Mycophenolic acid
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 2 and inosine-5'-monophosphate dehydrogenase 1.
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Commercial
Trade Name
FDA
EMA
Myfortic (generic drugs available since 2012-08-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mycophenolic sodium
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
MYFORTIC | Novartis | N-050791 RX | 2004-02-27 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
mycophenolic acid | ANDA | 2023-05-23 |
myfortic | New Drug Application | 2021-01-28 |
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 |
---|---|
J7518 | Mycophenolic acid, oral, 180 mg |
Clinical
Clinical Trials
508 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 146 | 1 | — | 4 | 1 | 152 | ||
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 5 | 12 | 5 | 1 | — | 19 |
Cataract | D002386 | EFO_0001059 | H26.9 | 1 | — | 1 | 9 | 2 | 13 |
Infections | D007239 | EFO_0000544 | 5 | 1 | 3 | 1 | 1 | 11 | |
Endophthalmitis | D009877 | 2 | 5 | 3 | 4 | — | 11 | ||
Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | 5 | 2 | 1 | 10 |
Bacterial infections | D001424 | A49 | 3 | — | 1 | 4 | 1 | 9 | |
Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | 1 | 4 | 3 | — | 8 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | — | 2 | 1 | — | 7 |
Chronic bronchitis | D029481 | J42 | — | — | 2 | 1 | 4 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 11 | 8 | — | 2 | 17 |
Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | 7 | 8 | — | — | 9 | |
Community-acquired infections | D017714 | — | 2 | 3 | — | — | 5 | ||
Lung diseases | D008171 | EFO_0003818 | J98.4 | 2 | 1 | 2 | — | — | 4 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | 2 | — | — | 4 |
Extensively drug-resistant tuberculosis | D054908 | — | 4 | 4 | — | — | 4 | ||
Contraception | D003267 | 1 | 1 | 1 | — | 1 | 4 | ||
Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 3 | — | — | 3 |
Keratitis | D007634 | H16 | — | — | 3 | — | — | 3 | |
Lymphoma | D008223 | C85.9 | 1 | — | 1 | — | 1 | 3 |
Show 33 more
Indications Phases 2
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | — | — | 1 | 4 |
Schizophrenia | D012559 | EFO_0000692 | F20 | 4 | — | — | — | — | 4 |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 4 | — | — | — | — | 4 |
Alzheimer disease | D000544 | EFO_0000249 | F03 | 4 | — | — | — | — | 4 |
Asthma | D001249 | EFO_0000270 | J45 | 3 | — | — | — | — | 3 |
Hepatitis c | D006526 | B19.2 | 3 | — | — | — | — | 3 | |
Dyslipidemias | D050171 | HP_0003119 | 3 | — | — | — | — | 3 | |
Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | — | — | — | 1 | 2 |
Cardiovascular abnormalities | D018376 | EFO_0003848 | 1 | — | — | — | 1 | 2 | |
Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | — | — | — | 2 |
Show 45 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 2 | 2 |
Pathologic dilatation | D004108 | — | — | — | — | 2 | 2 | ||
Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
Regeneration | D012038 | — | — | — | — | 2 | 2 | ||
Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
Delirium | D003693 | R41.0 | — | — | — | — | 1 | 1 | |
Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 1 | 1 |
Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 1 | 1 |
Chemical and drug induced liver injury | D056486 | — | — | — | — | 1 | 1 | ||
Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
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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 |
Target
Agency Approved
IMPDH2
IMPDH2
IMPDH1
IMPDH1
Organism
Homo sapiens
Gene name
IMPDH2
Gene synonyms
IMPD2
NCBI Gene ID
Protein name
inosine-5'-monophosphate dehydrogenase 2
Protein synonyms
epididymis secretory sperm binding protein, IMP (inosine 5'-monophosphate) dehydrogenase 2, IMP (inosine monophosphate) dehydrogenase 2, IMP dehydrogenase II, IMP oxireductase 2, IMPD 2, IMPDH 2, IMPDH-II, inosine 5' phosphate dehydrogenase 2, inosine monophosphate dehydrogenase type II, Inosine-5'-monophosphate dehydrogenase type II
Uniprot ID
Mouse ortholog
Impdh2 (23918)
inosine-5'-monophosphate dehydrogenase 2 (Q91Z11)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Myfortic - Novartis
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Mycophenolic acid, Myfortic
Adverse Events
Top Adverse Reactions
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25,278 adverse events reported
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