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voclosporin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| ciclosporin derivatives | 4366 | 515814-01-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Voclosporin is a calcineurin-inhibitor immunosuppressant. The mechanism of voclosporin suppression of calcineurin has not been fully established. Activation of lymphocytes involves an increase in intracellular calcium concentrations that bind to the calcineurin regulatory site and activate calmodulin binding catalytic subunit and through dephosphorylation activates the transcription factor, Nuclear Factor of Activated T-Cell Cytoplasmic (NFATc). The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 47.40 | mg | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.060 | Moderate | 0.77 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 18.923 | Moderate | 0.77 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 10.162 | 10^-6 cm/s | Moderate | 0.77 |
| dh-clint | Dog hepatocyte intrinsic clearance | 41.783 | uL/min/10^6 cells | Moderate | 0.77 |
| dppb | Dog plasma protein binding (% unbound) | 1.850 | % | Moderate | 0.77 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 4.050 | % | Moderate | 0.77 |
| herg | hERG pIC50 | 4.295 | pIC50 | Moderate | 0.77 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.592 | uL/min/10^6 cells | Moderate | 0.77 |
| hlm-clint | Human liver microsomal intrinsic clearance | 18.621 | uL/min/mg protein | Moderate | 0.77 |
| hppb | Human plasma protein binding (% unbound) | 3.570 | % | Moderate | 0.77 |
| kinase-safety-class | EIF2AK3,GRK2,PDK1,PDK2,PDK4 | 5 | |||
| kinase-selectivity-class | PDK1 | 1 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 50.234 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 24.434 | Moderate | 0.77 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 9.036 | Moderate | 0.77 | |
| mppb | Mouse plasma protein binding (% unbound) | 1 | Moderate | 0.77 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 226.986 | Moderate | 0.77 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | High | 0.88 | |
| pppb | Pig plasma protein binding (% unbound) | 0.770 | % | Moderate | 0.77 |
| rat-kpuu-brain | Rat brain Kpuu | 0.005 | % | High | 0.88 |
| rh-clint | Rat hepatocyte intrinsic clearance | 11.298 | uL/min/10^6 cells | Moderate | 0.77 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 8.310 | % | Moderate | 0.77 |
| rppb | Rat plasma protein binding (% unbound) | 1.510 | % | Moderate | 0.77 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 82.224 | uM | Moderate | 0.77 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 22, 2021 | FDA | AURINIA PHARMA U.S. | |
| Sept. 15, 2022 | EMA | OTSUKA PHARMACEUTICAL NETHERLANDS B.V. |
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 |
|---|---|---|---|---|---|---|
| Urine protein/creatinine ratio increased | 782.32 | 39.28 | 112 | 3361 | 900 | 90624074 |
| Proteinuria | 674.81 | 39.28 | 160 | 3313 | 23131 | 90601843 |
| Glomerular filtration rate decreased | 621.29 | 39.28 | 141 | 3332 | 16791 | 90608183 |
| Blood creatinine increased | 210.56 | 39.28 | 94 | 3379 | 101292 | 90523682 |
| Therapy interrupted | 169.97 | 39.28 | 66 | 3407 | 50042 | 90574932 |
| Hypertension | 155.98 | 39.28 | 133 | 3340 | 457399 | 90167575 |
| Blood pressure increased | 149.05 | 39.28 | 93 | 3380 | 197124 | 90427850 |
| Absence of immediate treatment response | 106.60 | 39.28 | 12 | 3461 | 4 | 90624970 |
| Treatment noncompliance | 91.54 | 39.28 | 43 | 3430 | 51684 | 90573290 |
| Renal impairment | 90.41 | 39.28 | 54 | 3419 | 105367 | 90519607 |
| Herpes simplex colitis | 76.18 | 39.28 | 11 | 3462 | 93 | 90624881 |
| Double stranded DNA antibody positive | 66.80 | 39.28 | 12 | 3461 | 430 | 90624544 |
| Urine albumin/creatinine ratio increased | 64.00 | 39.28 | 12 | 3461 | 546 | 90624428 |
| Urine abnormality | 52.17 | 39.28 | 17 | 3456 | 7720 | 90617254 |
| Complement factor C3 decreased | 50.52 | 39.28 | 9 | 3464 | 307 | 90624667 |
