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alteplase (Reveliza / GNR004 / Revelise)

✓ Approved

Generium Pharmaceutical · PLAT · Recombinant Proteins

What is alteplase?

alteplase is a recombinant proteins developed by Generium Pharmaceutical. It is approved for therapeutic indications via injectable (others).

Drug Profile

Brand NamesReveliza, GNR004, Revelise
CompanyGenerium Pharmaceutical
Drug ClassRecombinant Proteins
Molecular TargetPLAT
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, Generium Pharmaceutical

Mechanism of Action

Molecular Targets

alteplase acts on 1 molecular target:

PLATplasminogen activator, tissue type (TPA, T-PA)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

alteplase is developed for 3 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Cardiac disordersMyocardial infarction✓ Approved
Respiratory, thoracic and mediastinal disordersPulmonary thrombosis✓ Approved
Nervous system disordersDelayed ischaemic neurological deficit✓ Approved

Related Research Articles

PubMedStroke2026-10-13

Thrombolysis in the Delayed Treatment Window for Acute Ischemic Stroke: Updated Systematic Review and Meta-Analysis.

Pitchan Velammal Praveen Nandha Kumar PNK, Dhasakeerthi Thirumalaivasan T, Manzoori Devin D, Mummareddy Sai Sreehith SS et al.

Intravenous thrombolysis is a standard treatment for acute ischemic stroke but has traditionally been limited to 4.5 hours after symptom onset. This time-based restriction may exclude patients with salvageable brain tissue, especially those with wake-up or unknown-onset strokes. Multimodal imaging allows for the identification of viable penumbra beyond traditional treatment windows. This study compiles randomized evidence evaluating intravenous thrombolysis in imaging-selected patients treated after 4.5 hours. We conducted a systematic review and meta-analysis in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, Embase, and Cochrane Central were searched through February 2026 for randomized trials comparing intravenous thrombolysis (alteplase or tenecteplase) with best medical therapy in patients presenting beyond 4.5 hours or with wake-up/unknown-onset stroke selected by imaging. The primary outcome was excellent functional outcome at 90 days (modified Rankin Scale score 0-1). Secondary outcomes included functional independence (modified Rankin Scale score 0-2), symptomatic intracranial hemorrhage, and 90-day mortality. Fourteen trials involving 4192 participants were analyzed. Intravenous thrombolysis improved excellent functional outcomes (modified Rankin Scale score 0-1; risk ratio, 1.22 [95% CI, 1.16-1.29]) and functional independence (modified Rankin Scale score 0-2; risk ratio, 1.12 [95% CI, 1.06-1.18]). Both alteplase and tenecteplase contributed to these benefits. Thrombolysis increased the risk of symptomatic intracranial hemorrhage (risk ratio, 2.58 [95% CI, 1.58-4.22]) but did not significantly affect 90-day mortality (risk ratio, 1.15 [95% CI, 0.97-1.35]). In patients selected using advanced imaging, intravenous thrombolysis performed after 4.5 hours improves functional outcomes without increasing mortality, supporting a tissue-based rather than strictly time-based approach to treating acute ischemic stroke.

PMID 42866880
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PubMedNeurological research2026-10-12

Clinical outcomes after intravenous thrombolysis for acute ischemic stroke in low- and middle-income countries: a pooled analysis of 67,917 patients and systematic review.

Carbajal-Galarza Meiling M, Chinchihualpa-Paredes Nathaly Olga NO, Calisaya-Madariaga Irving I, Vascones Fritz F et al.

