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AboutPricing
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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Drug
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Events Timeline
5D
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3M
6M
YTD
1Y
2Y
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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
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 Application2024-11-21
mycophenolate mofetilANDA2025-01-13
myhibbinNew Drug Application2024-05-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriasisEFO_0000676D011565L40
graft vs host disease—D006086D89.81
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
1295 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autoimmune diseasesD001327HP_0002960M30-M36————11
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
3614
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
P20839
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 55,592 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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110,014 adverse events reported
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