Cerebrolysin
/ Porcine-brain-derived peptide preparation (low-molecular-weight neuropeptides plus free amino acids)Terms in this page you can click for a plain-English popup: , , , , , , , .
Approved in more than 50 countries but not FDA-approved. Substantial Western clinical literature exists including a Cochrane systematic review.
Cerebrolysin is a porcine-brain-derived preparation produced by EVER Neuro Pharma. Proposed mechanisms in peer-reviewed literature include neurotrophic-factor mimicry (BDNF, NGF, GDNF-like activity), reduction of excitotoxicity and oxidative stress, modulation of APP processing and tau phosphorylation, and anti-apoptotic effects via calpain inhibition.
Substantial — by far the most clinically studied peptide in the cognitive / longevity category. Multi-center Western and Asian RCTs exist for acute ischemic stroke (CASTA, CARS), vascular dementia, Alzheimer’s disease, and traumatic brain injury. The 2020 Cochrane systematic review is the appropriate critical touchpoint and reached cautious conclusions.
Factual reporting of what cited studies used — not a recommendation.
- Stroke RCTs including CASTA — Adult humans with acute ischemic stroke — 30-50 mL/day Intravenous, 10-21 daysREFCASTA (Heiss 2012)
Generally well tolerated across clinical programs. The Cochrane review noted a signal of increased non-fatal serious adverse events at higher doses in stroke, with heterogeneous specific events. Infrequent allergic reactions have been reported.
Regulatory status
- FDA status:
- Not FDA-approved
- Compounding:
- Compounding eligibility ambiguous
Efficacy remains debated. The 2020 Cochrane systematic review concluded no clear beneficial effect on death or dependence in acute ischemic stroke, while industry-sponsored meta-analyses reach more optimistic conclusions. Heterogeneity across trials in dose, timing, and population is substantial.