Stroke is a leading cause of disability and mortality worldwide. Patients in low- and middle-income countries (LMICs) are disproportionately affected, yet thrombolysis outcomes in these settings are underexplored. We searched PubMed, Embase, Scopus, Web of Science, and Global Index Medicus through April 2024. Outcomes were 90-day functional independence (mRS 0-2), symptomatic intracerebral hemorrhage (sICH), and 90-day mortality. Risk of bias used Cochrane RoB 2 and ROBINS-I; random-effects meta-analyses estimated pooled proportions with I2. Of 1,865 records screened, 79 studies (67,917 patients; 24 countries) were included. Most used alteplase; others examined tenecteplase, recombinant prourokinase, or reteplase; eight compared low- vs standard-dose alteplase. Pooled estimates were functional independence 63% (95% CI, 58-67), sICH 4% (95% CI, 3-5), and mortality 8% (95% CI, 6-10). Functional independence was similar across continents; sICH was lowest in Asia, mortality lowest in Africa. Heterogeneity was high, partly explained by baseline stroke severity and study size. Overall risk of bias was low to moderate. Standard-dose thrombolysis within 4.5 hours in LMICs shows efficacy and safety comparable to reports from high-income countries, with regional variation in safety and mortality. These results support broader implementation of thrombolysis in resource-limited settings to reduce global stroke disparities.

PMID 42860667
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PubMedThe Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians2026-10-11

Apixaban After Alteplase for Pulmonary Embolism.

Wasowski Erik M EM, Beattie Mya M

Pulmonary embolism guidelines recommend starting parenteral anticoagulation after completion of thrombolytic therapy for patients who receive thrombolytics; however, there is no guidance on dosing factor Xa inhibitors in this population upon transition to oral anticoagulation. Prior to the Food and Drug Administration approval of direct oral anticoagulants, warfarin was the standard of care, which does not have a standard dose; rather, it has a standard goal international normal range. The study's aim was to assess the safety and efficacy of apixaban at standard thromboembolic dosing versus alternative dosing after alteplase in patients who received systemic thrombolytic therapy for pulmonary embolism. This study was approved by the institutional review board and was a retrospective, non-interventional cohort study completed at Cleveland Clinic Ohio Hospitals from January 1, 2018, to October 1, 2025, that analyzed patients who received systemic alteplase for initial management of pulmonary embolism and were transitioned to apixaban prior to discharge. A total of 205 patients received alteplase, with 58 patients meeting the inclusion criteria, including 50 patients receiving standard apixaban dosing and 8 receiving alternative dosing. Bleeding events were similar between groups: 8% versus 13%, P = .538; however, this study was underpowered. Death was more common in the alternative dosing group: standard group was 2% versus 25% in the alternative group; P = .047; however, no deaths were related to anticoagulation adverse events. Limitations to the study include small sample size and a single health system. Patients who received systemic thrombolytic therapy for pulmonary embolism had similar rates of bleeding when using standard apixaban dosing compared with alternative apixaban dosing.

PMID 42859618
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PubMedFrontiers in neurology2026-10-11

Tenecteplase versus alteplase for intravenous thrombolysis in acute ischemic stroke: a single-center propensity-weighted cohort study.

Ma Jin J, Wulayimu Heyireguli H, Ma Zhiqiang Z

Tenecteplase can be given as a single bolus, but comparative estimates from routine stroke care are susceptible to treatment-selection bias. Methods: We reviewed 269 adults treated at one center with intravenous tenecteplase (n = 110) or alteplase (n = 159) within 4.5 h of symptom onset from March 2024 through March 2026. The primary outcome was functional independence at 90 days [modified Rankin Scale (mRS) 0-2]. A logistic propensity-score model included pretreatment clinical and laboratory variables. Stabilized average-treatment-effect weights were truncated at the 1st and 99th percentiles. We report weighted risks, risk differences (RDs), odds ratios (ORs), and robust 95% confidence intervals (CIs). Secondary neurological/workflow and safety outcomes were adjusted within separate families using the Holm procedure. After weighting, 90-day functional independence was 77.9% with tenecteplase and 81.3% with alteplase (RD, -3.5 percentage points; 95% CI, -17.0 to 10.1; p = 0.616; OR, 0.81; 95% CI, 0.36-1.82). Holm-adjusted p values for the other functional outcomes were 1.000. The weighted mean difference in door-to-needle time was -5.0 min (95% CI, -9.0 to -0.9; unadjusted p = 0.017; Holm-adjusted p = 0.068). Day-7 early neurological deterioration occurred in no tenecteplase recipient and nine alteplase recipients (weighted RD, -5.1 percentage points; 95% CI, -8.5 to -1.7; Holm-adjusted p = 0.016). SITS-MOST symptomatic intracranial hemorrhage occurred in four patients, with a weighted RD of 0.2 percentage points (95% CI, -1.7 to 2.1). Tenecteplase was not associated with greater 90-day functional independence in this propensity-weighted cohort. No clear between-group difference was observed in major hemorrhagic outcomes. DNT was shorter before multiplicity adjustment, and day-7 deterioration was less frequent after adjustment within the secondary neurological/workflow family.

