Description
PrymaLab · Research Use Only
Cerebrolysin Nasal Spray
Porcine brain-derived peptide preparation · mixture, not a single molecule
Cerebrolysin nasal spray supplies a peptide preparation obtained by enzymatic breakdown of purified porcine brain tissue. Every other product in this catalogue is a defined molecule with a CAS number and a molecular weight. This one is not. That difference governs how it can be verified, cited and compared.
Specification Table
| Property | Value |
|---|---|
| Product type | Biological preparation. A mixture of low molecular weight peptides and free amino acids |
| Single molecular entity | No. There is no one compound to assign a structure to |
| CAS number | None applicable to the preparation as a defined substance |
| Molecular weight | Not applicable. Component peptides are reported below approximately 10 kDa |
| Source material | Purified porcine brain tissue |
| Production method | Standardised enzymatic breakdown, followed by removal of protein and lipid |
| Reported composition | Predominantly free amino acids, with a minority fraction of low molecular weight peptides |
| Sequence | Not definable. The peptide fraction is heterogeneous |
| Originator | Developed and marketed by EVER Pharma |
| Approval status abroad | Approved as an injectable in a number of countries including Russia, China and several CIS and Asian states |
| United States status | Not approved by the FDA for any indication |
| Approved route where authorised | Parenteral. No approved nasal formulation exists anywhere |
| Format | Metered nasal spray, solution state |
| Physical state | Aqueous solution, supplied ready to use |
| Purity | Per lot-specific certificate of analysis |
| Storage | 2-8°C, protected from light. Do not freeze |
| Regulatory status of this product | Research chemical. Not the approved injectable preparation in a different container |
Why Does Cerebrolysin Nasal Spray Need Different Questions?
Almost every quality question that works elsewhere in this catalogue fails here, and understanding why is the most useful thing this page can offer.
A defined peptide has a sequence, a formula, a molecular weight and a CAS registration. Those four facts let a buyer ask whether the material in the bottle matches them.
This preparation has none of them. It is what remains after purified porcine brain tissue is broken down enzymatically and the protein and lipid fractions are removed.
What comes out is a mixture, reported as predominantly free amino acids with a minority fraction of low molecular weight peptides below roughly 10 kilodaltons.
There is no single molecule to weigh, no sequence to confirm and no purity figure in the sense that word carries for a synthetic compound.
Asking a supplier for the molecular weight or the CAS number of this product is asking a question that has no answer, and a vendor who supplies one has invented it.
The questions that do work concern the process rather than the molecule: source material, production method, and how consistency between lots is demonstrated.
That shift from product specification to process specification is the whole difference, and it is the reason this page is structured the way it is.
How Is a Mixture Verified at All?
Verifying cerebrolysin nasal spray rests on reproducibility of a process rather than identity of a compound, which is a lower bar in one sense and a higher one in another.
Amino acid analysis is genuinely useful here, unusually so. It returns a quantitative profile of the free amino acid fraction, and that profile should be consistent between lots of a well-controlled preparation.
Size exclusion chromatography characterises the peptide fraction by size distribution, which is the closest available analogue to a purity chromatogram.
Total nitrogen or total peptide content by a colorimetric method gives a bulk concentration figure, and it is what most specifications for preparations of this kind rely on.
None of those confirm identity in the way a mass spectrum confirms a synthetic peptide. They confirm that the material resembles previous material.
That is why lot-to-lot comparison matters more here than anywhere else in this catalogue. A single certificate in isolation says very little.
A supplier able to show the same profile across several lots has demonstrated something meaningful. One offering a single number has not.
For a study spanning months, holding the work on one lot removes a variable that cannot be recovered afterwards, and here that variable is larger than for any defined compound.
What Is the Regulatory Position?
This compound has an unusual status that is easy to state incorrectly in either direction, so it is worth setting out precisely.
An injectable preparation under this name is approved in a number of countries, including Russia, China and several CIS and Asian states, where it has been in clinical use for decades.
It is not approved by the FDA for any indication in the United States, and there is no approved nasal formulation of it anywhere in the world.
So the accurate statement is neither that the compound is unapproved nor that it is approved. An injectable form holds approvals abroad, and this is not that form.
This product is a research chemical in a spray bottle. It is not the approved injectable preparation in a different container, and the two should not be treated as interchangeable.
