Cerebrolysin 60mg vial

                                           NOT FOR HUMAN CONSUMPTION

Cerebrolysin is a parenterally administered neurotrophic compound derived from enzymatically digested porcine brain proteins. It contains a mixture of low molecular weight peptides (≤10 kDa) and free amino acids. This unique composition enables it to cross the blood–brain barrier and exert neuroprotective and neurorestorative effects similar to endogenous neurotrophic factors.It has been investigated for use in multiple neurological and neurodegenerative disorders, such as:

• Ischemic and hemorrhagic stroke

• Traumatic brain injury (TBI)

• Alzheimer’s disease and vascular dementia

• Parkinson’s disease

• Multiple sclerosis (MS)

Cerebrolysin has been available in Europe and Asia for several decades and is included in therapeutic protocols in countries such as Russia, China, and parts of Eastern Europe. However, its approval status and adoption vary globally due to inconsistent trial outcomes and regulatory standards.

2. Mechanism of Action

Cerebrolysin acts via pleiotropic mechanisms that reflect the multifunctionality of neurotrophins:

2.1 Neurotrophic Activity

• Mimics the effects of brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), and glial-derived neurotrophic factor (GDNF)

• Promotes neuronal survival, axon growth, and synaptic plasticity

2.2 Anti-apoptotic Effects

• Inhibits caspase-dependent apoptotic pathways

• Protects neurons from programmed cell death induced by excitotoxicity, oxidative stress, or ischemia

2.3 Antioxidant and Anti-inflammatory Action

• Reduces levels of pro-inflammatory cytokines (e.g., TNF-α, IL-1β)

• Limits microglial activation and oxidative damage

2.4 Modulation of Neurotransmission

• Enhances cholinergic transmission by upregulating acetylcholine synthesis

• Supports glutamatergic and dopaminergic systems, which may underlie its proposed efficacy in dementia and Parkinson’s disease

3. Clinical Applications and Efficacy

3.1 Stroke (Ischemic and Hemorrhagic)

Clinical Evidence:

• CARS trial (2013): Randomized controlled trial (RCT) in 208 patients with ischemic stroke showed that Cerebrolysin significantly improved motor recovery at 90 days (especially upper limb function).

• Meta-analyses suggest benefits in functional outcomes (modified Rankin Scale, NIH Stroke Scale) and cognitive recovery, though findings are not uniformly replicated.

Dosing:

• 30 mL IV daily for 10–21 days post-stroke

Limitations:

• Variability in trial design and endpoints; many studies are open-label or inadequately powered

3.2 Traumatic Brain Injury (TBI)

• Several studies, including RCTs and observational cohorts, report that Cerebrolysin improves Glasgow Outcome Scores, cognitive function, and activities of daily living (ADLs) in moderate to severe TBI.

• Thought to accelerate white matter repair and synaptic reorganization

3.3 Alzheimer’s Disease and Vascular Dementia

Evidence:

• Multiple small-to-moderate size RCTs report improvements in:

  • Mini-Mental State Examination (MMSE)

  • ADL scales (e.g., ADAS-Cog, CGI)

• Most benefit is seen in mild-to-moderate dementia over short-to-intermediate treatment periods (up to 6 months)

• Combination therapy with acetylcholinesterase inhibitors (e.g., donepezil) may have additive effects

Limitations:

• Longer-term efficacy and disease-modifying effects remain uncertain

• Some trials show minimal or no effect; methodological quality varies

3.4 Parkinson’s Disease

• Investigated as an adjunct to L-DOPA and dopamine agonists

• Shown to modestly improve bradykinesia, cognitive impairment, and motor fluctuations

• Neurotrophic support may help slow progression, but evidence is limited and exploratory

3.5 Other Indications

• Multiple Sclerosis: Pilot studies suggest improved cognitive processing and fatigue, possibly through anti-inflammatory mechanisms

• Spinal Cord Injury, Post-COVID cognitive dysfunction, and perioperative neurocognitive disorders are under exploratory investigation

4. Safety and Tolerability

Cerebrolysin has demonstrated an excellent safety profile across multiple trials and real-world studies.

Common Adverse Events:

• Mild injection site reactions

• Dizziness, headache, agitation, or transient confusion

• Rarely: seizures, particularly in patients with uncontrolled epilepsy

Tolerability:

• Well tolerated in elderly populations

• No significant interaction with standard neuropsychiatric medications

5. Pharmacokinetics

• Administered via intravenous (IV) or intramuscular (IM) injection

• Crosses the blood-brain barrier

• Elimination half-life is not well defined due to the peptide mixture’s complexity

• No accumulation with repeated use; not hepatotoxic or nephrotoxic

6. Regulatory Status and Availability

• Approved in over 50 countries, primarily in Eastern Europe, China, and Southeast Asia

• Not approved by the U.S. FDA or EMA due to:

  • Lack of large, consistent Phase 3 trial data

  • Regulatory concerns regarding standardization and peptide complexity

However, it remains widely used off-label and in integrative neurological clinics globally.

7. Conclusion

Cerebrolysin is a unique, multimodal neurotrophic therapy with demonstrated benefits in neuroprotection, neuroplasticity, and recovery in various central nervous system disorders. Despite promising clinical results in stroke, TBI, and dementia, inconsistent data and the lack of regulatory standardization have limited its widespread acceptance in Western medicine.

As ongoing and future large-scale, high-quality RCTs progress, Cerebrolysin may yet find a more formal place in global neurorehabilitative protocols. Meanwhile, its excellent safety profile, broad neurotrophic activity, and clinical versatility continue to support its use in select patient populations under expert guidance.

Key References

1. Lang W et al. (2013). “Cerebrolysin in stroke recovery after rehabilitation.” Stroke, 44(3): 682–689.

2. Guekht A et al. (2017). “Efficacy of Cerebrolysin in Alzheimer's Disease: A Meta-analysis.” Drugs & Aging, 34(6): 423–433.

3. Zhang C et al. (2019). “Efficacy and safety of Cerebrolysin in acute ischemic stroke: a meta-analysis of RCTs.” Neuropsychiatric Disease and Treatment, 15: 3731–3740.

4. Zhou Y et al. (2022). “Neurotrophic and neuroprotective treatment in TBI: Role of Cerebrolysin.” Brain Injury, 36(5): 634–642.