Voyxact (sibeprenlimab-szsi) / Otsuka - LARVOL DELTA

Efficacy and safety of sibeprenlimab in IgA nephropathy: interim analysis of the China cohort in the phase 3 VISIONARY trial. (PubMed, Clin Kidney J) - P3 | "The incidence of treatment-emergent adverse events was similar between treatment groups. Interim efficacy and safety results for the mainland China cohort were consistent with the IA of the global cohort of the VISIONARY trial (ClinicalTrials.gov: NCT05248646)."

Journal • P3 data • P3 data: top line • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN) (clinicaltrials.gov) - P3 | N=24 | Not yet recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

New P3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and safety of BAFF/APRIL-pathway inhibitors versus placebo in adults with IgA nephropathy: a systematic review with pairwise and network meta-analysis. (PubMed, BMC Nephrol) - "In adults with IgAN, BAFF/APRIL-pathway inhibitors consistently and substantially reduced proteinuria versus placebo, with a small short-term eGFR difference and no evident short-term safety signal, although longer follow-up is required to define uncommon, infectious, and immunological risks. Whether this antiproteinuric effect, seen over approximately 6 to 12 months, translates into durable preservation of kidney function remains uncertain. The between-agent and biomarker estimates are exploratory, and longer trials reporting kidney-failure endpoints are needed to confirm a disease-modifying effect."

Clinical • Journal • Retrospective data • Review • Glomerulonephritis • IgA Nephropathy • Renal Disease

Sibeprenlimab (Voyxact) for primary immunoglobulin A nephropathy. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

Approved therapies in the IgA nephropathy armamentarium: a summary of the evidence. (PubMed, Kidney Int Suppl (2011)) - "Recent approvals include Nefecon, sparsentan, iptacopan, atrasentan, and sibeprenlimab. Nefecon, a targeted-release formulation of budesonide, is the only US Food and Drug Administration and European Medicines Agency fully approved agent that is designed to target the primary source of IgAN: galactose-deficient IgA1 production in the gut mucosa...Sparsentan demonstrated a significant reduction in proteinuria and estimated glomerular filtration rate decline compared with irbesartan...The endothelin A receptor antagonist atrasentan and A proliferation binding ligand inhibitor sibeprenlimab have also received accelerated US Food and Drug Administration approval, based on interim phase 3 results showing significant proteinuria reduction versus placebo in patients with IgAN. This expanded clinical armamentarium offers clinicians and patients greater choice and improved disease control in IgAN management."

Journal • Review • Fibrosis • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammation • Renal Disease • CFB

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) (clinicaltrials.gov) - P3 | N=530 | Active, not recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed ➔ Active, not recruiting | Trial completion date: May 2026 ➔ Jan 2027

Enrollment closed • Trial completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and safety of B-cell directed therapies in IgA nephropathy: A collaborative meta-analysis (ERA 2026) - "Results Results We identified 8 eligible trials evaluating B-cell directed therapies (sibeprenlimab, atacicept, povitacicept, telitacicept, felzartamab) in 1408 participants with IgAN. Conclusion Conclusion In patients with IgA nephropathy at risk of disease progression, B-cell directed therapies reduce proteinuria and stabilise kidney function, without increasing the risk of serious adverse events or infection. These findings support the role of B-cell directed therapies as a foundational disease‑modifying treatment strategy in patients with IgAN at risk of kidney function loss."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

Effect of Sibeprenlimab on eGFR in Adults With IgA Nephropathy: A Prespecified Interim Analysis of the VISIONARY Phase 3 Trial (ERA 2026) - No abstract available

Clinical • P3 data • P3 data: top line • Glomerulonephritis • IgA Nephropathy • Renal Disease

Humoral Response to COVID-19 Vaccines and Infection During Sibeprenlimab Treatment of IgA Nephropathy: Data from the ENVISION Trial. (PubMed, Clin J Am Soc Nephrol) - P2 | "APRIL inhibition with sibeprenlimab reduced pathogenic IgA while preserving mucosal immunity and systemic antibody responses to COVID-19 vaccination and infection. The absence of B-cell perturbations and the apparent absence of an increased risk of impaired vaccine response suggest that sibeprenlimab may not confer clinically significant immunosuppressive risks; the substudy's size and exploratory design preclude definitive conclusions, warranting further evaluation."

