Cellcept(mycophenolate mofetil)
CellCept (mycophenolate mofetil) is a small molecule pharmaceutical. Mycophenolate mofetil was first approved as Cellcept on 1995-05-03. It is used to treat graft vs host disease and psoriasis in the USA. It has been approved in Europe to treat graft rejection. The pharmaceutical is active against inosine-5'-monophosphate dehydrogenase 1 and inosine-5'-monophosphate dehydrogenase 2.
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Commercial
Trade Name
FDA
EMA
Cellcept (generic drugs available since 2008-07-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mycophenolate mofetil
Mycophenolate mofetil hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CELLCEPT | Roche | N-050758 RX | 1998-08-12 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cellcept | New Drug Application | 2020-10-16 |
| mycophenolate mofetil | ANDA | 2023-05-09 |
| mycophenolic acid | ANDA | 2023-05-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| graft vs host disease | — | D006086 | D89.81 |
| psoriasis | EFO_0000676 | D011565 | L40 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7517 | Mycophenolate mofetil, oral, 250 mg |
Clinical
Clinical Trials
833 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | 7 | 21 | 26 | 60 | 6 | 115 | ||
| Graft vs host disease | D006086 | D89.81 | 11 | 29 | 4 | 1 | 4 | 42 | |
| Lupus nephritis | D008181 | EFO_0005761 | — | 12 | 14 | 7 | 6 | 38 | |
| Liver transplantation | D016031 | EFO_0010682 | 1 | 4 | 5 | 13 | 2 | 25 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 3 | 6 | 3 | 7 | 3 | 19 |
| Heart transplantation | D016027 | EFO_0010673 | — | 2 | 4 | 9 | 1 | 16 | |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 2 | 6 | 7 | 3 | 1 | 16 |
| Immunosuppression therapy | D007165 | 1 | 2 | 1 | 7 | 3 | 14 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 3 | 3 | 2 | 6 | — | 12 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | 2 | 3 | 2 | 4 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 39 | 94 | 5 | — | 11 | 133 | |
| Myeloid leukemia acute | D015470 | C92.0 | 27 | 69 | 11 | — | 6 | 101 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 21 | 54 | 5 | — | 7 | 79 | |
| Leukemia | D007938 | C95 | 17 | 53 | 2 | — | 6 | 71 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 15 | 49 | 2 | — | 6 | 64 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 9 | 47 | 4 | — | 6 | 60 | |
| Lymphoma | D008223 | C85.9 | 12 | 43 | 2 | — | 7 | 60 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 10 | 44 | 6 | — | 5 | 58 | |
| Multiple myeloma | D009101 | C90.0 | 14 | 38 | 3 | — | 7 | 56 | |
| Hodgkin disease | D006689 | C81 | 13 | 43 | 3 | — | 4 | 56 |
Show 38 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 13 | 20 | — | — | 2 | 29 | |
| Plasma cell neoplasms | D054219 | 7 | 22 | — | — | 3 | 29 | ||
| Follicular lymphoma | D008224 | C82 | 4 | 21 | — | — | 5 | 27 | |
| Burkitt lymphoma | D002051 | C83.7 | 3 | 18 | — | — | 4 | 23 | |
| Hematologic neoplasms | D019337 | 8 | 15 | — | — | 2 | 19 | ||
| B-cell lymphoma marginal zone | D018442 | C88.4 | 3 | 12 | — | — | 5 | 18 | |
| Large-cell lymphoma anaplastic | D017728 | C84.6 | 3 | 12 | — | — | 3 | 16 | |
| Lymphomatoid granulomatosis | D008230 | C83.8 | 3 | 12 | — | — | 3 | 16 | |
| Anemia | D000740 | EFO_0004272 | D64.9 | 7 | 11 | — | — | — | 16 |
| Extranodal nk-t-cell lymphoma | D054391 | C86.0 | 3 | 11 | — | — | 3 | 15 |
Show 114 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 14 | — | — | — | 2 | 16 | ||
| Diffuse scleroderma | D045743 | EFO_0000404 | 1 | — | — | — | 1 | 2 | |
| Glioblastoma | D005909 | EFO_0000515 | 2 | — | — | — | — | 2 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Germ cell and embryonal neoplasms | D009373 | 1 | — | — | — | — | 1 | ||
| Medulloblastoma | D008527 | 1 | — | — | — | — | 1 | ||
| Ependymoma | D004806 | 1 | — | — | — | — | 1 | ||
| Choroid plexus neoplasms | D016545 | EFO_0007206 | 1 | — | — | — | — | 1 | |
| Primitive neuroectodermal tumors | D018242 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lysosomal storage diseases | D016464 | — | — | — | — | 1 | 1 | ||
| Nervous system diseases | D009422 | G00-G99 | — | — | — | — | 1 | 1 | |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Viremia | D014766 | B34.9 | — | — | — | — | 1 | 1 | |
| Nephritis | D009393 | N05 | — | — | — | — | 1 | 1 | |
| Plasmapheresis | D010956 | — | — | — | — | 1 | 1 | ||
| Plasmacytoma | D010954 | C90.3 | — | — | — | — | 1 | 1 | |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | — | — | — | 1 | 1 | |
| Chronic granulomatous disease | D006105 | EFO_0000338 | D71 | — | — | — | — | 1 | 1 |
| Inborn errors metabolism | D008661 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MYCOPHENOLATE MOFETIL |
| INN | mycophenolic acid |
| Description | Mycophenolic acid is a member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases. It has a role as an antineoplastic agent, an antimicrobial agent, an EC 1.1.1.205 (IMP dehydrogenase) inhibitor, an immunosuppressive agent, a mycotoxin, a Penicillium metabolite, an environmental contaminant, a xenobiotic and an anticoronaviral agent. It is a gamma-lactone, a member of phenols, a monocarboxylic acid and a member of 2-benzofurans. It is functionally related to a hex-4-enoic acid. It is a conjugate acid of a mycophenolate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2 |
Identifiers
| PDB | — |
| CAS-ID | 24280-93-1 |
| RxCUI | 7145 |
| ChEMBL ID | CHEMBL1456 |
| ChEBI ID | 8764 |
| PubChem CID | 446541 |
| DrugBank | DB00688 |
| UNII ID | HU9DX48N0T (ChemIDplus, GSRS) |
Target
Agency Approved
IMPDH1
IMPDH1
IMPDH2
IMPDH2
Organism
Homo sapiens
Gene name
IMPDH1
Gene synonyms
IMPD1
NCBI Gene ID
Protein name
inosine-5'-monophosphate dehydrogenase 1
Protein synonyms
IMP (inosine 5'-monophosphate) dehydrogenase 1, IMP (inosine monophosphate) dehydrogenase 1, IMPD 1, IMPDH 1, IMPDH-I
Uniprot ID
Mouse ortholog
Impdh1 (23917)
inosine-5'-monophosphate dehydrogenase 1 (P50096)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Cellcept - Roche
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Cellcept, Mycophenolate mofetil, Mycophenolic acid
Adverse Events
Top Adverse Reactions
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55 adverse events reported
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