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Lupkynis(voclosporin)
Lupkynis (voclosporin) is a protein pharmaceutical. Voclosporin was first approved as Lupkynis on 2021-01-22. It is used to treat lupus nephritis in the USA. It has been approved in Europe to treat lupus nephritis. The pharmaceutical is active against peptidyl-prolyl cis-trans isomerase A.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Lupkynis
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Voclosporin
Tradename
Company
Number
Date
Products
LUPKYNISAurinia PharmaceuticalsN-213716 RX2021-01-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lupkynisNew Drug Application2021-01-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lupus nephritisEFO_0005761D008181—
Agency Specific
FDA
EMA
Expiration
Code
VOCLOSPORIN, LUPKYNIS, AURINIA
2026-01-22NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Voclosporin, Lupkynis, Aurinia
102860362037-12-07U-3056
116229912037-12-07U-3056
73324722023-10-17DS, DPU-3056
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AD: Calcineurin inhibitors
— L04AD03: Voclosporin
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lupus nephritisD008181EFO_0005761—23—16
PsoriasisD011565EFO_0000676L40——3——3
PanuveitisD015864EFO_1001082H44.11——3——3
Dry eye syndromesD015352H04.12—21——2
Keratoconjunctivitis siccaD007638EFO_1000906111——2
Kidney transplantationD016030——1—12
Intermediate uveitisD015867EFO_1000986——2——2
Posterior uveitisD015866EFO_1001119——2——2
Anterior uveitisD014606EFO_1000811——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney diseasesD007674EFO_0003086N08—1———1
Covid-19D000086382U07.1—1———1
Focal segmental glomerulosclerosisD005923EFO_0004236—1———1
Systemic lupus erythematosusD008180EFO_0002690M32—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD0043471————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Immunosuppression therapyD007165————11
Coronary artery diseaseD003324I25.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVOCLOSPORIN
INNvoclosporin
Description
Voclosporin is a homodetic cyclic peptide.
Classification
Protein
Drug classcyclosporin derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=C/C=C/C[C@@H](C)[C@@H](O)[C@H]1C(=O)N[C@@H](CC)C(=O)N(C)CC(=O)N(C)[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](C(C)C)C(=O)N1C
Identifiers
PDB—
CAS-ID515814-01-4
RxCUI—
ChEMBL IDCHEMBL2218919
ChEBI ID—
PubChem CID6918486
DrugBankDB11693
UNII ID2PN063X6B1 (ChemIDplus, GSRS)
Target
Agency Approved
PPIA
PPIA
Organism
Homo sapiens
Gene name
PPIA
Gene synonyms
CYPA
NCBI Gene ID
5478
Protein name
peptidyl-prolyl cis-trans isomerase A
Protein synonyms
Cyclophilin A, Cyclosporin A-binding protein, epididymis secretory sperm binding protein Li 69p, peptidylprolyl isomerase A (cyclophilin A), PPIase A, Rotamase A, T cell cyclophilin
Uniprot ID
P62937
Mouse ortholog
Ppia (268373)
peptidyl-prolyl cis-trans isomerase A (Q9R137)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 289 documents
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Safety
Black-box Warning
Black-box warning for: Lupkynis
Adverse Events
Top Adverse Reactions
Mock data
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6,238 adverse events reported
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