Data Sheet 1_Tanshinone IIA and sodium tanshinone IIA sulfonate in ischemic stroke: evidence, exposure, and translational readiness.pdf

Most pathway claims, however, rely on single laboratories, early dosing, young healthy rodents, short follow-up, or surrogate outcomes. Human evidence comprises one 42-patient STS-plus-rt-PA trial and a 2025 meta-analysis of 22 trials involving 2,289 participants. These findings suggest short-term signals but do not establish benefits for ordinal disability, survival, recurrent stroke, or uncommon bleeding.

An injectable product and human plasma pharmacokinetic methods make STS more operationally tractable; superior efficacy remains unproven. Progression should require a fixed product, exposure-linked target engagement, durable benefit in aged and comorbid reperfusion models, and independent multicenter validation. Biological plausibility remains substantially stronger than translational readiness.</p>