北京若生智能科技有限公司
Drug Database
AL

alteplase (Reveliza / GNR004 / Revelise)

✓ Approved

Generium Pharmaceutical · PLAT · 重组蛋白

什么是 alteplase？

alteplase 是一种重组蛋白，由Generium Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

商品名Reveliza, GNR004, Revelise
公司Generium Pharmaceutical
药物类别重组蛋白
分子靶点PLAT
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, Generium Pharmaceutical

作用机制

分子靶点

alteplase 作用于 1 个分子靶点：

PLATplasminogen activator, tissue type (TPA, T-PA)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

alteplase 针对 3 个适应症，涉及 3 个治疗领域。

治疗领域疾病/病症分期
Cardiac disordersMyocardial infarction✓ Approved
Respiratory, thoracic and mediastinal disordersPulmonary thrombosis✓ Approved
Nervous system disordersDelayed ischaemic neurological deficit✓ Approved

相关研究文献

PubMedFrontiers in cardiovascular medicine2026-10-25

Case Report: Staged alteplase administration under VA-ECMO support for high-risk pulmonary embolism with severe thrombocytopenia.

Kang Le L, Lin Yanfei Y, Wang Shuai S, Ji Xia X

High-risk pulmonary embolism (PE) with severe thrombocytopenia creates competing reperfusion and bleeding risks. A 28-year-old man presented with obstructive shock and central pulmonary arterial filling defects. The last documented platelet count before alteplase was 21 × 10⁹/L; platelet transfusion intervened, and the count at infusion initiation was unknown. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) and hemostatic support were instituted. With increasing vasoactive requirements, the team selected bedside systemic thrombolysis after multidisciplinary consideration of surgical and catheter-based alternatives. Unfractionated heparin was paused at the first 20-mg alteplase infusion at 17:00. Arterial cannulation-site bleeding at 17:20 was treated with compression. The progress note documented that bleeding had stopped by 19:03; despite reduced vasoactive requirements, support dependence persisted. A second 20-mg infusion began at 19:25. Each stage lasted approximately 1 h. Heparin was restarted after the second infusion. Vasopressors were stopped on Day 1 and VA-ECMO was removed on Day 7. Hemoglobin fell from 150 to 117 g/L on Day 0 and reached 75 g/L on Day 8, prompting red-cell transfusion. Major bleeding could not be excluded. The patient was discharged on Day 19; Day 103 imaging showed no obvious residual pulmonary arterial filling defect. This case describes individualized decisions during multimodal care, not a validated alteplase regimen or evidence of its safety.

PMID 42923273
阅读全文 →
PubMedJournal of the American Heart Association2026-10-25

Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial.

Xie Dongshu D, Li Haiwei H, Li Dengxing D, Huang Weidong W et al.

For patients with large-vessel occlusion stroke who undergo endovascular thrombectomy without prior intravenous thrombolysis, the efficacy and safety of adjunctive intra-arterial alteplase (IAA) after successful endovascular reperfusion remain uncertain. This was a prespecified subgroup analysis of the PEARL (Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Acute Stroke) randomized clinical trial conducted at 28 centers in China, focusing on patients who underwent endovascular thrombectomy without prior intravenous thrombolysis. Patients were stratified by treatment assignment: IAA treatment versus standard treatment (control). The primary efficacy outcome was the proportion of patients achieving excellent functional outcome, defined as a modified Rankin Scale score of 0 to 1 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage, any intracranial hemorrhage within 36 hours, and 90-day all-cause mortality. Among 324 patients originally randomized in the PEARL trial, 189 underwent endovascular thrombectomy without prior intravenous thrombolysis and were included in this analysis. Of the 189 patients, 95 were assigned to the IAA treatment group and 94 to the standard treatment group. Excellent functional outcome at 90 days was significantly higher in the IAA treatment group compared with the standard treatment group (43.2% [41/95] versus 22.6% [21/93]; adjusted risk ratio [aRR], 1.86; 95% CI, 1.19-2.91; P=0.007). The absolute risk reduction was 20.6% (95% CI, 7.0%-33.1%). Results were consistent in per-protocol sensitivity analyses (P=0.002). No significant differences were observed in symptomatic intracranial hemorrhage (aRR, 0.93; 95% CI, 0.28-3.13; P=0.908), any intracranial hemorrhage (aRR, 1.04; 95% CI, 0.68-1.60; P=0.843), or 90-day mortality (hazard ratio [HR], 1.00; 95% CI, 0.49-2.04; P>0.99). In patients who did not receive prior intravenous thrombolysis, adjunctive IAA after successful endovascular thrombectomy was associated with a higher likelihood of excellent functional outcome at 90 days, without an apparent increase in symptomatic intracranial hemorrhage or mortality. URL: clinicaltrials.gov; Unique Identifier: NCT05856851.

PMID 42924842
阅读全文 →
PubMedClinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis2026-10-23

Long-Term Outcomes of Mortality and CTEPH in Patients With Massive/Submassive Pulmonary Embolism Treated With Thrombolytics: Retro-Prospective Analysis.

Oğuz Esra E, Annakkaya Ali Nihat AN

AimThis study aimed to determine mortality and morbidity in patients receiving fibrinolytic therapy for massive/submassive PE and the clinical factors affecting these outcomes.Materials and MethodsAll patients diagnosed with massive/submassive PE who received fibrinolytic therapy (alteplase) in our clinic between 2012 and 2024 were included in the study. Patients' medical records were retrospectively reviewed using the automation system and patient files.ResultsA total of 50 cases (31 women, 62%; 19 men, 38%) were included in the study. The mean age of the cases was 64±16 years (min: 21 - max: 93), and the median follow-up period was 1661 days (min: 1 - max: 4566 days). Half-dose fibrinolytic therapy was administered to 26% of cases, and full-dose therapy to 74%. The 2-day mortality rate was 10% (5/50), the 10-day mortality rate was26% (13/50), and the 30-day mortality rate was 28% (14/50). The median survival was found to be 2352 days (standard error: 304 days) for all cases who underwent reperfusion therapy. The 30-day mortality rate was significantly higher in patients receiving half-dose fibrinolytic therapy compared to those receiving full-dose therapy (53.8% vs. 18.9%, p=0.029). According to Cox regression analysis, malignancy was an independent risk factor negatively affecting survival, while obesity was a positive factor. CTEPH was detected in 28.5% (6/21) of the long-term followed cases.ConclusionThe effects of factors such as malignancy, obesity, and half-dose fibrinolytic therapy on mortality and morbidity in patients undergoing thrombolytic therapy with a diagnosis of massive/submassive PE should be investigated in more comprehensive studies.

PMID 42913495
阅读全文 →
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
阅读全文 →
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
阅读全文 →
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
阅读全文 →

注册免费账户还可查看另外 3699 篇文献

免费注册查看全部文献 →

了解更多alteplase