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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

PubMedNo shinkei geka. Neurological surgery2026-10-20

[Novel Drugs and Therapeutic Strategies for Acute Ischemic Stroke:Focus on Tenecteplase].

Arakaki Yoshito Y, Toyoda Kazunori K

Intravenous thrombolysis remains a cornerstone of acute ischemic stroke treatment, but alteplase has a short half-life and requires complex administration. Tenecteplase (TNK) , a genetically modified variant of alteplase, is regarded as a next-generation recombinant tissue-type plasminogen activator. TNK has greater fibrin specificity, a longer half-life, and greater resistance to plasminogen activator inhibitor-1, enabling single-bolus administration. Several randomized trials have supported its efficacy and safety, and its clinical use has expanded internationally. However, in Japan, alteplase at 0.6 mg/kg is the approved standard dose, and direct evidence comparing this regimen with TNK has been lacking. The investigator-initiated T-FLAVOR trial directly compared TNK 0.25 mg/kg with alteplase 0.6 mg/kg in patients with large-vessel occlusion scheduled for mechanical thrombectomy. In the T-FLAVOR trial, TNK achieved a higher rate of reperfusion on initial angiography, with comparable safety outcomes. These findings provide important evidence supporting the potential regulatory approval and clinical implementation of TNK in Japan. Other emerging therapies, including thrombolytic agents (JX10), neuroprotective agents (nerinetide), anti-edema drugs (glibenclamide), and antithrombotic agents such as factor XIa inhibitors (milvexian and asundexian), may further broaden treatment options across the acute treatment and secondary prevention phases of ischemic stroke.

PMID 42901799
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PubMedNo shinkei geka. Neurological surgery2026-10-20

[Intravenous Thrombolysis for Acute Ischemic Stroke: Current Evidence and Perspectives].

Maekawa Hidetsugu H

Since its introduction, intravenous thrombolysis (IVT) with alteplase has remained a mainstay of reperfusion therapy in the hyperacute management of acute ischemic stroke (AIS). Recent clinical evidence has driven a major paradigm shift from a strictly "time-based" approach to a "tissue-based" approach. Advanced neuroimaging techniques, including diffusion-weighted imaging-fluid-attenuated inversion recovery (DWI-FLAIR mismatch) and perfusion mismatch analyses, have enabled extension of the treatment window beyond 4.5 h and treatment of patients with strokes of unknown onset, particularly benefiting those who are ineligible for endovascular thrombectomy (EVT). Furthermore, the treatment criteria have been refined to recommend IVT for disabling deficits regardless of the baseline stroke severity score while withholding it from patients with minor, nondisabling presentations. An emerging challenge in clinical practice is determining whether IVT should be contraindicated in patients receiving novel amyloid-targeting therapies for Alzheimer's disease. Meanwhile, prehospital protocols involving mobile stroke units (MSUs) may help reduce onset-to-needle time in selected regions. IVT continues to evolve through personalized patient selection aimed at maximizing safety and improving functional outcomes.

PMID 42901789
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PubMedNo shinkei geka. Neurological surgery2026-10-20

[The Background of rt-PA Implementation and Its Impact on Nationwide Adoption in Japan].

Kimura Kazumi K

Around the year 2000, Japan became a global leader in clinical research on intravenous recombinant tissue plasminogen activator (rt-PA). However, due to patent-related issues surrounding the drug, domestic development came to a standstill, plunging the country into a prolonged "dark age" for reperfusion therapy. In contrast, alteplase was approved in the United States in 1996, and rt-PA treatment soon became widely adopted worldwide. Japan, however, could not introduce rt-PA until 2005. Following its approval, stroke care in Japan underwent a dramatic transformation. The concept that "time is brain" became deeply ingrained in the field, and minimizing the time from symptom onset to intravenous rt-PA administration emerged as the most critical challenge for the entire healthcare system. This shift represented far more than the addition of a new therapeutic option; it catalyzed sweeping reforms across multiple domains, including public awareness, establishment of prehospital emergency medical services (EMS), improvements in hospital triage and acceptance processes, acute management in stroke units and stroke care units (SU/SCUs), development of stroke centers, revisions to emergency reimbursement under the national insurance system, and education and training of medical personnel. The advent of rt-PA marked a watershed moment in acute stroke care, fundamentally reshaping treatment paradigms.