| Urine protein/creatinine ratio abnormal | 43.35 | 39.28 | 6 | 3467 | 36 | 90624938 |
| Protein urine present | 41.70 | 39.28 | 14 | 3459 | 6970 | 90618004 |
| Headache | 41.06 | 39.28 | 97 | 3376 | 862649 | 89762325 |
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 |
|---|---|---|---|---|---|---|
| Proteinuria | 172.82 | 62.28 | 41 | 395 | 22942 | 42597957 |
| Urine protein/creatinine ratio increased | 151.84 | 62.28 | 22 | 414 | 795 | 42620104 |
| Glomerular filtration rate decreased | 116.45 | 62.28 | 28 | 408 | 16323 | 42604576 |
| Hypertension | 79.93 | 62.28 | 37 | 399 | 167167 | 42453732 |
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 | 656.14 | 38.50 | 95 | 2413 | 1478 | 110585313 |
| Glomerular filtration rate decreased | 508.51 | 38.50 | 120 | 2388 | 28836 | 110557955 |
| Proteinuria | 464.99 | 38.50 | 119 | 2389 | 39899 | 110546892 |
| Hypertension | 153.58 | 38.50 | 111 | 2397 | 509973 | 110076818 |
| Blood creatinine increased | 147.28 | 38.50 | 75 | 2433 | 182814 | 110403977 |
| Blood pressure increased | 128.21 | 38.50 | 77 | 2431 | 258296 | 110328495 |
| Therapy interrupted | 96.99 | 38.50 | 38 | 2470 | 49784 | 110537007 |
| Herpes simplex colitis | 79.93 | 38.50 | 11 | 2497 | 114 | 110586677 |
| Treatment noncompliance | 64.62 | 38.50 | 32 | 2476 | 72958 | 110513833 |
| Urine albumin/creatinine ratio increased | 62.02 | 38.50 | 12 | 2496 | 1101 | 110585690 |
| Double stranded DNA antibody positive | 56.86 | 38.50 | 10 | 2498 | 542 | 110586249 |
| Absence of immediate treatment response | 55.74 | 38.50 | 6 | 2502 | 3 | 110586788 |
| Urine abnormality | 53.87 | 38.50 | 16 | 2492 | 9080 | 110577711 |
| Renal impairment | 45.19 | 38.50 | 36 | 2472 | 188409 | 110398382 |
| Complement factor C3 decreased | 39.90 | 38.50 | 7 | 2501 | 374 | 110586417 |
| Systemic lupus erythematosus | 39.62 | 38.50 | 38 | 2470 | 254300 | 110332491 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AD03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Calcineurin inhibitors |
| FDA EPC | N0000175457 | Calcineurin Inhibitor Immunosuppressant |
| FDA MoA | N0000175458 | Calcineurin Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
| FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
Related Drugs by ATC class:
L04AD Calcineurin inhibitors 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Lupus nephritis | indication | 68815009 | |
| Noninfectious Uveitis | indication |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 7.9MG | LUPKYNIS | AURINIA | N213716 | Jan. 22, 2021 | RX | CAPSULE | ORAL | 7332472 | Oct. 17, 2027 | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS |
| 7.9MG | LUPKYNIS | AURINIA | N213716 | Jan. 22, 2021 | RX | CAPSULE | ORAL | 10286036 | Dec. 7, 2037 | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS |
| 7.9MG | LUPKYNIS | AURINIA | N213716 | Jan. 22, 2021 | RX | CAPSULE | ORAL | 11622991 | Dec. 7, 2037 | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 7.9MG | LUPKYNIS | AURINIA | N213716 | Jan. 22, 2021 | RX | CAPSULE | ORAL | Jan. 22, 2026 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Peptidyl-prolyl cis-trans isomerase A | Enzyme | INHIBITOR | Kd | 7.82 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| D09033 | KEGG_DRUG |
| 4040008 | VANDF |
| C2607219 | UMLSCUI |
| CHEMBL5314379 | ChEMBL_ID |
| DB11693 | DRUGBANK_ID |
| C484071 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11388 | IUPHAR_LIGAND_ID |
| 8889 | INN_ID |
| 2PN063X6B1 | UNII |
| 6918486 | PUBCHEM_CID |
| 2475166 | RXNORM |
| 343010 | MMSL |
| 39286 | MMSL |
| d09707 | MMSL |
| 018620 | NDDF |
| 1149151008 | SNOMEDCT_US |
| 1149188006 | SNOMEDCT_US |
| CHEBI:135957 | CHEBI |
| 2PN063X6B1 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LUPKYNIS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75626-001 | CAPSULE | 7.90 mg | ORAL | NDA | 33 sections |
| LUPKYNIS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75626-001 | CAPSULE | 7.90 mg | ORAL | NDA | 33 sections |