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The Peptide Effect
approvedNeuroprotection & Cognitive

Cerebrolysin

Also known as: FPF-1070, Cerebrolysate

Cerebrolysin is a proprietary neurotrophic peptide preparation derived from purified porcine (pig) brain proteins. It consists of a standardized mixture of low-molecular-weight neuropeptides (approximately 25%) and free amino acids (approximately 75%) that mimic the activity of naturally occurring nerve growth factors. Approved in over 40 countries for stroke recovery, Alzheimer's disease, and traumatic brain injury, Cerebrolysin is one of the most extensively studied neuroprotective agents, though it notably lacks FDA approval.

Key Facts

Mechanism
Cerebrolysin contains bioactive peptide fragments that functionally mimic brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), glial cell line-derived neurotrophic factor (GDNF), and ciliary neurotrophic factor (CNTF). These peptides activate intracellular signaling cascades including PI3K/Akt and MAPK/ERK pathways, promoting neuronal survival, synaptic plasticity, and neurogenesis. Cerebrolysin also inhibits calpain-mediated neurodegeneration, reduces amyloid beta aggregation, modulates tau phosphorylation, and attenuates glutamate excitotoxicity. Its multimodal mechanism affects multiple pathological processes simultaneously, which distinguishes it from single-target pharmaceutical approaches.
Research Status
approved
Half-Life
Short (peptide mixture — individual components vary)
Primary Use
Neuroprotection & Cognitive
Table of Contents

Benefits

  • Stroke recovery — multiple randomized controlled trials demonstrate reduced disability scores and improved functional outcomes when administered within 72 hours of ischemic strokestrong
  • Alzheimer's disease symptom improvement — meta-analyses show significant improvement in global clinical impression and cognitive function scores (ADAS-cog) compared to placebomoderate
  • Traumatic brain injury recovery — clinical evidence supports improved cognitive and functional recovery in moderate-to-severe TBI patientsmoderate
  • Enhanced neuroplasticity — promotes synaptogenesis, dendritic branching, and neurogenesis through neurotrophic factor mimicrymoderate
  • Vascular dementia improvement — preliminary clinical data shows cognitive benefit in patients with vascular cognitive impairmentpreliminary
  • Potential neuroprotection in Parkinson's disease — animal studies show dopaminergic neuron preservation; clinical evidence is limitedpreliminary

Dosage Protocols

RouteDosage RangeFrequencyNotes
Intramuscular injection5–10 mL dailyDaily for 10–20 day cyclesIM injection limited to 5 mL per injection site. For doses above 5 mL, split across two injection sites. Suitable for outpatient cognitive enhancement and mild neurodegenerative conditions.
Intravenous infusion (stroke/TBI)10–30 mL daily diluted in 100–250 mL normal salineDaily for 10–21 days; infuse over 15–60 minutesStandard protocol for acute stroke: 30 mL IV daily started within 72 hours of onset. For TBI: 10–30 mL IV daily. Must be diluted in physiological saline and infused slowly.
Intravenous infusion (Alzheimer's/dementia)10–30 mL daily diluted in normal salineDaily for 20 day cycles, repeated at 2–3 month intervalsAlzheimer's protocols typically use repeated 20-day cycles with 2–3 month intervals between courses. Higher doses (30 mL) have shown greater efficacy in clinical trials.

Medical disclaimer

Dosage information is provided for educational reference only. Always follow your prescriber's instructions and consult a qualified healthcare provider before starting any peptide protocol.

Side Effects

  • Dizziness — reported in approximately 5–10% of patients in clinical trials; usually mild and transientcommon
  • Headache — one of the most frequently reported adverse events; generally mildcommon
  • Injection site pain — particularly with intramuscular administration of larger volumescommon
  • Agitation or restlessness — occasionally reported, especially in elderly patients or at higher dosesrare
  • Fever — low-grade temperature elevation reported infrequently, may reflect immune response to porcine-derived peptidesrare
  • Allergic reaction — rare hypersensitivity reactions possible due to porcine origin; contraindicated in patients with known pork allergyserious

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Frequently Asked Questions

Is Cerebrolysin safe given its porcine (pig) origin?
Cerebrolysin has been used clinically for over 40 years in over 40 countries with a well-established safety profile. The manufacturing process purifies and standardizes the peptide mixture, removing large proteins and potential pathogens. The risk of prion disease transmission is considered negligible due to the enzymatic proteolysis process. However, patients with known allergies to pork or porcine-derived products should not use Cerebrolysin. Adverse reactions have been generally mild across thousands of patients in clinical trials.
Why is Cerebrolysin not FDA approved?
Cerebrolysin has never been submitted for FDA approval by its manufacturer (EVER Neuro Pharma, Austria). The US regulatory pathway would require extensive and expensive Phase 3 clinical trials specifically conducted under FDA oversight. Additionally, Cerebrolysin is a complex biologic mixture rather than a single molecular entity, which adds regulatory complexity. The manufacturer has focused on markets in Europe, Asia, and South America where it is already approved and widely used. Some US clinics offer it through compounding pharmacies or as an imported medicine.
How is Cerebrolysin administered — IV or IM?
Both routes are used, depending on the indication and setting. Intravenous infusion (diluted in saline) is preferred for acute conditions like stroke and TBI, as it allows larger doses (up to 50 mL) and faster distribution. Intramuscular injection is more practical for outpatient use and cognitive enhancement but is limited to 5 mL per injection site. IV administration should be performed by healthcare professionals. The peptides are not orally bioavailable, so oral administration is not an option.
How long do Cerebrolysin treatment cycles last?
Standard treatment cycles are 10–20 days of daily injections or infusions. For chronic conditions like Alzheimer's disease, cycles of 20 days are typically repeated every 2–3 months. Acute conditions (stroke, TBI) may use continuous daily treatment for up to 21 days starting as early as possible after the event. Some cognitive enhancement protocols use shorter 10-day cycles with monthly breaks. The cumulative evidence suggests that repeated cycles produce better long-term outcomes than single courses.
Is there strong evidence that Cerebrolysin works for Alzheimer's?
The evidence is moderate and mixed. A 2015 Cochrane review found that Cerebrolysin showed statistically significant improvements in global clinical impression scores in Alzheimer's patients, but noted that the clinical relevance of these improvements was uncertain and that trial quality was variable. Several meta-analyses have confirmed benefits on cognitive scores (ADAS-cog) and global impression, but effect sizes are modest. It is approved for Alzheimer's treatment in several countries but is not considered a first-line therapy. It is typically used as an adjunct to standard treatments like cholinesterase inhibitors.

References

  1. 1
    Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial(2013)PubMed ↗
  2. 2
    A global clinical measure versus the conventional outcome measures in a randomized controlled trial of Cerebrolysin in acute stroke(2011)PubMed ↗
  3. 3
    Cerebrolysin in Alzheimer's disease: a randomized, double-blind, placebo-controlled trial with a neurotrophic agent(2006)PubMed ↗
  4. 4
    Cerebrolysin for acute ischaemic stroke — Cochrane systematic review(2020)PubMed ↗

Last updated: 2026-02-14