The distinction matters when reading the literature, because a substantial share of the clinical record concerns the approved injectable given parenterally under a defined protocol.
Citing that record in support of a statement about a nasal research preparation crosses two gaps at once, the route and the product.
Anyone drawing on the published work should note which preparation, which route and which jurisdiction each study used.
What Does the Published Record Cover?
The literature here is larger than for most compounds in this catalogue and it is concentrated in a particular place.
Clinical work has been conducted over several decades, largely in the countries where the injectable holds approval, with neurological endpoints assessed by standard rating instruments.
A number of randomised trials and several meta-analyses exist. That is more than can be said for almost anything else in this range.
That literature has also attracted methodological criticism, including on trial design, outcome selection and the geographic concentration of positive results.
Independent replication outside the approving jurisdictions is thinner than the volume of publication suggests, and reading the meta-analyses alongside their critiques is worth the time.
Preclinical work reports neurotrophic activity in cell and animal models. That body of work is the mechanistic basis usually cited.
Intranasal delivery of this preparation has a very small literature, and the clinical record does not transfer to that route without an absorption argument that has not been made.
The honest summary is a substantial parenteral clinical record of contested quality, a preclinical mechanistic account, and almost nothing on the nasal route.
How Does the Mixture Affect Nasal Transport?
A defined molecule has one molecular weight and therefore one answer on transport. Cerebrolysin nasal spray does not. A mixture has a distribution, which changes the question.
Nasal absorption falls steeply with molecular weight, with the practical transition around 1,000 daltons where paracellular passage becomes inefficient.
The free amino acid fraction here sits far below that, in the low hundreds of daltons, where transport is comparatively efficient.
The peptide fraction spans a range up to roughly 10 kilodaltons, and the upper end of that range sits well into the region where transport is poor.
So different components of the same bottle cross the mucosa at very different rates, and what is delivered is not a scaled-down version of what was applied.
The composition of what crosses differs from the composition of what was sprayed, which is a consideration with no equivalent for a single-compound product.
That effect has not been characterised for this preparation in the published literature, so its magnitude is unknown rather than small.
For experimental design the implication is that this route delivers an ill-defined subset of an ill-defined mixture, which is a real limit on what a result can support.
Why Does the Source Material Matter?
A preparation derived from animal tissue raises a category of question that no synthetic compound in this catalogue does.
The starting material is purified porcine brain tissue, which means the product carries whatever the sourcing and purification steps failed to remove.
Removal of protein and lipid fractions is part of the standard process, and the specification for those steps is what separates a controlled preparation from an uncontrolled one.
Viral and prion safety in tissue-derived products is handled by sourcing controls and by process steps validated to inactivate or remove agents, and those are documented for approved manufacture.
A research preparation sold outside that framework may or may not carry equivalent controls, and the answer is not visible from a certificate of analysis.
Asking where the tissue came from and what inactivation steps were applied is therefore a reasonable question, and it is one that has no analogue for a synthetic peptide.
The same applies to endotoxin, which is routine to test for and frequently absent from specifications on research-grade material.
None of this is an argument against the preparation. It is an argument for knowing which questions apply to a tissue-derived product and asking them explicitly.
How Should the Spray Be Stored and Recorded?
Storing cerebrolysin nasal spray follows the general rules for a peptide mixture, with one addition that matters more here than elsewhere.
Hold the bottle between 2 and 8 degrees Celsius, protected from light, and do not freeze a solution-state product.
Microbial growth is the leading practical concern in an opened aqueous container, and a mixture rich in free amino acids is a more favourable growth medium than a solution of a single synthetic peptide.
That makes aseptic handling and attention to the opening date more important here than for the defined compounds in this range.
Visible cloudiness or particulate is a reason to stop using the bottle rather than to filter it and continue.
Record the lot above everything else. For a biological preparation the lot is a larger part of the sample identity than for any synthetic compound in this catalogue.
Log the stated concentration or total peptide content, the date first opened, the storage temperature and the actuation count alongside it.
Where a study spans more than one lot, say so in the methods rather than assuming equivalence, because equivalence between lots is precisely what cannot be assumed here.
What Is Cerebrolysin Approved For, and Where?
