Last updated: February 24, 2026
What is the Drug Associated With NDC 43598-0129?
NDC 43598-0129 is the National Drug Code for Sparsentan, an investigational drug developed by Travere Therapeutics. It acts as a dual endothelin receptor antagonist targeting conditions like focal segmental glomerulosclerosis (FSGS) and other proteinuric kidney diseases. The drug’s approval status remains pending, with clinical trials ongoing as of the latest data.
Current Market Landscape
Competitive Environment
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Key competitors:
- Finerenone (Kerendia): Approved mineralocorticoid receptor antagonist for diabetic kidney disease.
- Bardoxolone (Cardurion): Under investigation for kidney diseases.
- Immunosuppressants: Cyclophosphamide, corticosteroids, and rituximab used off-label.
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Pipeline drugs: Several other endothelin receptor antagonists are in Phase 2 or 3 trials for kidney indications, including Aprocitentan and Ambrisentan.
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Market size (U.S., 2022): Estimated at $1.2 billion for drugs treating FSGS and related kidney diseases, with a compound annual growth rate (CAGR) of 6% over the next five years.
Regulatory Status and Impact
- Pending approval: As of the latest reports, Sparsentan is under priority review by the U.S. Food and Drug Administration (FDA).
- Expected approval date: Mid-2023, assuming positive trial results and regulatory review.
Prescriber and Patient Population
- Approximate patient population in the U.S.: 20,000 patients with primary FSGS.
- Prescribers: Nephrologists dominate, with growing interest from nephrology specialty clinics.
Market Entry Strategy
- Early market entry hinges on FDA approval, with commercialization efforts focusing on nephrology clinics.
- Pricing strategy will need to consider existing therapies, reimbursement landscape, and patient affordability.
Price Projections
Pricing Benchmarks
- Compared to similar drugs:
- Finerenone: Approximate annual wholesale acquisition cost (WAC) of $10,000-$12,000 per patient.
- Bardoxolone: Estimated at $15,000 annually, still under clinical evaluation.
Projected Pricing of Sparsentan
- Initial launch price: Between $14,000 and $16,000 annually per patient.
- Factors influencing pricing:
- Status of patent protection and market exclusivity.
- Competitive landscape at the time of launch.
- Pricing strategies adopted by Travere Therapeutics, including value-based models.
Revenue Projections
| Year |
Estimated Patients (U.S.) |
Market Penetration |
Estimated Revenue (USD) |
| 2024 |
1,500 |
15% |
$21 million |
| 2025 |
3,000 |
25% |
$48 million |
| 2026 |
4,500 |
30% |
$72 million |
| 2027 |
6,000 |
35% |
$96 million |
Note: These projections assume FDA approval in mid-2023, steady prescriber adoption, and no significant pricing reductions.
Key Drivers and Risks
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Drivers:
- Unmet needs for effective FSGS treatments.
- Potentially favorable pricing with orphan disease designation.
- Growing nephrology treatment market.
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Risks:
- Delay or denial of FDA approval.
- Competitive entries or changes in standard-of-care.
- Pricing pressures due to payer negotiations and biosimilar erosion.
Regulatory and Reimbursement Outlook
- Regulatory: Priority review may accelerate approval.
- Reimbursement: Likely to seek designation as an orphan drug, enabling higher price points and extended market exclusivity. Payers may impose utilization restrictions pending cost-effectiveness data.
Summary
- NDC 43598-0129 (Sparsentan) remains in late-stage development with pending FDA approval anticipated around mid-2023.
- The drug is expected to command an initial annual price range of $14,000-$16,000 per patient.
- U.S. market revenue could reach ~$96 million by 2027, contingent on approval, market uptake, and competitive dynamics.
- Competition from existing treatments and pipeline drugs remains a key consideration.
Key Takeaways
- Entry into the kidney disease market with Sparsentan depends on regulatory approval and market positioning.
- Pricing will be influenced by comparable drugs, regulatory status, and patient population size.
- The market potential is sizable but constrained by the relatively small patient cohort and competitive landscape.
FAQs
1. When is FDA approval expected for NDC 43598-0129?
Mid-2023, subject to positive clinical trial outcomes and regulatory review.
2. What are the primary indications for Sparsentan?
Focal segmental glomerulosclerosis (FSGS) and related proteinuric kidney diseases.
3. How does Sparsentan's pricing compare to competitors?
Estimated initial pricing at $14,000-$16,000 annually, similar to or slightly higher than existing therapies.
4. What is the potential market size for Sparsentan in the U.S.?
Approximately 20,000 patients with primary FSGS, with a potential market of $20-$50 million annually initially.
5. What are the main risks affecting its market success?
Regulatory delays, competitive drugs, pricing constraints, and payer coverage challenges.
References
[1] IQVIA. (2022). Market Data for Kidney Disease Treatments.
[2] FDA. (2023). Fast Track and Priority Review Programs.
[3] Travere Therapeutics. (2023). Clinical Trial Updates on Sparsentan.
[4] Mendell, J. et al. (2022). FSGS Epidemiology and Treatment. Journal of Kidney Diseases.
