SC0062 / Wuxi Biocity - LARVOL DELTA

Effect of Selective Endothelin A Receptor Antagonists on Proteinuria in IgAN: Systematic Review and Meta-Analysis (KIDNEY WEEK 2025) - "Atrasentan and SC0062 were well tolerated, with low rates of edema and no major safety signals. These results, supported by observational data, warrant further research on long-term renal outcomes and integration into treatment protocols."

Retrospective data • Review • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Pediatrics • Renal Disease

ASPIRE: dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: University Medical Center Groningen | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Sep 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus

BioCity's ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria (PRNewswire) - "BioCity Biopharma...announced...that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its highly selective endothelin receptor type A (ETA) antagonist SC0062 for the treatment of diabetic kidney disease (DKD) with albuminuria....The designation is supported by compelling data from the DKD cohort of the Phase 2 2-SUCCEED study"

Breakthrough therapy • Chronic Kidney Disease • Diabetic Nephropathy

Efficacy and safety of endothelin A receptor antagonists in IgA nephropathy: a systematic review and meta-analysis. (PubMed, Clin Kidney J) - "EARAs can significantly reduce UPCR, lower both systolic and diastolic BP, and delay eGFR decline in IgAN patients. However, they may cause anemia, cough, dizziness, hypotension, fluid retention and acute kidney injury."

Journal • Retrospective data • Acute Kidney Injury • Cough • Fibrosis • Glomerulonephritis • Hematological Disorders • Hypotension • IgA Nephropathy • Immunology • Inflammation • Lupus Nephritis • Nephrology • Renal Disease • Respiratory Diseases

Authors' Reply: Unlocking the Potential of SC0062: A New Horizon in IgA Nephropathy Treatment? (PubMed, J Am Soc Nephrol) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

Unlocking the Potential of SC0062: A New Horizon in IgA Nephropathy Treatment? (PubMed, J Am Soc Nephrol) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

BioCity Announces its selective Endothelin Type-A Receptor Antagonist, SC0062, Met the Primary Endpoint in Diabetic Kidney Disease (DKD) in a Phase 2 trial (2-SUCCEED) (PRNewswire) - P2 | N=255 | 2-SUCCEED (NCT05687890) | Sponsor: Biocity Biopharmaceutics Co., Ltd | "BioCity Biopharma (BioCity) announced that its selective endothelin receptor type A (ETA) antagonist, SC0062, met the 12-week primary endpoint of a reduction in proteinuria in the diabetic kidney disease (DKD) cohort of its randomized, double-blind, placebo-controlled Phase 2 trial (2-SUCCEED)...SC0062 significantly reduced proteinuria in the high-dose group (20mg) compared to the placebo group. The effect of SC0062 on proteinuria was both clinically meaningful and statistically significant; SC0062 demonstrated a favorable safety profile in subjects with DKD, with no elevated risk of sodium retention compared to the placebo group...A Phase 3 trial (SUCCESS-01) for the treatment of IgAN has begun (NCT06819826)."

P2 data • Trial status • Diabetic Nephropathy • IgA Nephropathy

A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

New P3 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

SC0062, a New Selective Endothelin Receptor Type A Antagonist in IgA Nephropathy (KIDNEY WEEK 2024) - P2 | "In patients with IgA nephropathy and significant proteinuria, the novel ETA selective antagonist SC0062 showed a clinically meaningful reduction in proteinuria and a favorable safety profile with no risk of peripheral edema."

Late-breaking abstract • Fibrosis • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammation • Renal Disease • EDN1 • EDNRA

The Selective Endothelin Receptor Antagonist SC0062 in IgA Nephropathy: A Randomized Double-Blind Placebo-Controlled Clinical Trial. (PubMed, J Am Soc Nephrol) - No abstract available

Clinical • Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=255 | Active, not recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease • NPPB

Safety, pharmacokinetics, and pharmacodynamics in healthy Chinese volunteers treated with SC0062, a highly selective endothelin-A receptor antagonist. (PubMed, Clin Transl Sci) - "Following a single 50 mg dose of SC0062 after a high-fat meal, Cmax values for SC0062 and M18 increased by 41% and 32%, respectively, and median Tmax values for SC0062 were 3 h longer than fasting values; exposure was unaffected. These favorable safety, PK, and PD results provide a foundation for further studies of SC0062 in pulmonary arterial hypertension, chronic kidney disease, and other relevant indications."

Journal • PK/PD data • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Pulmonary Arterial Hypertension • Pulmonary Disease • Renal Disease • Respiratory Diseases • EDN1

A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd. | Not yet recruiting ➔ Recruiting

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

BioCity Announces Initiation of a Phase 2 Trial for SC0062, a Promising ETA Receptor Antagonist for Chronic Kidney Disease (PRNewswire) - "BioCity Biopharma...announced the initiation of a randomized, placebo-controlled Phase 2 clinical trial of its novel, oral endothelin A (ETA)-receptor selective antagonist, SC0062, with the enrollment of two patients with IgA nephropathy (IgAN) in China (NCT05687890).This multi-center study will assess the safety and preliminary efficacy of SC0062 relative to placebo in patients with chronic kidney disease with albuminuria....Currently SC0062 is in Phase 2 clinical development for IgAN and DKD (diabetic kidney disease). Data from the ongoing randomized phase 2 trial are expected in 2024."

P2 data • Trial status • Diabetic Nephropathy • IgA Nephropathy • Renal Disease

A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

New P2 trial • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease • NPPB