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Drug ReportsCyclosporine
Sandimmune, Ikervis(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 Application2025-03-06
cyclosporineANDA2025-12-09
cyclosporine, modfiedANDA2025-09-17
cyclosporine/chondroitin pfunapproved drug other2020-02-10
cyclosporine/chondroitin sulfate pfunapproved drug other2018-02-26
gengrafANDA2024-08-21
neoralNew Drug Application2025-12-22
restasisNew Drug Application2024-09-09
restasis multidoseNew Drug Application2025-08-21
sandimmuneNew Drug Application2025-12-22
Show 2 more
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
1318 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C953211121416163
Myelodysplastic syndromesD009190D462910111116142
Kidney transplantationD016030418425213126
Dry eye syndromesD015352H04.12514263924105
Myeloid leukemia acuteD015470C92.0236516111104
Graft vs host diseaseD006086D89.81195220913103
Aplastic anemiaD000741D61.99537111586
SyndromeD01357714451122085
AnemiaD000740EFO_0004272D64.91440531062
Myeloid leukemiaD007951C92113561249
Show 114 more
Indications Phases 3
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients34438
Drug interactionsD00434755
Rhabdoid tumorD01833522
Churg-strauss syndromeD015267EFO_0007208M30.1112
Cardiac surgical proceduresD006348112
HepacivirusD016174112
Triple negative breast neoplasmsD06472622
Corneal neovascularizationD016510EFO_1000880H16.422
Alopecia areataD000506EFO_0004192L63112
Venous thromboembolismD054556EFO_0004286I7411
Show 26 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uveomeningoencephalitic syndromeD014607Orphanet_3437H20.8233
Juvenile arthritisD001171EFO_1002007M0833
Psoriatic arthritisD015535EFO_0003778L40.522
Immune toleranceD00710822
Choroidal neovascularizationD02025611
Critical illnessD01663811
Common coldD003139EFO_0007214J0011
Myasthenia gravisD009157EFO_0004991G70.011
Muscle weaknessD01890811
XerophthalmiaD014985E50.711
Show 47 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
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
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
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
Mouse ortholog
Ppid (67738)
peptidyl-prolyl cis-trans isomerase D (Q9CR16)
Variants
No data
Financial
Revenue by drug
$
£
Restasis multidose AbbVie
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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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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 18,831 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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100,490 adverse events reported
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