Last reviewed 2026-04-20 · How we verify

Alteplase Injectable Product

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Hematuria
• Urinary tract infection
• Haemorrhagic transformation stroke
• Cerebral haemorrhage
• Haemorrhagic infarction
• Hypokalaemia
• Headache
• Subarachnoid haemorrhage
• Haemorrhage intracranial
• Anaemia
• Constipation
• Dysphagia

Key clinical trials

• Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window. (PHASE3)
• Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion (PHASE3)
• Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke (PHASE3)
• Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND (PHASE3)
• TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS) (PHASE3)
• CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2). (PHASE3)
• Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction (PHASE3)
• Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Alteplase Injectable Product CI brief — competitive landscape report
• Alteplase Injectable Product updates RSS · CI watch RSS
• Semmelweis University portfolio CI