Tnkase, Metalyse(tenecteplase)
Metalyse, TNKase (tenecteplase) is an enzyme pharmaceutical. Tenecteplase was first approved as Tnkase on 2000-06-02. It is used to treat coronary thrombosis and myocardial infarction in the USA. It has been approved in Europe to treat myocardial infarction.
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Commercial
Trade Name
FDA
EMA
Tnkase
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Tenecteplase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| TNKase | tenecteplase | Genentech | N-103909 RX | 2000-06-02 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tnkase | Biologic Licensing Application | 2020-01-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| coronary thrombosis | EFO_1000883 | D003328 | I21 |
| myocardial infarction | EFO_0000612 | D009203 | I21 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| G8601 | Iv alteplase not initiated within three hours (<= 180 minutes) of time last known well for reasons documented by clinician (e.g. patient enrolled in clinical trial for stroke, patient admitted for elective carotid intervention, patient received tenecteplase (tnk)) |
| J3101 | Injection, tenecteplase, 1 mg |
Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | 10 | 14 | 2 | 2 | 25 | ||
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 6 | 7 | 1 | 1 | 15 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 7 | 2 | 3 | 12 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | 1 | 2 | 1 | — | 4 |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | 1 | — | 2 | |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | 1 | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| St elevation myocardial infarction | D000072657 | — | — | 2 | — | — | 2 | ||
| Retinal artery occlusion | D015356 | EFO_1001154 | H34.1 | — | — | 1 | — | — | 1 |
| Intracranial thrombosis | D020767 | — | — | 1 | — | — | 1 | ||
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | 1 | — | — | 1 |
| Thrombosis | D013927 | — | — | 1 | — | — | 1 | ||
| Pleural effusion | D010996 | J90 | — | 1 | 1 | — | — | 1 | |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TENECTEPLASE |
| INN | tenecteplase |
| Description | Tenecteplase, sold under the trade names TNKase, Metalyse and Elaxim, is an enzyme used as a thrombolytic drug.
|
| Classification | Enzyme |
| Drug class | enzymes: tissue-type plasminogen activators |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 191588-94-0 |
| RxCUI | 259280 |
| ChEMBL ID | CHEMBL2108791 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00031 |
| UNII ID | WGD229O42W (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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