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

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

Duration of Absolute Proteinuria Response with Nefecon in Patients with Primary IgAN: Results from the Two-Year NefIgArd Trial (KIDNEY WEEK 2025) - "These data show that nefecon treatment enables a substantial proportion of patients to achieve absolute target proteinuria levels for sustained periods and experience improved kidney outcomes. Proportion of patients experiencing an absolute UPCR response (defined as UPCR ≤1 g/gram) for at least 6, 9, 12, and 18 months"

Clinical • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

When IgA Strikes Twice: The Battle Beyond Transplant (KIDNEY WEEK 2025) - "Initial management included losartan 100 mg daily, which led to a modest improvement in proteinuria (1.2 g/g) and creatinine (1.7 mg/dL)...Targeted-release budesonide (TRF-budesonide; Tarpeyo) was initiated at 16mg/d in addition to standard triple immunosuppression and resulted in a significant reduction in proteinuria (0.9g/g), resolution of hematuria, and stabilization of allograft function over 4 months (Figure)...Its targeted mechanism at the gut mucosal immunity provides the necessary immunosuppressive effect while avoiding additional systemic immunosuppression in this high-risk population. We encourage clinical trials to establish long-term efficacy and safety in the transplant population."

Cardiovascular • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Hypertension • IgA Nephropathy • Metabolic Disorders • Nephrology • Transplantation

Creation and Initial Demographics of the PERFORM Patient Registry: Novel Real-World Registry of Patients Treated for IgAN in the United States (KIDNEY WEEK 2025) - "To address this need, the PERFORM Patient Registry TM (PPR) has been created to assess 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). Conclusion While enrollment is ongoing, the current PPR population contains 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."

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

Therapies for IgAN in the Cure Glomerulonephropathy Network (CureGN) (KIDNEY WEEK 2025) - "Few participants (n=5) received newer IgAN therapies (eg, sparsentan, targeted delayed-release budesonide)...Conclusion The impact of traditional IST on long term kidney function requires further exploration. Despite availability of novel IgAN therapies, conservative management (RAS inhibition, SGLT2i) and traditional IST remain most used."

Glomerulonephritis • IgA Nephropathy • Renal Disease

Safety Profile of Combined Nefecon and Sparsentan Therapy (KIDNEY WEEK 2025) - "Our findings show that compared to monotherapy, combined use of Nefecon and sparsentan reduces the spectrum of AEs. Table 1 *denotes previously reported."

Clinical • Glomerulonephritis • IgA Nephropathy

Nefecon Treatment in Patients with IgAN: A Real-World Observational Study (KIDNEY WEEK 2025) - "Nefecon, a new oral targeted-release formulation of budesonide which acts on gut mucosal immune system, has been proven in reducing proteinuria and slowing down kidney function lost in patients with IgAN. Five patients(31%) developed facial edema during follow-up. Conclusion After 6 months, Nefecon has demonstrated promising preservation of kidney function aligning with significant proteinuria reduction, with a rather safe profile in IgAN patients."

Clinical • Observational data • Real-world • Real-world evidence • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Efficacy and Safety of Nefecon in Patients with IgAN: A Real-World Study (KIDNEY WEEK 2025) - "Conclusion NEFECON may reduce proteinuria and preserve eGFR levels in IgAN patients, with a favourable safety profile. Table 1 and Figure 1"

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Dyspepsia • Glomerulonephritis • IgA Nephropathy • Renal Disease

Beyond Nine Months: Real-World Efficacy and Safety of Extended Nefecon Therapy in IgAN (KIDNEY WEEK 2025) - "Nefecon, a targeted-release budesonide, showed short-term efficacy in the 9-month NefIgArd trial. Its targeted delivery offered a more favorable safety profile, supporting the benefit of extended treatment duration beyond 9 months. Clinical characteristics of the Nefecon group and control group after PSM"

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Chronic Kidney Disease • CNS Disorders • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease • Sleep Disorder • Women's Health

Nefecon (Targeted-Release Formulation of Budesonide) for IgAN: Two Case Reports (KIDNEY WEEK 2025) - "Initial treatment included methylprednisolone, prednisone, and telitacicept...The patient received irbesartan and entecavir...Discussion These cases highlight the potential of Nefecon as an effective therapy for IgAN, even in patients with advanced histologic damage and impaired renal function. The observed clinical benefits, including reduction in proteinuria and stabilization of renal function, supports its therapeutic value in real-world settings."

