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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Commercial
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cequa | New Drug Application | 2023-04-26 |
| cyclosporine | NDA authorized generic | 2024-09-23 |
| cyclosporine, modfied | ANDA | 2024-09-23 |
| cyclosporine/chondroitin pf | unapproved drug other | 2020-02-10 |
| cyclosporine/chondroitin sulfate pf | unapproved drug other | 2018-02-26 |
| gengraf | ANDA | 2024-08-21 |
| neoral | New Drug Application | 2024-07-18 |
| restasis | New Drug Application | 2024-09-09 |
| restasis multidose | New Drug Application | 2024-09-09 |
| sandimmune | New Drug Application | 2024-07-10 |
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Indications
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EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CYCLOSPORINE, VERKAZIA, HARROW EYE | |||
| 2028-06-23 | ODE-358 | ||
| 2024-06-23 | NP | ||
CYCLOSPORINE, VEVYE, HARROW EYE | |||
| 2026-05-30 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cyclosporine, Vevye, Harrow Eye | |||
| 11413323 | 2039-10-11 | U-3627 | |
| 11154513 | 2038-11-20 | DP | U-1900 |
| 10813976 | 2037-09-22 | DP | |
| 8614178 | 2030-12-13 | DP | |
| Cyclosporine, Cequa, Sun Pharm | |||
| 10918694 | 2037-02-28 | DP | |
| 8980839 | 2033-08-23 | DP | U-1483 |
| 9937225 | 2033-08-23 | DP | U-1483 |
| 10441630 | 2033-08-23 | DP | |
| Cyclosporine, Restasis, Abbvie | |||
| 9669974 | 2034-05-11 | DP | |
| 9676525 | 2034-02-07 | DP | |
| 8561859 | 2032-04-16 | DP | |
| 8292129 | 2031-02-25 | DP | |
| 8629111 | 2024-08-27 | DP | |
| 8633162 | 2024-08-27 | U-1479 | |
| 8642556 | 2024-08-27 | DP | |
| 8648048 | 2024-08-27 | U-1483 | |
| 8685930 | 2024-08-27 | DP | |
| 9248191 | 2024-08-27 | U-1479 | |
| Cyclosporine, Verkazia, Harrow Eye | |||
| 9132071 | 2029-06-02 | DP | |
| 8298568 | 2027-11-03 | DP | |
| 7973081 | 2026-01-27 | DP | |
| 8524779 | 2026-01-27 | DP | |
| 9220694 | 2026-01-27 | DP | |
| 9956289 | 2026-01-27 | DP | |
| 11612658 | 2026-01-27 | U-3560 | |
ATC Codes
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 |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 43 | 137 | 26 | 4 | 24 | 207 |
| Syndrome | D013577 | — | — | 30 | 81 | 16 | 9 | 26 | 147 |
| Myelodysplastic syndromes | D009190 | — | D46 | 29 | 99 | 11 | 1 | 15 | 139 |
| Kidney transplantation | D016030 | — | — | 4 | 18 | 43 | 52 | 12 | 126 |
| Preleukemia | D011289 | — | — | 25 | 75 | 8 | 1 | 13 | 108 |
| Anemia | D000740 | HP_0001903 | D64.9 | 17 | 63 | 8 | 10 | 12 | 99 |
| Graft vs host disease | D006086 | — | D89.81 | 17 | 51 | 18 | 9 | 13 | 98 |
| Myeloid leukemia | D007951 | — | C92 | 21 | 64 | 13 | 1 | 10 | 97 |
| Dry eye syndromes | D015352 | — | H04.12 | 4 | 14 | 24 | 35 | 19 | 93 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 18 | 56 | 15 | 1 | 10 | 90 |
Show 119 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 25 | 77 | 13 | — | 15 | 117 |
| Multiple myeloma | D009101 | — | C90.0 | 22 | 52 | 4 | — | 11 | 78 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 14 | 44 | 12 | — | 8 | 70 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 12 | 42 | 7 | — | 6 | 59 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 12 | 41 | 5 | — | 7 | 58 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 9 | 40 | 9 | — | 5 | 55 |
| Lymphoid leukemia | D007945 | — | C91 | 13 | 31 | 6 | — | 7 | 51 |
| Plasma cell neoplasms | D054219 | — | — | 15 | 31 | 2 | — | 8 | 49 |
| Hematologic neoplasms | D019337 | — | — | 14 | 29 | 6 | — | 6 | 47 |
| Hodgkin disease | D006689 | — | C81 | 8 | 32 | 4 | — | 4 | 42 |
Show 78 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 3 | 15 | — | — | 5 | 21 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 3 | 12 | — | — | 5 | 18 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 3 | 12 | — | — | 4 | 17 |
| T-cell lymphoma | D016399 | — | — | 3 | 11 | — | — | 4 | 16 |
| Refractory anemia | D000753 | — | — | 6 | 11 | — | — | — | 15 |
| T-cell lymphoma peripheral | D016411 | — | — | 3 | 10 | — | — | 3 | 14 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 3 | 8 | — | — | 4 | 13 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | 3 | 9 | — | — | 3 | 13 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | 3 | 9 | — | — | 3 | 13 |
| Lymphomatoid granulomatosis | D008230 | — | C83.8 | 3 | 9 | — | — | 3 | 13 |
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 | — | — | — | 4 | 34 |
| Pathologic neovascularization | D009389 | — | — | 2 | — | — | — | 1 | 3 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Wiskott-aldrich syndrome | D014923 | EFO_0003903 | D82.0 | 2 | — | — | — | 1 | 3 |
| Rhabdoid tumor | D018335 | — | — | 2 | — | — | — | — | 2 |
| Churg-strauss syndrome | D015267 | EFO_0007208 | M30.1 | 1 | — | — | — | 1 | 2 |
| Cardiac surgical procedures | D006348 | — | — | 1 | — | — | — | 1 | 2 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | 1 | 2 |
| Corneal neovascularization | D016510 | EFO_1000880 | H16.4 | 2 | — | — | — | — | 2 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | — | — | 3 | 3 |
| Immune tolerance | D007108 | — | — | — | — | — | — | 2 | 2 |
| Uveomeningoencephalitic syndrome | D014607 | Orphanet_3437 | H20.82 | — | — | — | — | 2 | 2 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | — | 1 | 1 |
| Choroidal neovascularization | D020256 | — | — | — | — | — | — | 1 | 1 |
| Critical illness | D016638 | — | — | — | — | — | — | 1 | 1 |
| Common cold | D003139 | EFO_0007214 | J00 | — | — | — | — | 1 | 1 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | — | — | 1 | 1 |
| Muscle weakness | D018908 | HP_0001324 | — | — | — | — | — | 1 | 1 |
| Xerophthalmia | D014985 | — | E50.7 | — | — | — | — | 1 | 1 |
Show 43 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cyclosporine |
| INN | ciclosporin |
| 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 | Protein |
| Drug class | Calcineurin 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-ID | 59865-13-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL160 |
| ChEBI ID | 4031 |
| PubChem CID | 5284373 |
| DrugBank | DB00091 |
| UNII ID | 83HN0GTJ6D (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
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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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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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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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