Mycophenolic acid
Mycophenolic, Myfortic (mycophenolic acid) is a small molecule pharmaceutical. Mycophenolic acid was first approved as Myfortic on 2004-02-27. It is used to treat graft vs host disease and psoriasis in the USA. The pharmaceutical is active against inosine-5'-monophosphate dehydrogenase 1 and inosine-5'-monophosphate dehydrogenase 2.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
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Drug Products
FDA
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 |
|---|---|---|
| cellcept | New Drug Application | 2025-05-19 |
| mycophenolate mofetil | ANDA | 2025-08-02 |
| mycophenolic acid | ANDA | 2025-07-23 |
| myfortic | New Drug Application | 2025-06-27 |
| myhibbin | New Drug Application | 2025-07-30 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
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Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7518 | Mycophenolic acid, oral, 180 mg |
Clinical
Clinical Trials
1325 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 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 3 | 2 | 2 | — | 6 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | 1 | — | 4 | — | 5 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | 1 | 2 | 4 |
| 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 | — | 2 | 5 | — | — | 7 |
| 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 |
| Muscle weakness | D018908 | — | — | — | — | 2 | — | — | 2 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | 1 | — | — | 2 |
| Glomerulonephritis | D005921 | — | N05 | — | 2 | 1 | — | — | 2 |
Show 7 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 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | 1 | — | — | 1 | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Preleukemia | D011289 | — | — | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 1 | — | — | — | 1 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 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 |
| Vasculitis | D014657 | EFO_0006803 | M31 | 1 | — | — | — | — | 1 |
| Microscopic polyangiitis | D055953 | EFO_1000784 | M31.7 | 1 | — | — | — | — | 1 |
| Systemic vasculitis | D056647 | — | — | 1 | — | — | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | — | — | — | — | 1 |
| Urologic diseases | D014570 | — | N39.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 | Mycophenolic acid |
| 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)O)C(=O)OC2 |
Identifiers
| PDB | — |
| CAS-ID | 24280-93-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL866 |
| ChEBI ID | 168396 |
| PubChem CID | 446541 |
| DrugBank | DB01024 |
| UNII ID | HU9DX48N0T (ChemIDplus, GSRS) |
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
No data
Financial
Estimated US medical usage
Mycophenolic acid
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 60,175 documents
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Safety
Black-box Warning
Black-box warning for: Cellcept, Mycophenolate mofetil, Mycophenolic acid, Myfortic, Myhibbin
Adverse Events
Top Adverse Reactions
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119,248 adverse events reported
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