Takeda’s Mezagitamab Trial Signals Growing Ambition in IgA Nephropathy Market

Takeda Pharmaceutical Company (TAK) announced an update on their ongoing clinical study.

Study Overview
Takeda is running a Phase 3 trial titled “A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy.” The goal is to see if mezagitamab can lower protein in the urine and help protect kidney function in adults with primary IgA nephropathy, a chronic kidney disease that can lead to long-term kidney damage. The study matters because IgA nephropathy has limited targeted treatment options, and strong results could position Takeda in a growing niche kidney-disease market.

Intervention/Treatment
The main treatment tested is mezagitamab (TAK-079), an injectable drug given under the skin. It is designed to act on the immune system to reduce the harmful protein build-up in the kidneys that drives IgA nephropathy. Patients in the control arm receive a placebo injection that looks the same but has no active drug. An open-label arm gives mezagitamab to a smaller group of higher-risk patients or those who took the drug in an earlier study.

Study Design
This is an interventional Phase 3 trial with patients randomly assigned to either mezagitamab or placebo in a 2:1 ratio. That means two out of three participants get the active drug and one gets placebo. The study uses a parallel-group design, where each patient stays in their assigned group, and it is “quadruple blind”: the patients, their doctors, the study staff, and those assessing results do not know who receives the drug or placebo. The main purpose is to test mezagitamab as a treatment, focusing on how well it works and how safe it is over time.

Study Timeline
The study was first submitted on April 30, 2025, indicating when the sponsor formally moved the program into this late-stage trial. Primary completion will occur once the main outcome data, such as changes in urine protein, are collected; this is the key point investors will watch for the first clear readout on efficacy. Final completion will come later, after all long-term safety and kidney function data are recorded. The most recent update, submitted on January 22, 2026, shows that the trial is active and still recruiting, which confirms that the program is progressing and that the design or timelines have been recently reviewed.

Market Implications
For investors, this ongoing Phase 3 study supports Takeda’s push into specialty kidney disease, an area where pricing power and patient stickiness can be strong. Positive future data showing reduced protein in urine and preserved kidney function could unlock a meaningful new revenue stream and support a higher valuation multiple for Takeda, especially as it seeks to offset patent pressures in other franchises. The update also keeps Takeda in the conversation alongside other kidney-focused drug developers, where competition in IgA nephropathy is building but still relatively early. While near-term earnings won’t move on this trial alone, steady progress and regular updates can boost investor confidence in Takeda’s pipeline execution and may support sentiment ahead of later readouts.

The study remains ongoing and recently updated, with full and current details available on the ClinicalTrials.gov portal under the listed identifier.

To learn more about TAK’s potential, visit the Takeda Pharmaceutical Company drug pipeline page.