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Sandimmune, Ikervis(cyclosporine)
Cequa, Ikervis, Neoral, Restasis, Sandimmune, Verkazia, Vevye (cyclosporine) is a protein pharmaceutical. Cyclosporine was first approved as Sandimmune on 1983-11-14. It is used to treat focal segmental glomerulosclerosis, myasthenia gravis, psoriasis, rheumatoid arthritis, and systemic lupus erythematosus in the USA. It has been approved in Europe to treat conjunctivitis, corneal diseases, and keratitis. The pharmaceutical is active against peptidyl-prolyl cis-trans isomerase A. In addition, it is known to target solute carrier organic anion transporter family member 1B1, fMet-Leu-Phe receptor, solute carrier organic anion transporter family member 1B3, broad substrate specificity ATP-binding cassette transporter ABCG2, hepatic sodium/bile acid cotransporter, and peptidyl-prolyl cis-trans isomerase D.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
nervous system diseasesD009422
eye diseasesD005128
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Cequa, Neoral, Restasis, Restasis multidose, Sandimmune, Verkazia, Vevye (generic drugs available since 1999-10-29, discontinued: Gengraf)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cyclosporine
Tradename
Company
Number
Date
Products
RESTASIS MULTIDOSEAbbVieN-050790 RX2016-10-27
1 products, RLD, RS
RESTASISAbbVieN-050790 RX2002-12-23
1 products, RLD, RS
VEVYENOVALIQ GMBHN-217469 RX2023-05-30
1 products, RLD, RS
SANDIMMUNENovartisN-050573 RX1983-11-14
1 products, RLD, RS
SANDIMMUNENovartisN-050574 RX1983-11-14
1 products, RLD, RS
SANDIMMUNENovartisN-050625 RX1990-03-02
3 products, RLD, RS
NEORALNovartisN-050715 RX1995-07-14
2 products, RLD, RS
NEORALNovartisN-050716 RX1995-07-14
1 products, RLD, RS
VERKAZIASantenN-214965 RX2021-06-23
1 products, RLD, RS
CEQUAsparcN-210913 RX2018-08-14
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cequaNew Drug Application2021-01-28
gengrafANDA2021-02-01
neoralNew Drug Application2020-06-13
restasis multidoseNew Drug Application2016-10-01
sandimmuneNew Drug Application2020-07-25
verkaziaNew Drug Application2021-07-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
focal segmental glomerulosclerosisEFO_0004236D005923—
myasthenia gravisEFO_0004991D009157G70.0
psoriasisEFO_0000676D011565L40
rheumatoid arthritisEFO_0000685D001172M06.9
systemic lupus erythematosusEFO_0002690D008180M32
Agency Specific
FDA
EMA
Expiration
Code
CYCLOSPORINE, VERKAZIA, SANTEN
2028-06-23ODE-358
2024-06-23NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Cyclosporine, Cequa, Sun Pharm
109186942037-02-28DP
89808392033-08-23DPU-1483
99372252033-08-23DPU-1483
104416302033-08-23DP
Cyclosporine, Restasis, Abbvie
96699742034-05-11DP
96765252034-02-07DP
85618592032-04-16DP
82921292031-02-25DP
86291112024-08-27DP
86331622024-08-27U-1479
86425562024-08-27DP
86480482024-08-27U-1483
86859302024-08-27DP
92481912024-08-27U-1479
Cyclosporine, Verkazia, Santen
91320712029-06-02DP
82985682027-11-03DP
79730812026-01-27DP
85247792026-01-27DP
92206942026-01-27DP
99562892026-01-27DP
116126582026-01-27U-3560
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AD: Calcineurin inhibitors
— L04AD01: Ciclosporin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA18: Ciclosporin
HCPCS
Code
Description
G9507
Documentation that the patient is on a statin medication or has documentation of a valid contraindication or exception to statin medications; contraindications/exceptions that can be defined by diagnosis codes include pregnancy during the measurement period, active liver disease, rhabdomyolysis, end stage renal disease on dialysis and heart failure; provider documented contraindications/exceptions include breastfeeding during the measurement period, woman of child-bearing age not actively taking birth control, allergy to statin, drug interaction (hiv protease inhibitors, nefazodone, cyclosporine, gemfibrozil, and danazol) and intolerance (with supporting documentation of trying a statin at least once within the last 5 years or diagnosis codes for myostitis or toxic myopathy related to drugs)
J7502
Cyclosporine, oral, 100 mg
J7515
Cyclosporine, oral, 25 mg
Clinical
Clinical Trials
765 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4627816111111
LeukemiaD007938C9518691011094
Kidney transplantationD016030—102725263
Myeloid leukemia acuteD015470C92.0153981561
Dry eye syndromesD015352H04.123914261061
Graft vs host diseaseD006086D89.819311121059
