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

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

Nefecon provides kidney benefit irrespective of baseline eGFR in patients with IgAN: a subanalysis of the NefIgArd study (ERA 2025) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy

Effects of nefecon on Hits 1, 2, and 3 of the pathogenic cascade of IgA nephropathy: a full NefIgArd analysis (ERA 2025) - No abstract available

Glomerulonephritis • IgA Nephropathy • Renal Disease

The NefXtend trial, investigating extended nefecon treatment beyond 9 months in patients with IgAN (ERA 2025) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy

Nefecon provides kidney benefit irrespective of time since diagnosis in patients with IgAN: a subanalysis of the NefIgArd study (ERA 2025) - No abstract available

Clinical • Glomerulonephritis • IgA Nephropathy

Exploring the gut-targeted mechanism of nefecon: effects on GALT-associated and systemic IgA markers in IgA nephropathy (ERA 2025) - No abstract available

Glomerulonephritis • IgA Nephropathy • Renal Disease

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) - No abstract available

Clinical • P3 data • Glomerulonephritis • IgA Nephropathy

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

Early Intervention in IgA Nephropathy: An Update on a Potential Disease-Modifying Therapy (KIDNEY WEEK 2024) - "Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi's sarcoma...Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine...Infants exposed to inutero corticosteroids, including budesonide, are at risk for hypoadrenalism. Please see Full Prescribing Information."

Acne Vulgaris • Cardiovascular • Cataract • Dermatitis • Dermatology • Dyspepsia • Gastroenterology • Glaucoma • Glomerulonephritis • Hepatitis B • Hepatology • Herpes Simplex • Hypertension • IgA Nephropathy • Immunology • Infectious Disease • Kaposi Sarcoma • Measles • Metabolic Disorders • Musculoskeletal Pain • Ocular Infections • Oncology • Ophthalmology • Osteoporosis • Pain • Peptic Ulcer • Renal Disease • Respiratory Diseases • Rheumatology • Sarcoma • Solid Tumor • Tuberculosis • Varicella Zoster

NeflgArd Open-Label Extension: Efficacy and Safety of Nefecon in Patients with IgAN Who Completed the 2-Year Phase 3 Trial (KIDNEY WEEK 2024) - P3 | "These study findings provide valuable insights into the efficacy and safety of additional tx with Nefecon and demonstrate that, in pts previously treated with Nefecon, a second 9-mo tx course had an effect on proteinuria and kidney function decline similar to a first tx course, without additional safety concerns."

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

Specificity of Nefecon in Targeting Pathogenic IgA in IgA Nephropathy While Preserving Systemic Humoral Immunity (KIDNEY WEEK 2024) - "The ability of Nefecon to specifically modulate pathogenic Gd-IgA1 production in the GALT, while leaving systemic IgA responses and total IgA and IgG levels unchanged, supports its use as a generally well tolerated, targeted, locally-acting treatment option for IgAN. Unlike other B cell−directed therapies currently in development for IgAN, Nefecon does not impair systemic humoral immunity and, therefore, offers a therapeutic advantage by selectively reducing pathogenic Gd-IgA1 while preserving overall serum Ig levels."

Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease • Tetanus

Follow-Up Kidney Biopsy Might Be a Mandatory Procedure after Treatment in IgA Nephropathy (KIDNEY WEEK 2024) - "Background: IgA nephropathy is one of the most common chronic glomerulonephritis and 30-45% fall into CKD over a period of 20 to 25 years.Lots of therapeutic regimens have been tried such as ARB,ACEi,omega-3, corticosteroids, endothelin inhibitors, Nefecon, complement inhibitors[K1] , finerenone, methylprednisolone pulse, SGLT2 inhibitor etc, however need a longterm follow up studies to confirm the efficacy.Disappearance of proteinuria has long been regarded as surrogate marker of treatment effect, however we have reported that disappearance of proteinuria could not be a surrogate marker after treatment (2022 ASN) At this time we compare the pathological changes who showed clinically improved by methylprednisolone pulse therapy in IgAN. During last 10 years our clinic performed 1,982 cases of renal biopsy were done, of which 619 cases (31.2%) were IgAN. Among the 160 cases of clinically improved cases, only 83 (51.9 %) were pathologically improved,Normalized urinary..."

Biopsy • Chronic Kidney Disease • Fibrosis • Glomerulonephritis • IgA Nephropathy • Immunology • Lupus Nephritis • Renal Disease