Tarpeyo (budesonide) / Everest Medicines, Calliditas, Stada - LARVOL DELTA

RETROSPECTIVE REAL-WORLD STUDY OF THE EFFECTIVENESS OF BUDESONIDE ENTERIC-COATED CAPSULES IN IGA NEPHROPATHY (ISN-WCN 2026) - "Nefecon, an oral targeted -release budesonide formulation, suppresses galactose-deficient IgA1–related pathogenic processes in IgAN...AE rate was 15.4%, highest in the immunosuppressant group, mainly infections.Conclusion NFC reduced proteinuria and improved eGFR in IgAN with acceptable safety in this real-world cohort. Findings suggest differential benefits across combination strategies but are limited by single-center design, small sample size, and baseline imbalances; randomized larger studies are needed."

Real-world • Real-world evidence • Retrospective data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

APPLICATION OF TRF-BUDESONIDE (NEFECON) IN THE TREATMENT OF PEDIATRIC PATIENT WITH IGA NEPHROPATHY: A CASE REPORT (ISN-WCN 2026) - "Introduction Immunoglobulin A nephropathy (IgAN) is one of the most common primary glomerular diseases in children and adolescents, with 20% of affected children progressing to end-stage kidney disease (ESKD) within 20 years of diagnosis. A 6-month follow-up confirmed sustained benefits with Benazepril alone. These findings suggest Nefecon may be a safe and effective option for pediatric IgAN, but further large-scale studies are needed to confirm long-term safety, optimal dosing, and efficacy across diverse pediatric populations."

Case report • Clinical • Acne Vulgaris • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Human Immunodeficiency Virus • IgA Nephropathy • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pediatrics • Renal Disease

NETWORK META-ANALYSIS OF TARGETED-RELEASE BUDESONIDE (NEFECON) VS. SYSTEMIC GLUCOCORTICOIDS FOR IGA NEPHROPATHY: A SYSTEMATIC REVIEW OF EFFICACY AND SAFETY BASED ON RANDOMIZED CONTROLLED TRIALS (ISN-WCN 2026) - "In addition, Nefecon was associated with substantially fewer adverse events, particularly infectious complications and osteonecrosis. These results support Nefecon as the most promising therapeutic option for optimizing both efficacy and safety in the management of IgAN."

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

BUDESONIDE MODULATES B- AND T-CELL IMMUNITY IN PEYER'S PATCHES: IMPLICATIONS FOR IGA NEPHROPATHY (ISN-WCN 2026) - "These findings support the localized action of nefecon for the treatment of IgAN. Further studies using transcriptomic profiling and disease models are warranted to elucidate budesonide's immunological mechanisms in PPs.I have potential conflict of interest to disclose.Funding/commercial Support: Calliditas TherapeuticsI did not use generative AI and AI-assisted technologies in the writing process."

Glomerulonephritis • IgA Nephropathy • Renal Disease • CASP3 • CD69 • CD86 • FAS • FOXP3 • IFNG • IL10 • IL2RA • SDC1

REAL-WORLD ASSESSMENT OF NEFECON AS FIRST-LINE THERAPY IN IGA NEPHROPATHY: EFFICACY AND SAFETY OUTCOMES (ISN-WCN 2026) - "In addition, eGFR increased from 55.27 ± 31.73 mL/min/1.73 m2 to 61.50 ± 34.38 mL/min/1.73 m2 (P < 0.01), with a median increase of 13.38% (IQR –3.02 to 31.17). No serious adverse events were reported during the treatment period.Download: Download high-res image (133KB)Download: Download full-size imageConclusion Nefecon, as an initial therapeutic option for patients newly diagnosed with primary IgAN, was well tolerated and demonstrated a favorable efficacy profile, significantly reducing proteinuria and hematuria while improving renal function as reflected by eGFR."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Renal Disease

TARGETED-RELEASE FORMULATION OF BUDESONIDE IN REAL-WORLD FOLLOW-UP STUDY OF PATIENTS WITH IGA NEPHROPATHY (ISN-WCN 2026) - "An early decrease in serum Gd-IgA1 correlated with subsequent proteinuria response, suggesting its potential role as a pharmacodynamic biomarker. These findings provide real-world evidence supporting the effectiveness of Nefecon in Chinese patients with IgAN and may help guide its use in broader Asian populations."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Renal Disease

