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

Nefecon provides kidney benefit irrespective of baseline eGFR in patients with IgAN: a subanalysis of the NefIgArd study (ERA 2025) - "This NefIgArd subanalysis demonstrated that the efficacy of a 9-month nefecon treatment course in reduction of proteinuria and preservation of kidney function was independent of baseline eGFR, both at the end of 9 months of treatment and throughout the remaining 15 month off-drug observation period."

Clinical • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy

Ileum Delivery of Budesonide by 3D Micro-structure Design for the Treatment of IgA Nephropathy (ERA 2025) - "Tlag and Tmax after administration show less variability compared to Nefecon... 1. MED 3D printing technology and 3D microstructure can be used to develop products with desired release profile and deliver API to targeted GI location. 2."

Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Renal Disease

Effects of nefecon on Hits 1, 2, and 3 of the pathogenic cascade of IgA nephropathy: a full NefIgArd analysis (ERA 2025) - P3 | "The gut-associated lymphoid tissue (GALT) is considered to be a major site for Gd-IgA1 production in patients with IgAN; nefecon is an oral, targeted‑release formulation of budesonide that is designed to inhibit Gd-IgA1 production in the GALT. Nefecon 16 mg/day was the first fully approved treatment for IgAN based on the Phase 3 NefIgArd trial findings. The 18-month NefIgArd biomarker data represent the most complete analysis to date of the effects of a drug on the IgAN pathogenic cascade, showing clear reductions in markers of Hits 1, 2, and 3 with nefecon compared with standard of care alone. These findings, coupled with other previously published data, demonstrate that treatment with nefecon has a direct disease-modifying effect in IgAN."

Glomerulonephritis • IgA Nephropathy • Inflammation • Renal Disease

Predictive Value of Gd-IgA1, Poly-IgA in the Treatment of IgA Nephropathy with Targeted Release Formulation-Budesonide. (ERA 2025) - "The early changes in Gd-IgA1 or poly-IgA during the first two months, especially poly-IgA, were associated with future proteinuria reduction. These findings suggest that Gd- IgA1 and poly-IgA may serve as biomarkers for Nefecon response."

Glomerulonephritis • IgA Nephropathy • Renal Disease

The NefXtend trial, investigating extended nefecon treatment beyond 9 months in patients with IgAN (ERA 2025) - P4 | "Nefecon is an oral, targeted-release capsule formulation of the glucocorticoid budesonide specifically designed to achieve localized delivery to the mucosal Peyer's patches of the distal ileum. This trial is currently recruiting patients and will evaluate whether extending treatment with nefecon to 2 years in total may provide additional and better-sustained proteinuria reduction as well as more complete kidney function preservation in patients with IgAN."

Clinical • Cardiovascular • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Hypertension • IgA Nephropathy • Infectious Disease • Metabolic Disorders

Sustainability and depth of UPCR reduction in patients with primary IgAN treated with nefecon: a secondary analysis of the Phase 3 NefIgArd trial (ERA 2025) - "These findings demonstrate that a substantial proportion of patients receiving nefecon is expected to achieve a deep and sustained reduction in proteinuria as a result of the 9-month treatment period, highlighting the disease-modifying effect of nefecon 16 mg/day treatment and providing support for the favorable nefecon effect on eGFR deterioration and kidney function stabilization."

Clinical • P3 data • Glomerulonephritis • IgA Nephropathy

Exploring the gut-targeted mechanism of nefecon: effects on GALT-associated and systemic IgA markers in IgA nephropathy (ERA 2025) - P3 | "These 18-month NefIgArd biomarker data represent the most complete analysis to date of the effects of a drug on markers of GALT activity and systemic immunosuppression in IgAN. The significant reduction in anti-casein IgA levels at all time points and anti-gliadin IgA levels at 6 and 9 months with nefecon versus placebo suggests a targeted reduction in IgA production within the GALT. This localized effect is further supported by the lack of significant changes in total IgA and anti-tetanus toxoid IgA levels, indicating that nefecon does not induce systemic immunosuppression but specifically modulates the mucosal immune response."

