Temodar, Temodal(temozolomide)
Temodal, Temodar, Temomedac, Temozolomide (temozolomide) is a small molecule pharmaceutical. Temozolomide was first approved as Temodal on 1999-01-26. It is used to treat glioblastoma and melanoma in the USA. It has been approved in Europe to treat glioblastoma and glioma.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Temodar, Temozolomide (discontinued: Temodar, Temozolomide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Temozolomide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEMODAR | Merck & Co | N-022277 RX | 2009-02-27 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| temodar | New Drug Application | 2024-10-30 |
| temozolomide | ANDA | 2024-10-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| glioblastoma | EFO_0000515 | D005909 | — |
| melanoma | — | D008545 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
Clinical
Clinical Trials
1137 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 11 | 16 | 2 | 1 | 4 | 31 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 5 | 9 | 2 | — | — | 13 |
| Astrocytoma | D001254 | EFO_0000271 | — | 2 | 4 | 1 | — | 3 | 10 |
| Central nervous system neoplasms | D016543 | — | — | — | 3 | 1 | — | — | 4 |
| Nervous system neoplasms | D009423 | — | — | — | 1 | 1 | — | — | 2 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | 2 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 3 | 9 | — | — | 3 | 14 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 5 | 9 | — | — | — | 12 |
| Neoplasms | D009369 | — | C80 | 2 | 7 | — | — | — | 9 |
| Gliosarcoma | D018316 | — | — | 3 | 4 | — | — | — | 7 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 7 | — | — | — | 7 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 4 | — | — | — | 6 |
| Recurrence | D012008 | — | — | 1 | 4 | — | — | — | 5 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 4 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 3 | — | — | — | 4 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | — | 4 | — | — | — | 4 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malignant mesothelioma | D000086002 | — | — | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | 1 | — | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | — | 1 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Meningeal neoplasms | D008577 | EFO_0003851 | C70 | 1 | — | — | — | — | 1 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | 1 | — | — | — | — | 1 |
| Meningitis | D008581 | HP_0001287 | G03 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Temozolomide |
| INN | temozolomide |
| Description | Temozolomide is an imidazotetrazine that is 3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine which is substituted at positions 3, 4, and 8 by methyl, oxo, and carboxamide groups, respectively. A prodrug for MTIC (5-(3-methyltriaz-1-en-1-yl)-1H-imidazole-4-carboxamide, formed by spontaneous hydrolysis of temozolomide in the body), it is used as an oral alkylating agent for the treatment of newly diagnosed malignant glioblastoma multiforme (concomitantly with radiotherapy) and malignant melanoma. It has a role as an antineoplastic agent, a prodrug and an alkylating agent. It is an imidazotetrazine, a monocarboxylic acid amide and a triazene derivative. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cn1nnc2c(C(N)=O)ncn2c1=O |
Identifiers
| PDB | — |
| CAS-ID | 85622-93-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL810 |
| ChEBI ID | 72564 |
| PubChem CID | 5394 |
| DrugBank | DB00853 |
| UNII ID | YF1K15M17Y (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Temodar – Merck & Co
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Trends
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Additional graphs summarizing 52,695 documents
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Safety
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Adverse Events
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24,801 adverse events reported
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