Filspari (sparsentan) / Travere Therap, Ligand, CSL Behring, Roche - LARVOL DELTA

Assessing the real-world safety of sparsentan for immunoglobulin A nephropathy: insights from a comprehensive analysis of FAERS database. (PubMed, Int Urol Nephrol) - "This study provides real-world data on the clinical application of sparsentan and analyzes the AEs associated with its use. It not only confirms several known adverse effects, but also identifies potential new AEs. These findings offer valuable guidance for clinicians prescribing sparsentan, aiding in the reduction of drug-related risks."

Journal • Real-world evidence • Glomerulonephritis • Hypotension • IgA Nephropathy • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • Renal Disease

Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine. (PubMed, Cureus) - "This review synthesizes current evidence on evolving treatments, with a focus on A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) (e.g., sibeprenlimab, atacicept, povetacicept, telitacicept), complement pathway modulators (e.g., iptacopan, cemdisiran, ravulizumab), and novel agents such as felzartamab and sparsentan. It also explores precision medicine strategies, including biomarker-guided therapy, individualized risk stratification, and combination regimens. Supported by high-quality recent clinical trial data and the latest kidney disease outcome guidelines, these innovations represent a paradigm shift toward personalized, disease-modifying treatment in IgAN, offering a new horizon for improved renal outcomes and long-term disease control."

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

Evaluating the Effect of Sparsentan vs Irbesartan on Urine Inflammatory and Profibrotic Biomarkers in the Phase 3 Protect Trial of Patients With Immunoglobulin a Nephropathy (ISN-WCN 2026) - No abstract available

Biomarker • Clinical • Late-breaking abstract • P3 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

IgA Nephropathy in Adults: A Review. (PubMed, JAMA) - "Based on the Kidney Disease: Improving Global Outcomes 2025 clinical practice guideline for the management of IgAN, treatment for patients with proteinuria greater than 0.5 g per day includes behavioral modifications (eg, dietary sodium <2 g/d, smoking cessation, weight control, exercise), antihypertensive medications for goal blood pressure less than 120/70 mm Hg, and therapies to reduce the formation of IgA-containing immune complexes (eg, targeted-release budesonide), decrease glomerular injury (eg, systemic glucocorticoids, iptacopan), and manage existing IgAN-induced nephron loss (eg, renin-angiotensin system inhibitor or dual endothelin angiotensin receptor antagonist [eg, sparsentan] alone or in combination with a sodium-glucose cotransporter 2 inhibitor). Patients with suspected IgAN and proteinuria greater than or equal to 0.5 g per day should undergo kidney biopsy to confirm the diagnosis. Treatment of IgAN includes behavioral modifications, blood pressure..."

Journal • Ankylosing Spondylitis • Celiac Disease • Chronic Kidney Disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Seronegative Spondyloarthropathies • Spondylarthritis • Tobacco Cessation • Vasculitis

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

Travere Therapeutics, Inc…announced Tuesday that the U.S. Food and Drug Administration has extended the review timeline for its supplemental New Drug Application (sNDA) for FILSPARI in focal segmental glomerulosclerosis (FSGS). (Investing.com) - "The new Prescription Drug User Fee Act target action date is April 13, 2026....The extension follows Travere’s recent submission of additional information requested by the FDA to further characterize the clinical benefit of FILSPARI. The FDA determined these responses constituted a Major Amendment to the application. No additional information regarding safety or manufacturing has been requested by the regulatory agency."

PDUFA • Focal Segmental Glomerulosclerosis

Travere stock plunges after FDA requests more data on kidney drug (Investing.com) - "The biotech firm disclosed that it recently received information requests from the FDA to further characterize the clinical benefit of Filspari in treating focal segmental glomerulosclerosis (FSGS), a rare kidney disorder. Travere has submitted responses to address the agency’s questions, which are currently under review...The timing of these submissions has created uncertainty around the drug’s approval status, as the Prescription Drug User Fee Act (PDUFA) action date for the supplemental new drug application is Tuesday."

FDA event • Focal Segmental Glomerulosclerosis

Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated Focal Segmental Glomerulosclerosis Enrolled in the DUPLEX Trial. (PubMed, Clin J Am Soc Nephrol) - "These findings support sparsentan's antiproteinuric benefit in patients with gFSGS, a subgroup that is often resistant to other therapeutic interventions."

