RESEARCH PAPER
Cerebrolysin in neurology and intensive care: new clinical trials and their implications for routine care
More details
Hide details
1
Military Medical Institute – National Research Institute, Department of Neurology, Poland
2
Military Medical Institute – National Research Institute, Department of Anesthesiology and Intensive Care, Poland
3
Military Medical Institute – National Research Institute, Interventional Radiology Unit, Department of Radiology, Poland
4
Military Medical Institute – National Research Institute, Department of Rehabilitation, Poland
Submission date: 2026-02-05
Acceptance date: 2026-03-12
Publication date: 2026-06-30
Corresponding author
Jacek Staszewski
Wojskowy Instytut Medyczny – Państwowy Instytut Badawczy, Klinika Neurologii, ul. Szaserów 128, 04-141, Warszawa, Polska
LW 2026;104(2):151-162
KEYWORDS
TOPICS
ABSTRACT
Introduction and objective: Cerebrolysin is a multimodal cerebroprotective agent that may improve the function of the blood–brain barrier, the neurovascular unit, and plasticity-related processes following central nervous system injury. This study aims to provide a comprehensive overview and critical evaluation of new clinical data (published after 2020) on the use of cerebrolysin in the acute phase of ischaemic stroke, including combination therapy with reperfusion strategies, and in neurointensive care for patients with traumatic brain injury (TBI). Materials and methods: A narrative review of randomised clinical trials (RCTs) involving cerebrolysin, meta-analyses, and prospective/observational studies was conducted, including analysis of the primary endpoints: National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), haemorrhagic transformation (HT/sHT), safety, and treatment feasibility. Results: In the acute phase of ischaemic stroke, a meta-analysis of 14 RCTs showed a modest benefit in NIHSS scores without a consistent effect on 90-day mRS outcomes; CEREHETIS reported lower sHT when cerebrolysin was added early to thrombolysis, while the multinational C-REGS2 registry demonstrated a favourable ordinal shift in 90-day mRS and improved cognition without additional safety concerns. Observational post-thrombectomy studies, including cyclic regimens with 12-month follow-up, suggested higher odds of functional independence and reduced HT, although causal inference remains limited. In TBI, the CAPTAIN trial (185 moderate-to-severe cases) demonstrated a benefit on a multidomain global outcome at 90 days with comparable safety. Broader meta-analyses suggested improvement in Glasgow Outcome Scale scores, without a clear effect on mortality and with substantial heterogeneity across studies. Conclusions: Cerebrolysin appears most promising as an adjunct to reperfusion and rehabilitation in the acute phase of ischaemic stroke and as supportive therapy in TBI. Definitive multicentre RCTs are needed to refine patient selection, timing, and dosing.