Fibrosis • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Inflammation • Renal Disease • Tetanus

Nefecon provides kidney benefit irrespective of time since diagnosis in patients with IgAN: a subanalysis of the NefIgArd study (ERA 2025) - "This NefIgArd subanalysis demonstrated that nefecon conferred treatment benefit in all patients versus placebo, irrespective of time since diagnosis; however, nefecon preserved kidney function to a greater extent versus placebo in patients recently diagnosed with IgAN. This supports the benefit of early initiation of nefecon treatment to slow disease progression and loss of kidney function."

Clinical • Glomerulonephritis • IgA Nephropathy

Everest Medicines Announces NMPA Full Approval of NEFECON for the Treatment of Primary Immunoglobulin A nephropathy (IgAN) in Adults at Risk of Disease Progression (PRNewswire) - "Everest Medicines...announced that the supplemental New Drug Application for NEFECON has been granted full approval by the China National Medical Products Administration (NMPA). NEFECON is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels. This approval marks NEFECON as the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China....The full approval by the NMPA is based on data from the global Phase 3 NefIgArd clinical trial."

China approval • IgA Nephropathy

Cost-effectiveness analysis of targeted-release formulation of budesonide (Tarpeyo) in conjunction with optimized renin-angiotensin system inhibitor (RASi) therapy relative to optimized RASi therapy alone for adults with primary immunoglobulin A nephropathy in the United States. (PubMed, J Manag Care Spec Pharm) - "Clinical trials suggest that adding Tarpeyo to optimized RASi can help preserve kidney function by reducing estimated glomerular filtration rate loss in patients with IgAN. This addition was estimated to produce a greater QALY gain and reduced overall net costs from the payer and societal perspective in the United States."

HEOR • Journal • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease • Transplantation

eGFR slope modelling predicts long-term clinical benefit with nefecon in a real-world IgAN population. (PubMed, Clin Kidney J) - "Nefecon is an oral, targeted-release formulation of budesonide approved to reduce kidney function loss in patients with immunoglobulin A nephropathy (IgAN). Of patients receiving only supportive care, 52% were modelled to have a clinical outcome within 10 years versus 24% of nefecon-treated patients. This modelling analysis indicates that the eGFR benefit seen with nefecon predicts a substantial delay in progression to kidney failure."

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

Transforming IgA Nephropathy Treatment: The Role of Kinpeygo® 4 mg▼ (modified-release hard capsules budesonide) in Preventing Nephron Loss (UKKW 2025) - "Sponsored by STADA UK"

Glomerulonephritis • IgA Nephropathy • Renal Disease

Beyond Symptom Management: The Disease-Modifying Effect of Kinpeygo® 4 mg▼ (modified-release hard capsules budesonide) (UKKW 2025) - "Sponsored by STADA UK The symposium is sponsored by STADA UK. The symposium is intended for UK healthcare professionals only and may contain promotional content."

A Targeted-Release Formulation of Budesonide for the Treatment of IgA Nephropathy Patients With Severe Renal Impairment. (PubMed, Kidney Int Rep) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

Relative Bioavailability Study of HR19042 in Healthy Subjects (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Autoimmune Hepatitis • Glomerulonephritis • Hepatology • IgA Nephropathy • Immunology • Inflammation • Renal Disease

Everest Medicines Announces Financial Results for Full Year Ended December 31, 2024 (PRNewswire) - "On January 1, 2025, with the official implementation of the latest update of NRDL, NRDL pricing now applies to NEFECON which will benefit more IgAN patients. NEFECO is the only approved treatment for primary IgAN in adults at risk of disease progression in China; In March 2025, the HSA has granted full approval of NEFEGAN indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g); We expect to commercially launch NEFECON in Taiwan region and South Korea in 2025; We expect to receive NEFECON full approval from NMPA in 2025; We expect inclusion of NEFECON in the KDIGO 2025 guidelines as well as in the first Chinese guideline for IgAN in 2025."