Case report • Clinical • Glomerulonephritis • Hepatitis B • Hepatology • IgA Nephropathy • Infectious Disease • Inflammation • Lupus Nephritis • Nephrology • Renal Disease

Efficacy of Budesonide Delayed-Release Capsules in the Treatment of IgAN and IgA Vasculitis Nephritis in Pediatric Patients (KIDNEY WEEK 2025) - "Background Nefecon, a targeted-released budesonide for the gut-associated lymphoid tissue at Peyer’s patches (the principal site of Gd-IgA1 production), has been approved for the treatment of adult IgA nephropathy (IgAN) worldwide. Conclusion This first real-world evidence in pediatric IgAN/IgAVN indicates that Nefecon achieved significant reductions in both proteinuria and hematuria within 12 weeks. However, long-term efficacy and safety data warrant further investigation."

Clinical • Glomerulonephritis • IgA Nephropathy • Nephrology • Pediatrics • Renal Disease • Vasculitis

Real-World Treatment for IgAN in the Veterans Health Administration (KIDNEY WEEK 2025) - "IgAN treatments, including systemic glucocorticoids (SGC), other immunosuppressants (azathioprine, mycophenolate, or cyclophosphamide), angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), sodium-glucose co-transporter 2 inhibitors (SGLT2i), and novel treatments (iptacopan, sparsentan, targeted delayed-release budesonide) were ascertained using pharmacy records and categorized as continued use at IgAN diagnosis, incident use at IgAN diagnosis, discontinued use after IgAN diagnosis, or no use...Conclusion Low rates of existing and novel treatment use in this cohort reveal an opportunity to improve adherence to draft updates to IgAN guidelines that suggest using immunomodulating agents concurrently with supportive therapies such as ACEi/ARBs and SGLT2is. Many people discontinued treatments, suggesting a possible role for novel therapies as alternative options."

Clinical • HEOR • Real-world • Real-world evidence • Ankylosing Spondylitis • Chronic Kidney Disease • Dermatitis • Dermatology • Glomerulonephritis • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • IgA Nephropathy • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Renal Disease • Rheumatology • Seronegative Spondyloarthropathies

Real-World Experience with Targeted-Release Budesonide in the Treatment of IgAN (KIDNEY WEEK 2025) - "At the initiation of Tarpeyo, ten patients were receiving renin-angiotensin-aldosterone system (RAAS) inhibitors, including three patients on sparsentan. No serious infections were reported during the treatment period. Conclusion At our center, Tarpeyo produced outcomes comparable to those observed in the Phase III NefIgArd trial, with a significant reduction in proteinuria and an acceptable safety and tolerability profile."

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Cardiovascular • Glomerulonephritis • Hypertension • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Nephrology • Renal Disease

Efficacy and Safety of a Targeted-Release Formulation of Budesonide in Patients with IgAN and Severe Renal Impairment: A Real-World Study (KIDNEY WEEK 2025) - "Funding Government Support – Non-U.S. Conclusion Nefecon, when administered to IgAN patients with severe renal impairment and persistent proteinuria, was well-tolerated and resulted in a significant reduction in both proteinuria and hematuria, along with an improvement in eGFR. Changes in (a, b) UPCR, (c, d) UACR, (e, f) urinary RBC count, and (g, h) eGFR during treatment with Nefecon."

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

Absolute Proteinuria over Time with Nefecon vs. Placebo in Patients with IgAN: Results from the Phase 3 NefIgArd Trial (KIDNEY WEEK 2025) - "Conclusion 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."

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

Investigating Extended Nefecon Treatment Beyond Nine Months in Patients with IgAN: The Phase 4 NefXtend Trial (KIDNEY WEEK 2025) - P4 | "Description Nefecon is an oral, targeted-release budesonide formulation approved for immunoglobulin A nephropathy (IgAN). Safety outcomes include adverse events (AEs), serious AEs, and AEs of special interest (steroid effects, infections). This trial will evaluate whether extending nefecon treatment to 2 years may provide additional, better-sustained proteinuria reduction and more complete kidney function preservation vs only 9 months of treatment in patients with IgAN."

