Drugs / Sparsentan
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | ||||||
| Phase 3 | NCT03762850 | Dec 2018 → Aug 2023 overdue | IgA glomerulonephritis | Travere Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07224776 Comparator | Jun → Dec 2026 expected | proteinuria | Brigham and Women's Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | CSL Behring | England's NICE recommends FILSPARI® (sparsentan) as a treatment option for IgA nephropathy csl.com ↗ |
| 2025-04-29 | CSL Behring | CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy csl.com ↗ |
| 2024-10-17 | CSL Behring | CSL Vifor and Travere Therapeutics Announce Swissmedic approval of FILSPARI® (sparsentan) for the treatment of IgA Nephropathy csl.com ↗ |
| 2024-04-24 | CSL Behring | CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy csl.com ↗ |
| 2024-02-23 | CSL Behring | CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy csl.com ↗ |
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 NCT05856760 ↗ |
| 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 ↗ |