Tecfidera(dimethyl fumarate)
Dimethyl, Skilarence, Tecfidera (dimethyl fumarate) is a small molecule pharmaceutical. Dimethyl fumarate was first approved as Tecfidera on 2013-03-27. It has been approved in Europe to treat multiple sclerosis, psoriasis, and relapsing-remitting multiple sclerosis.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Dimethylfumarate, Tecfidera (discontinued: Dimethylfumarate)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dimethyl fumarate | ANDA | 2024-12-23 |
| dimethyl fumarate dimethyl fumarate | ANDA | 2025-04-01 |
| tecfidera | New Drug Application | 2024-03-14 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DIMETHYL FUMARATE, TECFIDERA, BIOGEN INC | |||
| 2023-02-05 | M-260 | ||
Patent Expiration
HCPCS
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Clinical
Clinical Trials
167 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 5 | 14 | 16 | 17 | 54 |
| Sclerosis | D012598 | — | — | 2 | 5 | 14 | 12 | 14 | 47 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 2 | 12 | 9 | 6 | 30 |
| Flushing | D005483 | — | R23.2 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | 1 | — | — | 9 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | 1 | 1 | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 1 | — | — | 1 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Lymphopenia | D008231 | — | D72.810 | — | — | — | — | 1 | 1 |
| Leukoencephalopathies | D056784 | — | R90.82 | — | — | — | — | 1 | 1 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dimethyl fumarate |
| INN | — |
| Description | Dimethyl fumarate is an enoate ester resulting from the formal condensation of both carboxy groups of fumaric acid with methanol. Used for treatment of adults with relapsing forms of multiple sclerosis. It has a role as an immunomodulator and an antipsoriatic. It is an enoate ester, a methyl ester and a diester. It is functionally related to a methanol and 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)OC |
Identifiers
| PDB | — |
| CAS-ID | 624-49-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107333 |
| ChEBI ID | 76004 |
| PubChem CID | 637568 |
| DrugBank | DB08908 |
| UNII ID | — |
Target
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Variants
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Tecfidera – Biogen
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Estimated US medical usage
Dimethyl fumarate
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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Adverse Events
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115,084 adverse events reported
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