THE CREATION AND INITIAL DEMOGRAPHICS OF THE PERFORM™ PATIENT REGISTRY: A NOVEL REAL-WORLD REGISTRY OF PATIENTS TREATED FOR IGA NEPHROPATHY IN THE UNITED STATES (ISN-WCN 2026) - "To address this need, the PERFORM™ Patient Registry (PPR) has been created to assess the longitudinal disease characteristics, healthcare utilization, clinical management, and treatment utilization patterns of patients treated with delayed-release budesonide (Tarpeyo®) for IgAN in the United States (US). Among participants, 61% were male, 11% were Hispanic/Latino, 72% were White, 4% were Black/African American, 12% were Asian, and 10% were of other races.Conclusion While enrollment is ongoing, the current PPR population comprises a varied cohort of patients treated with Tarpeyo® for IgAN. This registry will allow for further understanding of IgAN management and outcomes for patients treated with Tarpeyo® for IgAN.This abstract was also submitted for the American Society of Nephrology Kidney Week 2025 congress.I have potential conflict of interest to disclose.Funding/commercial support: Calliditas TherapeuticsI did not use generative AI and AI-assisted..."

Clinical • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Renal Disease

IMPACT OF TREATMENT WITH NEFECON ON SERUM BIOMARKERS OF GUT-ASSOCIATED LYMPHOID TISSUE FUNCTION IN PATIENTS WITH IMMUNOGLOBULIN A NEPHROPATHY FROM THE PHASE 3 NEFIGARD TRIAL (ISN-WCN 2026) - "Nefecon is a targeted-release budesonide formulation that delivers high, localized concentrations of budesonide to the terminal ileum of the GALT, reducing the production of pathogenic forms of IgA. We previously reported that in these same participants, treatment with nefecon significantly reduced serum levels of galactose-deficient IgA1 (Gd-IgA1), anti–Gd-IgA1 immunoglobulin G (IgG) and IgA-IgG immune complexes. Collectively these data support a disease-modifying role for nefecon in the treatment of IgAN.I have potential conflict of interest to disclose.Funding/commercial support: Calliditas TherapeuticsI did not use generative AI and AI-assisted technologies in the writing process."

Biomarker • Clinical • P3 data • Glomerulonephritis • IgA Nephropathy • Renal Disease • CCL11 • CCL19 • CCL20 • CD27 • CXCL13 • CXCL5 • CXCL6 • IL18BP

DEMOGRAPHIC AND CLINICAL PROFILES OF C3 GLOMERULOPATHY AND IGA NEPHROPATHY IN BRAZIL: A REAL-WORLD COHORT FROM 2018-2025 (ISN-WCN 2026) - "Targeted therapies included eculizumab in 4.2% of C3G and Nefecon in 2.5% of IgAN patients.Conclusion In a Brazilian real-world cohort, IgAN and C3G patients were often identified with KDIGO A3 proteinuria, indicating high risk at presentation. Research funding for these studies is provided to his institution; no personal payments were received beyond institutional salary supportI used generative AI and AI-assisted technologies in the writing process.During the preparation of this work the author(s) used Novartis Internal IA tool in order to improve wording and readability. After using this tool/service, the author(s) reviewed and edited the content as needed and take(s) full responsibility for the content of the publication."

Clinical • Real-world • Real-world evidence • Complement-mediated Rare Disorders • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Renal Disease

ABSOLUTE PROTEINURIA OVER TIME WITH NEFECON VS PLACEBO IN PATIENTS WITH IMMUNOGLOBULIN A NEPHROPATHY: RESULTS FROM THE PHASE 3 NEFIGARD TRIAL (ISN-WCN 2026) - "UPCR response of ≤0.5 g/gram was achieved by 34.6% of patients receiving nefecon vs 10.4% receiving placebo.Download: Download high-res image (93KB)Download: Download full-size imageConclusion In the NefIgArd trial, nefecon led to a substantial and sustainable reduction in proteinuria; no appreciable reduction was seen with placebo. Mean proteinuria levels below 1 g/gram were observed with nefecon from 6 months and continued throughout the off-treatment phase to Month 24.This abstract was also submitted for the American Society of Nephrology Kidney Week 2025 congress.I have potential conflict of interest to disclose.Funding/commercial support: Calliditas TherapeuticsI did not use generative AI and AI-assisted technologies in the writing process."

