Alteplase is an enzyme drug that the ChEMBL database records as an approved medicine whose first approval year is 1996. ChEMBL gives its molecule type as Enzyme, places it under the stem -ase, which it defines as the tissue-type plasminogen activators, and marks it for parenteral rather than oral use. The WHO Anatomical Therapeutic Chemical index files it under B01AD02 in the Enzymes subgroup of the blood group and, for ophthalmic use, under S01XA13 among the other ophthalmologicals. The DailyMed label for the Activase kit describes it as alteplase for injection for intravenous use, indicated for acute ischemic stroke and for acute myocardial infarction to reduce mortality and the incidence of heart failure. The WHO Model List of Essential Medicines, 24th list (2025), carries it in the complementary list. This entry records classification and approval facts only and is not medical advice.
Facts
Classification
Approval Status ATC ClassB: Blood and Blood Forming Organs 2 Route of Administration WHO Essential Medicine First Approved / Isolated Year Connections
Treats
Source ChEMBL, EMBL-EBI: Alteplase approved indications (ChEMBL)
Source ChEMBL, EMBL-EBI: Alteplase approved indications (ChEMBL)
Source ChEMBL, EMBL-EBI: Alteplase approved indications (ChEMBL)
Source ChEMBL, EMBL-EBI: Alteplase approved indications (ChEMBL)
Sources
1. Alteplase (ChEMBL molecule record)
ChEMBL molecule record, first_approval
"first_approval": 1996
ChEMBL molecule record, max_phase 4
"max_phase": "4.0"
View the Source2. RxNav RxClass, National Library of Medicine: RxClass ATC classes of Alteplase
RxNav RxClass, National Library of MedicineRxClass ATC class of the drug (levels 1 to 4); ATC class derived from cited code B01AD (main group B)
"classId": "B01AD", "className": "Enzymes", "classType": "ATC1-4"
RxClass ATC class of the drug (levels 1 to 4); ATC class derived from cited code S01XA (main group S)
"classId": "S01XA", "className": "Other ophthalmologicals", "classType": "ATC1-4"
View the Source 3. DailyMed, National Library of Medicine: Activase (alteplase) kit label, DailyMed
DailyMed, National Library of MedicineHighlights of prescribing information, title lineQuote, Highlights of prescribing information, title line
Activase (alteplase) for injection, for intravenous use
4. World Health Organization: The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list
World Health OrganizationPDF page 47; section 12.5.2; the entry alteplase is in the Complementary List of the WHO Model List of Essential Medicines, 24th list (2025)Quote, PDF page 47; section 12.5.2; the entry alteplase is in the Complementary List of the WHO Model List of Essential Medicines, 24th list (2025)
alteplase Powder for injection: 10 mg; 20 mg; 50 mg in vial.
ChEMBL, EMBL-EBI: Alteplase approved indications (ChEMBL)
ChEMBL, EMBL-EBITreats: Pulmonary Embolism, drug_indication record, maximum phase 4, MeSH heading Pulmonary Embolism
"max_phase_for_ind": "4.0", "mesh_heading": "Pulmonary Embolism", "molecule_chembl_id": "CHEMBL1201593"
Treats: Stroke, drug_indication record, maximum phase 4, MeSH heading Stroke
"max_phase_for_ind": "4.0", "mesh_heading": "Stroke", "molecule_chembl_id": "CHEMBL1201593"
Treats: Myocardial Infarction, drug_indication record, maximum phase 4, MeSH heading Myocardial Infarction
"max_phase_for_ind": "4.0", "mesh_heading": "Myocardial Infarction", "molecule_chembl_id": "CHEMBL1201593"
Treats: Heart Failure, drug_indication record, maximum phase 4, MeSH heading Heart Failure
"max_phase_for_ind": "4.0", "mesh_heading": "Heart Failure", "molecule_chembl_id": "CHEMBL1201593"
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