Journal • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) (clinicaltrials.gov) - P3 | N=530 | Completed | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Trial completion date: Dec 2026 ➔ May 2026 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

Comparative Network Meta-Analysis (NMA) of Sibeprenlimab Efficacy in the Treatment of Immunoglobulin A Nephropathy (IgAN) (NKF-SCM 2026) - "Treatments analyzed were: sibeprenlimab, atacicept, atrasentan, sparsentan, cemdisiran, TRF-budesonide, ravulizumab, and iptacopan. CONCLUSION Sibeprenlimab demonstrates clinically significant reductions in uPCR compared with other treatments, suggesting potential in IgAN. Updated NMA will be conducted when full Phase 3 results for sibeprenlimab are available."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN) (clinicaltrials.gov) - P2/3 | N=600 | Enrolling by invitation | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Trial completion date: Dec 2028 ➔ Dec 2029

Trial completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

Impact of SGLT2i Use on Sibeprenlimab Outcomes in IgA Nephropathy (IgAN): Subgroup Analysis From the Phase 3 VISIONARY Trial Interim Analysis (NKF-SCM 2026) - "CONCLUSION Sibeprenlimab led to similar clinically and statistically significant proteinuria reduction regardless of SGLT2i use at BL. These data support the use of sibeprenlimab independent of SGLT2i therapy."

P3 data • P3 data: top line • Glomerulonephritis • IgA Nephropathy • Renal Disease

Evaluation of Immunoglobulin G Reduction and Infection Incidence in an Interim Analysis of the Phase 3 VISIONARY Trial of Sibeprenlimab in IgA Nephropathy (NKF-SCM 2026) - "In the sibeprenlimab arm, significant hypogammaglobulinemia was rare, reductions in IgG levels did not appear to increase the overall infection risk, and serious infections were uncommon across all IgG strata. Evaluation of 24-month safety data is planned."

P3 data • P3 data: top line • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

900: Overview of the Sibeprenlimab-szsi Clinical Program (NKF-SCM 2026) - "Session Description This program reviews the mechanism of action of sibeprenlimab-szsi. It also explores clinical trial findings for sibeprenlimab-szsi."

Clinical

Sibeprenlimab in IgA Nephropathy: Achievement of Target Proteinuria Thresholds in the Phase 3 VISIONARY Trial Interim Post Hoc Analysis (NKF-SCM 2026) - P3 | "NNT values ranged from 2-9 across all proteinuria targets and generally trended downward over time. CONCLUSION The low NNT values and consistent benefit across all proteinuria thresholds reinforce the clinically meaningful efficacy of sibeprenlimab in IgAN."

P3 data • P3 data: top line • Retrospective data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and safety of sibeprenlimab in IgA nephropathy: a systematic review and meta-analysis of randomized controlled trials. (PubMed, BMC Nephrol) - No abstract available

Journal • Retrospective data • Glomerulonephritis • IgA Nephropathy • Renal Disease

EFFECT OF SIBEPRENLIMAB ON MICROSCOPIC HEMATURIA IN ADULTS WITH IGA NEPHROPATHY: INTERIM ANALYSIS OF THE "VISIONARY" PHASE 3 TRIAL (ISN-WCN 2026) - P3 | "These findings complement the robust proteinuria reductions observed with sibeprenlimab and provide evidence for its potential to target a key immune driver of kidney injury. VISIONARY is ongoing to evaluate the safety and efficacy of sibeprenlimab in preserving kidney function based on estimated glomerular filtration rate slope over a 24-month treatment period.I have potential conflict of interest to disclose.Advisory role: Otsuka Pharmaceutical, Vera Therapeutics, Viatris Honoraria: Novartis, Alexion Pharma, Chugai, Otsuka Pharmaceutical, ViatrisI did not use generative AI and AI-assisted technologies in the writing process."

