Trutakna (atacicept) for IgA nephropathy
What the FDA decided
The FDA approved Vera Therapeutics's BLA for Trutakna (atacicept) in 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 150 mg 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 this 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). Six 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 Trutakna (atacicept) in July 2026.
Prevalence: Incidence is about 1 in 100,000 people per year in the U.S. (IgA Nephropathy Foundation); an estimated 199,000 to 208,000 Americans were living with IgA nephropathy in 2021 (Otsuka-funded claims study, 2024). 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.
About the drug
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 six 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 inhibitor Fabhalta (iptacopan), the APRIL inhibitor Voyxact (sibeprenlimab), and, newest, Trutakna (atacicept), approved in July 2026 as the first FDA-approved dual BAFF/APRIL inhibitor. 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, povetacicept, and sefaxersen.
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, 91 IgA Nephropathy trials are recruiting
Whatever the FDA decides here, research on IgA Nephropathy does not stop. A few currently enrolling studies, US sites first:
Earlier-stage drugs Trial Friend tracks for IgA Nephropathy
You'll hear about future FDA decisions and new recruiting trials for IgA Nephropathy. Unsubscribe anytime.
Our coverage
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's 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 150 mg 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 6 FDA-approved drugs for IgA Nephropathy.
Approved: Tarpeyo (budesonide), Filspari (sparsentan), Fabhalta (iptacopan), Vanrafia (atrasentan), Voyxact (sibeprenlimab), Trutakna (atacicept).
Also coming: Felzartamab, Zigakibart, Povetacicept, Sefaxersen, Ultomiris (ravulizumab).
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 injection site reactions such as redness or pain (30% vs 5% on placebo). Most were mild or moderate.
More: the Trutakna drug page lists the 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.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Trutakna decision?
This page updates with the outcome the day it is announced.
If approved: 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.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from FDA approval notice. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.