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

Effectiveness and Safety of Nefecon in Primary IgA Nephropathy Across Different Baseline Proteinuria Levels: A Real-World Study. (PubMed, Adv Ther) - "In the real-world practice, nefecon was associated with favorable antiproteinuric and renal benefits with acceptable safety in patients with IgAN, including those with relatively low baseline proteinuria. This study suggests a potential benefit of early intervention following diagnosis."

Journal • Real-world evidence • Acne Vulgaris • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease

Efficacy and safety of Nefecon, glucocorticoids, or supportive therapyadded to RASi+SGLT2i in IgA nephropathy. (PubMed, Front Pharmacol) - "Nefecon is an oral budesonide formulation targeting the intestinal mucosa. The conclusion is robust after multi-factor correction, but the retrospective design leads to baseline imbalance and limited correction efficacy, which requires verification through a prospective study. Nefecon may be a potential alternative to glucocorticoids, but attention should be paid to the risk of infection during use."

Journal • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Nephrology • Renal Disease

NeFRIN: Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy (clinicaltrials.gov) - P4 | N=288 | Recruiting | Sponsor: Nanfang Hospital, Southern Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Renal Disease

Real-world multicenter evidence on Nefecon for attenuating proteinuria and kidney function decline in IgA nephropathy. (PubMed, Front Immunol) - "Serious adverse events were rare (2.5%). This real-world observational analysis shows Nefecon associated with improved proteinuria and eGFR outcomes across IgAN severity, extending randomized trial evidence to patients with advanced CKD and revealing substantial delayed response."

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

Real-World Comparative Evidence for Telitacicept, Glucocorticoids, and Nefecon in IgA Nephropathy: Clinical Value and Interpretive Considerations [Letter]. (PubMed, Drug Des Devel Ther) - No abstract available

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

Targeted release of budesonide modulates key gut microbial abnormalities in immunoglobulin A nephropathy. (PubMed, Front Immunol) - "Gut microbiota dysbiosis has been implicated in the pathogenesis of immunoglobulin A nephropathy (IgAN), but whether different therapies are associated with distinct microbial profiles remains unclear. Furthermore, microbiota composition correlated with renal pathological features, particularly segmental glomerulosclerosis and sclerosis ratio. Although limited by a small sample size, these findings suggest that targeted mucosal immunomodulation with Nefecon may partially restore gut microbial homeostasis in IgAN patients, providing new insight into the gut-kidney axis and the microbiota-related effects of therapy."

Journal • Focal Segmental Glomerulosclerosis • Glomerulonephritis • IgA Nephropathy • Immunology • Renal Disease

A complement C5-targeted GalNAc-conjugated siRNA with sustained efficacy in a non-human primate model of IgA nephropathy. (PubMed, Mol Ther) - "Furthermore, we conducted a head-to-head efficacy comparison with Nefecon, an approved therapeutic agent for IgAN, in a cynomolgus monkey IgAN model. While both treatments showed comparable improvements in key renal function parameters, the C5-siRNA achieved superior pathological remission and near-complete blockade of glomerular C5 deposition and membrane attack complex (MAC) formation. Collectively, this study provides a strong rationale for the clinical development of C5-siRNA as an excellent therapy for IgAN, either as a standalone monotherapy or in combination with agents targeting upstream pathogenic pathways."

Journal • Preclinical • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

An observational study of patients receiving delayed-release budesonide (Nefecon) for immunoglobulin A nephropathy in the United States: A case series of Asian-American patients. (PubMed, Clin Nephrol) - "Real-world IgA nephropathy treatment-associated outcomes with Nefecon in Asian-American patients for proteinuria and kidney function were consistent with those observed in the NefIgArd clinical trial. The reduction in proteinuria and improvement in kidney function was greater in patients who completed the 9-month course of therapy. These findings reveal an opportunity for further education among nephrologists regarding the recommended duration of treatment with Nefecon."

