Thiotepa, Tepadina(thiotepa)
Tepadina (thiotepa) is a small molecule pharmaceutical. Thiotepa was first approved as Thiotepa on 1982-01-01. It is used to treat adenocarcinoma, breast neoplasms, lymphoma, ovarian neoplasms, and sarcoma amongst others in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation and neoplasms. It is known to target cytochrome P450 2B6.
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Commercial
Trade Name
FDA
EMA
Tepadina (generic drugs available since 2001-04-02, discontinued: Thioplex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Thiotepa
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEPADINA | ADIENNE SA | N-208264 RX | 2017-01-26 | 2 products, RLD, RS |
Show 2 discontinued
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
THIOTEPA, TEPADINA, ADIENNE SA | |||
| 2024-01-26 | ODE-129 | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9340 | Injection, thiotepa, 15 mg |
Clinical
Clinical Trials
205 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 3 | 28 | 5 | — | 1 | 34 | |
| Myeloid leukemia acute | D015470 | C92.0 | 3 | 27 | 2 | — | 1 | 30 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 19 | 10 | — | — | 29 |
| Central nervous system neoplasms | D016543 | 4 | 13 | 2 | — | 2 | 21 | ||
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 2 | 20 | 1 | — | — | 20 | |
| Neuroblastoma | D009447 | EFO_0000621 | 4 | 13 | 3 | — | 1 | 20 | |
| Neoplasms | D009369 | C80 | 4 | 4 | 1 | — | 2 | 10 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 5 | 2 | — | 1 | 9 |
| Retinoblastoma | D012175 | 2 | 4 | 1 | — | 2 | 9 | ||
| Medulloblastoma | D008527 | 2 | 2 | 2 | — | 1 | 6 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | 5 | 18 | — | — | 2 | 21 | |
| Hodgkin disease | D006689 | C81 | 2 | 9 | — | — | 1 | 11 | |
| Hematologic neoplasms | D019337 | 4 | 7 | — | — | 2 | 11 | ||
| Germ cell and embryonal neoplasms | D009373 | 2 | 6 | — | — | 1 | 9 | ||
| Sarcoma | D012509 | 4 | 4 | — | — | 1 | 9 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 5 | 6 | — | — | — | 9 |
| Multiple myeloma | D009101 | C90.0 | 1 | 5 | — | — | 2 | 8 | |
| Biphenotypic leukemia acute | D015456 | C95.0 | — | 7 | — | — | — | 7 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 3 | 5 | — | — | 1 | 7 |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | 6 | — | — | 1 | 7 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Choroid plexus neoplasms | D016545 | EFO_0007206 | 1 | — | — | — | — | 1 | |
| Neuroepithelial neoplasms | D018302 | 1 | — | — | — | — | 1 | ||
| Pinealoma | D010871 | 1 | — | — | — | — | 1 | ||
| Chordoma | D002817 | EFO_0000334 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Extranodal nk-t-cell lymphoma | D054391 | C86.0 | — | — | — | — | 1 | 1 | |
| B-cell lymphoma marginal zone | D018442 | C88.4 | — | — | — | — | 1 | 1 | |
| Large-cell lymphoma anaplastic | D017728 | C84.6 | — | — | — | — | 1 | 1 | |
| T-cell lymphoma peripheral | D016411 | C84.9 | — | — | — | — | 1 | 1 | |
| Intraocular lymphoma | D064090 | — | — | — | — | 1 | 1 | ||
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | 1 | 1 | ||
| Large-cell lymphoma immunoblastic | D016400 | — | — | — | — | 1 | 1 | ||
| Lymphomatoid granulomatosis | D008230 | C83.8 | — | — | — | — | 1 | 1 | |
| Ewing sarcoma | D012512 | EFO_0000173 | — | — | — | — | 1 | 1 | |
| Hepatoblastoma | D018197 | C22.2 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | THIOTEPA |
| INN | thiotepa |
| Description | Thiotepa is a member of aziridines. |
| Classification | Small molecule |
| Drug class | antineoplastics (thiotepa derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | S=P(N1CC1)(N1CC1)N1CC1 |
Identifiers
| PDB | — |
| CAS-ID | 52-24-4 |
| RxCUI | 10473 |
| ChEMBL ID | CHEMBL671 |
| ChEBI ID | 9570 |
| PubChem CID | 5453 |
| DrugBank | DB04572 |
| UNII ID | 905Z5W3GKH (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP2B6
CYP2B6
Organism
Homo sapiens
Gene name
CYP2B6
Gene synonyms
NCBI Gene ID
Protein name
cytochrome P450 2B6
Protein synonyms
1,4-cineole 2-exo-monooxygenase, CYPIIB6, Cytochrome P450 IIB1, cytochrome P450, family 2, subfamily B, polypeptide 6, cytochrome P450, subfamily IIB (phenobarbital-inducible), polypeptide 6
Uniprot ID
Mouse ortholog
—
—
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,590 documents
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Safety
Black-box Warning
Black-box warning for: Tepadina
Adverse Events
Top Adverse Reactions
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11,675 adverse events reported
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