Tecfidera(dimethyl fumarate)
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
Trade Name
FDA
EMA
Tecfidera (generic drugs available since 2020-08-17)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dimethyl fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TECFIDERA | Biogen | N-204063 RX | 2013-03-27 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dimethyl fumarate | ANDA | 2023-03-15 |
| tecfidera | New Drug Application | 2021-01-31 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DIMETHYL FUMARATE, TECFIDERA, BIOGEN INC | |||
| 2023-02-05 | M-260 | ||
Patent Expiration
HCPCS
No data
Clinical
Clinical Trials
90 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | 3 | 4 | 12 | 10 | 6 | 34 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 3 | 4 | 10 | 12 | 30 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 1 | 3 | 1 | — | 6 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 6 | — | 1 | — | — | 7 | ||
| Chronic progressive multiple sclerosis | D020528 | — | 1 | 1 | — | — | 2 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | 3 | — | — | — | 3 | ||
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | C84.A | — | 1 | — | — | — | 1 | |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 1 | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | — | — | — | 1 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Glioblastoma | D005909 | EFO_0000515 | 1 | — | — | — | — | 1 | |
| Gliosarcoma | D018316 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 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 | 1373478 |
| ChEMBL ID | CHEMBL2107333 |
| ChEBI ID | 76004 |
| PubChem CID | 637568 |
| DrugBank | DB08908 |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tecfidera - Biogen
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,790 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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25,224 adverse events reported
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