Tenecteplase
Highest phase reached
Approved
Drug type
Enzyme
First approval year
2000
- First approval year
- 2000
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Enzyme
- Drug name
- Tenecteplase
- metalyse
- Metalyse
- Tenecteplase boehringer ingelheim pharma gmbh co. kg
- tenecteplase boehringer ingelheim pharma gmbh co kg
- 103 l asparagine 117 l glutamine 296 l alanine 297 l alanine 298 l alanine 299 l alanineplasminogen activator human tissue type
- 103-L-ASPARAGINE-117-L-GLUTAMINE-296-L-ALANINE-297-L-ALANINE-298-L-ALANINE-299-L-ALANINEPLASMINOGEN ACTIVATOR (HUMAN TISSUE TYPE)
- injection tenecteplase
- intravenous rhtnk tpa
- Intravenous rhTNK-tPA
- Intravenous tenecteplase
- Intravenous Tenecteplase
- Intravenous tenecteplase (TNK)
- Metalyse
- METALYSE®
- Recombinant tissue plasminogen activator variant (T103N,N117Q, KHRR(296-299)AAAA)
- recombinant tissue plasminogen activator variant t103n n117q khrr 296 299 aaaa
- rhtnk tpa
- rhTNK-tPA
- Rhtnk-tpa
- tenecteplasa
- Tenecteplasa
- tenecteplase
- Tenecteplase
- tenecteplase (group A)
- Tenecteplase (until trial protocol V04: Alteplase)
- TENECTEPLASE [EMA EPAR]
- tenecteplase [INN]
- TENECTEPLASE [MART.]
- TENECTEPLASE [MI]
And 17 more, listed on the interactive page.
- CAS registry numbers
- 191588-94-0
- ChEMBL ID
- CHEMBL2108791
- RxNorm IDs (RxCUI)
- 259280
- FDA ingredient codes (UNII)
- WGD229O42W
- B01AD
- B01AD11
Sources for recorded values
- Applicant
- GENENTECH
- Approval date
- 2 Jun 2000
- Application number
- BLA103909
- Status
- Authorised
- Status date
- 23 Feb 2001
- Authorisation date
- 23 Feb 2001
- Approved indications
- Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms. Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.
- Product number
- EMEA/H/C/000306
- Authorisation holder
- Boehringer Ingelheim International GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Myocardial Infarction
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -ase
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Tissue-type plasminogen activator exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Tissue-type plasminogen activator
- Protein identifier
- P00750
Open Targets mechanisms
- Mechanism
- Tissue-type plasminogen activator exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Tissue-type plasminogen activator
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Nervous System Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000618
- Subject identifier
- D009422
- Condition
- Stroke
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Pulmonary Embolism
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003827
- Subject identifier
- D011655
- Condition
- Death, Sudden, Cardiac
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004278
- Subject identifier
- D016757
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008583
- Subject identifier
- D009203
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
- Condition
- Pleural Effusion
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009637
- Subject identifier
- D010996
- Condition
- Respiratory Distress Syndrome
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000637
- Subject identifier
- D012128
- Condition
- Retinal Artery Occlusion
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001154
- Subject identifier
- D015356
- Condition
- Ischemic Stroke
- Highest recorded phase
- 3
- Condition identifier
- HP:0002140
- Subject identifier
- D000083242
- Condition
- Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- HP:0004419
- Subject identifier
- D013927
- Condition
- Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0000831
- Subject identifier
- D013927
- Condition
- Cerebral Infarction
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002679
- Subject identifier
- D002544
- Condition
- Brain Ischemia
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005299
- Subject identifier
- D002545
- Condition identifier
- EFO_0000551
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000712
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003827
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004278
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008583
- Condition identifier
- EFO_0008585
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009492
- Highest recorded phase
- 3
- Condition identifier
- EFO_0010177
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000637
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001154
- Highest recorded phase
- 3
- Condition identifier
- HP_0001297
- Highest recorded phase
- 3
- Condition identifier
- HP_0002140
- Highest recorded phase
- 3
- Condition identifier
- HP_0002202
- Highest recorded phase
- 2
- Condition identifier
- HP_0004419
- Condition identifier
- HP_0004419
- Highest recorded phase
- 4
- Condition identifier
- HP_0030746
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0001208
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004781
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005068
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005098
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005264
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005279
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006502
- Highest recorded phase
- 1
And 5 more, listed on the interactive page.
