Sparsentan

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Sparsentan
Sparsentan.svg
Clinical data
Trade names Filspari
Other namesRE-021, PS433540
AHFS/Drugs.com Monograph
MedlinePlus a623018
License data
Pregnancy
category
  • Contraindicated
Routes of
administration 		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
UNII
KEGG
ChEBI
ECHA InfoCard 100.275.317 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
3D model (JSmol)
  • CCCCC1=NC2(CCCC2)C(=O)N1CC1=CC=C(C(COCC)=C1)C1=CC=CC=C1S(=O)(=O)NC1=NOC(C)=C1C
  • InChI=1S/C32H40N4O5S/c1-5-7-14-29-33-32(17-10-11-18-32)31(37)36(29)20-24-15-16-26(25(19-24)21-40-6-2)27-12-8-9-13-28(27)42(38,39)35-30-22(3)23(4)41-34-30/h8-9,12-13,15-16,19H,5-7,10-11,14,17-18,20-21H2,1-4H3,(H,34,35)
  • Key:WRFHGDPIDHPWIQ-UHFFFAOYSA-N

Sparsentan, sold under the brand name Filspari, is a medication used for the treatment of primary immunoglobulin A nephropathy. [1] Sparsentan is an endothelin and angiotensin II receptor antagonist. [1] [4] It is taken by mouth. [1]

Contents

The most common side effects include swelling of the extremities, low blood pressure, dizziness, high blood potassium, anemia, injury to the kidney, and increased liver enzymes in the blood. [5]

It was approved for medical use in the United States in February 2023. [5] [6] [7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]

Medical uses

Sparsentan is indicated to reduce proteinuria in people with primary immunoglobulin A nephropathy. [1] [5]

While sparsentan is only approved for IgA nephropathy, a supplemental new drug application is under review by the FDA for its potential use in treating Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disorder. [9] [10]

Adverse effects

The most common side effects include swelling of the extremities, low blood pressure, dizziness, high blood potassium, anemia, injury to the kidney, and increased liver enzymes in the blood. [5]

Other potential risks of sparsentan include low blood pressure, injury to the kidney, high potassium in the blood, and fluid retention. [5] Sparsentan can cause changes in liver tests. [5] Some medicines that are like sparsentan can cause liver failure. [5]

Sparsentan can cause serious birth defects if taken during pregnancy and should not be started in someone who is pregnant. [5]

History

Sparsentan was discovered by Pharmacopeia, Inc. and developed as PS433540 as their lead compound in a new class of agents called dual acting receptor antagonists (DARA). PS433540 was originally developed as a treatment for hypertension and diabetic nephropathy. [11] After Pharmacopeia was acquired by Ligand Pharmaceuticals, the DARA programs was licensed to Retrophin and developed as RES-021 in 2012. [12] Retrophin would then be rebranded as Travere Therapeutics. [13]

Sparsentan was evaluated in a randomized, double-blind, active-controlled, clinical trial (PROTECT) in participants with IgA nephropathy. [5] Participants with IgA nephropathy and protein in the urine were randomly assigned to receive either sparsentan or irbesartan once daily. [5] The primary endpoint for accelerated approval was the mean change in urine protein at week 36 compared to baseline. [5]

The US Food and Drug Administration (FDA) granted accelerated approved to sparsentan based on evidence from a clinical trial (PROTECT) of participants with IgA nephropathy. [5] The trial was conducted at 156 sites in 18 countries in North America, Europe, and Asia-Pacific. [5] The same trial was used to assess both efficacy and safety. [5] The efficacy analyses were based on an interim analysis of 281 participants (141 on sparsentan, 140 on irbesartan) who reached week 36 in the trial. [5] The safety analyses were based on 404 participants (202 each on sparsentan and irbesartan) who received at least one dose of either drug. [5]

Society and culture

Sparsentan was approved in the US under accelerated approval based on reduction of proteinuria. [1] [5] [14] In September 2024, the US FDA converted the conditional approval in the kidney disease IgA nephropathy (IgAN) into a full approval based on positive long-term confirmatory results from the PROTECT Study demonstrating that sparsentan significantly slowed kidney function decline over two years compared to irbesartan. [15] [16]

