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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
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
immune system diseasesD007154
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
MYFORTICNovartisN-050791 RX2004-02-27
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mycophenolic acidANDA2023-05-23
myforticNew Drug Application2021-01-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
graft vs host disease—D006086D89.81
psoriasisEFO_0000676D011565L40
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
J7518
Mycophenolic acid, oral, 180 mg
Clinical
Clinical Trials
508 clinical trials
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Mock data
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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—1461—41152
TuberculosisD014376EFO_0000774A15-A1951251—19
CataractD002386EFO_0001059H26.91—19213
InfectionsD007239EFO_00005445131111
EndophthalmitisD0098772534—11
PneumoniaD011014EFO_0003106J18—252110
Bacterial infectionsD001424A493—1419
Bacterial conjunctivitisD003234EFO_1000829H10.0—143—8
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.94—21—7
Chronic bronchitisD029481J42——2147
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A15—118—217
Multidrug-resistant tuberculosisD018088EFO_0007381—78——9
Community-acquired infectionsD017714—23——5
Lung diseasesD008171EFO_0003818J98.4212——4
Breast neoplasmsD001943EFO_0003869C50112——4
Extensively drug-resistant tuberculosisD054908—44——4
ContraceptionD003267111—14
Bacterial pneumoniaD018410EFO_1001272J15.9——3——3
KeratitisD007634H16——3——3
LymphomaD008223C85.91—1—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059971———8
NeoplasmsD009369C8021——14
Parkinson diseaseD010300EFO_0002508G2031———4
CholangitisD002761K83.0—1———1
Corneal ulcerD003320H16.0—1———1
Meningeal tuberculosisD014390A17.0—1———1
Graft vs host diseaseD006086D89.81—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B203———14
SchizophreniaD012559EFO_0000692F204————4
Type 2 diabetes mellitusD003924EFO_0001360E114————4
Alzheimer diseaseD000544EFO_0000249F034————4
AsthmaD001249EFO_0000270J453————3
Hepatitis cD006526B19.23————3
DyslipidemiasD050171HP_00031193————3
HypoglycemiaD007003HP_0001943E16.21———12
Cardiovascular abnormalitiesD018376EFO_00038481———12
HypertensionD006973EFO_0000537I102————2
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Long qt syndromeD008133HP_0001657I45.81————22
Pathologic dilatationD004108————22
KeratoconusD007640EFO_0004223H18.6————22
RegenerationD012038————22
PeritonitisD010538EFO_0008588K65————22
DeliriumD003693R41.0————11
Mycoplasma pneumoniaD011019EFO_0007387J15.7————11
AppendicitisD001064EFO_0007149K37————11
Chemical and drug induced liver injuryD056486————11
Macular degenerationD008268EFO_0001365H35.30————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMYCOPHENOLIC ACID
INNmycophenolic 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
PDB1MEH
CAS-ID24280-93-1
RxCUI7145
ChEMBL IDCHEMBL866
ChEBI ID168396
PubChem CID446541
DrugBankDB01024
UNII IDHU9DX48N0T (ChemIDplus, GSRS)
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,682 documents
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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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