Clinical • P3 data • P3 data: top line • Glomerulonephritis • IgA Nephropathy • Renal Disease

EVALUATING SIBEPRENLIMAB IN PATIENTS WITH IGA NEPHROPATHY: RESULTS FROM AN INTERIM ANALYSIS OF THE CHINA COHORT OF THE PHASE 3 VISIONARY TRIAL (ISN-WCN 2026) - P3 | "Safety findings were comparable to placebo. Safety and the key secondary efficacy endpoint (eGFR slope) will be assessed at 24 months.I have potential conflict of interest to disclose.Consultancy and/or honoraria: Alexion/AstraZeneca, Alpine Immune Sciences/Vertex, Biogen, Calliditas Therapeutics, Chinook Therapeutics, Everest Medicines, George Clinical, Novartis, Omeros, Otsuka, Roche, Vera.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • P3 data • P3 data: top line • Glomerulonephritis • IgA Nephropathy • Renal Disease

VISOR: AN ONGOING REPEAT-BIOPSY CLINICAL TRIAL ASSESSING CHANGES IN KIDNEY HISTOLOGY IN PEOPLE WITH IGA NEPHROPATHY TREATED WITH SIBEPRENLIMAB (ISN-WCN 2026) - P2, P3 | "Consulting fees from Alexion, Boehringer Ingelheim, Calliditas, CSL Vifor, Dimerix, George Clinical, Novartis, Otsuka Pharmaceutical, Roche, Stada, Travere Therapeutics, Vera Therapeutics, Vertex. Honoria from Calliditas, CSL Vifor, Novartis, Otsuka Pharmaceutical, Stada, Travere Therapeutics, Vera Therapeutics, Vertex.I did not use generative AI and AI-assisted technologies in the writing process."

Biopsy • Clinical • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Renal Disease • CD68

Sibeprenlimab: First Approval. (PubMed, Drugs) - "Treatment with sibeprenlimab suppressed APRIL levels and reduced proteinuria in patients with IgA nephropathy, according to interim analyses from the ongoing VISIONARY phase III clinical trial. This article summarizes the milestones in the development of sibeprenlimab leading to this first approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression."

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease • Sjogren's Syndrome

EnVISage: A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's (clinicaltrials.gov) - P2 | N=83 | Active, not recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Sjogren's Syndrome

Sibeprenlimab for the treatment of IgA nephropathy: VISIONARY phase 3 interim and prespecified subgroup analyses (UKKW 2026) - P3 | "In total, 320 patients were included in the IA (sibeprenlimab N=152; placebo N=168). At 12 months, sibeprenlimab achieved a 56.6% reduction in uPCR-24h (95% CI: 50.8 to 61.7) versus 5.1% with placebo (95% CI: −6.7 to 15.7) (Figure 1). Spot uPCR showed progressive reductions starting at 4 weeks and sustained through 12 months (Figure 1)."

P3 data • P3 data: top line • Glomerulonephritis • IgA Nephropathy • Renal Disease

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) (clinicaltrials.gov) - P3 | N=530 | Active, not recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Trial primary completion date: Dec 2026 ➔ May 2026

Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Renal Disease

Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine. (PubMed, Cureus) - "This review synthesizes current evidence on evolving treatments, with a focus on A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) (e.g., sibeprenlimab, atacicept, povetacicept, telitacicept), complement pathway modulators (e.g., iptacopan, cemdisiran, ravulizumab), and novel agents such as felzartamab and sparsentan. It also explores precision medicine strategies, including biomarker-guided therapy, individualized risk stratification, and combination regimens. Supported by high-quality recent clinical trial data and the latest kidney disease outcome guidelines, these innovations represent a paradigm shift toward personalized, disease-modifying treatment in IgAN, offering a new horizon for improved renal outcomes and long-term disease control."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease