On March 3, 2025, the FDA approved tenecteplase to treat acute ischemic stroke. Historically, only alteplase was FDA-approved, but the stroke guidelines suggest tenecteplase as a reasonable alternative and many centers have made the change to use tenecteplase.
The EXTEND-IA TNK trial showed benefit of tenecteplase over alteplase in patients who were candidates for mechanical thrombectomy. The newer AcT trial found that tenecteplase was non-inferior to alteplase for patients eligible for thrombolysis, regardless of thrombectomy candidacy. There was no difference in safety outcomes, specifically ICH or angioedema in either trial.
Tenecteplase will soon be available in a new 25 mg vial with stroke-specific packaging (potentially as early as June 2025). Currently, there is only a 50 mg vial that is used for STEMI and PE which has higher maximum dosing compared to stroke.
The dosing is now recommended in weight-based groupings based on the supplemental appendix from the AcT trial. This is likely a change in practice for most centers that previously implemented tenecteplase for stroke before the FDA approval. Consult with your stroke and pharmacy team to discuss potential protocol changes at your institution.
Campbell BCV, et al. NEJM 2018;378:1573-1582.
Menon BK, et al. Lancet 2022;400:161-69.
TNKase [package insert]. South San Francisco, CA. Genetech, Inc. 2025.
Genetech Press Release: https://www.gene.com/media/press-releases/15053/2025-03-03/fda-approves-genentechs-tnkase-in-acute-#:~:text=South%20San%20Francisco%2C%20CA%20%2D%2D,stroke%20(AIS)%20in%20adults.