- Event
- abdominal compartment syndrome
- Reports
- 2
- Reporting signal score
- 7.20113
- Event
- agnosia
- Reports
- 3
- Reporting signal score
- 14.1251
- Event
- angioedema
- Reports
- 21
- Reporting signal score
- 28.3264
- Event
- anuria
- Reports
- 5
- Reporting signal score
- 9.05448
- Event
- aphasia
- Reports
- 18
- Reporting signal score
- 35.667
- Event
- aspiration
- Reports
- 4
- Reporting signal score
- 7.75043
- Event
- blood fibrinogen decreased
- Reports
- 4
- Reporting signal score
- 14.6853
- Event
- brain compression
- Reports
- 2
- Reporting signal score
- 8.81918
- Event
- brain stem stroke
- Reports
- 2
- Reporting signal score
- 8.06551
- Event
- cardiac arrest
- Reports
- 12
- Reporting signal score
- 16.9928
- Event
- cardiac tamponade
- Reports
- 6
- Reporting signal score
- 14.773
- Event
- cardiac ventricular thrombosis
- Reports
- 3
- Reporting signal score
- 10.0566
- Event
- cardiogenic shock
- Reports
- 12
- Reporting signal score
- 29.0868
- Event
- cardiovascular disorder
- Reports
- 5
- Reporting signal score
- 6.95317
- Event
- cerebellar haematoma
- Reports
- 2
- Reporting signal score
- 8.258
- Event
- cerebellar haemorrhage
- Reports
- 4
- Reporting signal score
- 13.3171
- Event
- cerebral artery occlusion
- Reports
- 3
- Reporting signal score
- 9.55957
- Event
- cerebral haematoma
- Reports
- 7
- Reporting signal score
- 22.1107
- Event
- cerebral haemorrhage
- Reports
- 56
- Reporting signal score
- 184.689
- Event
- cerebral infarction
- Reports
- 11
- Reporting signal score
- 16.2902
- Event
- cerebrovascular accident
- Reports
- 20
- Reporting signal score
- 14.8393
- Event
- chest pain
- Reports
- 20
- Reporting signal score
- 11.6359
- Event
- compartment syndrome
- Reports
- 3
- Reporting signal score
- 6.77271
- Event
- coronary artery dissection
- Reports
- 3
- Reporting signal score
- 10.2214
- Event
- decompressive craniectomy
- Reports
- 1
- Reporting signal score
- 6.59068
And 49 more, listed on the interactive page.
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And 26 more, listed on the interactive page.
- Dose
- 15-25 mg
- Route
- Intravenous
- How often
- Single bolus over 5 seconds
- Administer as a single bolus over 5 seconds
- Discard unused solution
- Do not shake
- Flush lines with 0.9% sodium chloride solution if using dextrose
- Reconstitute immediately before use
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Related records
Trials (211)
- A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
- A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults
- A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
- A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
- A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion
- A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients
- A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks
- A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)
- A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
- A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia
- A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
- A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
- A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
- A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
- A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
- A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
- A Study of the Safety and Efficacy of EBV Specific T-cell Lines
- A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
- A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults
- A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Approved for (3)
In development for (10)
- Acute respiratory distress syndrome Phase 1
- Brain ischemia Phase 2
- Cerebral infarction Phase 2
- Ischemic stroke Phase 3
- Nervous system disorder Phase 2
- Pulmonary embolism Phase 3
- Retinal artery occlusion Phase 3
- ST-elevation myocardial infarction Phase 3
- Stroke disorder Phase 3
- Sudden cardiac arrest Phase 3
Targets (1)
- PLAT Tissue-type plasminogen activator exogenous protein