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Drug ReportsMycophenolate mofetil
Cellcept(mycophenolate mofetil)
CellCept, Myclausen, Mycophenolate Mofetil, Myfenax, Myhibbin (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 2 and inosine-5'-monophosphate dehydrogenase 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
immune system diseasesD007154
immune system phenomenaD055633
Trade Name
FDA
EMA
Cellcept, Mycophenolate mofetil, Myhibbin (discontinued: Mycophenolate mofetil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mycophenolate mofetil
Tradename
Company
Number
Date
Products
MYHIBBINAzurityN-216482 RX2024-05-01
1 products, RLD, RS
CELLCEPTRocheN-050722 RX1995-05-03
1 products, RLD, RS
CELLCEPTRocheN-050723 RX1997-06-19
1 products, RLD, RS
CELLCEPTRocheN-050759 RX1998-10-01
1 products, RLD, RS
Mycophenolate mofetil hydrochloride
Tradename
Company
Number
Date
Products
CELLCEPTRocheN-050758 RX1998-08-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cellceptNew Drug Application2024-02-21
mycophenolate mofetilANDA2024-11-06
myhibbinNew Drug Application2024-05-07
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA06: Mycophenolic acid
HCPCS
Code
Description
J7517
Mycophenolate mofetil, oral, 250 mg
Clinical
Clinical Trials
1294 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 transplantationD01603020525512228263
LeukemiaD007938C955815715222227
SyndromeD01357730837311120
Graft vs host diseaseD006086D89.811638136770
RecurrenceD012008194152361
NephritisD009393N051191891258
Lupus nephritisD008181EFO_00057611191891157
Renal insufficiencyD051437HP_0000083N19911917748
Liver transplantationD016031EFO_00106822141117648
Kidney diseasesD007674EFO_0003086N084612141043
Show 119 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4645120717170
LymphomaD008223C85.932111616150
Myeloid leukemia acuteD015470C92.030891210128
Myeloid leukemiaD007951C922886119122
PreleukemiaD0112893280312114
Precursor cell lymphoblastic leukemia-lymphomaD05419823697999
Multiple myelomaD009101C90.0246841398
Non-hodgkin lymphomaD008228C85.917656988
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034014637682
Hematologic neoplasmsD01933724574676
Show 73 more
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E46336
Islets of langerhans transplantationD016381123
GlioblastomaD005909EFO_000051522
AstrocytomaD001254EFO_000027122
Chronic granulomatous diseaseD006105EFO_0000338D71112
Brain neoplasmsD001932EFO_0003833C7111
GliomaD005910EFO_000052011
Germ cell and embryonal neoplasmsD00937311
MedulloblastomaD00852711
Rhabdoid tumorD01833511
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bone diseasesD001847M89.922
ProteinuriaD011507HP_0000093R8022
InfertilityD007246HP_000078922
Uveomeningoencephalitic syndromeD014607Orphanet_3437H20.8222
Heart disease risk factorsD00008274211
Antibody formationD00091711
Choroidal neovascularizationD02025611
Pathologic neovascularizationD00938911
ScleritisD015423HP_0100534H15.011
Lysosomal storage diseasesD01646411
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMycophenolate mofetil
INN
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)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Identifiers
PDB
CAS-ID24280-93-1
RxCUI7145
ChEMBL IDCHEMBL1456
ChEBI ID8764
PubChem CID446541
DrugBankDB00688
UNII ID
Target
Agency Approved
IMPDH1
IMPDH1
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
No data
Financial
Revenue by drug
$
£
Cellcept Roche
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Estimated US medical usage
Mycophenolate mofetil
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 39,978 documents
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Safety
Black-box Warning
Black-box warning for: Cellcept, Mycophenolate mofetil, Myhibbin
Adverse Events
Top Adverse Reactions
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85,327 adverse events reported
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