sparsentan
Trade name: FILSPARI
Small moleculeapprovedOrphan Drug FDA
Approved
Feb 17, 2023
Clinical trial activity
12 trials · 9 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
9
Phase 3
2
Phase 4
1
Earliest trial started Aug 1, 2007 (NCT00522925)
Timeline
2000s
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 2
- Autoimmune Diseases · Phase 2
- Cardiovascular Diseases · Phase 2
- Glomerulonephritis · Phase 2
- Glomerulonephritis, IGA · Phase 3
- Glomerulosclerosis, Focal Segmental · Phase 4
- Healthy Volunteers · Phase 1
- Hypertension · Phase 2
- IgA Vasculitis · Phase 2
- Immune System Diseases · Phase 2
- Kidney Diseases · Phase 4
- Kidney Transplantation · Phase 4
- Nephritis, Hereditary · Phase 2
- Nephrosis, Lipoid · Phase 2
- Proteinuria · Phase 4
Mechanism of action
- Endothelin receptor ET-AANTAGONIST
EDNRA antagonist
- Type-1 angiotensin II receptorANTAGONIST
AGTR1 antagonist
Approval history
- approvedPriority reviewAcceleratedFeb 17, 2023
Chemistry & pharmacology
Loading structure…
SMILES
CCCCC1=NC2(CCCC2)C(=O)N1Cc1ccc(-c2ccccc2S(=O)(=O)Nc2noc(C)c2C)c(COCC)c1- Mol. weight
- 592.76 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL539423 ↗
Also known as
- ps433540
- ps433540
- ps-433540
- ps-433540
- re-021
- re-021
- re-021
- sparsentan
- sparsentan
- sparsentan
- sparsentan
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07224776 | Phase 1 | Dec 1, 2025 | Harvard University, Travere Therapeutics, Inc. |
| NCT07219121 | Phase 4 | Oct 7, 2025 | Travere Therapeutics, Inc. |
| NCT05856760 | Phase 2 | May 19, 2023 | Travere Therapeutics, Inc. |
| NCT05630612 | Phase 2 | Dec 1, 2022 | Travere Therapeutics, Inc., University of Edinburgh |
| NCT05003986 | Phase 2 | Aug 12, 2021 | Travere Therapeutics, Inc. |
| NCT04663204 | Phase 2 | Dec 10, 2020 | Travere Therapeutics, Inc., University of Leicester |
| NCT05562362 | Phase 1 | Jun 18, 2020 | Travere Therapeutics, Inc. |
| NCT03762850 | Phase 3 | Dec 20, 2018 | Travere |
| NCT03493685 | Phase 3 | Apr 3, 2018 | Travere |
| NCT01613118 | Phase 2 | Dec 1, 2013 | New York University, Travere |
| NCT00635232 | Phase 2 | Mar 1, 2008 | Ligand Pharmaceuticals, Orange County Research Center |
| NCT00522925 | Phase 2 | Aug 1, 2007 | Integrium, Ligand Pharmaceuticals |
Showing 12 of 12 trials
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Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Travere Therapeutics, Inc. | For profit | 7 | 4 | 3 | 2020 |
| Travere | For profit | 3 | 3 | 2 | 2013 |
| Ligand Pharmaceuticals | For profit | 2 | 2 | 1 | 2007 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Integrium | For profit | 1 | 0 | 1 | 2007 |
| New York University | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Orange County Research Center | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Edinburgh | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Leicester | Academic/Hospital | 1 | 1 | 1 | 2020 |
9 organizations
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