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sparsentan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| endothelin receptor antagonists | 5711 | 254740-64-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ETAR) and the angiotensin II type 1 receptor (AT1R). Sparsentan has high affinity for both the ETAR (Ki= 12.8 nM) and the AT1R (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 contribute to the pathogenesis of IgAN via the ETAR and AT1R, respectively
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.795 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.589 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 59.841 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 32.211 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 0.970 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 2.660 | % | High | 1 |
| herg | hERG pIC50 | 4.738 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 48.306 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 166.725 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.960 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,MAPKAPK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK | 19 | |||
| kinase-selectivity-class | AXL,GRK2,TEK | 3 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 3.741 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 93.972 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.910 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 40.926 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 2.340 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 192.752 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 30.340 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.550 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 74.645 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 17, 2023 | FDA | TRAVERE |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hypotension | 121.01 | 37.41 | 55 | 623 | 325342 | 90302427 |
| Blood chloride increased | 38.54 | 37.41 | 8 | 670 | 3202 | 90624567 |
| Glomerular filtration rate decreased | 38.32 | 37.41 | 11 | 667 | 16921 | 90610848 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Urine protein/creatinine ratio increased | 152.79 | 46.17 | 25 | 1052 | 792 | 42619466 |
| Urine albumin/creatinine ratio increased | 97.26 | 46.17 | 16 | 1061 | 522 | 42619736 |
| Glomerular filtration rate decreased | 95.08 | 46.17 | 29 | 1048 | 16322 | 42603936 |
| Glucose urine present | 82.27 | 46.17 | 16 | 1061 | 1359 | 42618899 |
| Proteinuria | 69.92 | 46.17 | 25 | 1052 | 22958 | 42597300 |
| Blood creatinine increased | 64.74 | 46.17 | 38 | 1039 | 109965 | 42510293 |
| Contraindicated product administered | 56.72 | 46.17 | 22 | 1055 | 25250 | 42595008 |
| Blood urea increased | 47.90 | 46.17 | 21 | 1056 | 32772 | 42587486 |
| Hypotension | 47.25 | 46.17 | 44 | 1033 | 257587 | 42362671 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Urine protein/creatinine ratio increased | 144.87 | 43.91 | 24 | 1473 | 1549 | 110586253 |
| Glomerular filtration rate decreased | 141.30 | 43.91 | 39 | 1458 | 28917 | 110558885 |
| Glucose urine present | 122.63 | 43.91 | 22 | 1475 | 2267 | 110585535 |
| Urine albumin/creatinine ratio increased | 109.67 | 43.91 | 18 | 1479 | 1095 | 110586707 |
| Blood creatinine increased | 100.49 | 43.91 | 49 | 1448 | 182840 | 110404962 |
| Hypotension | 96.39 | 43.91 | 69 | 1428 | 523780 | 110064022 |
| Blood urea increased | 74.58 | 43.91 | 28 | 1469 | 54929 | 110532873 |
| Blood glucose increased | 74.16 | 43.91 | 36 | 1461 | 132460 | 110455342 |
| Blood chloride increased | 62.54 | 43.91 | 15 | 1482 | 6357 | 110581445 |
| Dizziness | 53.82 | 43.91 | 56 | 1441 | 698137 | 109889665 |
| Proteinuria | 52.84 | 43.91 | 20 | 1477 | 39998 | 110547804 |
| Protein urine present | 49.23 | 43.91 | 14 | 1483 | 11470 | 110576332 |
| Contraindicated product administered | 48.36 | 43.91 | 34 | 1463 | 248233 | 110339569 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C09XX01 | CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM Other agents acting on the renin-angiotensin system |
| FDA MoA | N0000175364 | Endothelin Receptor Antagonists |
| FDA EPC | N0000175561 | Angiotensin 2 Receptor Blocker |
| FDA EPC | N0000175581 | Endothelin Receptor Antagonist |
| FDA MoA | N0000180999 | Angiotensin 2 Type 1 Receptor Antagonists |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000185507 | Cytochrome P450 2C9 Inducers |
| FDA MoA | N0000185607 | Cytochrome P450 2C19 Inducers |
| FDA MoA | N0000187064 | Cytochrome P450 2B6 Inducers |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:51452 | endothelin A receptor antagonist |
| CHEBI has role | CHEBI:61016 | angiotensin receptor antagonist |
| CHEBI has role | CHEBI:76595 | nephroprotective agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Primary immunoglobulin A nephropathy | indication | 68779003 | |
| Pregnancy, function | contraindication | 289908002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9662312 | March 29, 2030 | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME |
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9993461 | March 29, 2030 | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME |
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9993461 | March 29, 2030 | TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK FOR DISEASE PROGRESSION |
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9993461 | March 29, 2030 | TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9662312 | March 29, 2030 | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9993461 | March 29, 2030 | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9993461 | March 29, 2030 | TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK FOR DISEASE PROGRESSION |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | 9993461 | March 29, 2030 | TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | Feb. 17, 2028 | NEW CHEMICAL ENTITY |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | Feb. 17, 2028 | NEW CHEMICAL ENTITY |
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | April 13, 2029 | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | April 13, 2029 | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME |
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | Feb. 17, 2030 | TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | Feb. 17, 2030 | TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G |
| 200MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | Sept. 5, 2031 | TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON FEBRUARY 17, 2023 |
| 400MG | FILSPARI | TRAVERE | N216403 | Feb. 17, 2023 | RX | TABLET | ORAL | Sept. 5, 2031 | TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON FEBRUARY 17, 2023 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Type-1 angiotensin II receptor | GPCR | ANTAGONIST | Ki | 9.44 | DRUG LABEL | DRUG LABEL | |||
| Endothelin-1 receptor | GPCR | ANTAGONIST | Ki | 7.89 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:229526 | CHEBI |
| CHEMBL539423 | ChEMBL_ID |
| C000634424 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8448 | IUPHAR_LIGAND_ID |
| DB12548 | DRUGBANK_ID |
| 548411000202103 | SNOMEDCT_US |
| 4042062 | VANDF |
| C4489760 | UMLSCUI |
| 10092 | INN_ID |
| 10257882 | PUBCHEM_CID |
| 365302 | MMSL |
| 41258 | MMSL |
| d10011 | MMSL |
| 019314 | NDDF |
| D11776 | KEGG_DRUG |
| 9242RO5URM | UNII |
| 2630535 | RXNORM |
| 9242RO5URM | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| FILSPARI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68974-200 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 27 sections |
| FILSPARI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68974-400 | TABLET, FILM COATED | 400 mg | ORAL | NDA | 27 sections |