Journal • Observational data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Targeted-release budesonide versus systemic corticosteroids in IgA nephropathy: a real-world comparative study. (PubMed, Front Immunol) - "Targeted-release budesonide (Nefecon) has demonstrated efficacy in randomized trials for IgA nephropathy (IgAN), yet direct comparative real-world evidence against systemic corticosteroids is scarce, limiting clinical decision-making. Severe infections and steroid-related adverse events were numerically less frequent in the Nefecon group, but limited event counts warrant cautious interpretation. Longer follow-up is required to determine whether these exploratory findings are clinically meaningful."

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

Differing effects of Nefecon and Sparsentan in a patient with recurrent IgA nephropathy post-kidney transplantation. (PubMed, Clin Kidney J) - "Treatment with targeted-release budesonide (Nefecon) was associated with a delayed and incomplete antiproteinuric response, clinically relevant systemic glucocorticoid-related adverse effects and progressive graft function decline. After discontinuation of Nefecon, combined therapy with Sparsentan and empagliflozin resulted in sustained albuminuria reduction, stabilization of graft function, improved blood pressure control, and resolution of metabolic complications. This case highlights challenges and opportunities in integrating novel IgAN therapies into post-transplant care."

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease • Transplantation

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

Management of IgA nephropathy and the expanding role of immunomodulation. (PubMed, Kidney Int Suppl (2011)) - "Targeted therapies, such as Nefecon (targeted-release formulation budesonide) and iptacopan, which address the immune-mediated pathogenic triggers of nephron loss, are important additions. Lifestyle modification, renin-angiotensin system inhibition, sodium-glucose cotransporter-2 inhibitors, and newer agents, such as sparsentan and atrasentan, are also available to manage the generic responses to IgAN-induced nephron loss common to many forms of proteinuric chronic kidney disease. As our understanding of the pathogenic mechanisms underlying disease progression in IgAN has expanded, so has the recognition that IgAN-specific, targeted immunomodulatory therapies are needed, and that these can be used in combination with other agents addressing the more generic causes of nephron loss. These approaches together can help to modify the course of the disease in patients and avoid progression to kidney failure."

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

IgA nephropathy management: what does the future hold? (PubMed, Kidney Int Suppl (2011)) - "Two agents have been fully approved for use in patients with IgAN in some regions: Nefecon, an oral targeted-release formulation of budesonide, and sparsentan, a dual endothelin A and angiotensin II receptor antagonist. Iptacopan and atrasentan are conditionally approved on the basis of proteinuria data; full approval will be evaluated once data on kidney function are available...Combination therapies with different classes of drugs will likely become the new standard of care for chronic kidney disease as they target distinct pathogenic mechanisms or "hits" (namely, hemodynamic, immune, galactose-deficient IgA1-generating, inflammatory, and fibrotic processes involved in IgAN and chronic kidney disease progression). To improve personalized care for patients with IgAN, further research is needed to identify and validate noninvasive biomarkers for diagnosis, prognosis, treatment selection, and monitoring response."

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

The Efficacy and Safety of Telitacicept versus the Recommended Regimens in IgA Nephropathy: A Single-Center Experience. (PubMed, Drug Des Devel Ther) - "Our study confirmed that glucocorticoids have superior efficacy to nefecon, but are associated with a higher incidence of adverse events. Telitacicept offered both efficacy and safety, and can be recommended for high-risk IgAN patients who are intolerant to glucocorticoids."

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

IgA nephropathy shortly follwed by seroconversion of positive anti-GBM antibodies and rapid progressive glomerulonephritis in a Chinese boy: coincidental overlap or pathogenic link? (PubMed, BMC Nephrol) - "We report a pediatric male case in whom anti-glomerular basement membrane disease developed secondarily during the clinical course of IgA nephropathy. This case strongly suggests that in patients with newly diagnosed chronic glomerulonephritis, such as IgA nephropathy, a high index of suspicion for concurrent autoimmune diseases including anti-glomerular basement membrane disease should be maintained when rapid progression of glomerulonephritis occurs."

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

Everest Medicines and Hainan Herui have entered into a commercialization collaboration relating to Hainan Herui's budesonide enteric capsules (The Manila Times) - "This collaboration is expected to enhance patient access to the combined franchise of NEFECON and Hainan Herui's budesonide enteric capsules."

