What the FDA decided on Trutakna for IgA nephropathy
The FDA approved Trutakna (atacicept) for IgA nephropathy.
Accelerated approval to reduce protein in the urine in adults with primary IgA nephropathy who are at risk of their disease getting worse. Trutakna is a 150mg injection under the skin once a week, given at home by the patient or a caregiver. It is the first FDA-approved drug that blocks both BAFF and APRIL.
Who the Trutakna decision matters to
IgA nephropathy is the most common primary glomerulonephritis worldwide, caused by abnormal IgA1 antibodies depositing in the kidney's mesangium, activating complement pathways and triggering inflammation that progressively damages the kidneys. While some patients have a benign course, about 1 in 5 people with IgA nephropathy develop kidney failure within 10 years (NIDDK).
Seven disease-specific therapies, including a gut-targeted steroid and drugs targeting complement, endothelin, and the APRIL/BAFF pathway have reached FDA approval since 2021, most recently Ultomiris (ravulizumab), whose accelerated approval AstraZeneca announced on October 21, 2026.
Prevalence: About 2 new cases per 100,000 people each year in the U.S., and an estimated 199,000 to 208,000 Americans were living with IgA nephropathy in 2021 (Otsuka-funded study, Clinical Nephrology, 2025). About 1 in 10 kidney biopsies in the U.S. show IgA nephropathy (NIDDK). Significantly more common in East Asian and Pacific Islander populations, with reported incidence up to 4 times higher. See our full IgA Nephropathy page for current treatments, recruiting trials, and community resources.
How Trutakna works
Trutakna: TACI-Fc fusion protein that neutralizes both BAFF and APRIL cytokines, reducing B-cell survival and pathogenic IgA production. Our full Trutakna profile covers how it works, side effects in plain language, and its trial history.
Where IgA Nephropathy treatment stands today
Read our full IgA Nephropathy treatment summary
IgA nephropathy treatment has transformed dramatically, with 7 disease-specific FDA-approved therapies now available: targeted-release budesonide (Tarpeyo), the endothelin blockers Filspari (sparsentan, which also blocks angiotensin) and Vanrafia (atrasentan), the complement inhibitors Fabhalta (iptacopan) and Ultomiris (ravulizumab), the APRIL inhibitor Voyxact (sibeprenlimab), and Trutakna (atacicept), approved in July 2026 as the first FDA-approved dual BAFF/APRIL inhibitor. Ultomiris is the newest, with accelerated approval announced by AstraZeneca on October 21, 2026.
Beyond the approved options, active trials include Biohaven's BHV-1400, a first-in-class degrader that selectively removes the pathogenic Gd-IgA1 antibody and whose pivotal trial is expected to start in the second half of 2026, plus late-stage programs like felzartamab, zigakibart and sefaxersen. Povetacicept is under FDA review, with a decision due November 30, 2026.
These targeted options represent a genuine shift from generic immunosuppression toward addressing the specific mechanisms of kidney damage. The IgA Nephropathy Foundation and NephCure maintain current trial databases.
If you have persistent protein in your urine above 0.5-1 gram per day despite maximum supportive therapy, you may qualify for trials of emerging therapies, and with multiple approved drugs now available, discussing the full treatment sequence with your nephrologist matters more than ever. A kidney biopsy is essential for diagnosis and helps predict your individual risk of progression.
The IgA Nephropathy page has every treatment and trial →Meanwhile, 93 IgA Nephropathy studies are open or about to open
The FDA's decision does not end research on IgA Nephropathy. The most recently updated:
Earlier-stage drugs Trial Friend tracks for IgA Nephropathy
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Frequently asked questions
Has the FDA decided on Trutakna?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: FDA approval notice
What was Trutakna approved for?
The FDA approved Vera Therapeutics' BLA for Trutakna in IgA nephropathy.
What to know: Accelerated approval to reduce protein in the urine in adults with primary IgA nephropathy who are at risk of their disease getting worse. Trutakna is a 150mg injection under the skin once a week, given at home by the patient or a caregiver. It is the first FDA-approved drug that blocks both BAFF and APRIL.
How it works: TACI-Fc fusion protein that neutralizes both BAFF and APRIL cytokines, reducing B-cell survival and pathogenic IgA production.
More: the Trutakna drug page explains it in plain language.
Is there already an FDA-approved treatment for IgA Nephropathy?
Yes. Trial Friend's drug list includes 7 FDA-approved drugs for IgA Nephropathy.
Approved: Tarpeyo (budesonide), Filspari (sparsentan), Fabhalta (iptacopan), Vanrafia (atrasentan), Voyxact (sibeprenlimab), Trutakna (atacicept), Ultomiris (ravulizumab).
Also coming: Felzartamab, Zigakibart, Povetacicept, Sefaxersen.
Check: the IgA Nephropathy page also searches FDA drug labels for approved treatments.
What did the Trutakna trials show?
The Phase 3 ORIGIN 3 trial (NCT04716231) reduced proteinuria by 46% from baseline with atacicept versus 7% with placebo at week 36, a 42% placebo-adjusted reduction (p<0.0001), with results published in the New England Journal of Medicine in November 2025. It also reduced harmful Gd-IgA1 antibody by 68% and resolved blood in urine in 81% of patients with baseline hematuria.
More: the Trutakna drug page has the full trial history and sources.
What are the side effects of Trutakna?
The most common side effects in the main trial were infections (32% vs 28% on placebo), most often upper respiratory infections such as colds (12% vs 9%), and reactions where the shot was given (30% vs 5% on placebo), most often redness or a skin reaction at the spot. Most were mild or moderate.
More: the Trutakna drug page has the label's warnings in full.
How much will Trutakna cost?
Trial Friend does not list a price for Trutakna. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Trutakna decision?
The FDA approved Trutakna for IgA nephropathy on July 7, 2026.
Next steps: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
Where this outcome comes from
The outcome on this page comes from FDA approval notice. This page rechecks against our calendar, which is re-verified daily.