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FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy

Final two-year results from the ORIGIN 3 trial show that Vera Therapeutics' Trutakna stabilizes kidney function and reduces the risk of disease progression by 76 percent. The data positions the company to seek full FDA approval for the once-weekly injection by the end of 2026.

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Trutakna is administered as a once-weekly subcutaneous injection.From: Two-Year Phase 3 Data Confirms Trutakna's Efficacy in IgA Nephropathy, Intensifying Race for Full Approval

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Key numbers

46%
Reduction in proteinuria at 36 weeks
160,000
Estimated IgAN patients in the U.S.
150 mg
Once-weekly subcutaneous dose

From: FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy

Charts, maps and images

Two-year data shows the active treatment stabilized kidney function compared to the placebo group's steady decline.From: Two-Year Phase 3 Data Confirms Trutakna's Efficacy in IgA Nephropathy, Intensifying Race for Full Approval ·
By inhibiting both BAFF and APRIL, the therapy targets the upstream immune drivers of IgA nephropathy.From: Two-Year Phase 3 Data Confirms Trutakna's Efficacy in IgA Nephropathy, Intensifying Race for Full Approval ·
In IgA nephropathy, abnormal antibodies clump together and scar the kidneys' microscopic filtering units.From: FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy ·
Patients receiving Trutakna achieved a 46 percent reduction in proteinuria during the Phase 3 ORIGIN 3 trial.From: FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy ·
The dual-inhibitor design simultaneously blocks the BAFF and APRIL survival signals, starving the rogue B-cells.From: FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy ·
The two-year data provides clinical evidence that early reductions in proteinuria translate to long-term kidney preservation.From: Two-Year Phase 3 Data Confirms Trutakna's Efficacy in IgA Nephropathy, Intensifying Race for Full Approval ·
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The therapy is delivered via a once-weekly subcutaneous autoinjector, allowing patients to manage their treatment at home.From: FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy ·

Timeline

September 2026

  1. Two-Year Phase 3 Data Confirms Trutakna's Efficacy in IgA Nephropathy, Intensifying Race for Full Approval

July 2026

  1. FDA Approves Trutakna, a First-in-Class Dual Inhibitor for IgA Nephropathy