed warning: it can cause serious birth defects and must not be taken during pregnancy. You need a pregnancy test before starting, and anyone who can become pregnant must use effective birth control before, during, and for 2 weeks after treatment. The most common side effects are swelling in the legs and arms and low red blood cell count (anemia). Vanrafia can also affect the liver, so your doctor will check liver blood tests before you start. It may lower sperm count in men. Tell your doctor right away if you gain weight quickly, feel short of breath, have swollen ankles, or have signs of liver problems such as yellow skin, dark urine, or pain in the upper right belly.
▸How is Atrasentan taken?
One tablet taken by mouth once per day with or without food. The standard dose is 0.75 mg daily. Swallow the tablet whole.
▸Is Atrasentan FDA approved?
Yes, Atrasentan (Vanrafia) is FDA approved (2025) for the treatment of IgA Nephropathy.
▸What is an endothelin receptor antagonist?
Endothelin is a molecule that narrows blood vessels and drives inflammation and scarring in the kidneys. Atrasentan selectively blocks the endothelin A receptor, reducing these harmful effects. This is a different mechanism from other IgAN treatments that target the immune system.
▸What did the ALIGN trial demonstrate?
The ALIGN trial showed atrasentan reduced protein in urine by 38% at week 36, compared to a 3% reduction with placebo. Accelerated FDA approval was granted April 2, 2025. Final ALIGN results, reported in February 2026, favored Vanrafia on kidney function over about 2.5 years but just missed statistical significance on the main measure (p = 0.057). Measured as a yearly rate, kidney function declined 1.4 points a year more slowly with Vanrafia. Novartis submitted these results to the FDA for full approval by July 2026, and Vanrafia remains on accelerated approval until the FDA decides.
▸What side effects should I watch for with atrasentan?
Common side effects include swelling in arms and legs, low red blood cell count, and fluid retention. Contact your doctor right away if you gain weight quickly, feel short of breath, or have swollen ankles, as these may indicate fluid retention.
▸Can atrasentan affect fertility?
Vanrafia must not be taken during pregnancy because it can cause serious birth defects (a boxed warning). A pregnancy test is needed before starting, and effective birth control is required during treatment and for 2 weeks after stopping. In men, it may lower sperm count, which could affect the ability to father a child. Talk with your doctor about family planning before starting.
▸How is atrasentan dosed?
Atrasentan (Vanrafia) is taken as one 0.75 mg tablet by mouth once daily, with or without food. The tablet should be swallowed whole.
▸How does atrasentan compare to other IgAN treatments?
Atrasentan targets endothelin-mediated kidney inflammation and fibrosis, a different mechanism from complement inhibitors like iptacopan or BAFF/APRIL blockers like atacicept. It adds another treatment option for patients at risk of progressive kidney disease.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- The Lancet 2026;407:2387-2401 · 2026-06-04. Atrasentan in patients with IgA nephropathy (ALIGN): final 2.5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. https://pubmed.ncbi.nlm.nih.gov/42242268/
- Novartis · 2026-07-21. Novartis Q2 2026 results media release. https://www.novartis.com/sites/novartis_com/files/q2-2026-media-release-en.pdf
- U.S. Food and Drug Administration (DailyMed) · June 2026. VANRAFIA (atrasentan) tablets, Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a7e7f85-bfd0-44a0-beda-3bcfa8215c64