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Monomethyl fumarate
Bafiertam (monomethyl fumarate) is a small molecule pharmaceutical. Monomethyl fumarate was first approved as Bafiertam on 2020-04-28. It is known to target hydroxycarboxylic acid receptor 2.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Bafiertam
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Monomethyl fumarate
Tradename
Company
Number
Date
Products
BAFIERTAMBanner Life SciencesN-210296 RX2020-04-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bafiertamNew Drug Application2022-11-07
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Monomethyl Fumarate, Bafiertam, Banner Life Sciences
115900952036-03-18U-1384
109459852035-08-14DP
109186152035-08-12DPU-1384
109186172035-08-10DP
109186162035-06-03U-1384
93269472035-02-27DP
93269652035-02-27U-1384
95110432035-02-27U-1384
95172092035-02-27DP
95662592035-02-27DP
96363182035-02-27U-1384
96363192035-02-27DP
98146912035-02-27U-1384
98146922035-02-27U-1384
98209602035-02-27DP
98209612035-02-27DPU-1384
100988632035-02-27DPU-1384
101053352035-02-27DP
101053362035-02-27DPU-1384
101053372035-02-27DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Relapsing-remitting multiple sclerosisD020529EFO_00039292———13
Multiple sclerosisD009103EFO_0003885G351————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMONOMETHYL FUMARATE
INNmonomethyl fumarate
Description
Monomethyl fumarate is a dicarboxylic acid monoester resulting from the formal condensation of one of the carboxy groups of fumaric acid with methanol. Is is a metabolite of dimethyl fumarate and used for the the treatment of patients with relapsing multiple sclerosis (MS). It also induces the NFE2L2 (Nrf2) transcription factor by binding to KEAP1. It has a role as an immunomodulator, an antioxidant and a drug metabolite. It is an enoate ester, a methyl ester and a dicarboxylic acid monoester. It is functionally related to a fumaric acid.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COC(=O)/C=C/C(=O)O
Identifiers
PDB—
CAS-ID2756-87-8
RxCUI1546433
ChEMBL IDCHEMBL589586
ChEBI ID—
PubChem CID5369209
DrugBankDB14219
UNII ID45IUB1PX8R (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HCAR2
HCAR2
Organism
Homo sapiens
Gene name
HCAR2
Gene synonyms
GPR109A, HCA2, HM74A, NIACR1
NCBI Gene ID
338442
Protein name
hydroxycarboxylic acid receptor 2
Protein synonyms
G protein-coupled receptor HM74a, G-protein coupled receptor 109A, G-protein coupled receptor HM74A, hydroxy-carboxylic acid receptor 2, Niacin receptor 1, Nicotinic acid receptor
Uniprot ID
Q8TDS4
Mouse ortholog
Hcar2 (80885)
hydroxycarboxylic acid receptor 2 (Q9EP66)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 630 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29 adverse events reported
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