PMID 42901782
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PubMedJournal of stroke2026-10-19

Tenecteplase for Acute Ischemic Stroke: From Molecular Bioengineering to Phase III Pivotal Trials.

Jung Jae Wook JW, Lee Jin Soo JS

Intravenous thrombolysis with alteplase is a primary reperfusion therapy for acute ischemic stroke, yet its clinical utility is constrained by a short half-life, continuous infusion requirements, and susceptibility to plasminogen activator inhibitor-1. Tenecteplase, a bioengineered variant of alteplase, was developed to address these limitations through a prolonged half-life, increased fibrin specificity, and enhanced resistance to plasminogen activator inhibitor-1. These structural modifications enable single-bolus administration and reduce systemic fibrinolytic disturbance. In this review, we examine how the targeted molecular modifications of tenecteplase shaped its stepwise translational development in acute ischemic stroke. We first detail the limitations of alteplase, which motivated the transition to alternative agents, the molecular rationale for tenecteplase, and its preclinical evidence. Furthermore, we synthesize the phase II dose-finding trials that established 0.25 mg/kg as providing the optimal efficacy and safety balance, distinguishing it from the excess intracranial hemorrhage observed with the 0.4 mg/kg dose. Finally, we review the pivotal phase III trials across diverse populations demonstrating that tenecteplase 0.25 mg/kg is non-inferior to alteplase and represents a practical, evidence-based alternative, particularly where single-bolus administration may facilitate workflow or transfer for endovascular thrombectomy. Viewed through this molecular-to-clinical framework, the development of tenecteplase illustrates how targeted protein engineering can translate into pharmacological, operational, and clinical advantages in stroke reperfusion therapy.

PMID 42894449
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PubMedOxford medical case reports2026-10-18

Fibrinolytics in the Management of Complex Abdominal Collections: a case report and review of the literature.

Almuallem Sultan S

Complex intra-abdominal collections typically present management challenges, with percutaneous drainage remaining the standard of care. Fibrinolytic therapy has limited data for complex intra-abdominal collections despite solid evidence in intrapleural empyema. Here, we report a case of successful fibrinolytic therapy in a patient with persistent intra-abdominal collection. A 57-year-old woman with a history of open Roux-en-Y gastric bypass presented with a perforated marginal ulcer. Following successful surgical management, she developed a recurrent/persistent intra-abdominal collection that failed several percutaneous drainage attempts. Alteplase was administered through the abdominal drain, resulting in complete resolution of the collection. Despite limited evidence, fibrinolytic therapy for complex abdominal collections appears applicable and safe in selected cases. Further large series and randomized trials are needed to examine its efficacy and cost-effectiveness.

PMID 42893119
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PubMedAdvanced healthcare materials2026-10-16

Translating Stroke Microenvironment Cues Into Materials Design: Intelligent Nanomaterials for Ischemic Stroke Therapy.

Chen Jiajun J, Li Xiangqi X, Deng Jiali J, Wang Ying Y et al.

Ischemic stroke (IS), caused by cerebral blood vessel occlusion, leads to ischemia, hypoxia, and irreversible brain tissue damage. Current treatments primarily rely on thrombolytic agents like alteplase, urokinase, and streptokinase for rapid reperfusion. However, these therapies are limited by narrow therapeutic windows, rapid clearance, poor blood-brain barrier (BBB) penetration, off-target effects, and the complex ischemic microenvironment. These have led to increased interest in nanomaterial-based platforms to improve the precision and efficacy of IS treatment. The IS microenvironment, characterized by oxidative stress, inflammation, ionic imbalance, acidosis, and BBB disruption, provides valuable cues for designing responsive nanomaterials. Nanomaterials engineered to respond to reactive oxygen species, pH, enzymes, light, ultrasound, or magnetic fields can enable targeted drug delivery, controlled release, and multi-modal interventions, enhancing therapeutic precision. This review discusses the IS microenvironment, limitations of traditional therapies, recent advances in intelligent nanomaterials for IS treatment, and the major barriers that currently limit clinical translation.

PMID 42885941
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