At a glance
- Mechanism of action
- Multimodal, pleiotropic action: fragments mimic BDNF, NGF, GDNF, and CNTF, promote neuroprotection (protection against hypoxia/excitotoxicity), anti-neuroinflammation, and synaptic plasticity.
- Benefits & use
- Main indications: ischemic stroke (acute and recovery), traumatic brain injury, Alzheimer's and vascular dementia. Investigated clinically primarily for the improvement of early recovery.
- Study status
- Several meta-analyses on stroke (Zhang 2017, Bornstein 2018, CARS 2017) and CAPTAIN II on TBI (2020) consistently show benefits; the Cochrane review on vascular dementia (2019) remains cautious regarding evidence quality.
- Dosing note
- In studies, 5-30 ml i.v. per day over 10-20 days was common. This is not a dosing instruction - every application must be under medical supervision and follows the product information of the respective country.
Cerebrolysin is a peptide active substance complex composed of low-molecular-weight neuropeptides and free amino acids, derived from porcine brain protein (215.2 mg/ml concentrate). It mimics the action of endogenous neurotrophic factors such as BDNF, NGF, GDNF, and CNTF and is used in over 50 countries for the treatment of stroke, traumatic brain injury, and dementia. It is not approved by the FDA in the United States.
What is Cerebrolysin?
Cerebrolysin is not a single peptide, but a peptide hormone-like complex: enzymatic cleavage of porcine brain protein produces a standardized fraction of short neuropeptides (≤10 kDa) and free amino acids. The mixture mimics the activity of endogenous neurotrophic factors and can cross the blood-brain barrier. The preparation is manufactured by the Austrian company EVER Neuro Pharma GmbH under the brand name Cerebrolysin®.
How does Cerebrolysin work?
The mechanism of action is multimodal and pleiotropic:
- Neurotrophic stimulation: Fragments mimic BDNF, NGF, GDNF, and CNTF and promote survival, differentiation, and plasticity of neurons.
- Neuroprotection: Protection against hypoxia, lactic acidosis, and excitotoxic damage (glutamate modulation).
- Anti-neuroinflammation: Dampening of microglial activation and pro-inflammatory cytokines.
- Synaptic plasticity: Promotion of synaptogenesis and LTP-like processes.
What is Cerebrolysin used for?
Main areas of application are ischemic stroke (acute and recovery phase), traumatic brain injury, Alzheimer's dementia, and vascular dementia. An in vitro study published in 2024 additionally showed upregulation of BDNF in neuronal cells (Cureus, doi:10.7759/cureus.54665).
How well is Cerebrolysin researched?
The study landscape is extensive but heterogeneous:
- Stroke: Several meta-analyses (Zhang 2017, PMID 28656143; Bornstein 2018, PMID 29248999; Guekht 2017/CARS, PMID 28707130) consistently show improvement in early recovery, without a significant reduction in mortality.
- Traumatic brain injury: The CAPTAIN-II study (Muresanu 2020, PMID 31897941) demonstrated benefit in moderate-to-severe TBI.
- Dementia: A meta-analysis (Gauthier 2015, PMID 25832905) found moderate effects in mild-to-moderate Alzheimer's dementia; the Cochrane review on vascular dementia (Cui 2019, PMID 31710397) remained skeptical regarding evidence quality.
Overall, Peptipedia classifies Cerebrolysin as Evidence Level 3: approved in many countries and clinically well investigated, but with inconsistent study quality.
Regulatory Status
Cerebrolysin is approved in over 50 countries, including Austria, Russia, China, and South Korea. The EMA considers its safety to be unobjectionable. In the United States, the preparation is not FDA-approved and is not available through legal channels.
Dosage and Administration - What You Should Know
Cerebrolysin is primarily administered as an intravenous infusion (ampoules of 1, 5, and 10 ml). In clinical studies, 5-30 ml per day over 10-20 days was common. This is not a dosing instruction - every application must be under medical supervision and depends on the indication, country, and product information. For handling ampoules, our guide on mixing and storage will help.
Tolerability and Contraindications
The preparation is considered well tolerated; the most common side effects are mild, transient reactions at the infusion site, headaches, or dizziness. Contraindications include epilepsy, severe renal insufficiency, and known hypersensitivity.
How does Cerebrolysin fit with other neuropeptides?
Closely related in topic are DSIP (sleep-wake rhythm) as well as Selank & Semax - both are peptides with effects on the CNS and cognition, but of completely different origin and with different mechanisms.
Current Developments
New clinical studies have started in 2024 and 2025: NCT06489925 is investigating Cerebrolysin as an add-on in basilar thrombosis, NCT06899464 is testing safety and feasibility in primary intracerebral hemorrhage (Phase 4).
No medical advice. Cerebrolysin is a prescription medication in most countries and must be used exclusively under medical supervision.
Related peptides
Sources
- Zhang D et al. Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials. Biomed Res Int 2017 (PMID 28656143)
- Bornstein NM et al. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials. Neurol Sci 2018 (PMID 29248999)
- Guekht A et al. Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trials. Neurol Sci 2017 (PMID 28707130)
- Muresanu DF et al. Efficacy and safety of Cerebrolysin in neurorecovery after moderate-severe TBI: results from the CAPTAIN II trial. Neurol Sci 2020 (PMID 31897941)
- Gauthier S et al. Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of RCTs. Dement Geriatr Cogn Disord 2015 (PMID 25832905)
- Cui S et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev 2019 (PMID 31710397)
- Poljakovic Z et al. Efficacy and safety of Cerebrolysin after futile recanalisation therapy in patients with severe stroke. Clin Neurol Neurosurg 2021 (PMID 34214867)
- ClinicalTrials.gov NCT06489925 - Cerebrolysin als Add-On bei Basilaristhrombose