CEREBROLYSIN


Cerebrolysin is a mixture of peptides and amino acids obtained from porcine brain tissue. It has shown marked improvements in patients with Alzheimer's patients with mild to moderate symptoms. 

CEREBROLYSIN OVERVIEW

Category: Porcine Brain-Derived Peptide Mixture, Neuropeptide Drug

 

How It Works: acts as a multimodal neuropathic factor analog. Promotes neuroprotection, neurogenesis, and neuroplasticity. It does this by mimicking endogenous growth factors (BDNF, NGF)

 

Chemical Structure:  Complex mixture of low molecular weight peptides and free amino acids. 

Alternative Names: FPF-1070, Cerebroprotein Hydrolysate

 

 

CAS Number: Not Applicable

WHAT IS CEREBROLYSIN

Cerebrolysin is a mixture of several neurotrophic factors and active peptide fragments. It has a multimodal action on brain cells, including neuroprotection, neuroregeneration, and angiogenesis. Injections consist of biological peptides that enhance nerve repair. 

Unlike synthetic peptides, Cerebrolysin is a hydrolysate. Hydrolysates are natural blends of breakdown products. Therapeutic factors are attributed to their overall composition, which structurally and functionally mimics endogenous neurotrophic factors (NTFs).

Sourced from porcine (pig) brain tissues, the mixture has fragments similar to or identical to growth factors such as brain-derived neurotrophic factor (BDNF), Nerve growth Factor (NGF), and Ciliary neurotrophic factor (CNTF). 

WHAT DOES CEREBROLYSIN DO?

Thanks to its classification as a multi-modal neuroprotective and neurorestorative agent, its core function is to enhance the brain's natural self-healing factors by targeting the neurovascular unit (NVU), which is the brain's blood vessels and neural tissue. On top of this, it acts on the central nervous system to protect nerves and improve brain function. 

1.) Nuroprotection (Acute Phase): It protects existing neurons from damage immediately following acute injuries (such as stroke or TBI) by inhibiting further pathological cascades. 

  • Rudces excitotoxicity (damage caused by overstimulation)
  • Decreases apoptosis (programmed cell death) by inhibiting enzymes like caspase-3.
  • Rudces oxidative stress and neutralizes free radicals. 

2.) Neurotrophic Support and Neuroplasticity (Recovery Phase): Stimulates the maintenance and repair of neuronal networks:

  • Mimics & modulates NTFs: promoting neuronal survival, differentiation, and migration. 

BENEFITS/ CLINICAL TRIALS

 Cerebrolysin has been pushed through the trial phase in many countries (Eastern Europe, China, and many parts of Asia) thanks to the results shown in clinical trials and meta-analyses. However, in the United States, Cerebrolysin has not been approved by the FDA.

Documented Benefits: 

  • Stoke: reduced the furthering of neuronal death, showed an accelerated motor function recovery, and improved the independence and quality of life for patients who were administered Cerebrolysin within the acute phase (within 72 hours of stroke)
  • Alzheimer's Disease (Mild to Moderate): meta-analyses show overall beneficial effects. Including improvement to cognitive function and global clinical change. Further analyses show it could also be beneficial in combination with other approved drugs. 
  • TBI: shows efficacy in promoting early recovery, improving memory, and concentration. 
  • Vascular Dementia: has shown statistically significant improvements in cognitive function and overall clinical function when used in cycles.

Clinical Trials:

  • Multiple randomized, double blind, placebo-controlled trials have shown favorable outcomes in regards to dementia and TBI. A large-scale trial showed marked improvement in dementia patients lasting up to 24 weeks. 
  • Many studies have shown benefit; however, some large-scale trials have yielded inconsistent results. This has led to some global guidelines to neither strongly encourage nor discourage the use of Cerebrolysin. 

SIDE EFFECTS

Common Side Effects: 

  • Injection site redness
  • Nervous system: headaches, dizziness, agitation, and restlessness (often attributed to the stimulating effects of Cerebrolysin)
  • Gastrointestinal: Nausea, vomiting, indigestion, and diarrhea.
  • Systemic: mild fever, feeling hot, and on rare occasions, irregular heartbeats or chills. 

Cautions: 

  •  Epilepsy/Seizure Disorder: has a chance to increase seizure frequency
  • Hypersensitivity: known allergy to any components inside of Cerebrolysin (such as the porcine-derived material).

IS CEREBROLYSIN SAFE?

While Cerebrolysin is generally considered safe and well-tolerated, with its adverse events being mild and transient in nature, many events were comparable to events shown in the placebo group.

Other Factors:

AlcoholCONSULT YOUR DOCTOR. It is not known whether it is safe to consume alcohol with Cerebrolysin Injection. Please consult your doctor.

Pregnancy: CONSULT YOUR DOCTOR. Information regarding the use of Cerebrolysin Injection during pregnancy is not available. Please consult your doctor.

