Drugs / Sparsentan
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed focal segmental glomerulosclerosis 1 milestone | |||||
| Filed | US (FDA) | Filspari | focal segmental glomerulosclerosis | 2025-03-17 | “sNDA to the FDA seeking priority review for traditional approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS)” ligand.com ↗ |
| Filed IgA glomerulonephritis 3 milestones | |||||
| Filed | Japan (PMDA) | — | IgA glomerulonephritis | 2026-06-19 | “it filed a regulatory application with the Ministry of Health, Labour and Welfare for sparsentan for the treatment of patients with IgA nephropathy.” chugai-pharm.co.jp ↗ |
| Filed | EU (EMA) | — | IgA glomerulonephritis | 2022-11-07 | “Travere subsequently announced the European Medicines Agency has accepted for review the Conditional Marketing Authorization for sparsentan for IgAN in Europe” ligand.com ↗ |
| Filed | US (FDA) | Filspari | IgA glomerulonephritis | — | “In March, Travere Therapeutics announced the submission of an NDA to the FDA for accelerated approval of sparsentan for IgA nephropathy (IgAN).” ligand.com ↗ “FDA recently accepted Travere’s sNDA requesting modification of the liver monitoring REMS requirement for Filspari in IgAN” ligand.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | FILSPARI | — | 2024-09-05 – 2026-04-13 | fda.gov ↗ |
| Approved | EU (EMA) | Filspari | — | 2024-04-19 | europa.eu ↗ |
| Approved | US (FDA) | FILSPARI | — | 2023-02-17 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05562362 | Jun → Nov 2020 | — | Travere Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT05856760 | May 2023 → Oct 2024 | IgA glomerulonephritis | Travere Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05630612 | Dec 2022 → Jul 2024 overdue | anti-neutrophil cytoplasmic antibody-associated vasculitis, kidney disorder | University of Edinburgh | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05003986 | Aug 2021 → Mar 2027 expected | Alport syndrome, IgA glomerulonephritis, focal segmental glomerulosclerosis, immunoglobulin A vasculitis +1 | Travere Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04663204 | Dec 2020 → Dec 2027 expected | IgA glomerulonephritis, autoimmune disease | University of Leicester | Recruiting | No outcome recorded |
| Phase 2 | NCT01613118 | Mar 2014 → Jun 2016 | focal segmental glomerulosclerosis | Travere Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT00635232 | Mar → Nov 2008 | hypertensive disorder | Ligand Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00522925 | Aug 2007 → Apr 2008 | hypertensive disorder | Ligand Pharmaceuticals | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT03762850 | Dec 2018 → Aug 2023 overdue | IgA glomerulonephritis | Travere Therapeutics, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03493685 | Apr 2018 → Mar 2023 | focal segmental glomerulosclerosis | Travere Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07219121 | Oct 2025 → Mar 2027 expected | IgA glomerulonephritis, focal segmental glomerulosclerosis, proteinuria | Travere Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07224776 Comparator | Jun → Dec 2026 expected | proteinuria | Brigham and Women's Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-06-19 | Chugai Pharmaceutical | Regulatory Chugai Files New Drug Application in Japan for Sparsentan for the Treatment of IgA Nephropathy chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed a regulatory application with the Ministry of Health, Labour and Welfare for sparsentan for the treatment of patients with IgA nephropathy. |
| 2026-04-14 | Ligand Pharmaceuticals | Regulatory Ligand Partner Travere Therapeutics Receives Full FDA Approval for FILSPARI® (sparsentan) in FSGS ligand.com ↗
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Travere Therapeutics, Inc. (Nasdaq: TVTX) has received approval from the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. |
| 2024-09-06 | Ligand Pharmaceuticals | Regulatory Ligand Partner Travere Therapeutics Receives Full FDA Approval for FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy ligand.com ↗
Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. |
| 2023-09-21 | Ligand Pharmaceuticals | Results Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint Versus Active Control ligand.com ↗
The PROTECT study showed all topline efficacy endpoints favored FILSPARI, and patients treated with FILSPARI over two years exhibited one of the slowest annual rates of kidney function decline seen in clinical trials to-date. |
| 2023-02-17 | Ligand Pharmaceuticals | Regulatory Ligand’s Partner Travere Therapeutics Announces FDA Accelerated Approval of FILSPARI™ (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy ligand.com ↗
This indication is granted under accelerated approval based on reduction in proteinuria. |
| 2021-08-16 | Ligand Pharmaceuticals | Results Ligand Partner Travere Therapeutics Announces Positive Topline Interim Results from the Ongoing Phase 3 PROTECT Study of Sparsentan in IgA Nephropathy ligand.com ↗
The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p<0.0001). |
| 2021-02-02 | Ligand Pharmaceuticals | Results Ligand Partner Travere Therapeutics Announces Achievement of Interim Proteinuria Endpoint in the Ongoing Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis ligand.com ↗
Sparsentan, an investigational product candidate, demonstrated a statistically significant response on FPRE compared to the active control, irbesartan (p=0.0094). |
| 2016-11-21 | Ligand Pharmaceuticals | Results Ligand Partner Retrophin Reports Additional Positive Data from Phase 2 DUET Study of Sparsentan in Focal Segmental Glomerulosclerosis at ASN Kidney Week 2016 ligand.com ↗
Ligand Partner Retrophin Reports Additional Positive Data from Phase 2 DUET Study of Sparsentan in Focal Segmental Glomerulosclerosis at ASN Kidney Week 2016 |
| 2016-09-07 | Ligand Pharmaceuticals | Results Ligand Partner Retrophin Announces Positive Top-Line Results from Phase 2 DUET Study of Sparsentan in Patients with Focal Segmental Glomerulosclerosis ligand.com ↗
The study achieved statistical significance in the primary efficacy endpoint for the overall sparsentan treatment group, demonstrating a greater than two-fold reduction of proteinuria compared to irbesartan after the eight-week, double-blind treatment period. |
| 2015-01-09 | Ligand Pharmaceuticals | Regulatory Ligand Partner Retrophin Receives Orphan Drug Designation for Sparsentan ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that its partner Retrophin, Inc. (NASDAQ:RTRX) has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for Sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). |
| 2009-02-02 | Ligand Pharmaceuticals | Results Ligand Announces Phase IIb Results With DARA ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) (the "Company" or "Ligand") today announced positive preliminary results from the Phase IIb study for PS433540, the first-in-class Dual Acting Receptor Agonist (DARA) that targets the angiotensin and endothelin receptors. |
All press releases naming this drug 16 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sparsentan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05003986 ↗ |
| Known as | Esparsentan | ChEMBL registry synonym — accepted as the source's own label CHEMBL539423 ↗ |
| Known as | Filspari | ChEMBL registry synonym — accepted as the source's own label CHEMBL539423 ↗ |
| Known as | PS433540 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00522925 ↗ |
| Known as | RE-021 | “RE-021, sparsentan - Subjects will be randomized 1 of 3 dose level” NCT05562362 ↗ |
| Action | Inhibit | “Dual Angiotensin and Endothelin Receptor Antagonist” NCT00522925 ↗2“Type-1 angiotensin II receptor antagonist” CHEMBL539423 ↗ “Endothelin receptor ET-A antagonist” CHEMBL539423 ↗ |
| Modality | Small molecule | — CHEMBL539423 ↗ |
| Route | Oral | “Oral, once-daily” NCT01613118 ↗ |
| Target | AGTR1 | “Type-1 angiotensin II receptor antagonist” CHEMBL539423 ↗ |
| Target | EDNRA | “Endothelin receptor ET-A antagonist” CHEMBL539423 ↗ |