PMID 42856933
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PubMedInternational journal of surgery case reports2026-10-11

Endovascular salvage of graft hepatic artery dissection with intrahepatic extension following right lobe living donor liver transplantation: a case report with literature review.

Nguyen Manh V MV, Nguyen Quynh V QV, Le Thanh V TV, Le Hieu T HT et al.

Hepatic artery complications after liver transplantation are uncommon but potentially catastrophic because the biliary tree depends entirely on the arterial blood supply. Graft hepatic artery dissection (GHAD) is extremely rare following living donor liver transplantation (LDLT), and optimal management strategies remain unclear. A 68-year-old man with hepatocellular carcinoma and underlying alcohol-related cirrhosis underwent right-lobe LDLT. During donor hepatectomy, intimal dissection of the graft hepatic artery, extending deep into the liver parenchyma, was identified. After arterial reconstruction, intraoperative Doppler ultrasound demonstrated absent arterial flow. The abdomen was closed, and the patient was transferred for urgent endovascular intervention. Angiography confirmed compromised arterial inflow, and a drug-eluting stent was deployed across the arterial anastomosis, followed by catheter-directed thrombolysis using alteplase. Postoperatively, the patient developed intra-abdominal bleeding requiring emergency re-laparotomy for hemostasis. Despite this complication, hepatic arterial perfusion was successfully restored. Liver function gradually improved, and follow-up imaging confirmed adequate graft perfusion. The patient was discharged 3 weeks after transplantation with preserved graft function. GHAD is a rare but serious vascular complication that may result in graft ischemia, biliary complications, and graft failure if not promptly treated. When surgical revision is not feasible, endovascular techniques - including stent placement and thrombolysis - can serve as effective salvage strategies. However, thrombolytic therapy carries a significant risk of hemorrhagic complications, requiring careful postoperative monitoring. Early diagnosis and multidisciplinary management are essential for the successful salvage of GHAD after LDLT.

PMID 42857416
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PubMedBMC neurology2026-10-10

Discontinuation of intravenous thrombolysis in acute ischemic stroke.

Krämer Matthias M, Sekita Alexander A, Borutta Matthias C MC, Singer Ludwig L et al.

Alteplase (rt-PA) was the standard thrombolytic in acute ischemic stroke (AIS) for decades. Due to its short half-life it must be administered over 1 h after an initial bolus, but the administration can be stopped when serious side effects occur. However, there are limited data about the frequency and reasons for interrupted or stopped intravenous thrombolysis (IVT) in AIS. We retrospectively analyzed our stroke registry over a time of more than six years (January 1, 2018 - March 31, 2024) to determine the proportion of discontinued IVT. We compared the baseline, stroke and treatment characteristics between discontinued and non-discontinued patients. We investigated the reasons for discontinuation and followed up patients who had discontinued treatment to detect any treatment-related complications. Total 1,504 patients underwent IVT with rt-PA and the treatment was discontinued in 23 patients (1.5%). Of these, 5 patients (0.3%) had their treatment interrupted and 18 patients (1.2%) had their treatment stopped early. On average 61% of the planned dosage was administered in the discontinued patients. The most common reasons for discontinuation were extracranial bleedings, reevaluation of the acute cerebral imaging and deterioration of the neurological symptoms incl. patient agitation. In 7 patients the discontinuation was due to adverse effects of rt-PA, but no patient suffered a symptomatic intracranial hemorrhage. The proportion of additional endovascular thrombectomy was higher in patients with discontinuation than in patients without (47.8% vs. 27.9%; p = 0.035). In our cohort, discontinuation of IVT in the treatment of acute ischemic stroke was rare and the quantity of not administered rt-PA was low. N.a.

PMID 42855672
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