dimethyl fumarate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4757	624-49-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dimethyl fumarate tecfidera methyl fumarate boletic acid dimethyl ester BG-12	A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS. Molecular weight: 144.13 Formula: C6H8O4 CLOGP: 0.78 LIPINSKI: 0 HAC: 4 HDO: 0 TPSA: 52.60 ALOGS: -1.05 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dimethyl fumarate
tecfidera
methyl fumarate
boletic acid dimethyl ester
BG-12

A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.

Molecular weight: 144.13
Formula: C6H8O4
CLOGP: 0.78
LIPINSKI: 0
HAC: 4
HDO: 0
TPSA: 52.60
ALOGS: -1.05
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.48	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Jan. 30, 2014	EMA	BIOGEN NETHERLANDS B.V.
March 27, 2013	FDA	BIOGEN IDEC INC

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
Flushing	4908.91	13.63	1991	53320	73096	63360615
Multiple sclerosis relapse	3712.75	13.63	1443	53868	47035	63386676
Prescribed underdose	687.09	13.63	387	54924	29302	63404409
Lymphopenia	638.15	13.63	314	54997	18013	63415698
Lymphocyte count decreased	511.03	13.63	322	54989	29935	63403776
Abdominal pain upper	367.01	13.63	650	54661	205794	63227917
Central nervous system lesion	366.51	13.63	181	55130	10454	63423257
Hot flush	356.07	13.63	320	54991	50839	63382872
Fall	341.82	13.63	926	54385	391408	63042303
General symptom	334.21	13.63	116	55195	2692	63431019

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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
Multiple sclerosis relapse	1760.54	20.86	494	13600	12639	34930198
Flushing	1151.70	20.86	447	13647	31973	34910864
Prescribed underdose	232.99	20.86	99	13995	8834	34934003
Central nervous system lesion	214.07	20.86	85	14009	6378	34936459
Lymphopenia	195.46	20.86	106	13988	16229	34926608
Lymphocyte count decreased	178.39	20.86	112	13982	22510	34920327
Relapsing-remitting multiple sclerosis	174.86	20.86	47	14047	1003	34941834
Balance disorder	170.80	20.86	137	13957	40517	34902320
Fall	170.74	20.86	298	13796	202587	34740250
Memory impairment	163.16	20.86	137	13957	43181	34899656

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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
Flushing	4276.12	15.09	1715	47718	86553	79608402
Multiple sclerosis relapse	3954.59	15.09	1367	48066	45166	79649789
Prescribed underdose	747.05	15.09	365	49068	29149	79665806
Lymphopenia	658.87	15.09	339	49094	30218	79664737
Lymphocyte count decreased	448.89	15.09	309	49124	46980	79647975
Central nervous system lesion	432.68	15.09	196	49237	13172	79681783
Abdominal pain upper	429.85	15.09	607	48826	223212	79471743
Fall	403.43	15.09	914	48519	486715	79208240
Hot flush	344.84	15.09	280	49153	54597	79640358
General symptom	280.05	15.09	91	49342	2443	79692512

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AX07	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:50748	antipsoriatic drug
CHEBI has role	CHEBI:50846	Immunologic factor
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D011838	Radiation-Sensitizing Agents

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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
Plaque psoriasis	indication	200965009
Relapsing remitting multiple sclerosis	indication	426373005	DOID:2378

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	8399514	Feb. 7, 2028	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10391160	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10555993	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10994003	March 13, 2035	METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	10959972	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11007166	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11007167	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11129806	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	11246850	Nov. 16, 2035	METHOD OF TREATING MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	8399514	Feb. 7, 2028	METHOD OF TREATING MULTIPLE SCLEROSIS

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
120MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Feb. 5, 2023	INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
240MG	TECFIDERA	BIOGEN INC	N204063	March 27, 2013	RX	CAPSULE, DELAYED RELEASE	ORAL	Feb. 5, 2023	INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Kelch-like ECH-associated protein 1	Cytosolic other	Q14145	KEAP1_HUMAN	INHIBITOR				CHEMBL	CHEMBL
Hydroxycarboxylic acid receptor 2	GPCR	Q8TDS4	HCAR2_HUMAN		Ki	6.74		CHEMBL

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External reference:

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ID	Source
9HB	PDB_CHEM_ID
009199	NDDF
1373478	RXNORM
200501	MMSL
29369	MMSL
337937	MMSL
4032290	VUID
4032290	VANDF
637568	PUBCHEM_CID
7045	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-9218	CAPSULE	120 mg	ORAL	NDA	26 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-9218	CAPSULE	120 mg	ORAL	NDA	26 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-9219	CAPSULE	240 mg	ORAL	NDA	26 sections
dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-9219	CAPSULE	240 mg	ORAL	NDA	26 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0396	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	28 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0396	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	28 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0396	CAPSULE, DELAYED RELEASE	120 mg	ORAL	ANDA	28 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0399	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	28 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0399	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	28 sections
Dimethyl fumarate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0399	CAPSULE, DELAYED RELEASE	240 mg	ORAL	ANDA	28 sections

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