In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the granting of a conditional marketing authorization for the medicinal product Filspari, intended for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). [2] The applicant for this medicinal product is Vifor France. [2] Sparsentan was approved for medical use in the European Union in April 2024. [2] [3]

Patents

Sparsentan (marketed as Filspari), which is owned by Travere Therapeutics, is covered by numerous patents in the USA and in other countries. Key patents cover the compound itself, its use in treating specific kidney diseases, and its formulation. [17]

Compound and method of use patents

• U.S. Patent No. 9,993,461: This patent covers the use of sparsentan for treating IgA nephropathy (IgAN) and specifies a dose range of 200 to 800 mg per day. It has an expiration date of March 30, 2030.

• U.S. Patent No. 9,662,312: This patent covers the use of sparsentan to treat glomerulosclerosis, including focal segmental glomerulosclerosis (FSGS).

• European Patent No. EP2732818: This patent also covers the use of sparsentan for treating glomerulosclerosis. [18]

Composition and formulation patents

• U.S. Patent Application Publication No. US20220048900A1: This publication describes patents related to amorphous sparsentan compositions.

• AU2019404552A1 and KR20210125994A: These international patents cover amorphous compositions of sparsentan.

• WO2025064688A1: A more recent international patent publication regarding sparsentan.

Clinical application patents

• WO-2022266370-A1: This international patent application relates to the use of sparsentan for treating idiopathic pulmonary fibrosis (IPF).

Pricing

In most countries, Sparsentan is a specialty medication, so pricing is not available through regular online pharmacies and is often influenced by commercial discounts negotiated with healthcare systems. The list prices available are extremely high, which is typical for rare disease treatments. Its brand name is Filspari®. [19] Here is a breakdown of pricing and relevant information for Sparsentan in different countries:

United States

List Price: In February 2023, the maker of Filspari announced a list price of $9,900 per month, or approximately $118,800 per year. [20]

Negotiated Price: Actual costs vary widely for individual patients based on insurance coverage and discount programs. Some discount cards show prices ranging from $11,000 to over $13,000 for a 30-tablet supply. [21]

Financial Assistance: The manufacturer offers assistance programs (Travere TotalCare®) to help eligible patients with out-of-pocket costs, potentially bringing the monthly price down to $0 for some.

Restriction: Because of potential liver toxicity and embryo-fetal harm, the drug is available only through a restricted distribution program (Filspari® REMS).

United Kingdom

List Price: The list price for a 30-pack of either 200 mg or 400 mg tablets is £3,401.71 (approx. $4,300 USD), excluding VAT.

Negotiated Price: The price available to the National Health Service (NHS) is lower due to a confidential discount arrangement. [22]

Recommendation: England's National Institute for Health and Care Excellence (NICE) officially recommended sparsentan for routine use for some patients as of May 2025, after initially drafting against the recommendation due to cost-effectiveness concerns.

India

Pricing: Sparsentan appears to be available through import and specialty suppliers, with varying prices listed on trade sites. Prices range from ₹3,425 to ₹27,000 per box ($41 to $323 USD) for 200mg or 400mg tablets, but these are from trading platforms and may not reflect the full cost or official distribution channels. [23]

Manufacturer: The branded version, Filspari®, is supplied by Travere Therapeutics. Variability: The wide price variation on Indian business-to-business marketplaces like IndiaMART suggests that prices are likely influenced by import costs and supplier markups.

European Union

Status: Sparsentan has received marketing authorization in the EU, though country-specific list prices are not readily available online. Like in the UK, pricing will be subject to negotiation between the manufacturer and national health authorities. [24]

Israel

As of October, 2025 Sparsentan has not been approved in Israel. [25]

