mycophenolic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1860	37415-62-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: mycophenolate mycophenolic acid mycophenolate sodium mycophenolic acid monosodium salt sodium mycophenolate	Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION. Molecular weight: 320.34 Formula: C17H20O6 CLOGP: 2.29 LIPINSKI: 0 HAC: 6 HDO: 2 TPSA: 93.06 ALOGS: -3.96 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

mycophenolate
mycophenolic acid
mycophenolate sodium
mycophenolic acid monosodium salt
sodium mycophenolate

Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.

Molecular weight: 320.34
Formula: C17H20O6
CLOGP: 2.29
LIPINSKI: 0
HAC: 6
HDO: 2
TPSA: 93.06
ALOGS: -3.96
ROTB: 6

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
2	g	O
2	g	P

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	9.70 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	64.22 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	2.33 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.77 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Feb. 27, 2004	FDA	NOVARTIS

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Cytomegalovirus infection	795.31	12.13	331	34380	20621	63433690
Transplant rejection	720.03	12.13	257	34454	10523	63443788
Kidney transplant rejection	477.04	12.13	150	34561	4121	63450190
Post transplant lymphoproliferative disorder	425.03	12.13	143	34568	4888	63449423
Complications of transplanted kidney	314.21	12.13	96	34615	2390	63451921
Thrombotic microangiopathy	277.73	12.13	129	34582	10432	63443879
Polyomavirus-associated nephropathy	249.13	12.13	75	34636	1773	63452538
BK virus infection	233.37	12.13	82	34629	3197	63451114
Immunosuppressant drug level increased	217.63	12.13	80	34631	3558	63450753
Cytomegalovirus viraemia	216.69	12.13	90	34621	5559	63448752

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Kidney transplant rejection	706.11	12.77	283	41172	7214	34908262
Transplant rejection	682.89	12.77	303	41152	10008	34905468
Cytomegalovirus infection	622.57	12.77	387	41068	25748	34889728
Complications of transplanted kidney	493.65	12.77	191	41264	4418	34911058
Post transplant lymphoproliferative disorder	442.32	12.77	195	41260	6333	34909143
Polyomavirus-associated nephropathy	358.00	12.77	144	41311	3700	34911776
COVID-19	323.47	12.77	428	41027	77122	34838354
Immunosuppressant drug level increased	301.20	12.77	146	41309	5909	34909567
BK virus infection	272.35	12.77	134	41321	5604	34909872
Transplant dysfunction	232.12	12.77	95	41360	2554	34912922

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Cytomegalovirus infection	1235.37	11.17	641	67585	42003	79634159
Transplant rejection	1192.84	11.17	492	67734	18945	79657217
Post transplant lymphoproliferative disorder	994.89	11.17	373	67853	11091	79665071
Kidney transplant rejection	953.78	11.17	351	67875	9895	79666267
Complications of transplanted kidney	678.20	11.17	241	67985	6125	79670037
Polyomavirus-associated nephropathy	584.21	11.17	209	68017	5418	79670744
Immunosuppressant drug level increased	511.55	11.17	216	68010	8811	79667351
COVID-19	490.09	11.17	638	67588	157036	79519126
BK virus infection	466.91	11.17	201	68025	8603	79667559
Thrombotic microangiopathy	435.98	11.17	250	67976	19919	79656243

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AA06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:53746	EC 1.1.1.205 inhibitor
CHEBI has role	CHEBI:25442	mycotoxins
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:76964	Penicillium metabolites
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:149553	anticoronaviral drug

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Prevention of Liver Transplant Rejection	indication
Prevention of Cardiac Transplant Rejection	indication
Prevention of Kidney Transplant Rejection	indication
Prevention of Lung Transplant Rejection	off-label use
Herpes zoster	contraindication	4740000	DOID:8536
Progressive multifocal leukoencephalopathy	contraindication	22255007	DOID:643
Cytomegalovirus infection	contraindication	28944009
Constitutional aplastic anemia	contraindication	28975000	DOID:1342
Gastrointestinal ulcer	contraindication	40845000
Gastrointestinal perforation	contraindication	51875005

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.67	acidic
pKa2	11.03	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Inosine-5'-monophosphate dehydrogenase (IMPDH)	Enzyme	P12268 P20839	IMDH2_HUMAN IMDH1_HUMAN	INHIBITOR	IC50	4.70	CHEMBL	CHEMBL
Inosine-5'-monophosphate dehydrogenase 1	Enzyme	P20839	IMDH1_HUMAN		Ki	7.48	CHEMBL
Inosine-5'-monophosphate dehydrogenase 2	Enzyme	P12268	IMDH2_HUMAN		Ki	8.22	CHEMBL
Inosine-5'-monophosphate dehydrogenase	Unclassified		IMDH_CRYNJ		IC50	6.92	CHEMBL

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External reference:

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ID	Source
MOA	PDB_CHEM_ID
005013	NDDF
009984	NDDF
18132	MMSL
210716	MMSL
24280-93-1	SECONDARY_CAS_RN
265323	RXNORM
2950	INN_ID
4021418	VANDF
4025598	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4201	TABLET, DELAYED RELEASE	180 mg	ORAL	ANDA	29 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4201	TABLET, DELAYED RELEASE	180 mg	ORAL	ANDA	29 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4201	TABLET, DELAYED RELEASE	180 mg	ORAL	ANDA	29 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4202	TABLET, DELAYED RELEASE	360 mg	ORAL	ANDA	29 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4202	TABLET, DELAYED RELEASE	360 mg	ORAL	ANDA	29 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4202	TABLET, DELAYED RELEASE	360 mg	ORAL	ANDA	29 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6785	TABLET, DELAYED RELEASE	180 mg	ORAL	ANDA	23 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6785	TABLET, DELAYED RELEASE	180 mg	ORAL	ANDA	23 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6786	TABLET, DELAYED RELEASE	360 mg	ORAL	ANDA	23 sections
Mycophenolic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6786	TABLET, DELAYED RELEASE	360 mg	ORAL	ANDA	23 sections

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