Sparsentan is an angiotensin 2 receptor blocker indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, among other approved uses. MedsAcross supplies Sparsentan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FILSPARI is an endothelin and angiotensin II receptor antagonist indicated: • To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. • To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
Source: US FDA prescribing information
Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ET A R) and the angiotensin II type 1 receptor (AT 1 R). Sparsentan has high affinity for both the ET A R (Ki= 12.8 nM) and the AT 1 R (Ki=0.36 nM), and greater than 500-fold selectivity for these receptors over the endothelin type B and angiotensin II subtype 2 receptors. Endothelin 1 and angiotensin II are thought to be involved in the pathogenesis of IgAN and FSGS via the ET A R and AT 1 R, respectively.
Source: US FDA prescribing information
• Prior to initiating treatment with FILSPARI, discontinue use of renin- angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs). • IgAN (Adult Patients): Initiate treatment with FILSPARI at 200 mg orally once daily. After 14 days, increase to 400 mg once daily, as tolerated. • FSGS (Adult and Pediatric Patients 8 years and older): • Greater than 50 kg: Initiate treatment with FILSPARI at 400 mg orally once daily. After 14 days, increase to 800 mg once daily, as tolerated. • 50 kg and less: Initiate treatment with FILSPARI at 200 mg orally once daily. After 14 days, increase to 400mg once daily, as tolerated. • When resuming FILSPARI after interruption, consider re-titration. • Instruct patients to swallow tablets whole with water prior to the morning or evening meal.
Source: US FDA prescribing information
Use of FILSPARI is contraindicated in patients who are pregnant. Do not co-administer FILSPARI with ARBs, ERAs, or aliskiren. • Pregnancy. • Concomitant use with angiotensin receptor blockers (ARBs), ERAs, or aliskiren.
Source: US FDA prescribing information
Boxed warning (hepatotoxicity and embryo-fetal toxicity): Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients, and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. • Hypotension. • Acute Kidney Injury. • Hyperkalemia. • Fluid Retention Hepatotoxicity Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge.
Source: US FDA prescribing information
Clinically significant adverse reactions that appear in other sections of the label include: • Hepatotoxicity • Embryo-Fetal Toxicity • Hypotension • Acute Kidney Injury • Hyperkalemia • Fluid Retention Most common adverse reactions in patients with IgAN (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. Most common adverse reactions in patients with FSGS (≥5%) are peripheral edema, hypotension (including orthostatic hypotension), hyperkalemia, dizziness, and anemia.
Source: US FDA prescribing information
• Strong CYP3A inhibitors: Avoid concomitant use. Increased sparsentan exposure. • Moderate CYP3A inhibitors: Monitor adverse reactions. Increased sparsentan exposure. • Strong CYP3A inducers: Avoid concomitant use. Decreased sparsentan exposure. • Non-steroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase (COX-2) inhibitors: Monitor for signs of worsening renal function. Increased risk of kidney injury. • CYP2B6, 2C9, and 2C19 substrates: Monitor for substrate efficacy. Decreased exposure of these substrates. • P-gp substrates: Monitor for adverse reactions of P-gp substrates with narrow therapeutic indices. Increased exposure to substrates. • Agents Increasing Serum Potassium: Increased risk of hyperkalemia, monitor serum potassium frequently.
Source: US FDA prescribing information
Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store FILSPARI in its original container.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Sparsentan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Filspari 200 mg tabletOral | Travere Therapeutics | US FDA | Available on request |
| Filspari 400 mg tabletOral | Travere Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Sparsentan and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Sparsentan, including Filspari.
Yes. The US FDA first approved Sparsentan on 17 February 2023, according to Drugs@FDA.
Yes. Sparsentan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Sparsentan is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sparsentan is classified under ATC code C09XX01 (Sparsentan).
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