# Cerebrolysin

> Evidence tier A — Controlled human trials · Mind · reviewed 2026-11-08
> Source page: https://peptidemeta.com/p/cerebrolysin/

Also known as: FPF-1070, Cerebroprotein hydrolysate

## Quick answers

**What is Cerebrolysin?**

A peptide preparation produced by enzymatic hydrolysis of porcine brain proteins, containing low-molecular-weight peptides and amino acids. Not a single peptide: an enzymatic hydrolysate of porcine brain proteins containing low-molecular-weight peptides and free amino acids, so no single sequence or molecular weight applies.

**How strong is the evidence for Cerebrolysin?**

Tier A (controlled human trials) on the peptidemeta evidence scale. Multiple RCTs in stroke and dementia (e.g. CARS trial, Stroke 2016; vascular dementia trial, 2011); nationally authorised in several countries but never FDA-approved or centrally EMA-authorised.

**Is Cerebrolysin FDA-approved?**

No. Cerebrolysin is not approved by the FDA for any use. Outside the US: Nationally authorised in several European countries (e.g. Romania, authorisation 4804/2012) and elsewhere; not centrally authorised by the EMA.

**Is Cerebrolysin banned in sport?**

No. Cerebrolysin is not on the World Anti-Doping Agency Prohibited List.

**How does Cerebrolysin work?**

Cerebrolysin is an enzymatic hydrolysate of porcine brain proteins containing low-molecular-weight peptides and free amino acids. Its peptides are proposed to mimic the activity of endogenous neurotrophic factors (BDNF, NGF, GDNF), supporting neuronal survival and synaptic plasticity, although its exact active components are not defined.

**What is known about the safety of Cerebrolysin?**

Multiple published RCTs; reported side effects include dizziness, headache, injection site pain, and insomnia. Generally well-tolerated in clinical trials.

## Key facts

- **Evidence tier:** A (Controlled human trials)
- **FDA:** not approved
- **Other approvals:** Nationally authorised in several European countries (e.g. Romania, authorisation 4804/2012) and elsewhere; not centrally authorised by the EMA
- **WADA:** not on the Prohibited List
- **Peptide:** yes
- **Routes studied:** Intramuscular, Intravenous

## Overview

A peptide preparation produced by enzymatic hydrolysis of porcine brain proteins, containing low-molecular-weight peptides and amino acids. It is authorised as a medicine in several countries for stroke, traumatic brain injury, and dementia, but not in the US or via the EMA.

## Mechanism

Cerebrolysin is an enzymatic hydrolysate of porcine brain proteins containing low-molecular-weight peptides and free amino acids. Its peptides are proposed to mimic the activity of endogenous neurotrophic factors (BDNF, NGF, GDNF), supporting neuronal survival and synaptic plasticity, although its exact active components are not defined.

## Effects reported in research

_Reported outcomes, not promises; see the evidence tier._

- Neurotrophic factor delivery to the brain
- Studied for recovery after stroke or TBI
- Enhanced neuroplasticity and synaptogenesis
- Reduced neurodegeneration in dementia models

## Safety & unknowns

Multiple published RCTs; reported side effects include dizziness, headache, injection site pain, and insomnia. Generally well-tolerated in clinical trials. Not FDA-approved in the US. Must be administered parenterally.

## Studies

- Guekht AB, Moessler H, Novak PH, et al. (2011). *Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial*. Journal of Stroke and Cerebrovascular Diseases. Clinical trial. https://pubmed.ncbi.nlm.nih.gov/20656516/
  In a 24-week randomized, double-blind, placebo-controlled multicenter trial in vascular dementia, adding Cerebrolysin improved cognitive (ADAS-cog+) and global (CIBIC+) outcomes and was well tolerated.

## Status sources

- [Muresanu et al., Stroke 2016 (CARS RCT)](https://pubmed.ncbi.nlm.nih.gov/26564102/)
- [Guekht et al., J Stroke Cerebrovasc Dis 2011 (vascular dementia RCT)](https://pubmed.ncbi.nlm.nih.gov/20656516/)
- [Romania ANMDM marketing authorisation 4804/2012 — Cerebrolysin](https://www.anm.ro/_/_AMB/amb_4804_17.07.12.pdf)
- [WADA Prohibited List 2026](https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list)

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Educational reference only — not medical advice. No dosing information is published. Tiers rate the strength of published evidence, not effectiveness or safety.