Scientific context only. Not medical advice, not a recommendation to use.
At a glance
Cerebrolysin (FPF-1070) is not a single peptide but a porcine-brain-derived preparation of low-molecular-weight peptides and free amino acids, produced by standardised enzymatic proteolysis. It is approved in several countries (including Austria, Russia and parts of Asia) for stroke, dementia and traumatic brain injury, but is not FDA-approved in the United States and not centrally approved by the EMA. Its efficacy is contested: Cochrane systematic reviews found no convincing benefit and flagged possible harm signals.
Not FDA-approved. Cerebrolysin has not been reviewed under any New Drug Application and is not approved for any medical indication in the United States.
Cerebrolysin is a mixture of low-molecular-weight peptides (predominantly below 10 kDa) and free amino acids obtained by enzymatic cleavage of lipid-free porcine brain proteins. The manufacturer and preclinical literature describe a neurotrophic and neuroprotective mode of action said to mimic endogenous neurotrophic factors; cell and animal models have reported effects on neuronal survival, synaptogenesis and anti-apoptotic signalling (including PI3K/Akt). Because it is a complex, incompletely characterised mixture, the precise mechanism in humans remains unclear.
02
Evidence at a glance
Reading note. The distribution shows on which evidence tier each observation sits. Strong colours mark stronger evidence — weaker tiers are deliberately visible, not hidden.
4 observations · 2 tiers
Human RCT
3
Preclinical
1
03
What the studies show
Preclinical
Zelle/Tier
Neuroprotective and neurotrophic effects observed in preclinical models (e.g. reduced neuronal cell death, promotion of synaptogenesis).
What does NOT follow: Preclinical findings do not translate directly to humans; Cerebrolysin is an incompletely characterised mixture.
Human RCT
Mensch
Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K 2023
In acute ischaemic stroke, a Cochrane review found no convincing benefit on all-cause mortality (moderate-certainty evidence).
What does NOT follow: The same review noted a possible increase in non-fatal serious adverse events.
Human RCT
Mensch
Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L 2019
In vascular dementia, some randomised trials reported improvements in cognition and global function.
What does NOT follow: The Cochrane assessment rates this evidence as very low due to high risk of bias and heterogeneity; clinically meaningful effects are not established.
Human RCT
Mensch
Poon W, Matula C, Vos PE, Muresanu DF, et al. 2020
In traumatic brain injury, the primary endpoint of the CAPTAIN I trial narrowly missed statistical significance in the intention-to-treat population.
What does NOT follow: Some secondary and per-protocol analyses were more favourable; the primary endpoint was formally not met.
04
Where studies disagree
Open question
Does Cerebrolysin have a proven clinical benefit in stroke and neurological disease?
POSITION A
Manufacturer-supported meta-analyses and some primary trials report favourable effects on early post-stroke recovery and on cognition.
POSITION B
Cochrane systematic reviews found no convincing benefit in acute ischaemic stroke and flagged possible harm signals (non-fatal serious adverse events); in vascular dementia the evidence is of very low quality.
CURRENT STATE · Efficacy remains scientifically contested. Differences in funding, risk of bias, endpoints and study design explain the diverging conclusions; despite approval in several countries, a consistent high-quality demonstration of efficacy is lacking.
05
Pharmacokinetics
No robust pharmacokinetic human data available. A model curve is not invented.
06
Routes of administration in the literature
Which routes of administration the available studies describe — neutral reporting, not a usage guide.
Intravenous
Investigated as an intravenous infusion in clinical studies.
Intramuscular
Also used intramuscularly in approving countries.
06d
Safer use & risks
Risk notes for harm reduction — descriptive, not a usage or dosing guide.
⚠ Important — please read
This platform does NOT provide usage or dosing instructions. The points below describe risks and are meant to help avoid harm — they do not replace medical advice. Anyone who uses a substance should discuss it with a doctor.
This substance is approved (in at least one country) — use belongs in medical hands, within the approved indication and a physician-set dose.
Online numbers are not a benchmark
Amounts from TikTok, YouTube and forums are mostly imitation rather than data — and are often wrongly derived from animal studies (µg/kg). Not a reliable benchmark for humans.
Sterility & infection risk
Injection solutions prepared or stored non-sterile carry an infection and abscess risk. Contamination is common with grey-market product.
Unknown product quality
Research-/grey-market product is not quality-tested: identity, purity and actual content are often unknown, and counterfeits occur.
Mind interactions
Combinations with medications or pre-existing conditions can carry risks (see the Interactions section). Clarify with a doctor beforehand.
Warning signs — seek medical help
With persistent pain, redness/swelling at the injection site, fever, shortness of breath, racing heart, chest pain or allergic reactions, seek medical help immediately.
A doctor, not a forum
Concrete questions about use and amount belong in a conversation with a doctor — not in a comment thread.
07
Known adverse events from studies
Factual reporting of what studies observed. Not a safety statement for individual use.
Human RCT
Non-fatal serious adverse events
The Cochrane stroke review flagged a possible increase in such events, particularly with higher treatment schedules.
07b
Interactions & combinations
Documented interactions and contraindications from studies, prescribing information and guidelines. Where no data exists, this is stated.
Reporting of risks, NOT a combination guide. The absence of an entry does not mean „safe to combine“ but „not sufficiently studied“.
No documented interactions recorded
We have not yet found robustly documented interactions for this peptide. This does NOT mean none exist — the data is limited.
11
Legal status by country
Country
Status
Note
Checked
United States
Unapproved
Not FDA-approved. Cerebrolysin has not been reviewed under any New Drug Application and is not approved for any medical indication in the United States.
2026-06-07
Germany
Unclear
There is no central EMA approval. The national status in Germany is reported inconsistently; broad regular availability as an approved medicine is not clearly documented. Factual statement, no sourcing guidance.
2026-06-07
Austria
Prescription
Approved in Austria; the manufacturer EVER Neuro Pharma (Unterach) markets the preparation. Prescription-only.
2026-06-07
RU
Prescription
Approved and clinically used for neurological indications in Russia.
2026-06-07
CN
Prescription
Approved in China and other Asian countries (including South Korea) for indications such as stroke and dementia.
2026-06-07
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Reconstitution calculator
Pure mg/mL maths — works like a calculator. Not a usage recommendation.
Peptides ship as a dry powder. Once dissolved in a liquid (reconstitution), this calculator answers a single question: how much substance is in one millilitre of solution afterwards?
1Enter the vial's substance amount (printed on the label).
2Enter how much solvent you add.
3Result = concentration in mg per mL.
Printed on the label
/
Liquid you add
=
2.50
mg / mL
5 mg in 2 mL gives 2.50 mg/mL — each millilitre contains 2.50 mg of substance.
Poon W, Matula C, Vos PE, Muresanu DF, et al. · 2020
Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial