7 Approved Drugs for IgA Nephropathy and What Their Labels Actually Promise

Your nephrologist says a drug name. You write it on the back of a receipt in the parking lot and look it up that night. The results say the FDA approved it for IgA nephropathy, which feels like the end of the question. It is closer to the beginning, because 7 drugs now carry that approval and they do not all promise the same thing.

Five years ago there were none at all, with not a single therapy approved to treat IgA nephropathy itself. Patients got blood pressure control, a RAS inhibitor, diet advice, and a waiting game, while the most common disease of the kidney's tiny filters anywhere in the world took its course. The absence of treatment was never for lack of interest.

Why IgA Nephropathy Went From 0 Approved Drugs to 7 in 5 Years

The obstacle was arithmetic. To prove a kidney drug works, you have to show it keeps kidneys working, and kidneys fail slowly. A trial built to catch that endpoint could take a decade or longer and thousands of participants with a disease that is not common, and few companies ran one.

The way out of that trap runs through a word your nephrologist says at every visit, so it helps to be clear on what it means. Healthy kidneys keep protein in your blood, where it belongs. When the filters are damaged, protein escapes into your urine instead, and the more of it that leaks, the more damage is underway. That leak is called proteinuria, a simple urine test measures it, and kidney doctors have tracked it for decades as a sign of how the disease is behaving.

For a long time, regulators would not accept that number as proof that a drug worked. Lowering the leak looked encouraging, but the FDA wanted evidence that patients actually stayed off dialysis, and finding that out meant waiting a decade to watch what happened to them.

In 2019, a Kidney Health Initiative workgroup, a partnership of the FDA and the American Society of Nephrology, reviewed the data from earlier IgA nephropathy studies and asked one pointed question (Thompson et al., 2019). When a treatment lowers the protein leak, do those patients do better years later? The relationship held up well enough that the FDA agreed to accept the urine number as stand-in evidence of likely benefit. The formal term is a surrogate endpoint reasonably likely to predict benefit, which supports accelerated approval but not full approval, and it opened the door to the approvals that followed.

A drug company could now run a 9-month study measuring urine protein instead of a 10-year study counting dialysis starts. In the years that followed, many companies launched IgA nephropathy trials.

The first approval arrived 2 years after that, and it came from an unexpected direction. Tarpeyo is budesonide, a corticosteroid that has been prescribed for decades in asthma inhalers and for Crohn's disease. What makes it work here is the packaging. The capsule is built to stay sealed until it reaches the lower part of the small intestine, which is where the immune tissue that produces the faulty antibodies actually sits, so the drug is meant to act near that source, though some of the steroid still reaches the rest of the body. The FDA cleared it in December 2021 (FDA, 2021). Filspari followed in February 2023, Fabhalta in August 2024, Vanrafia in April 2025, Voyxact in November 2025, Trutakna this past July, and AstraZeneca announced accelerated approval for Ultomiris on October 21st. One more decision, for povetacicept, is due November 30th.

Every one of the 7 reached patients through accelerated approval, a pathway that works as a loan rather than a gift. The FDA lets a drug onto the market based on the surrogate, in this case a drop in urine protein, on the condition that the company runs a longer confirmatory trial and comes back with evidence on the outcome that actually matters, which is slowing the loss of kidney function.

Three of the 7 have now repaid that loan. Tarpeyo converted to full approval in December 2023 on the strength of the NefIgArd trial, becoming the first therapy cleared to reduce loss of kidney function in IgA nephropathy. Filspari converted in September 2024. Fabhalta converted on July 16th of this year, after 24-month APPLAUSE-IgAN results showed a 48% slower decline in kidney function than placebo, a yearly eGFR change of -3.0 against -5.7mL/min/1.73m2 in the figures Novartis gave at approval (Novartis, 2026). The New England Journal of Medicine report of the same trial put the slowing at 49.3% (Barratt et al., NEJM 2026).

The other 4 are still carrying the debt, and their labels say so, describing proteinuria reduction rather than protection of kidney function. Whether they protect kidney function over years is being tested right now, in trials that have not finished.

None of this makes the newer 4 bad drugs. Accelerated approval exists because making patients wait a decade for a therapy that is reasonably likely to work carries its own harm, and the early signals here have been strong. Voyxact cut proteinuria by 50% at 9 months against a 2% increase on placebo (Otsuka, 2025). Trutakna produced a 42% reduction compared with placebo at 36 weeks in the ORIGIN 3 trial (Vera Therapeutics, 2026). Otsuka has since reported 2-year kidney function data for Voyxact and said on October 22, 2026 that it had completed its application for full approval, which the FDA has not yet ruled on.

The point is that you should know which kind of promise is printed on your bottle, because the honest answer to how much this drug will protect my kidneys is different for each group.

The 7 Approved IgA Nephropathy Drugs and How Each One Works

IgA nephropathy damages kidneys through a chain of events. The body makes a malformed version of an antibody called IgA1, the immune system attacks it, the resulting clumps lodge in the kidney's filters, and inflammation and scarring follow. The approved drugs interrupt that chain at 4 different points, which is why 2 of them can look nothing alike and both be correct choices.

Tarpeyo (budesonide, delayed release)

A corticosteroid in a capsule designed to dissolve in the lower small intestine, where immune tissue produces the faulty IgA1 in the first place. Taken by mouth as a 9-month course rather than indefinitely. Full approval since December 2023. Being a targeted-release steroid does not make it free of steroid effects, and a safety review still belongs in the conversation.

Filspari (sparsentan)

A daily pill that blocks 2 receptors at once, endothelin A and angiotensin II, reducing the pressure inside the kidney's filters and the protein that escapes them. This one works on the kidney's response to injury rather than the immune cause. Full approval since September 2024. Its label carries warnings about liver injury and use in pregnancy, so check the current monitoring schedule with your doctor.

Fabhalta (iptacopan)

An oral inhibitor of complement factor B, part of the immune cascade that amplifies damage once the IgA1 clumps arrive. Converted to full approval in July 2026 and the only complement inhibitor so far cleared on a kidney function claim in this disease. Because it suppresses part of the immune system, vaccination planning and infection monitoring come with it.

Vanrafia (atrasentan)

A daily pill blocking the endothelin A receptor selectively, a cousin of Filspari's approach without the angiotensin half. Accelerated approval since April 2025. Novartis reported final ALIGN results in 2026 showing less kidney function loss than placebo, though the end-of-study difference did not reach statistical significance (p=0.057), and Novartis said in July 2026 that it had filed for full approval in the US. Same cautions that follow the endothelin class: liver enzyme testing before and during treatment, fluid retention, and pregnancy, plus anemia and lower blood pressure seen in the trial.

Voyxact (sibeprenlimab)

The first therapy to block APRIL, a signal that drives the B cells making faulty IgA1. Given by injection. Accelerated approval since November 2025, with 2-year kidney function data reported in August 2026 and an application for full approval, completed in October 2026, awaiting an FDA decision. Infection risk and vaccine timing matter here too.

Trutakna (atacicept)

Blocks both APRIL and BAFF, 2 signals feeding the same B cells, and is self-administered weekly. Approved July 7th of this year on accelerated approval, and Vera applied for full approval on November 3, 2026. Same immune-suppression considerations as the other B-cell directed options.

Ultomiris (ravulizumab)

An antibody given by IV infusion that blocks complement C5, the last step of the same immune cascade Fabhalta targets earlier. After a loading dose, adults get weight-based infusions every 8 weeks. AstraZeneca announced its accelerated approval on October 21, 2026, based on urine protein, with kidney function results from the I CAN trial still to come. It carries a boxed warning for serious meningococcal infections, so meningococcal vaccines are needed at least 2 weeks before the first dose, and it is available only through a REMS program.

Every one of these has a plain-English profile with side effects and trial results in our Drug Decoder, and the IgA nephropathy page puts the approved options side by side along with the trials still recruiting.

Povetacicept's November 30th Decision and the New Ultomiris Approval

The field is not finished. AstraZeneca announced Ultomiris's accelerated approval on October 21, 2026, and povetacicept is still in front of the FDA with Phase 3 data already reported. If povetacicept is approved too, IgA nephropathy will have gone from zero treatments to 8 in almost exactly 5 years.

Povetacicept (Vertex), decision due November 30, 2026

Povetacicept blocks APRIL and BAFF together, the same 2 B-cell signals that Trutakna targets, and is given as an injection under the skin once every 4 weeks alongside your usual care. Vertex is seeking accelerated approval based on a planned checkpoint in the Phase 3 RAINIER trial, which enrolled 605 patients in all; the interim analysis covered the first 199 measured at week 36. Urine protein in the povetacicept group fell 52.0% from where it started, which worked out to a 49.8% drop compared with placebo. Vertex reported a p-value below 0.0001 for that result and said every secondary endpoint also improved (Vertex, 2026).

Two details are worth understanding. Vertex spent a priority review voucher to shorten the FDA review from 10 months to 6, which is why the decision arrives November 30th rather than in spring. RAINIER has also not ended. The trial is still running and still blinded, meaning neither the patients nor their doctors know who is receiving the drug, and it continues toward a final readout at 2 years that measures how fast kidney function actually changed. That is the confirmatory evidence, already underway, which puts povetacicept on the same accelerated approval path the other 7 took.

Ultomiris (ravulizumab), accelerated approval announced October 21, 2026

Ultomiris is not a new drug. AstraZeneca's Alexion unit already sells it for 4 other rare conditions, including paroxysmal nocturnal hemoglobinuria and generalized myasthenia gravis, so doctors have years of experience with it, including its boxed warning for serious meningococcal infections. IgA nephropathy has now been added to that list. Ultomiris blocks C5, the final step of the complement cascade. Fabhalta blocks an earlier step in that same system, which makes the 2 drugs cousins rather than twins, and AstraZeneca says Ultomiris is the first C5 blocker approved for this disease.

In the Phase 3 I CAN trial, urine protein fell 46.6% from baseline at week 34 against 5.6% on placebo, a placebo-adjusted reduction of 43.4%. The effect showed up by week 10 and held through week 34, and it was consistent across patient subgroups (AstraZeneca, 2026). After a priority review, AstraZeneca announced the accelerated approval on October 21, 2026, for adults at risk of disease progression. The company says it has not been established whether Ultomiris slows kidney function decline, and the I CAN trial measures that at week 106.

What a PDUFA date is and why one decision has a day and the other has a season

Both of those timelines come from the same machinery. Under the Prescription Drug User Fee Act, drugmakers pay fees to the FDA and the agency commits in return to review applications on a clock. A standard review runs 10 months from the day the FDA accepts the filing. A priority review runs 6. The deadline that falls at the end of that clock is the PDUFA date, also called the target action date.

Notice the word action there. A PDUFA date is the day the FDA promises to respond, not the day it promises to approve. The response can be an approval, or it can be a complete response letter saying the application is not approvable in its current form, and the reasons can range from manufacturing problems to questions about whether the drug works. The agency can also act early, and occasionally it runs past the date, usually after extending the review to examine new information.

Here is the part that explains your own confusion if you have ever tried to look one of these up. The FDA does not publish PDUFA dates, so companies disclose them or choose not to. Vertex named November 30th, while AstraZeneca said publicly only that its Ultomiris decision would fall in the fourth quarter. Companies decide how much of their timeline to disclose, and that is why a tracker like ours showed an exact day for one drug and a 3-month window for the other.

Povetacicept's date also reflects something patients rarely hear about. Vertex shortened its review from 10 months to 6 by redeeming a priority review voucher. Vouchers are awarded to companies that get a drug approved for a rare pediatric disease or a neglected tropical disease, and they can be sold to other companies, sometimes for large sums. A company buying one is buying 4 months of calendar, which for a drug like this could mean 4 months of patients starting treatment sooner if it is approved.

The povetacicept page on our rare disease FDA calendar updates with the outcome when it arrives, and you can get that decision by email the day it happens. Further back, felzartamab, zigakibart, and sefaxersen are working through Phase 3 of their own.

What to Ask Your Nephrologist Before Starting an IgA Nephropathy Drug

These are the questions that separate a prescription you understand from one you simply take.

Is this drug approved on proteinuria or on kidney function

The single most useful question in this whole field right now. It tells you what the evidence behind your treatment actually established, and it costs your nephrologist 10 seconds to answer.

Why this mechanism for me

There are 4 different pathways represented among the 7 approved drugs. The choice should connect to your biopsy, your proteinuria trend, your kidney function trajectory, and your other conditions, not to whichever drug is newest.

What are we measuring and when

Ask what your proteinuria and eGFR are today, what number would count as a response, and when you will check again. KDIGO points toward getting proteinuria below 0.5g per day and ideally below 0.3, while acknowledging that is not reachable for everyone with established scarring.

What does this do to my infection risk

Five of the 7 work by damping part of the immune system. Vaccination status, timing, and which vaccines are off limits during treatment are part of starting these drugs, not an afterthought.

What happens if this one does not work

With 7 approved and more coming, a first choice is no longer a last choice. Ask what the next option would be and what would trigger switching.

What will this cost me

Every one of these is a specialty drug, and insurers usually require prior authorization. Ask which specialty pharmacy dispenses it, whether a manufacturer support program exists, and who at the practice handles the appeal if coverage is denied.

IgA Nephropathy Patient Support and Advocacy Resources

Clinical information answers only part of a diagnosis. The IgA Nephropathy Foundation runs monthly virtual support groups split by situation, one for patients, one for caregivers and care partners, and one for people on dialysis or living with a transplant. For a disease where most people have never met another patient, that is a practical resource rather than a sentimental one.

Questions IgA Nephropathy Patients Are Asking About the New Drugs

There is a version of this story that is pure celebration, and it would be fair. A disease that offered nothing but blood pressure pills in 2020 now has 7 approved therapies and 1 more decision pending, and we wrote that story in March when the Fabhalta data published.

The less comfortable version is the one worth carrying into an appointment. More than half of these drugs are still proving they do the thing patients actually want, which is to keep kidneys working. That is how the pathway was built, and it was built that way on purpose so people would not have to wait out a decade of trials. Knowing which group you were handed is not pessimism. It is the difference between taking a drug and understanding it.