References

  1. 1 2 3 4 5 6 "Filspari- sparsentan tablet, film coated". DailyMed. 17 February 2023. Retrieved 6 March 2023.
  2. 1 2 3 4 "Filspari EPAR". European Medicines Agency (EMA). 22 February 2024. Retrieved 24 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. 1 2 "Filspari Product information". Union Register of medicinal products. 23 April 2024. Retrieved 7 September 2024.
  4. ↑ Chiu AW, Bredenkamp N (September 2023). "Sparsentan: A First-in-Class Dual Endothelin and Angiotensin II Receptor Antagonist". The Annals of Pharmacotherapy. 58 (6): 645–656. doi:10.1177/10600280231198925. PMID   37706310. S2CID   261743204.
  5. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 "Drug Trials Snapshots: Filspari". U.S. Food and Drug Administration (FDA). 17 February 2023. Archived from the original on 24 May 2024. Retrieved 7 September 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. ↑ "Travere Therapeutics Announces FDA Accelerated Approval of Filspari (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy" (Press release). Travere Therapeutics. 17 February 2023. Retrieved 17 February 2023– via GlobeNewswire.
  7. ↑ Syed YY (April 2023). "Sparsentan: First Approval". Drugs. 83 (6): 563–568. doi:10.1007/s40265-023-01864-x. PMC   10232600 . PMID   37022667.
  8. ↑ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
  9. ↑ https://www.renalandurologynews.com/news/sparsentan-under-review-for-focal-segmental-glomerulosclerosis/#:~:text=Chronic%20Kidney%20Disease-,Sparsentan%20Under%20Review%20for%20Focal%20Segmental%20Glomerulosclerosis,006).
  10. ↑ https://www.pharmacytimes.com/view/fda-approves-rems-modification-for-sparsentan-in-iga-nephropathy#:~:text=Sparsentan%20is%20indicated%20to%20slow,angiotensin%20II%20type%201%20receptor.
  11. ↑ "PHARMACOPEIA LAUNCHES STUDY OF DARA COMPOUND | FDAnews". www.fdanews.com.
  12. ↑ "Ligand Licenses DARA Program to Retrophin". investor.ligand.com. 21 February 2012.
  13. ↑ https://www.fiercebiotech.com/biotech/retrophin-sheds-shkreli-connection-new-name-travere-therapeutics.{{cite news}}: Missing or empty |title= (help)
  14. ↑ "Ongoing Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals". U.S. Food and Drug Administration (FDA). 21 August 2024. Archived from the original on 23 September 2023. Retrieved 7 September 2024.
  15. ↑ "Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy" (Press release). Travere Therapeutics. 5 September 2024. Retrieved 7 September 2024– via GlobeNewswire.
  16. ↑ "Despite trial scare, Travere's Filspari gains full FDA nod in kidney disease showdown with Novartis". fiercepharma.com.
  17. ↑ https://ir.travere.com/press-releases/news-details/2018/Retrophin-Announces-Expansion-of-Intellectual-Property-Estate-for-Sparsentan-with-Newly-Issued-U-S--Patent-06-14-2018/default.aspx#:~:text=View%20All%20News-,Retrophin%20Announces%20Expansion%20of%20Intellectual%20Property%20Estate%20for%20Sparsentan%20with,chief%20executive%20officer%20of%20Retrophin%20.
  18. ↑ https://ir.travere.com/press-releases/news-details/2018/Retrophin-Announces-Expansion-of-Intellectual-Property-Estate-for-Sparsentan-with-Newly-Issued-U-S--Patent-06-14-2018/default.aspx
  19. ↑ https://www.navlindaily.com/article/25191/nice-draft-declines-to-recommend-vifor-s-filspari-for-iga-nephropathy
  20. ↑ https://insiderx.com/drugs/filspari
  21. ↑ https://insiderx.com/drugs/filspari
  22. ↑ https://newsroom.csl.com/2025-05-23-Englands-NICE-recommends-FILSPARI-R-sparsentan-as-a-treatment-option-for-IgA-nephropathy#:~:text=g%20or%20more.-,3,to%20be%2027%20June%202025.
  23. ↑ https://indianpharmanetwork.co.in/medicines/product/filspari-sparsentan-price-india/#:~:text=Table_title:%20FILSPARI%20(sparsentan)%20tablets%2C%20for%20oral%20use,Approved%20By:%20%7C%20FILSPARI:%20EMA%2C%20USFDA%20%7C
  24. ↑ https://www.israelihospitals.org.il/how-much-does-car-t-cell-therapy-cost-europe.html#:~:text=This%20price%20can%20vary%20based%20on%20the,can%20lead%20to%20some%20variation%20in%20cost.
  25. ↑ https://www.cslvifor.us/our-company#:~:text=Driven%20by%20Our%20Promise,are%20driven%20by%20our%20promise.
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