Clinical • P3 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

DURATION OF ABSOLUTE PROTEINURIA RESPONSE WITH NEFECON IN PATEINTS WITH PRIMARY IMMUNOGLOBULILN A NEPHROPATHY: RESULTS FROM THE 2-YEAR NEFIGARD TRIAL (ISN-WCN 2026) - "Proportions of patients maintaining an absolute UPCR response, defined as UPCR ≤1 g/gram, for ≥6, ≥9, ≥12, and ≥18 months were determined.Download: Download high-res image (100KB)Download: Download full-size imageConclusion Almost three-quarters of nefecon-treated patients maintained UPCR at or below 1 g/gram for at least 9 months, and almost half for at least 18 months. These data show that nefecon treatment enables a substantial proportion of patients to achieve absolute target proteinuria levels of below 1 g/gram for sustained periods.This is an encore submission from the American Society of Nephrology 2026 meeting.I have potential conflict of interest to disclose.Paid position on advisory board of CalliditasI did not use generative AI and AI-assisted technologies in the writing process."

Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

URINE PROTEIN–CREATININE RATIO RESPONSE AT 12 MONTHS IN PATIENTS WITH IMMUNOGLOBULIN A NEPHROPATHY RECEIVING NEFECON VS PLACEBO: ANALYSIS OF NEFIGARD TRIAL DATA (ISN-WCN 2026) - "Nefecon-treated patients with a UPCR ≤1 g/gram had a smaller estimated glomerular filtration rate (eGFR) change than patients with >1 g/gram (mean [± standard error] absolute change from baseline at 12 months: 0.11 [–0.70, 0.93] and –4.82 [–6.30, –3.35] mL/min/1.73 m2, respectively).Conclusion In the NefIgArd trial, two-thirds of patients achieved an absolute UPCR ≤1 g/gram at 12 months, after 9 months of nefecon treatment and 3 months off treatment. Lower UPCR at 12 months translated into eGFR benefit, demonstrating the disease-modifying effect of nefecon in patients with IgAN.I have potential conflict of interest to disclose.Consultant to Calliditas, Inc.I did not use generative AI and AI-assisted technologies in the writing process."

Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

Nefecon Should Be Considered Before Complement Inhibition in Patients With IgAN at Risk of Progression (ISN-WCN 2026) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy

Complement Inhibition Should Be Considered Before Nefecon in Patients With IgAN at Risk of Progression (ISN-WCN 2026) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy

Hot Debate: Complement Inhibition vs Nefecon in IgA Nephropathy – Which First for Patients at Risk? (ISN-WCN 2026) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

Target-Release Budesonide in IgA Nephropathy: Rapid Proteinuria Reduction with Notable Steroid-Related Toxicity in Real-World Practice (UKKW 2026) - "Target-release formulation (TRF) budesonide (Kinpeygo®) acts on Peyer’s patches to reduce mucosal immune activation, offering a gut-targeted approach with limited systemic exposure. In this real-world cohort, TRF-budesonide produced a rapid and sustained fall in proteinuria with stable or improved kidney function. However, 20% of patients discontinued due to steroid-related toxicity, including metabolic complications. These findings highlight the importance of careful patient selection and close monitoring, even with gut-targeted steroid therapy."

Clinical • Real-world • Real-world evidence • Diabetes • Diabetic Nephropathy • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Metabolic Disorders • Nephrology • Renal Disease

Evaluation of side effects and evidence of systemic absorption in patients with IgA Nephropathy treated with targeted-release budesonide (Kinpeygo) (UKKW 2026) - "Budesonide is a highly potent steroid; 16mg is equivalent to oral prednisolone 213mg1. Future work to evaluate the longer-term effects of TRf-budesonide in different ethnic populations, including effects on the hypothalamic-pituitary-adrenal axis and adverse effects is required. References: 1: Equivalent dosage of commonly used steroids (Journal of Allergy and Clinical Immunology): https://www.jacionline.org/cms/10.1016/j.jaci.2015.07.046/attachment/9e6d93c6-b64b- 4468-8cf5-38a0e9b551e9/mmc2.pdf"

Adverse events • Clinical • Acne Vulgaris • Glomerulonephritis • Hematological Malignancies • IgA Nephropathy • Immunology • Infectious Disease • Lupus Nephritis • Lymphoma • Metabolic Disorders • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • Retinal Disorders • CYP3A4

