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
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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cellcept | New Drug Application | 2026-08-05 |
| mycophenolate mofetil | ANDA | 2026-10-13 |
| myhibbin | New Drug Application | 2026-07-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriasis | EFO_0000676 | D011565 | L40 |
| graft vs host disease | — | D006086 | D89.81 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7517 | Mycophenolate mofetil, oral, 250 mg |
Clinical
Clinical Trials
1397 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 | — | — | 2 | 2 | 6 | 11 | 5 | 25 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | — | 1 | 4 | 2 | 7 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | 1 | — | 4 | — | 5 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 2 | 1 | 2 | — | 5 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 1 | 1 | 2 |
| Polyomavirus infections | D027601 | EFO_0007451 | — | — | — | — | 1 | — | 1 |
| Corneal transplantation | D016039 | EFO_0010676 | — | — | — | — | 1 | — | 1 |
| Delayed graft function | D051799 | — | — | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 2 | 5 | — | — | 7 |
| Nephritis | D009393 | — | N05 | — | — | 4 | — | — | 4 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | 3 | — | — | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | 1 | — | — | 2 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | — | 2 | — | — | 2 |
| Pemphigus | D010392 | EFO_1000749 | L10 | — | — | 2 | — | — | 2 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 2 | — | — | 2 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | 1 | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | — | — | 3 | 4 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Preleukemia | D011289 | — | — | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 1 | — | — | — | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunosuppression therapy | D007165 | — | — | 1 | — | — | — | 1 | 2 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Microscopic polyangiitis | D055953 | EFO_1000784 | M31.7 | 1 | — | — | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 2 | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | — | — | — | 1 | 1 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mycophenolate 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) |  |
| 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 | — |
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
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Variants
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Financial
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Cellcept – Roche
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Estimated US medical usage
Mycophenolate mofetil
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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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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113,265 adverse events reported
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