Thiotepa, Tepadina(thiotepa)
Tepadina, Tepylute, Thiotepa (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, Tepylute, Thiotepa (discontinued: Thioplex, Thiotepa)
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 | N-208264 RX | 2017-01-26 | 2 products, RLD, RS |
| TEPYLUTE | Shorla Pharma | N-216984 RX | 2024-06-25 | 1 products, RLD, RS |
Show 2 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| ovarian neoplasms | EFO_0003893 | D010051 | C56 |
| sarcoma | — | D012509 | — |
| lymphoma | — | D008223 | C85.9 |
| urinary bladder neoplasms | — | D001749 | C67 |
| adenocarcinoma | — | D000230 | — |
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
307 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 24 | 73 | 10 | 1 | 9 | 105 |
| Lymphoma | D008223 | — | C85.9 | 15 | 56 | 3 | 1 | 5 | 73 |
| Myelodysplastic syndromes | D009190 | — | D46 | 15 | 48 | 5 | 1 | 4 | 66 |
| Preleukemia | D011289 | — | — | 12 | 35 | 3 | 1 | 1 | 46 |
| Syndrome | D013577 | — | — | 11 | 23 | 2 | 1 | 1 | 33 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 4 | 10 | — | 1 | 1 | 15 |
| Primitive neuroectodermal tumors | D018242 | — | — | 3 | 5 | 1 | 1 | 3 | 13 |
| Graft vs host disease | D006086 | — | D89.81 | 4 | 8 | 1 | 1 | — | 13 |
| Multiple myeloma | D009101 | — | C90.0 | 3 | 8 | — | 1 | 2 | 13 |
| Medulloblastoma | D008527 | — | — | 3 | 4 | 2 | 1 | 2 | 10 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 8 | 42 | 7 | — | 2 | 55 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 8 | 39 | 4 | — | 6 | 52 |
| Neoplasms | D009369 | — | C80 | 17 | 33 | 4 | — | 5 | 52 |
| Myeloid leukemia | D007951 | — | C92 | 7 | 36 | 3 | — | 4 | 46 |
| Hematologic neoplasms | D019337 | — | — | 9 | 31 | 3 | — | 3 | 42 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 7 | 33 | 2 | — | 2 | 40 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 22 | 13 | — | 1 | 37 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 4 | 26 | 3 | — | — | 30 |
| Central nervous system neoplasms | D016543 | — | — | 5 | 15 | 2 | — | 4 | 26 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 5 | 13 | 4 | — | 1 | 22 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hodgkin disease | D006689 | — | C81 | 3 | 11 | — | — | 1 | 14 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 6 | 10 | — | — | 1 | 14 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 7 | 8 | — | — | 1 | 12 |
| Sarcoma | D012509 | — | — | 4 | 5 | — | — | 2 | 11 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 3 | 5 | — | — | 2 | 10 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 6 | 7 | — | — | — | 10 |
| Recurrence | D012008 | — | — | 2 | 5 | — | — | 2 | 9 |
| Thalassemia | D013789 | EFO_1001996 | D56 | 4 | 5 | — | — | 1 | 8 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 6 | — | — | 1 | 7 |
| Pancytopenia | D010198 | HP_0001876 | D61.81 | 3 | 6 | — | — | 1 | 7 |
Show 137 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Choroid plexus neoplasms | D016545 | EFO_0007206 | — | 1 | — | — | — | — | 1 |
| Neuroepithelial neoplasms | D018302 | — | — | 1 | — | — | — | — | 1 |
| Lysosomal storage diseases | D016464 | — | — | 1 | — | — | — | — | 1 |
| Bone marrow transplantation | D016026 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | — | — | — | — | 2 | 2 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | — | — | — | 1 | 1 |
| Intraocular lymphoma | D064090 | — | — | — | — | — | — | 1 | 1 |
| T-cell lymphoma cutaneous | D016410 | — | — | — | — | — | — | 1 | 1 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | — | — | — | — | 1 | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 1 | 1 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | — | — | — | — | 1 | 1 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | — | — | — | 1 | 1 |
| Lymphomatoid granulomatosis | D008230 | — | C83.8 | — | — | — | — | 1 | 1 |
| Hepatoblastoma | D018197 | — | C22.2 | — | — | — | — | 1 | 1 |
Show 7 more
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 | — |
| 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
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Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,346 documents
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Safety
Black-box Warning
Black-box warning for: Tepadina, Tepylute, Thiotepa
Adverse Events
Top Adverse Reactions
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6,609 adverse events reported
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