Efficacy and safety of Nefecon in IgA nephropathy: real world clinical practice. (PubMed, Front Immunol) - "The targeted-release budesonide formulation (Nefecon) addresses IgA nephropathy (IgAN) by inhibiting mucosal immune dysregulation in gut-associated lymphoid tissue (GALT), leading to reduced production of galactose-deficient IgA1 (Gd-IgA1). The combination with immunosuppressive therapy may provide additive benefit that requires further validation. These findings extend trial results to real-world settings and highlight Nefecon as a practical treatment option for high-risk IgAN patients."

Journal • Real-world evidence • Retrospective data • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

The influence of CD27-CD21+ B cells and IgA plasma cell changes in patients with IgA nephropathy on the prognosis of treatment with Nefecon (ChiCTR) - P4 | N=96 | Not yet recruiting | Sponsor: Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University; Shenzhen Second People's Hospital, The First Affiliated Hospi

New P4 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and safety evaluation of Nefecon combined with low-dose mycophenolate mofetil in the treatment of primary IgA nephropathy: a prospective, multicenter, single arm study (ChiCTR) - P=N/A | N=40 | Recruiting | Sponsor: The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university

New trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Real-World Study of Nefecon in the Treatment of IgA Nephropathy After Kidney Transplantation (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Shanghai Changhai Hospital; Shanghai Changhai Hospital

New trial • Glomerulonephritis • IgA Nephropathy • Renal Disease • Transplantation

The latest pharmacotherapeutic options for the treatment of IgA nephropathy in the pediatric population. (PubMed, Expert Opin Pharmacother) - "The higher disease activity and longer life expectancy in pediatric patients create a critical need for the evaluation of modern therapies in children with IgAN. Thus, it is crucial to prioritize pediatric clinical trials and to focus on removing the barriers that limit their implementation."

Journal • Review • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Pediatrics • Renal Disease

Nefecon in IgA nephropathy: real-world renal efficacy, safety profile, and treatment response from a 9-month retrospective cohort analysis. (PubMed, Int Urol Nephrol) - "In real-world practice, Nefecon demonstrates significant efficacy in reducing proteinuria, improving renal function, and achieving high remission rates in IgAN patients over 9 months, with a favorable safety profile. Subgroup analyses highlight that baseline renal function, proteinuria severity, biopsy interval, and combination with immuno-suppressants may influence treatment response. Larger prospective studies are needed to validate these findings."

Journal • Real-world evidence • Retrospective data • Acne Vulgaris • Glomerulonephritis • IgA Nephropathy • Renal Disease

Matching-adjusted indirect comparison of kidney function in patients with immunoglobulin A nephropathy treated with nefecon or sparsentan. (PubMed, J Comp Eff Res) - P3 | "Aim: We compared the effects of nefecon, an oral targeted-release budesonide formulation, and sparsentan, an oral, dual endothelin-angiotensin receptor antagonist, on estimated glomerular filtration rate (eGFR) in patients with immunoglobulin A nephropathy, a leading cause of chronic kidney disease. Materials & We conducted an anchored matching-adjusted indirect comparison (MAIC) using patient-level data from NefIgArd (NCT03643965; n = 364), a randomized (1:1) trial of nefecon plus optimized renin-angiotensin system inhibitor (RASi) therapy versus placebo plus RASi; and aggregate data from PROTECT (NCT03762850; n = 404), a randomized (1:1) trial of sparsentan versus irbesartan, an angiotensin receptor blocker...Sensitivity analysis results were consistent with the main findings. In patients with immunoglobulin A nephropathy, nefecon plus optimized RASi may preserve kidney function to a greater extent than sparsentan."

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

Early Therapy with Nefecon in IgAN: Two Case Reports Demonstrating Improved Clinical Outcomes (KIDNEY WEEK 2025) - "Initial treatment with hydroxychloroquine and an angiotensin II receptor blocker showed minimal benefit. This proactive approach contrasts with traditional reactive strategies and warrants further study on timing, duration, and biomarker-guided management to improve long-term outcomes. Figure 1 Proteinuria and Urinary Creatinine Levels during Follow-up Visits"

Case report • Clinical • Clinical data • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Hypertension • IgA Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus