Good Evidence That Says No
Cerebrolysin
At a glance
- What it is
- Porcine-brain peptide mixture. Cochrane found more non-fatal serious adverse events.
- Evidence
- Clinical trialsHow the tiers workCochrane review CD007026.pub7, published 11 October 2023 with evidence to June 2022, pooled 7 randomised trials and 1,773 people with acute ischaemic stroke. Why this tier
- Half-life
- Not established in available literature
- Routes
- Intravenous
- Category
- Cognitive
- WADA
- We do not state a status
Putting Cerebrolysin on a schedule, with the vial it comes from and a log of each dose, happens in the app: Claritide for iPhone.
Why this tier
Cochrane review CD007026.pub7, published 11 October 2023 with evidence to June 2022, pooled 7 randomised trials and 1,773 people with acute ischaemic stroke. Cerebrolysin probably results in little to no difference in the total number of people with serious adverse events (RR 1.16, 95% CI 0.81–1.66, moderate certainty), comprising fatal serious adverse events at RR 0.90 (0.59–1.38) and a statistically significant increase in non-fatal serious adverse events at RR 2.39 (1.10–5.23). Probably no beneficial effect on all-cause death. The review notes only seven studies and pharmaceutical company involvement in three of them. A 2025 systematic review of 14 trials reported improved neurological recovery (NIHSS mean difference 1.39) with a non-significant trend for functional independence, a counterweight, not a refutation. NCT04124367 (IMPULSE) is terminated.
What it is
Cerebrolysin is a peptide mixture derived from porcine brain, not a single defined peptide, approved in more than 50 countries for stroke, traumatic brain injury, vascular dementia and Alzheimer’s disease. It is not FDA-approved and has no US regulatory pathway. It is here because it is one of the few compounds in this library where good-quality evidence exists and the answer it gives is no.
How it works
Cerebrolysin is a mixture of low-molecular-weight peptides and free amino acids produced by enzymatic breakdown of purified porcine brain protein. Because it is a mixture rather than a defined molecule, its mechanism is described at the level of effect rather than target: neurotrophic activity said to resemble endogenous growth factors, plus proposed neuroprotective effects on excitotoxicity and apoptosis. The absence of a single characterised active constituent is not a detail. It is why batch-to-batch definition and mechanistic study are both difficult.
Commonly researched ranges
- European guidance dose (acute ischaemic stroke)30 mL
Diluted to 100 mL of saline. 2021 European Academy of Neurology and European Federation of NeuroRehabilitation Societies guidance recommends this as an adjunct to early motor rehabilitation. It is an infusion given in a clinical setting.
| Phase | Amount | Frequency | Timing | Note |
|---|---|---|---|---|
| European guidance dose (acute ischaemic stroke) | 30 mL | Daily for at least 10 days | Not established in available literature | Diluted to 100 mL of saline. 2021 European Academy of Neurology and European Federation of NeuroRehabilitation Societies guidance recommends this as an adjunct to early motor rehabilitation. It is an infusion given in a clinical setting. |
- Cycle guidance
- The guidance protocol is a course of at least 10 daily infusions, not an ongoing regimen.
- Goals
- Cognition
Where this sits with the FDA
Approved in more than 50 countries and not FDA-approved, with no US regulatory pathway. Anything obtained in the US is imported, and a porcine-brain-derived biological product is not a category where an unverified supply chain is a small risk.
Primary sourceWADA status
Not named on the 2026 Prohibited List. We could not determine a classification and do not state one.
We looked and could not resolve it. This is not the same as "not prohibited". Treat it as unresolved and check with your federation before competing.
There is nothing to mix
Not applicable. None of the published routes for this compound take a diluent, so there is no concentration to calculate and no beyond-use window to track.
Week by week
Not established in available literature.
Side effects
Uncommon
- Non-fatal serious adverse events
Contraindications and interactions
Do not use if
Not established in available literature.
Interactions
Not established in available literature.
Absence from this list does NOT mean safety. It means lack of research.
Storage and cost
- Storage
- A manufactured solution diluted into saline for infusion in a clinical setting. There is no home reconstitution.
- Cost
- Not established in available literature
Cerebrolysin in full
Limited coverage
Cerebrolysin is a peptide mixture derived from porcine brain, produced by enzymatic breakdown of purified brain protein. It is not a single defined peptide, which matters for everything downstream: mechanism, batch consistency and study design.
It is approved in more than 50 countries for stroke, traumatic brain injury, vascular dementia and Alzheimer's disease. It is not FDA-approved and has no US regulatory pathway.
Why we carry it
Because it is the clearest case in this library of good evidence that says no, and a library that only publishes compounds with encouraging data is a catalogue.
Cochrane review CD007026.pub7, published 11 October 2023 with evidence current to June 2022, pooled 7 randomised trials and 1,773 people with acute ischaemic stroke.
- Total serious adverse events: RR 1.16, 95% CI 0.81–1.66, moderate certainty, probably little to no difference.
- Fatal serious adverse events: RR 0.90, 0.59–1.38.
- Non-fatal serious adverse events: RR 2.39, 95% CI 1.10–5.23, a statistically significant increase.
- Probably no beneficial effect on all-cause death.
More harm of one specific kind, no mortality benefit. The review's own stated limitations matter too: only seven studies, and pharmaceutical company involvement in three of them.
The counterweight
A 2025 systematic review of 14 randomised trials reported improved neurological recovery, with a mean difference of 1.39 on the NIH Stroke Scale, and a non-significant trend toward functional independence. European guidance from 2021 recommends 30 mL daily intravenously for at least 10 days as an adjunct to early motor rehabilitation.
So the picture is not unanimous. It is a moderate-certainty Cochrane finding of no benefit and a specific harm signal, against a positive but smaller-effect review with a non-significant functional endpoint. NCT04124367, IMPULSE, is terminated.
That is what a real evidence base looks like when it is not going anywhere good.
Sources
Every record in this library is free to read, and it stays free. Your own schedule, vials and log live in the app: Claritide for iPhone.