Breastfeeding: CONSULT YOUR DOCTOR. Information regarding the use of Cerebrolysin Injection during breastfeeding is not available. Please consult your doctor.

Driving: UNSAFE. Cerebrolysin Injection may decrease alertness, affect your vision, or make you feel sleepy and dizzy. Do not drive if these symptoms occur.

Kidney: UNSAFE. Cerebrolysin Injection is unsafe to use in patients with kidney disease and should be avoided.

Liver: CONSULT YOUR DOCTOR. There is limited data available on the use of Cerebrolysin Injection in patients with liver disease.

DOSAGE

Cerebrolysin is a prescription drug administered in a clinical setting in countries where it is approved. It is administered daily in cycles lasting between 10 to 30 days, with repeat cycles recommended 2-4 times per year.

  • Administration Routes: Intramuscular (IM), Intravenous (IV) push, or IV infusion.

  • IM Injection: Up to 5 mL undiluted, injected slowly over 3 minutes.

  • IV Push: Up to 10 mL undiluted, injected slowly over 3 minutes.

  • IV Infusion (Preferred for Higher Doses): 10 mL to 50 mL diluted in 100 mL of standard solution (e.g., saline, 5% glucose) and infused over 15-60 minutes.

  • Typical Daily Doses (Clinical Use):

    • Acute Stroke/TBI: 20 mL to 50 mL daily.

    • Dementia (Alzheimer's/Vascular): 10 mL to 30 mL daily.

RECONSTITUTION

Cerebrolysin is typically supplied as a pre-mixed aqueous solution.

Dilution of Commercial Aqueous Solution (Standard Practice)

Cerebrolysin is supplied as a ready-to-use liquid in ampoules (e.g., 5 mL or 10 mL).

  • Mixing for Infusion: If the dose exceeds 10 mL (requiring IV infusion), the volume must be diluted immediately before use with standard solutions such as 0.9% Sodium Chloride (saline), 5% Glucose solution, or Ringer’s Lactate.

  • Post-Opening: The solution must be administered immediately after opening the ampoule to maintain sterility. Any unused portion must be discarded.

  • Storage: Store at room temperature or refrigerated, protected from light.

Reconstitution of Powder for High-Concentration Stock (Research Practice)

If the compound is sourced as a lyophilized powder (e.g., 60 mg research vial) to create a highly concentrated solution for subsequent dilution:

  • Reconstitution Fluid: Use sterile or bacteriostatic water (BAC Water).

  • Dilution Ratio (60 mg Powder): To achieve a concentration of 20 mg/mL (a high research standard), add 3 mL of BAC Water to the 60 mg powder.

    • Calculation: 60 mg/ 3 mL = 20 mg/mL

  • Mixing Technique: Inject the BAC Water slowly down the side of the vial. DO NOT SHAKE vigorously. Gently swirl or roll the vial between your hands for several minutes until the powder is completely dissolved and the solution is clear.

  • Post-Reconstitution Storage (Powder Derived): Once reconstituted, the solution must be stored in the refrigerator (2C to 8C or 36F to 46F) and is typically stable for 14 to 28 days.

Step by step guidelines

WHERE TO BUY CEREBROLYSIN

Researchers should always vet their sources to ensure that a few key factors are present in their test subjects. With the rise in peptide popularity in recent years, many companies have created peptides that undergo little to no testing, quality standards, or regulations. As it is not regulated by the FDA, researchers must do their due diligence and look closely at the company's practices and standards. 

When selecting a supplier for Cerebrolysin, focus on transparency and quality assurance, not customer testimonials:

  1. Quality Documentation: A reputable supplier must provide:
    •  Certificate of Analysis (COA): This document must be recent (corresponding to the batch/lot number purchased) and demonstrate a minimum purity of >95% via High-Performance Liquid Chromatography (HPLC) testing.
    • Mass Spectrometry (MS) Data: The COA must include mass spectrometry (MS) confirmation to verify the compound’s exact molecular weight, confirming its chemical identity.
    • Contaminant Testing: Look for reports on heavy metals, microbial load, and solvent residues (e.g., residual trifluoroacetic acid, or TFA). The presence of these contaminants can severely compromise research and introduce unknown toxicity.
  2. Vendor Verification and Transparency 
    • Specialization: Prioritize vendors who specialize in the manufacturing and distribution of peptides for academic and biotechnology research, rather than general supplement vendors.

    • Manufacturing Origin: Inquire about the source of the raw materials and the manufacturing protocols. Ideal suppliers adhere to strict quality control processes.

    • Handling & Storage: The supplier must provide clear documentation on the proper storage and handling procedures for the peptide to maintain its stability and integrity.

Conclusion on Procurement: Given the high risk of contamination, mislabeling, and legal ambiguity. The use of Cerebrolysin outside of this defined research context poses unacceptable, unquantified risks to human health.

REFERENCES

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