Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Prevented Progression to Kidney Failure and Improved Kidney Function in IgA Nephropathy (IgAN)

July 1, 2026 |

11 min read

First ever APRIL inhibitor to demonstrate statistically significant eGFR stabilization with evidence of improvement versus placebo over two years, highlighting VOYXACT’s promising ability to provide long-term kidney protection and enhance clinical outcomes in IgAN
VOYXACT showed robust reductions in risk of progression to kidney failure, reinforcing the therapeutic potential of selectively blocking APRIL
VOYXACTreceived U.S. FDA accelerated approval for reduction in proteinuria in adults with IgAN in November 2025. These new findings complete the Phase 3 VISIONARY study dataset, marking another milestone in Otsuka’s rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for VOYXACT traditional approval

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced positive topline full study results from the Phase 3 VISIONARY trial. VOYXACT^® (sibeprenlimab-szsi) demonstrated statistically significant stabilization of kidney function, with evidence of improvement over two years, as assessed by annualized slope and mean change from baseline in estimated glomerular filtration rate (eGFR). These results align with the KDIGO 2025 IgAN Guidelines of reducing kidney function decline to near physiological levels (<1 mL/min/1.73 m² per year) in adults with primary IgA nephropathy (IgAN) at risk of disease progression¹. VOYXACT was well tolerated, with a favorable safety profile consistent with prior interim results and comparable to placebo. These data from the VISIONARY study will be submitted to support marketing applications with global health authorities, including in an sBLA, which will be submitted to the U.S. Food and Drug Administration (FDA) for the traditional approval of VOYXACT. These analyses will also be submitted for presentation at an upcoming scientific congress.

"In a condition defined by relentless kidney function decline, achieving not only preservation but improvement over two years marks a significant therapeutic advancement for patients with IgA nephropathy. These positive Phase 3 VISIONARY eGFR results demonstrate statistically significant and clinically meaningful kidney function stabilization that reinforce VOYXACT’s potential to fundamentally halt disease progression beyond symptom management," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. "These findings add to the growing body of evidence supporting selective APRIL inhibition as a disease-modifying therapeutic approach that targets underlying IgAN drivers, without causing broad B-cell depletion, and improves long-term kidney outcomes. We look forward to continuing to work with the U.S. FDA as we advance our sBLA for traditional approval, and to sharing the complete analyses from the VISIONARY study with the scientific community."

VOYXACT is the first and only U.S. FDA-approved selective APRIL inhibitor, offering an early, targeted therapy that addresses key drivers of IgAN to alter disease progression². VOYXACT was granted accelerated approval by the U.S. FDA in November 2025 after meeting the Phase 3 VISIONARY study's primary endpoint of statistically significant proteinuria reduction compared to placebo at nine months. The two-year (24-month) eGFR findings support the rationale for selective APRIL inhibition as a precise, disease-modifying therapeutic approach that modulates B-cell activity to reduce production of pathogenic IgA without broad B-cell depletion³. These results build on previously observed reductions in Gd-IgA1, proteinuria, and hematuria, underscoring VOYXACT’s ability to modify the disease and improve long-term clinical outcomes in IgAN^2,4.

About the VISIONARY Study
VISIONARY (NCT05248646) is a global, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of VOYXACT (sibeprenlimab-szsi) in adults with IgAN. The primary efficacy endpoint assessed proteinuria reduction, as measured by the change in 24-hour urine protein-to-creatinine ratio (uPCR) from baseline compared with placebo after nine months of treatment. The key secondary endpoint evaluates annualized eGFR slope over 24 months (two years), providing an assessment of kidney function over time. Mean change from baseline in eGFR at month 24 was also evaluated as a secondary endpoint, offering a complementary measure of overall treatment effect at a defined timepoint¹. This program continues to advance the science in IgAN, with future data forthcoming in an open-label, long-term extension study (NCT05248659).

About IgAN
IgA nephropathy (IgAN) is a progressive, immune-mediated, chronic kidney disease that typically manifests in adults aged 20-40 years and can lead to kidney failure (KF) over the lifetime of most patients^5-7. IgAN is characterized by the accumulation of Gd-IgA1 complexes in the kidneys⁸. IgAN can lead to progressive loss of kidney function and, eventually, KF, imposing a significant burden on patients⁶. Despite supportive care, there is an unmet need for treatments that address the root causes of the condition. Continued research in IgAN remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients⁸.

About VOYXACT^® (sibeprenlimab-szsi)
VOYXACT (sibeprenlimab-szsi) is a humanized monoclonal antibody that binds to and blocks APRIL, which plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic galactose-deficient IgA1 (Gd-IgA1)^2,8,9. Inhibition of APRIL results in reduced levels of serum galactose-deficient IgA1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN. VOYXACT is a self-administered, subcutaneous injection dosed once every four weeks. VOYXACT is the first and only U.S. FDA-approved treatment for adults with primary IgAN at risk for disease progression that selectively inhibits APRIL, a key immune driver of the disease². VOYXACT is the only U.S. FDA-approved selective APRIL inhibitor to demonstrate stabilization of eGFR compared with placebo over two years. VOYXACT was granted accelerated approval by the U.S. FDA on November 25, 2025. Otsuka has initiated a rolling submission of an sBLA to the U.S. FDA for VOYXACT traditional approval, which will include the 24-month (two-year) eGFR findings.

INDICATION and IMPORTANT SAFETY INFORMATION for

VOYXACT^® (sibeprenlimab-szsi)

INDICATION

VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT.

WARNINGS AND PRECAUTIONS

Immunosuppression and Increased Risk of Infections: VOYXACT suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with chronic or recurring infections may have an increased risk of serious infection. In clinical trials, infections occurred in 49% of patients treated with VOYXACT compared with 45% of patients treated with placebo.

Before initiating VOYXACT, assess patients for active infections. During treatment, monitor patients for signs and symptoms of infection. If a serious infection develops, consider interrupting VOYXACT until the infection is controlled.

Immunosuppression and Immunization Risks: Because of its mechanism of action, VOYXACT may interfere with immune responses to vaccines and increase the risk of infection from live vaccines. Live vaccines are not recommended within 30 days prior to initiation of VOYXACT or during treatment with VOYXACT as safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving VOYXACT or on the efficacy of immunizations administered while receiving VOYXACT.

Common Adverse Reactions: The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%). Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.

Pregnancy: There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies, such as sibeprenlimab-szsi, can be actively transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.

Lactation: There are no data on the presence of sibeprenlimab-szsi in human milk, the effects of sibeprenlimab-szsi on the breastfed infant, or the effects of sibeprenlimab-szsi on milk production.

Pediatric Use: Safety and effectiveness of VOYXACT in pediatric patients have not been established.

Geriatric Use: Clinical studies of VOYXACT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

Pregnant women exposed to VOYXACT, or their healthcare providers, should report VOYXACT exposure by calling 1-833-869-9228 or visiting www.VOYXACT.com

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at

1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION and PATIENT INFORMATION

About Otsuka
Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. are the US-based indirect subsidiaries of the global healthcare company Otsuka Pharmaceutical Co. Ltd. Otsuka’s US companies share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and immunology. At our core is perseverance–a fierce determination to overcome any obstacle, regardless of setbacks, on behalf of patients, caregivers, and their loved ones. We will not be bound by doing what’s been done before. Learn more at www.otsuka-us.com.

References

Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4S):S1-S71.
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