Clinical • P4 data • Cardiovascular • Diabetes • Glomerulonephritis • Hypertension • IgA Nephropathy • Infectious Disease • Metabolic Disorders • Renal Disease

Targeting IgAN Early: Considerations for Adding Potentially Disease Modifying Therapy to Frontline Treatment (KIDNEY WEEK 2025) - "Sponsored by Calliditas. A New Era for IgAN: The Importance of Early Intervention • Transforming IgAN Care: Key Advances to Guidelines That Are Redefining the Standard • For IgAN Patients at Risk of Progression: Start TARPEYO to Target a Key Source of IgAN at Diagnosis"

Glomerulonephritis • IgA Nephropathy

IgA nephropathy with monotypic IgA-κ deposits: a case report and literature review. (PubMed, Front Med (Lausanne)) - "After 12 months of follow-up, the patient was treated with maximal tolerated doses of renin-angiotensin system inhibitors combined with Nefecon, the patient's urine protein decreased significantly and renal function was stable, and no hematological disorders were found during the follow-up...Moreover, IgAN with monotypic IgA-κ deposits and proliferative glomerulonephritis with monoclonal IgA deposits (PGNMID) share similarities in pathological manifestations. Therefore, rigorous monitoring of hematological indices in IgAN patients with monotypic IgA-κ deposits is essential to remain vigilant against misdiagnosis or missed diagnosis of early-stage PGNMID."

Journal • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Novel therapies improve prognosis of IgAN and limit the applicability of the International IgA Nephropathy Prediction Tool. (PubMed, Clin Kidney J) - "We included 677 immunoglobulin A nephropathy (IgAN) patients (Peking University First Hospital, 2003-23) treated with endothelin receptor antagonists, Nefecon, sodium-glucose cotransporter 2 inhibitors, hydroxychloroquine or telitacicept, a BAFF/APRIL inhibitor. In this study, both versions of both models demonstrated limited performance and overestimated risks. Given the prognostic improvement with novel IgAN therapies, these prediction tools may need updating for use in currently treated patients."

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

Executive summary of the KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). (PubMed, Kidney Int) - "Approaches to achieve the first aim are currently limited to targeted-release budesonide (Nefecon) or reduced-dose systemic corticosteroid therapy and, in Chinese patients, mycophenolate mofetil. Little has changed for special situations of IgA-dominant immune complex glomerular diseases such as nephrotic syndrome, acute kidney injury, rapidly progressive glomerulonephritis, and pregnancy in IgAN, or children with IgAN or IgAV, given the lack of major clinical trials in these patient populations. Here, we provide an executive summary of the most important changes in the KDIGO 2025 IgAN and IgAV guideline as a quick reference."

Clinical guideline • Journal • Acute Kidney Injury • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease • Vasculitis

BAIN: Nefecon and Ambrisentan in IgA Nephropathy (clinicaltrials.gov) - P4 | N=129 | Recruiting | Sponsor: The First Hospital of Jilin University | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects. (PubMed, Clin Pharmacol Drug Dev) - "The Cmax of HR19042 was approximately 1.9-fold higher than that of Nefecon and 1.4-fold higher than that of Budenofalk. In vitro, the dissolution of HR19042 occurred 30 min earlier than that of Nefecon in the intestinal buffer medium. In conclusion, both in vivo and in vitro findings suggest that HR19042 exhibits a faster absorption rate and higher oral bioavailability."

Journal • PK/PD data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Rapidly Progressive Kidney Disease in a Patient With IgA Nephropathy and Focal Segmental Glomerulosclerosis Due to Nonadherence and Loss to Follow-Up. (PubMed, Cureus) - "Later, immunosuppressive therapy, including corticosteroids, mycophenolate mofetil (MMF), and targeted-release budesonide (Tarpeyo), was initiated, but her kidney function continued to worsen. This case underscores the importance of ongoing nephrology follow-up and patient re-engagement in managing progressive glomerular diseases, especially in patients who initially decline therapy."

Journal • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hypertension • IgA Nephropathy • Metabolic Disorders • Nephrology • Renal Disease

Exploring the molecular mechanism of budesonide enteric capsules in the treatment of IgA nephropathy based on bioinformatics. (PubMed, Sci Rep) - "Budesonide Enteric Capsules (Nefecon®) are the first treatment approved by the U.S. Food and Drug Administration (FDA) targeting galactose-deficient IgA1 (Gd-IgA1) synthesis in the terminal ileum for IgAN. Protein-protein interaction (PPI) network analysis identified 10 core targets, including IL-6, TNF, AKT1, and TGF-β1, all of which exhibited strong binding affinity with budesonide in molecular docking studies. This study suggests that budesonide may exert its therapeutic effects on IgAN through multi-target and multi-pathway synergistic actions, offering valuable insights for its application in the clinical management of IgAN."

Journal • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Oncology • Renal Disease • IL17A • IL6 • TGFB1