Tenecteplase is here: Navigating the shift of a stroke thrombolytic in the United States prior to FDA approval: a mini-review on rationale, barriers and pathways
Authors: Julian M. Burwell, Jason R. Howay, Lisa Wasko, Samantha Doucoure, Jamie L. Kerestes, Clemens M. Schirmer, David Ermak, Anthony Noto, Philipp Hendrix
Until March 2025, alteplase (TPA) was the sole thrombolytic agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS). That changed when the FDA granted approval for tenecteplase (TNK), a genetically modified variant of TPA originally approved for myocardial infarction. Although TPA’s FDA approval is limited to administration within 3 hours of symptom onset, the American Heart Association/American Stroke Association guidelines and The Joint Commission support its use up to 4.5 hours, based on additional clinical evidence.
Over the past decade, tenecteplase has emerged as a viable alternative to alteplase, demonstrating comparable efficacy and safety in multiple studies. Recent research has provided robust evidence supporting TNK’s use in AIS, prompting growing interest in its adoption across stroke systems nationwide. Operational advantages — including single-bolus administration, simplified dosing protocols and lower overall costs — have further strengthened the case for transitioning from TPA to TNK.
The shift from TPA to TNK represents a significant paradigm change in the management of acute ischemic stroke.
While adoption rates vary across institutions, TNK’s clinical, operational and economic benefits make it an increasingly compelling choice. Continued research and real-world implementation will help refine TNK’s role and inform future developments in thrombolytic therapy.
At Geisinger, the pre-FDA approval implementation of TNK was guided by a comprehensive change management strategy. This proactive approach enabled a smooth transition and yielded enduring improvements in stroke care delivery. The experience highlights the importance of strategic planning, stakeholder engagement, and evidence-based decision-making in adopting new therapeutic standards.
For a more detailed exploration of the rationale, implementation strategies and clinical outcomes associated with TNK adoption, readers are encouraged to review the full article available at Frontiers in Neurology.
Relevant publication
- Burwell JM, Howay JR, Wasko L, Doucoure S, Kerestes JL, Schirmer CM, Ermak D, Noto A, Hendrix P. (2025). Tenecteplase is here: navigating the shift of a stroke thrombolytic in the United States prior to FDA approval: a mini-review on rationale, barriers, and pathways. Frontiers in Neurology, 16:1563423.
