Inquiry
Form loading...

China Sparsentan Active Pharmaceutical Ingredient Suppliers and Factory for Quality Pharmaceutical Solutions

Basic Information

Explore our high-quality products manufactured in China, where we partner with leading Suppliers and our own Factory to ensure the best standards of excellence. Our commitment to quality and innovation sets us apart in the industry, making us the ideal choice for businesses looking for reliable and durable solutions. With our extensive network of Suppliers and our state-of-the-art Factory, we are able to offer a wide range of products tailored to meet your specific needs. Trust us to deliver exceptional value and quality, firmly establishing our reputation as a top provider in the China market
  • 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)

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
📉
40–50%
Reduction in proteinuria vs. single-target therapies (clinical trials)
🛡️
ESRD
Demonstrated renal protective effects, slowing progression to end-stage renal disease

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
🏅 Orphan Drug Designation (ODD)
⚡ FDA Fast Track Status
✔ FSGS / IgAN Approved
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)
What is Sparsentan and how does it work?
Sparsentan is a dual-acting receptor antagonist that simultaneously blocks endothelin type A (ETA) receptors and angiotensin II type 1 (AT1) receptors. This dual inhibition reduces vasoconstriction, inflammation, fibrosis, and glomerular pressure, providing a synergistic effect against rare glomerular diseases.
Which kidney diseases is Sparsentan indicated for?
Sparsentan is primarily indicated for the treatment of focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN) — two rare kidney disorders characterized by significant proteinuria and progressive loss of renal function. It is also being investigated for diabetic nephropathy and membranous nephropathy.
What regulatory designations has Sparsentan received?
Sparsentan has been granted Orphan Drug Designation (ODD) and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of FSGS and IgAN, recognizing its potential to address serious unmet medical needs in rare diseases.
How effective is Sparsentan in reducing proteinuria?
Clinical trials have demonstrated that Sparsentan can significantly reduce proteinuria by up to 40–50% compared to single-target therapies. It has also shown renal protective effects, helping to slow the progression toward end-stage renal disease (ESRD).
What are the common side effects 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 managed through appropriate dose adjustment and regular monitoring of renal function and electrolyte levels during therapy.
What are the storage requirements and shelf life of Sparsentan?
Sparsentan film-coated tablets should be stored at controlled room temperature (20–25°C), protected from moisture and light. Under these recommended storage conditions, the product has a shelf life of 24 months.

Leave Your Message