Every other compound in this catalogue has a dose that is, in principle, a mass — so many micrograms, so many milligrams, per dose or per kilogram. Cerebrolysin does not, and cannot.
It is dosed in millilitres, and that single fact explains most of what is unusual about it.
What it is
The current Cochrane review describes Cerebrolysin as a mixture of low-molecular-weight peptides and amino acids derived from porcine brain.
It is a biological extract, not a defined molecule. There is no single active ingredient to weigh, so there is no milligram figure to state, so the dose is the volume of solution administered. Everything downstream follows from that: the arithmetic this site does on reconstitution has nothing to work on here, because there is no concentration of a named active to divide into.
The 2023 Cochrane review pools it with what it calls Cerebrolysin-like agents, adding a trial of Cortexin — a comparable preparation derived from cattle brain. That the category is defined by preparation method rather than by molecule is itself the point.
Where it is licensed
There is no FDA approval and no US label, so the brief for this page — build it from the foreign label — is the only way it can be built.
A 2026 regulatory analysis in the International Journal of Risk and Safety in Medicine (2026;37(2):257–264) mapped exactly this question across nine countries' pharmaceutical registries. Its findings for Cerebrolysin:
| Status | |
|---|---|
| Registration across the Commonwealth of Independent States | Registered |
| National essential medicines lists | Listed in Russia, Armenia, Belarus, Kazakhstan, Uzbekistan |
| Russian clinical practice guidelines for Alzheimer's | Recommended as adjuvant therapy |
| WHO Model List of Essential Medicines | Not included |
| US, EU and UK clinical practice guidelines for Alzheimer's | Not mentioned as a treatment option |
That is not a gap in the record. It is two regulatory systems reaching opposite conclusions about the same product, and a reader who has only seen one of them has seen half the picture.
The registered doses
From the ClinicalTrials.gov v2 API on 20 September 2026: 42 studies list Cerebrolysin as an intervention. The dose figures their protocols state:
| Schedule | Route | Trial | Population |
|---|---|---|---|
| 0.1 mL/kg once weekly for 12 months (48 injections) | Intramuscular | NCT04751136, Phase 2, n=64, Mansoura University Children's Hospital | Infants with Down syndrome |
| 10 mL daily, 5 days a week for 4 weeks, repeated weeks 13–16 | Intravenous infusion | NCT00911807, Phase 2, n=217, Ever Neuro Pharma | Alzheimer's disease |
| 30 mL in 100 mL dilution, daily for 21 days | Intravenous | NCT02768571, Phase 4, n=80, Samsung Medical Center | Subacute stroke, with rehabilitation |
| 30 mL in 70 mL saline, days 4–17, once daily | Intravenous | NCT04427241, Phase 4, n=12, Konkuk University Medical Center | Prolonged disorders of consciousness |
| 50 mL in 50 mL saline, two 10-day courses 7 days apart | Slow intravenous drip | NCT02581371, Phase 4, n=30 | Ischaemic stroke |
| Per local marketing authorisation | — | NCT02541227, n=1,823, terminated | Stroke registry study |
From 0.1 mL/kg to 50 mL a day is roughly a 500-fold range by volume, across indications from infant developmental support to acute stroke. These are registered protocols. They are reported here as record and nothing on this page is a dosing instruction.
The finding: one schedule has a harm signal attached to it
This is the part worth carrying away, and it is the reason a dosage page for this compound is worth writing at all.
The current Cochrane review — CD007026.pub7, published 11 October 2023, seven randomised controlled trials, 1,773 participants — reports:
| Outcome | Result | Certainty |
|---|---|---|
| All-cause death | RR 0.96 (95% CI 0.65–1.41), 6 trials, 1,689 participants | Moderate |
| Total people with serious adverse events | RR 1.16 (0.81–1.66), 3 trials, 1,335 participants | Moderate |
| Fatal serious adverse events | RR 0.90 (0.59–1.38) | Moderate |
| Non-fatal serious adverse events | RR 2.39 (1.10–5.23), 3 trials, 1,335 participants | Moderate |
| Same, at 30 mL/day × 10 days (cumulative 300 mL) | RR 2.87 (1.24–6.69), 2 trials, 1,189 participants | — |
The authors' conclusion, in their own summary: moderate-certainty evidence indicates no beneficial effect on preventing all-cause death, no beneficial effect on the total number of people with serious adverse events, and a potential increase in non-fatal serious adverse events.
The pooled figures, the largest single trial (CASTA, 1,070 patients, null on its confirmatory endpoint) and the regulatory history are set out on this site's cognitive peptides page and are not restated here. What that page does not carry is the subgroup line below.
The subgroup line is the unusual one. Across every compound in this catalogue, this is the only instance where a systematic review has isolated a specific dosing schedule — 30 mL a day for ten days, 300 mL cumulative — and reported a larger harm signal at it. Most dose figures in this market travel with no safety analysis attached at all. This one travels with a confidence interval that excludes 1.
Anyone reading "30 mL for 10 days" as the Cerebrolysin stroke dose should know that this is the schedule the review named.
What the trials did not measure
A second line in the same review deserves as much attention as the results.
None of the included studies reported poor functional outcome — death or dependence at the end of follow-up — or early death, or quality of life, or time to restoration of capacity for work.
For a stroke treatment, those are the outcomes that matter to a patient. Seven randomised trials and 1,773 participants produced a readable answer on all-cause mortality and on adverse events, and no answer at all on whether anybody recovered better. That absence is a fact about the evidence base and it is not visible in any dose figure.
Who paid for the trials
The review records that the manufacturer of Cerebrolysin supported three multicentre studies — wholly, or by providing Cerebrolysin and matching placebo, randomisation codes, research grants, or statisticians — and judged several of the included studies to be at high or unclear risk of other bias.
This does not make the trials wrong. It is part of the record, it is stated in the review itself, and it never appears beside the dose figures in circulation.
Method
The registry census was run against the ClinicalTrials.gov v2 API on 20 September 2026, taking dose figures from the intervention description fields of the protocols named above. Cochrane figures are from CD007026.pub7, the current version as of that date, confirmed current by checking that its predecessor CD007026.pub6 (2020) is marked superseded rather than quoting the older numbers — the two versions differ, and the pooled counts and funding statement here are the 2023 ones. The regulatory mapping is from Int J Risk Saf Med 2026;37(2):257–264.
Related dose records in this catalogue: the dosage chart indexes every compound here by the tier of evidence behind its figure, and how to read a dosing claim covers what a registered protocol figure does and does not establish.