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Sparsentan.jpg

Sparsentan Active Pharmaceutical Ingredient from China Suppliers and Factory - High Quality APIs for Your Needs

Basic Information

Discover our premium products manufactured in China, where quality meets innovation. As a leading supplier in the industry, we take pride in our state-of-the-art factory equipped with advanced technology, ensuring that every item meets the highest standards. Partnering with us means you’ll have access to a wide range of products sourced directly from reliable China suppliers. Experience the perfect blend of quality and affordability as we cater to your specific needs, delivering exceptional results every time. Choose us for your next project and benefit from our expertise and commitment to excellence in manufacturing
  • Generic Name Sparsentan
  • Chemical Name (Dual Endothelin-Vasopressin Receptor Antagonist) – A novel small-molecule therapeutic with combined endothelin receptor type A (ETA) and angiotensin II subtype 1 (AT1) antagonism.
  • Molecular Formula C34H34FN5O6S2
  • Molecular Weight 699.79 g/mol
  • Pharmacological Class Dual-acting endothelin-angiotensin receptor antagonist (DEARA)
  • Administration Route Oral (tablets/capsules)
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Product Details

Key Therapeutic Functions
🎯 Primary Indication

Treatment of rare renal disorders, including focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), characterized by proteinuria and progressive loss of kidney function.

⚙️ Mechanism of Action

Dual Inhibition: Simultaneously blocks ETA receptors (reducing vasoconstriction, inflammation, and fibrosis) and AT1 receptors (lowering blood pressure and glomerular pressure).

Synergistic Effect: Combats pathogenic pathways in rare glomerular diseases by reducing proteinuria, preserving podocyte integrity, and delaying renal fibrosis.

📊 Clinical Efficacy

Proven to significantly reduce proteinuria (up to 40–50% in clinical trials) compared to single-target therapies.

Demonstrated renal protective effects, slowing the progression to end-stage renal disease (ESRD).

Technical Specifications
Dosage Forms Film-coated tablets (e.g., 200 mg, 400 mg strengths).
Pharmacokinetics High oral bioavailability with linear absorption.
Metabolized primarily via hepatic CYP450 enzymes (CYP3A4/5, CYP2C8).
Storage Store at controlled room temperature (20–25°C), protected from moisture and light.
Shelf Life 24 months under recommended storage conditions.
Therapeutic Applications
🩺 Rare Kidney Diseases

FSGS Targets podocyte injury and glomerular sclerosis in steroid-resistant patients.

IgA Nephropathy Reduces mesangial proliferation and immune complex deposition.

🔬 Potential Expansion

Investigated for other proteinuric kidney diseases (e.g., diabetic nephropathy, membranous nephropathy).

Clinical & Safety Profile
✅ Approvals

Granted Orphan Drug Designation (ODD) and Fast Track Status by the FDA for FSGS/IgAN.

🛡️ Safety

Well-tolerated in trials; common adverse effects include peripheral edema, hypotension, and hyperkalemia (managed via dose adjustment).

📋 Monitoring

Regular renal function and electrolyte assessments recommended during therapy.

⭐ Why Sparsentan Stands Out?

Sparsentan represents a paradigm shift in rare nephrology by addressing dual pathogenic pathways with a single molecule. Its precision-engineered design ensures potent efficacy in reducing proteinuria and preserving renal function, offering hope for patients with limited treatment options. Backed by rigorous clinical evidence and robust manufacturing standards, Sparsentan is positioned as a breakthrough therapy for debilitating glomerular diseases.

Frequently Asked Questions (FAQ)
Q What conditions is Sparsentan approved to treat?
Sparsentan has been granted Orphan Drug Designation and Fast Track status by the FDA for the treatment of focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN) — two rare and serious kidney diseases characterized by proteinuria and progressive loss of kidney function.
Q How does Sparsentan work differently from other kidney disease treatments?
Unlike conventional single-target therapies, Sparsentan employs a dual inhibition mechanism — simultaneously blocking both ETA receptors and AT1 receptors. This synergistic approach addresses multiple pathogenic pathways at once, reducing proteinuria, preserving podocyte integrity, and slowing renal fibrosis more effectively than single-agent treatments.
Q What clinical results has Sparsentan demonstrated in trials?
Clinical trials have shown that Sparsentan can reduce proteinuria by up to 40–50% compared to single-target therapies. It has also demonstrated significant renal protective effects, slowing the progression toward end-stage renal disease (ESRD) in patients with FSGS and IgAN.
Q What are the available dosage forms and storage requirements for Sparsentan?
Sparsentan is available as film-coated tablets in 200 mg and 400 mg strengths. It should be stored at a controlled room temperature of 20–25°C, protected from moisture and light, and has a shelf life of 24 months under recommended conditions.
Q What are the known side effects of Sparsentan and how are they managed?
Sparsentan is generally well-tolerated. The most commonly reported adverse effects include peripheral edema, hypotension, and hyperkalemia. These are typically manageable through dose adjustment, and regular monitoring of renal function and electrolyte levels is recommended throughout the course of therapy.
Q Can Sparsentan be used for kidney diseases beyond FSGS and IgAN?
Sparsentan is currently being investigated for potential use in other proteinuric kidney diseases, including diabetic nephropathy and membranous nephropathy. While these remain under clinical investigation, the drug's dual-pathway mechanism makes it a promising candidate for a broader range of glomerular diseases.

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