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 approval date
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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| LUPKYNIS | Aurinia Pharmaceuticals | N-213716 RX | 2021-01-22 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lupkynis | New Drug Application | 2024-12-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lupus nephritis | EFO_0005761 | D008181 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VOCLOSPORIN, LUPKYNIS, AURINIA | |||
| 2026-01-22 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 2 | 4 | — | 1 | 7 |
| Nephritis | D009393 | — | N05 | — | 2 | 3 | — | 1 | 6 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | 3 | — | — | 3 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 2 | 1 | — | — | 2 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 2 | 1 | — | — | 2 |
| Kidney transplantation | D016030 | — | — | — | 1 | 1 | — | — | 2 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | 1 | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | — | 1 |
| Chronic disease | D002908 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eye diseases | D005128 | EFO_0003966 | H44 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Focal segmental glomerulosclerosis | D005923 | EFO_0004236 | — | — | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Voclosporin |
| INN | voclosporin |
| Description | Voclosporin is a homodetic cyclic peptide. |
| Classification | Protein |
| Drug class | cyclosporin 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-ID | 515814-01-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2218919 |
| ChEBI ID | — |
| PubChem CID | 6918486 |
| DrugBank | DB11693 |
| UNII ID | 2PN063X6B1 (ChemIDplus, GSRS) |
Target
Agency Approved
PPIA
PPIA
Organism
Homo sapiens
Gene name
PPIA
Gene synonyms
CYPA
NCBI Gene ID
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
Mouse ortholog
Ppia (268373)
peptidyl-prolyl cis-trans isomerase A (Q9R137)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 601 documents
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Safety
Black-box Warning
Black-box warning for: Lupkynis
Adverse Events
Top Adverse Reactions
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6,449 adverse events reported
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