An approved product with this name exists, and separating it from what is on this page is the first thing a reader needs.
The approved preparation is a solution of porcine brain proteins, enzymatically digested down to low-molecular-weight neuropeptides and free amino acids. It is described by its manufacturer as a multi-modal neuropeptide drug.
It is supplied in ampoules and given by intravenous infusion or by intramuscular injection. An IM injection course over weeks is the usual pattern in the clinical literature.
It is licensed in a number of countries across Europe, Asia and the former Soviet states. It is not FDA-approved, and no nasal formulation is approved anywhere.
Indications in the jurisdictions that license it centre on stroke, dementia and traumatic brain injury.
The proposed mode of action is neurotrophic support. The claim is that the peptide fraction mimics neurotrophic factors such as BDNF and NGF, which are proteins far too large to be given as drugs.
Downstream, the MoA account runs through neurogenesis, neuroplasticity and protection against excitotoxicity, with calpain inhibition and reduced accumulation of toxic protein aggregates offered as supporting mechanisms.
Anti-inflammatory effects on pro-inflammatory cytokines and reduced oxidative damage from oxidative stress make up the rest of the neuroprotection argument.
That is a substantial mechanistic story for a mixture whose exact composition is not disclosed, which is the tension this product carries throughout.
What Does the Clinical Record Actually Show?
The trial record is larger than for anything else in this catalogue, and it is also genuinely contested.
Acute ischemic stroke is the most studied indication. The CARS trial reported benefit on functional recovery when the drug was added to neurorehabilitation after stroke.
Against that, Cochrane reviews of stroke recovery have concluded that the evidence does not establish benefit, and have raised concerns about trial quality and about serious adverse events.
Both of those statements are true at once, which is the honest summary a reader deserves rather than whichever half suits a listing.
Vascular dementia and Alzheimer’s disease have both been studied, with reported effects on cognitive impairment and on cognitive abilities measured by standard scales.
TBI is the third area, with traumatic brain injury trials reporting on functional recovery and brain function. Work in epilepsy and in other neurodegenerative diseases is thinner.
Reported side effects in that record include headaches, dizziness, agitation and injection-site reactions, with contraindications in severe renal impairment and in status epilepticus.
Drug interactions with antidepressants and MAO inhibitors appear in the prescribing information, and the excipients are part of why the injectable route matters clinically.
Every one of those findings describes the approved injectable preparation given at a stated dose under supervision. Not one of them describes a nasal spray.
No published study characterises this preparation given intranasally, so nothing in the trial record above transfers to this product.
How Does It Compare With the Nootropic Peptides?
This preparation is sold beside a group of compounds marketed for the brain, and it is the odd one out in that group.
Semax and Selank are defined sequences from a Russian programme. This is a mixture of unknown composition, which makes the comparison structural nonsense even where the marketing treats them as interchangeable.
What they share is a nootropic framing built on mental clarity, mental performance, memory loss and cognitive function, none of which is how the approved product is actually labelled.
NAD and its precursors turn up in the same listings for the same reason, and share nothing with any of them.
The one property worth comparing is size. Semax and Selank are single small peptides; this is a distribution of neurotrophic peptides across a range of masses, and only the lightest fraction has any chance of crossing an epithelium intact.
That is the whole difficulty with a mixture in a nasal format, and it is why neurological conditions treated with the approved product cannot be invoked for this one.
Published Literature
Selected references verified against the publisher record. Note that this literature concerns the approved injectable preparation given parenterally.
- (‘Ziganshina LE, Abakumova T, Hoyle CHV. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2020;7:CD007026.’, ‘https://doi.org/10.1002/14651858.CD007026.pub6’)
- (‘Masliah E, Diez-Tejedor E. The pharmacology of neurotrophic treatment with Cerebrolysin. Drugs Today. 2012;48 Suppl A:3-24.’, ‘https://doi.org/10.1358/dot.2012.48%28Suppl.A%29.1739716’)
- (‘Illum L. Nasal drug delivery: new developments and strategies. Drug Discov Today. 2002;7(23):1184-1189.’, ‘https://doi.org/10.1016/S1359-6446(02)02529-1’)
Frequently Asked Questions
What is Cerebrolysin nasal spray?