Licensing / partnership • Crohn's disease • IgA Nephropathy • Inflammatory Bowel Disease

Efficacy of Nefecon in IgA Nephropathy Patients with 24-Hour Urine Protein Excretion of 0.5–1.0 g: A 9-Month Retrospective Study (ERA 2026) - "Nefecon, a novel targeted-release oral budesonide formulation, has demonstrated efficacy in IgAN, but data in this specific subgroup remain limited...Additionally, some patients received combination therapy with other agents, including finerenone, mycophenolate mofetil (MMF), or Tripterygium wilfordii (thunder god vine), based on individual clinical circumstances...Prospective randomized controlled trials with larger cohorts are needed to confirm these findings and evaluate long-term outcomes. Image Fig1: Percentage Changes from Baseline During Nefecon Treatment (N=33)"

Retrospective data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Ophthalmology • Renal Disease

Efficacy of telitacicept and nefecon in the treatment of IgA nephropathy supported by histologic evidence (ERA 2026) - "Introduction Novel agents like telitacicept (a BAFF/APRIL inhibitor) and nefecon (targeted-release formulation of budesonide) offer new therapeutic avenues for IgAN...By January 2024, following a 4-month regimen of prednisone 50 mg qd and mycophenolate mofetil (MMF) 0.75 g q12h, sCr decreased to 154 μmol/L and proteinuria reduced to 3.7 g/d...Therapy was then adjusted to telitacicept 160 mg qw plus atrasentan, with ongoing follow-up...Why this case is exeptional This case demonstrates the successful use of two mechanistically distinct novel therapies and provides a treatment optimization strategy for progressive IgAN. Image The patient's kidney pathological features and lab values."

Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

Double-target Therapy (Telitacicept Combined with nefecon) for Refractory IgA Nephropathy with Collapsing FSGS and AKI: A Case Report (ERA 2026) - "Dual-target immunomodulatory therapy started: telitacicept 240 mg qd and nefecon 16 mg qd, alongside sacubitril/valsartan. However, evidence is lacking, and more studies are needed. Image"

Case report • Clinical • Cardiovascular • Chronic Kidney Disease • Fibrosis • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hypertension • IgA Nephropathy • Immunology • Infectious Disease • Pneumonia • Renal Disease • Respiratory Diseases • ACTN4 • TRPC6

Real-World Comparison of the Efficacy of Telitacicept and Nefecon in Patients with IgA Nephropathy: A Retrospective Observational Study (ERA 2026) - No abstract available

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

Real-world Effectiveness of Telitacicept, Nefecon, and Systemic Glucocorticoids in Patients with IgA Nephropathy: A Retrospective Cohort Study (ERA 2026) - No abstract available

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

A real-world experience of Telitacicept add-on with Nefecon in the sequential treatment of IgA nephropathy (ERA 2026) - No abstract available

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

More treatment options: Real-world efficacy and safety of Nefecon with or without immunosuppression in patients with IgA nephropathy (ERA 2026) - "Nefecon represents an innovative oral formulation of budesonide designed for targeted delivery, releasing the drug specifically in the distal ileum to maximize its interaction with B cells present in the Peyer's patches...The combination therapy included immunosuppression (Mycophenolate Mofetil/Tripterygium Glycosides Tablets/Telitacicept)...In the future, Nefecon is expected to serve as a foundational drug for IgA treatment, enabling the development of more personalized combination therapy regimens. Image"

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

Real-world data on early treatment of IgA nephropathy patients with baseline proteinuria of 0.5-1g/d using Nefecon for 9 months (ERA 2026) - "The 2025 KDIGO guideline recommends treatment with a 9-month course of Nefecon, a targeted - release budesonide, for patients who are at risk of progressive loss of kidney function with IgAN, according to result of NeflgArd study which included IgAN patients with proteinuria ³1 g per day. Therefore, for IgA nephropathy patients with proteinuria ranging from 0.5 to 1 g/d, treatment with Nefecon can be initiated as early as possible. Image"

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