Journal • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Renal Disease

Association between Complete Proteinuria Remission and Kidney Function in the Phase 3 PROTECT Trial of Sparsentan in IgA Nephropathy. (PubMed, Clin J Am Soc Nephrol) - P3 | "Participants in PROTECT who achieved CR36 or CR110 showed greater eGFR preservation, fewer kidney failure events, and similar safety profiles compared to non-CR participants. These data reinforce recommendations to maintain proteinuria levels ideally <0.3 g/day and underscore its relationship with kidney function preservation."

Clinical • Journal • P3 data • Cardiovascular • Glomerulonephritis • Hypertension • Hypotension • IgA Nephropathy • Renal Disease

Case Report: Maximizing the anti-proteinuric response: a multicenter real-world sparsentan case series in IgA disorders. (PubMed, Front Nephrol) - "We present a case series featuring seven patients - five diagnosed with IgAN and two with IgA vasculitis (IgAV) - with severe proteinuria who were treated with Sparsentan, sometimes in combination with other medications such as targeted-release formulation (TRF) budesonide, sodium-glucose cotransporter-2 (SGLT2) inhibitors, or mycophenolate. Sparsentan was well-tolerated overall, with no significant hyperkalemia or hepatotoxicity reported in this group. These cases emphasize the real-world experience, promising efficacy and safety of Sparsentan in reducing proteinuria in patients with IgA-mediated glomerular disorders, including its application in combination therapies and patients with concurrent or prior immunosuppression."

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

Treatment of Recurrent IgA Nephropathy After Kidney Transplantation: Case Report and Comprehensive Literature Review. (PubMed, Clin Case Rep) - "Recurrent IgA nephropathy after kidney transplantation remains a major cause of graft dysfunction. This case highlights successful management with targeted-release budesonide combined with sparsentan, underscoring the importance of early recognition and the promise of emerging therapies to preserve long-term allograft function."

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease • Transplantation

From RAAS blockade to regenerative medicine: evolving treatment strategies in Alport syndrome. (PubMed, Pediatr Nephrol) - "Adjunctive commercially available metabolic modulators, including SGLT2i, mineralocorticoid receptor antagonists, ezetimibe and GLP-1 receptor agonists, may offer additional kidney protection. Ameliorating therapies being tested in Phase II trials include endothelin receptor antagonists (e.g., atrasentan), dual endothelin receptor antagonist and angiotensin II receptor inhibition (e.g., sparsentan) FXR agonists (e.g., vonafexor), inducers of cholesterol efflux (e.g., VAR200 and R3R01), and NOX1/4 inhibitors (e.g., setanaxib), several of which are currently being evaluated in clinical trials. Novel strategies such as exon skipping, gene editing, and nonsense mutation readthrough (e.g., ELX-02) are advancing toward precision medicine approaches as disease modifying agents targeting the genetic cause of AS...This review summarizes the current landscape of AS classification and treatment, highlighting both standard interventions and experimental therapies. Emphasis is placed..."

Journal • Review • Fibrosis • Gene Therapies • Genetic Disorders • Glomerulonephritis • Immunology • Renal Disease • COL4A5

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

Effect of Sequential Targeted-Release Formulation (TRF)-Budesonide and Sparsentan Therapy in a Patient with IgAN: Can Histopathology Predict Therapeutic Response? (KIDNEY WEEK 2025) - "He was treated with Losartan 100 mg a day and Lisinopril 20 mg twice a day for many years In 2021, his UPC ratio was 2.4-3 mg/mg. He was started on Empagliflozin in July 2021 and Lisinopril decreased to 20 mg a day...The new guidelines have distinguished this and can help guide appropriate effective therapies based on histological variables. Improvement of UPCR with supportive therapies"

Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

Patients (Pts) with FSGS Reach Proteinuria <0.7 g/g More Often with Sparsentan (SPAR) vs. Irbesartan (IRB) in DUPLEX: Implications for Kidney Failure (KF) Risk (KIDNEY WEEK 2025) - P3 | "Conclusion In DUPLEX, pts with FSGS achieved UPCR <0.7 g/g earlier and more often with SPAR vs IRB. Together, clinical trial and real-world data indicate that reaching UPCR <0.7 g/g is associated with clinically meaningful reductions in KF risk both in the near- and long-term, supporting the long-term benefit of SPAR’s anti-proteinuric effect."

Clinical • Late-breaking abstract • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Renal Disease

New Era for FSGS Treatment (KIDNEY WEEK 2025) - "Participating nephrologists currently estimate 60% of their FSGS patients will be candidates for sparsentan and 58% for atrasentan, if/when they are approved and available. Conclusion Nephrologists are eager to begin using new FSGS treatment options and will look to clinical trial data (for FSGS and other glomerular diseases if available) that prove efficacy in reducing proteinuria and slowing eGFR decline."

Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Baseline Characteristics and Treatment Satisfaction of Patients (Pts) Enrolled in IgAN Bridge: Interim Results from a Home-Reported Outcomes (HROs) Study (KIDNEY WEEK 2025) - "The most common treatments selected included sparsentan (18%), fish oil (18%), and empagliflozin (14%). Pts with lower treatment satisfaction had greater symptom severity, and fatigue was the most frequently tracked symptom across satisfaction levels. This heterogeneity highlights the need to understand the diverse experiences and symptom burden of pts with IgAN."

Clinical • Fatigue • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology

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

Real-World Treatment Patterns of Patients (Pts) with Glomerular Inflammation in IgAN (KIDNEY WEEK 2025) - "Outcomes included proportion on IgAN therapies (renin–angiotensin–aldosterone system inhibitors [RAASi], sodium-glucose cotransporter-2 inhibitors [SGLT2i], immunosuppressants [IS, corticosteroids/glucocorticoids/MMF], targeted-release budesonide [TRB], and sparsentan [SPAR]); treatment sequencing (lines of therapy [LOTs]); and steroid-related adverse events (AEs) in pts with ≥1 IS/TRB claim...Conclusion In this real-world study, many pts with IgAN had glomerular inflammation. In this population, steroid-related AEs and high LOT discontinuation rates highlight the need for additional therapies and better matching of pts to treatments."

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

First Long-Term Real-World Evidence of Sparsentan Efficacy in Patients with IgAN Treated with SGLT2 Inhibitors (KIDNEY WEEK 2025) - "Conclusion In the extended follow-up of our real-world data subset we could confirm initial findings that sparsentan offers a significant and sustained antiproteinuric effect even in patients already receiving SGLT2 inhibitors. Course of proteinuria (UPCR) under therapy with sparsentan."

Clinical • HEOR • Real-world • Real-world evidence • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Renal Disease

Real-World Data on Low Proteinuria with Sparsentan (SPAR) in Patients (Pts) with IgAN: A Case Series (KIDNEY WEEK 2025) - "In PROTECT, SPAR was well tolerated (95% of pts received the target dose [400 mg/d]) and lowered proteinuria, leading to complete remission (CR) of proteinuria more often vs maximum labeled dose irbesartan. In 3 pts with intolerance to the 400-mg/d dose, dose modification (200 mg/d or alternating 200 mg/400 mg every other day) was well tolerated, with effective proteinuria control (UPCR <0.5 g/g). Discussion This case series supports the benefit of SPAR, alone or in combination with other txs, on achieving clinically meaningful low proteinuria thresholds, including CR, with real-world use in pts with IgAN."

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

More than Skin Deep: Successful Management of Rare IgA Vasculitis with Kidney Involvement (KIDNEY WEEK 2025) - "Diagnosed with IgAV with IgA dominant glomerulonephritis, she was started on prednisone, mycophenolate mofetil (MMF), and lisinopril. RAAS blockade, corticosteroids and cyclophosphamide or MMF are mainstay of treatment, but newer drugs like sparsentan and iptacopan, specifically targeting the immune system, have shown promise. From left to right: Gross specimen minimal interstitial fibrosis, IF granular mesangial IgA deposition, LM IgA-dominant mesangial deposits with mesangial hypercellularity and crescent."

Fatigue • Fibrosis • Glomerulonephritis • IgA Nephropathy • Immunology • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Renal Disease • Vasculitis

Case Series of Proteinuria Reduction with Sparsentan (SPAR) Combined with SGLT2 Inhibitors (SGLT2is) in Adults with IgAN at a Single Site (KIDNEY WEEK 2025) - "Discussion These cases show real-world experience of proteinuria reduction when SPAR is used with SGLT2i treatment in adults with IgAN, even in patients who previously tried immunosuppressive therapy or ARB standard of care. SPAR+SGLT2i was generally well-tolerated with no new safety signals."

Clinical • Glomerulonephritis • IgA Nephropathy • Renal Disease

An Atypical Case of IgAN with Chronic Daily Macroscopic Hematuria for 10 Years (KIDNEY WEEK 2025) - "He is in the process of obtaining sparsentan for further therapy...It is presently not directly implemented in the risk score but is said to correlate with the Oxford MEST system. Most treatments are tailored towards proteinuria management and data is sparse on the best approach to treatment in patients with persistent hematuria."

Clinical • Anemia • Fibrosis • Gastrointestinal Disorder • Glomerulonephritis • Hematological Disorders • IgA Nephropathy • Immunology • Nephrology • Otorhinolaryngology • Renal Disease