A metered aqueous solution of a peptide preparation obtained by enzymatic breakdown of purified porcine brain tissue. It is a mixture rather than a defined compound. Laboratory research use only.
Why does it have no CAS number?
Because a CAS registration identifies a defined substance and this is a mixture of low molecular weight peptides and free amino acids. Asking for a CAS number here is asking a question with no answer.
Does it have a molecular weight?
No. The component peptides are reported below roughly 10 kilodaltons, but there is no single molecule to weigh and no sequence to confirm.
So what should be asked instead?
Process questions rather than product questions. Source material, production method, and how consistency between lots is demonstrated. The shift from product specification to process specification is the whole difference.
How is a mixture verified?
Amino acid analysis for the free amino acid profile, size exclusion chromatography for the peptide size distribution, and total peptide or nitrogen content for bulk concentration. None confirms identity the way a mass spectrum does.
Why does lot comparison matter more here?
Because these methods confirm that material resembles previous material rather than confirming what it is. A supplier showing the same profile across several lots has demonstrated something. A single certificate has not.
What is the regulatory position?
An injectable preparation under this name holds approvals in a number of countries including Russia and China. It is not FDA approved in the United States, and no approved nasal formulation exists anywhere.
Is this product that approved preparation?
No. This is a research chemical in a spray bottle, not the approved injectable in a different container. Citing the clinical record for this product crosses two gaps at once, the route and the product.
What does the published record cover?
Several decades of clinical work largely in the approving countries, with randomised trials and meta-analyses, alongside methodological criticism of trial design and the geographic concentration of positive results.
How does the mixture affect nasal transport?
Differently across its components. The free amino acid fraction in the low hundreds of daltons crosses comparatively well, while the peptide fraction up to 10 kilodaltons sits well into the region where transport is poor.
What follows from that?
The composition of what crosses the mucosa differs from the composition of what was sprayed. That effect has not been characterised for this preparation, so its magnitude is unknown rather than small.
Is Cerebrolysin an approved drug?
The injectable preparation is licensed in a number of countries across Europe, Asia and the former Soviet states for stroke, dementia and TBI. It is not FDA-approved, and no nasal formulation is approved anywhere. This product is not the approved preparation.
How is the approved product given?
By intravenous infusion or intramuscular injection from ampoules, usually as an intramuscular course over weeks. Every clinical finding in the record describes that route at a stated dose under supervision, and none of it transfers to a nasal spray.
What is its proposed mode of action?
Neurotrophic support. The claim is that the peptide fraction mimics neurotrophic factors such as BDNF and NGF, which are proteins far too large to give as drugs. The MoA account then runs through neurogenesis, neuroplasticity and protection against excitotoxicity.
Does the stroke evidence hold up?
It is contested. The CARS trial reported benefit on functional recovery after acute ischemic stroke. Cochrane reviews of stroke recovery concluded the evidence does not establish benefit and raised concerns about trial quality. Both statements are true.
What are the reported neuroprotective effects?
An anti-inflammatory effect on pro-inflammatory cytokines, reduced neuroinflammation and oxidative damage, calpain inhibition and reduced toxic protein aggregates. Those are mechanistic claims for a mixture whose exact composition is not disclosed.
Does it cross the blood-brain barrier?
The low-molecular-weight fraction is argued to. That argument concerns the injected product reaching the brain from blood, which is a different question from whether anything in a mixture of NTF-mimicking peptides survives an epithelium, and nobody has measured the second one.
What is the main storage concern?
Microbial growth in an opened container. A mixture rich in free amino acids is a more favourable growth medium than a solution of a single synthetic peptide, so aseptic handling matters more here.
Compliance Statement
Cerebrolysin nasal spray is sold exclusively for laboratory research use. It is not a drug, food, or cosmetic product, and it is not a dietary product of any kind. It is not approved by the FDA or any comparable authority for human or veterinary use, this product is a research preparation rather than the injectable formulation approved in certain other countries, no approved nasal formulation exists in any jurisdiction, and the published clinical record concerns the approved injectable given parenterally. This product is not intended to diagnose, treat, cure, or prevent any disease. It must not be given to humans or animals. Purchase is restricted to qualified researchers and institutions operating within applicable laws. All handling is the responsibility of the purchasing laboratory.
5 reviews for Cerebrolysin 120mg Nasal Spray