China approval • Commercial • Launch non-US • IgA Nephropathy

Recurrent IgA Nephropathy (IgAN) In A Transplant Recipient Managed With Targeted-Release of Budesonide and Dapagliflozin (NKF-SCM 2025) - "Immunosuppression post was tacrolimus (goal 10-12 ng/dl), mycophenolate mofetil 1000mg , and prednisone 5mg daily. His creatinine has remained between 1.3-1.6mg/dL throughout his post transplant course.Results Traditional systemic corticosteroids are frequently limited by significant side effects, but can be mitigated by TR-budesonide, which targets Peyer's patches in the small intestine to reduce systemic exposure. This patient was successfully managed with TR-budesonide along with losartan and Dapa.Conclusion Tarpeyo is not currently approved for post-transplant IgAN, and its role in this context warrants further research."

Clinical • Chronic Kidney Disease • Cytomegalovirus Infection • Dermatology • Glomerulonephritis • Hidradenitis Suppurativa • IgA Nephropathy • Immunology • Lupus Nephritis • Nephrology • Renal Disease • Transplantation

The Rapidly Changing Treatment Landscape of IgA Nephropathy. (PubMed, Semin Nephrol) - "This has directly resulted in the approval of three novel therapies specifically for the treatment of IgAN (nefecon, sparsentan, and iptacopan), and several others are in the late stages of clinical development. In this review, we outline the rationale for new therapies in development for IgAN and emerging clinical trial data and propose a new paradigm for the treatment of this condition."

Journal • Review • Glomerulonephritis • IgA Nephropathy • Renal Disease

Expected and verified benefits from old and new corticosteroid treatments in IgA nephropathy: from trials in adults to new IPNA-KDIGO guidelines. (PubMed, Pediatr Nephrol) - "In this review, a critical analysis of adult data is provided for extrapolating information useful for children, with a parallel evaluation of the results of the TESTING Trial, employing oral methylprednisolone, and of the NEFIgArd Trial, using enteric release budesonide. Patients' characteristics and the scheme of the two studies are surprisingly similar: Nefecon and methylprednisolone showed 40-50% proteinuria reduction from baseline, with a fast effect of methylprednisolone (3-6 months) and a similar effect on renal function decline...The choice between old and new corticosteroids in treating children with IgAN is approaching. In the near future, the genetic data, complemented by blood and urine biomarkers, could be included in tools to guide therapeutic choices and monitoring."

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

The road ahead: emerging therapies for primary IgA nephropathy. (PubMed, Front Nephrol) - "Sparsentan is indicated for persisting proteinuria...To reduce Gd-IgA1 production, targeted-release budesonide is approved...The terminal pathway inhibitors cemdisiran and ravulizumab show promise in phase 2 studies. Our current approach for those requiring immunosuppression involves combining the reduction of Gd-IgA1 (nefecon) with suppressing the effects of inflammation (iptacopan). The optimal duration of such therapy is uncertain. Clearly, there is more to be learned with many trials underway."

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

NefXtend: Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients with Primary IgA Nephropathy (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Calliditas Therapeutics AB | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Renal Disease

Treatment of Patients with IgA Nephropathy: A call for a new paradigm. (PubMed, Kidney Int) - "A multitude of new therapies are now being evaluated in IgAN, and several drugs, such as sodium-glucose transporter-2 inhibitors, sparsentan (a dual endothelin-1 and angiotensin II receptor blocker), nefecon (a targeted release formulation of budesonide) and iptacopan (a complement factor B inhibitor) have been approved, with more to come in the next few years. In this review, we propose a new treatment paradigm that combines therapies with different mechanisms of action to target the immune components and the chronic kidney disease components of IgAN in parallel to preserve long-term kidney survival."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease • CFB • EDN1

Efficacy and Safety of Nefecon in Patients with IgA Nephropathy from Mainland China: 2-Year NefIgArd Trial Results. (PubMed, Kidney360) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

NefXtend: Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients with Primary IgA Nephropathy (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Calliditas Therapeutics AB

New P4 trial • Real-world • Real-world evidence • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301 (clinicaltrials.gov) - P3 | N=21 | Completed | Sponsor: Everest Medicines (Singapore) Pte. Ltd. | Active, not recruiting ➔ Completed | N=58 ➔ 21 | Trial completion date: Dec 2024 ➔ Jul 2024

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