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Drug ReportsCyclosporine
Cyclosporine
Cequa, Cyclosporine, Gengraf, 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 peptidyl-prolyl cis-trans isomerase D, solute carrier organic anion transporter family member 1B3, fMet-Leu-Phe receptor, broad substrate specificity ATP-binding cassette transporter ABCG2, hepatic sodium/bile acid cotransporter, and solute carrier organic anion transporter family member 1B1.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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, Cyclosporine, Gengraf, Neoral, Restasis multidose, Sandimmune, Verkazia, Vevye (discontinued: Cyclosporine, Gengraf, Neoral)
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
RESTASISAbbVieN-050790 RX2002-12-23
1 products, RLD, RS
RESTASIS MULTIDOSEAbbVieN-050790 RX2016-10-27
1 products, RLD, RS
VEVYEHarrowN-217469 RX2023-05-30
1 products, RLD, RS
VERKAZIAHarrowN-214965 RX2021-06-23
1 products, RLD, RS
NEORALNovartisN-050715 RX1995-07-14
2 products, RLD, RS
NEORALNovartisN-050716 RX1995-07-14
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
CEQUASun Pharmaceutical IndustriesN-210913 RX2018-08-14
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cequaNew Drug Application2023-04-26
cyclosporineNDA authorized generic2024-09-23
cyclosporine, modfiedANDA2024-09-23
cyclosporine/chondroitin pfunapproved drug other2020-02-10
cyclosporine/chondroitin sulfate pfunapproved drug other2018-02-26
gengrafANDA2024-08-21
neoralNew Drug Application2024-07-18
restasisNew Drug Application2024-09-09
restasis multidoseNew Drug Application2024-09-09
sandimmuneNew Drug Application2024-07-10
Show 2 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriasisEFO_0000676D011565L40
rheumatoid arthritisEFO_0000685D001172M06.9
focal segmental glomerulosclerosisEFO_0004236D005923—
systemic lupus erythematosusHP_0002725D008180M32
myasthenia gravisEFO_0004991D009157G70.0
Agency Specific
FDA
EMA
Expiration
Code
CYCLOSPORINE, VERKAZIA, HARROW EYE
2028-06-23ODE-358
2024-06-23NP
CYCLOSPORINE, VEVYE, HARROW EYE
2026-05-30NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Cyclosporine, Vevye, Harrow Eye
114133232039-10-11U-3627
111545132038-11-20DPU-1900
108139762037-09-22DP
86141782030-12-13DP
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, Harrow Eye
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
1254 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C954313726424207
SyndromeD013577——308116926147
Myelodysplastic syndromesD009190—D46299911115139
Kidney transplantationD016030——418435212126
PreleukemiaD011289——25758113108
AnemiaD000740HP_0001903D64.917638101299
Graft vs host diseaseD006086—D89.8117511891398
Myeloid leukemiaD007951—C9221641311097
Dry eye syndromesD015352—H04.1241424351993
Myeloid leukemia acuteD015470—C92.018561511090
Show 119 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9257713—15117
Multiple myelomaD009101—C90.022524—1178
Precursor cell lymphoblastic leukemia-lymphomaD054198——144412—870
Non-hodgkin lymphomaD008228—C85.912427—659
Myeloproliferative disordersD009196—D47.112415—758
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—9409—555
Lymphoid leukemiaD007945—C9113316—751
Plasma cell neoplasmsD054219——15312—849
Hematologic neoplasmsD019337——14296—647
Hodgkin diseaseD006689—C818324—442
Show 78 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD016393——315——521
B-cell lymphoma marginal zoneD018442—C88.4312——518
Hematologic diseasesD006402EFO_0005803D75.9312——417
T-cell lymphomaD016399——311——416
Refractory anemiaD000753——611———15
T-cell lymphoma peripheralD016411——310——314
Large-cell lymphoma anaplasticD017728—C84.638——413
Plasmablastic lymphomaD000069293—C83.339——313
Large-cell lymphoma immunoblasticD016400——39——313
Lymphomatoid granulomatosisD008230—C83.839——313
Show 186 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———30———434
Pathologic neovascularizationD009389——2———13
Drug interactionsD004347——3————3
Wiskott-aldrich syndromeD014923EFO_0003903D82.02———13
Rhabdoid tumorD018335——2————2
Churg-strauss syndromeD015267EFO_0007208M30.11———12
Cardiac surgical proceduresD006348——1———12
HepacivirusD016174——1———12
Corneal neovascularizationD016510EFO_1000880H16.42————2
Germ cell and embryonal neoplasmsD009373——1————1
Show 27 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Juvenile arthritisD001171EFO_1002007M08————33
Immune toleranceD007108——————22
Uveomeningoencephalitic syndromeD014607Orphanet_3437H20.82————22
Psoriatic arthritisD015535EFO_0003778L40.5————11
Choroidal neovascularizationD020256——————11
Critical illnessD016638——————11
Common coldD003139EFO_0007214J00————11
Myasthenia gravisD009157EFO_0004991G70.0————11
Muscle weaknessD018908HP_0001324—————11
XerophthalmiaD014985—E50.7————11
Show 43 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)Loading
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
RxCUI—
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
PPID
PPID
SLCO1B3
SLCO1B3
FPR1
FPR1
ABCG2
ABCG2
SLC10A1
SLC10A1
SLCO1B1
SLCO1B1
Organism
Homo sapiens
Gene name
PPID
Gene synonyms
CYP40, CYPD
NCBI Gene ID
5481
Protein name
peptidyl-prolyl cis-trans isomerase D
Protein synonyms
40 kDa peptidyl-prolyl cis-trans isomerase, 40 kDa peptidyl-prolyl cis-trans isomerase D, cyclophilin 40, cyclophilin D, Cyclophilin-40, Cyclophilin-related protein, CYP-40, PPIase D, Rotamase D, testicular tissue protein Li 147
Uniprot ID
Q08752
Mouse ortholog
Ppid (67738)
peptidyl-prolyl cis-trans isomerase D (Q9CR16)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Neoral – Novartis
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Restasis – Allergan
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Restasis – Warner Chilcott
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Restasis – AbbVie
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Estimated US medical usage
Cyclosporine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,922 documents
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Safety
Black-box Warning
Black-box warning for: Cyclosporine, modfied, Gengraf, Neoral, Sandimmune
Adverse Events
Top Adverse Reactions
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85,940 adverse events reported
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