Temodar, Temodal(temozolomide)
Temodal, Temodar (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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
Trade Name
FDA
EMA
Temodar (generic drugs available since 2010-03-01)
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 Sharp & Dohme | N-022277 RX | 2009-02-27 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| temodar | New Drug Application | 2020-11-20 |
| temozolomide | ANDA | 2023-06-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| glioblastoma | EFO_0000515 | D005909 | — |
| melanoma | — | D008545 | — |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
807 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 | 139 | 183 | 35 | 1 | 15 | 310 | |
| Glioma | D005910 | EFO_0000520 | 37 | 43 | 2 | 1 | 6 | 74 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 26 | 32 | 7 | 1 | 4 | 61 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | 43 | 59 | 10 | — | 6 | 105 | ||
| Gliosarcoma | D018316 | 39 | 39 | 6 | — | — | 68 | ||
| Melanoma | D008545 | 28 | 49 | 5 | — | — | 67 | ||
| Neoplasms | D009369 | C80 | 43 | 31 | 4 | — | — | 65 | |
| Astrocytoma | D001254 | EFO_0000271 | 24 | 24 | 13 | — | 3 | 57 | |
| Neuroblastoma | D009447 | EFO_0000621 | 15 | 22 | 1 | — | — | 32 | |
| Oligodendroglioma | D009837 | EFO_0000631 | 10 | 12 | 4 | — | — | 25 | |
| Medulloblastoma | D008527 | 10 | 12 | 1 | — | — | 20 | ||
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 3 | 17 | 1 | — | — | 20 |
| Sarcoma | D012509 | 10 | 9 | 1 | — | — | 18 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | C34.90 | 2 | 12 | — | — | — | 12 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 10 | — | — | — | 12 |
| Rhabdomyosarcoma | D012208 | 6 | 8 | — | — | — | 11 | ||
| Lymphoma | D008223 | C85.9 | 4 | 5 | — | — | 2 | 10 | |
| Colorectal neoplasms | D015179 | 1 | 7 | — | — | — | 8 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 7 | — | — | — | 8 |
| Small cell lung carcinoma | D055752 | 3 | 8 | — | — | — | 8 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 5 | — | — | — | 8 |
| Primitive neuroectodermal tumors | D018242 | 6 | 2 | — | — | — | 7 | ||
| Neuroectodermal tumors | D017599 | 6 | 2 | — | — | — | 7 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningioma | D008579 | EFO_0003098 | D32.9 | 4 | — | — | — | — | 4 |
| Craniopharyngioma | D003397 | 4 | — | — | — | — | 4 | ||
| Phenylketonurias | D010661 | E70.0 | 2 | — | — | — | — | 2 | |
| Leukemia | D007938 | C95 | 2 | — | — | — | — | 2 | |
| Mesothelioma | D008654 | C45 | 1 | — | — | — | — | 1 | |
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 1 | — | — | — | — | 1 |
| Carcinoid tumor | D002276 | D3A.00 | 1 | — | — | — | — | 1 | |
| Adrenal cortex neoplasms | D000306 | C74.0 | 1 | — | — | — | — | 1 | |
| Medullary carcinoma | D018276 | 1 | — | — | — | — | 1 | ||
| Multiple endocrine neoplasia type 1 | D018761 | E31.21 | 1 | — | — | — | — | 1 |
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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 | 37776 |
| ChEMBL ID | CHEMBL810 |
| ChEBI ID | 72564 |
| PubChem CID | 5394 |
| DrugBank | DB00853 |
| UNII ID | YF1K15M17Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Temodar - Merck Sharp & Dohme
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Trends
PubMed Central
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Additional graphs summarizing 43,248 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,317 adverse events reported
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