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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
cyclosporineANDA2025-04-02
cyclosporine, modfiedANDA2025-09-17
cyclosporine/chondroitin pfunapproved drug other2020-02-10
cyclosporine/chondroitin sulfate pfunapproved drug other2018-02-26
gengrafANDA2024-08-21
neoralNew Drug Application2025-06-18
restasisNew Drug Application2024-09-09
restasis multidoseNew Drug Application2025-08-21
sandimmuneNew Drug Application2025-08-12
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriasisEFO_0000676D011565L40
rheumatoid arthritisEFO_0000685D001172M06.9
focal segmental glomerulosclerosisEFO_0004236D005923—
systemic lupus erythematosusEFO_0002690D008180M32
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
1309 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.0—1———1
Plasma cell neoplasmsD054219———1———1
LeukemiaD007938—C95—1———1
B-cell chronic lymphocytic leukemiaD015451—C91.1—1———1
Lymphoid leukemiaD007945—C91—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40————33
Psoriatic arthritisD015535EFO_0003778L40.5————11
ArthritisD001168EFO_0005856M05-M14————11
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
$
€
£
₣
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 17,156 documents
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Safety
Black-box Warning
Black-box warning for: Cyclosporine, Cyclosporine, modfied, Gengraf, Neoral, Sandimmune
Adverse Events
Top Adverse Reactions
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98,252 adverse events reported
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