Aplastic anemiaD000741HP_0001915D61.942613335
PsoriasisD011565EFO_0000676L403525215
Atopic dermatitisD003876EFO_0000274L20—235515
Liver transplantationD016031EFO_0010682—139—13
Show 44 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.912367—958
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011324—649
Non-hodgkin lymphomaD008228C85.97301—639
Multiple myelomaD009101C90.010242—738
B-cell chronic lymphocytic leukemiaD015451C91.17262—636
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003405243—534
Hodgkin diseaseD006689C817233—432
Plasma cell neoplasmsD0542197181—427
Mantle-cell lymphomaD020522C83.14172—525
Myeloproliferative disordersD009196D47.17151—524
Show 41 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelomonocytic leukemia chronicD015477C93.1813——219
Follicular lymphomaD008224C82413——519
Burkitt lymphomaD002051C83.7312——417
AnemiaD000740EFO_0004272D64.9711———16
B-cell lymphoma marginal zoneD018442C88.439——515
Myelodysplastic-myeloproliferative diseasesD054437211——314
Large-cell lymphoma immunoblasticD01640039——313
Lymphomatoid granulomatosisD008230C83.839——313
Large-cell lymphoma anaplasticD017728C84.638——312
Extranodal nk-t-cell lymphomaD054391C86.037——311
Show 123 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—23———225
Drug interactionsD0043473————3
PharmacokineticsD0105992————2
InflammationD0072492————2
Severe combined immunodeficiencyD016511D81.01———12
X-linked combined immunodeficiency diseasesD053632EFO_10014511———12
Venous thromboembolismD054556EFO_0004286I741————1
HyperkalemiaD006947HP_0002153E87.51————1
Hereditary angioedemasD054179EFO_00041311————1
Invasive pulmonary aspergillosisD055744B44.01————1
Show 13 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
KeratoconjunctivitisD007637H16.2————22
Juvenile arthritisD001171EFO_0002609M08————22
Lysosomal storage diseasesD016464————11
Hemophilia aD006467EFO_0007267D66————11
Wiskott-aldrich syndromeD014923D82.0————11
Type 1 hyper-igm immunodeficiency syndromeD053307————11
Common variable immunodeficiencyD017074EFO_0000367D83————11
Leukocyte-adhesion deficiency syndromeD018370EFO_1001359————11
ThalassemiaD013789EFO_1001996D56————11
Neutrophilic leukemia chronicD015467D47.1————11
Show 15 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCYCLOSPORINE
INNciclosporin
Description
Cyclosporin A is a cyclic nonribosomal peptide of eleven amino acids; an immunosuppressant drug widely used in post-allogeneic organ transplant to reduce the activity of the patient's immune system, and therefore the risk of organ rejection. Also causes reversible inhibition of immunocompetent lymphocytes in the G0- and G1-phase of the cell cycle. It has a role as an antifungal agent, an antirheumatic drug, a dermatologic drug, an immunosuppressive agent, a metabolite, a carcinogenic agent, an anti-asthmatic drug, an EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor, an anticoronaviral agent and a geroprotector.
Classification
Peptide
Drug classCalcineurin inhibitor
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
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-ID59865-13-3
RxCUI3008
ChEMBL IDCHEMBL160
ChEBI ID4031
PubChem CID5284373
DrugBankDB00091
UNII ID83HN0GTJ6D (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
SLCO1B1
SLCO1B1
FPR1
FPR1
SLCO1B3
SLCO1B3
ABCG2
ABCG2
SLC10A1
SLC10A1
PPID
PPID
Organism
Homo sapiens
Gene name
SLCO1B1
Gene synonyms
LST1, OATP1B1, OATP2, OATPC, SLC21A6
NCBI Gene ID
10599
Protein name
solute carrier organic anion transporter family member 1B1
Protein synonyms
Liver-specific organic anion transporter 1, LST-1, OATP-2, OATP-C, Organic anion transporter SLC21A6, Sodium-independent organic anion-transporting polypeptide 2, solute carrier family 21 (organic anion transporter), member 6, Solute carrier family 21 member 6
Uniprot ID
Q9Y6L6
Mouse ortholog
—
—
Variants
Clinical Variant
No data
Financial
Restasis - Allergan
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Restasis - Warner Chilcott
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Restasis - AbbVie
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Neoral - Novartis
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 72,707 documents
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Safety
Black-box Warning
Black-box warning for: Gengraf, Neoral, Sandimmune
Adverse Events
Top Adverse Reactions
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2,162 adverse events reported
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