Cerebrolysin Dosage: What the Trials Gave, and What the Largest One Found

Cerebrolysin at a glance

What it is

A porcine (swine) brain hydrolysate — MeSH supplementary concept C006952 defines it as a "swine brain hydrolysate containing amino acids and small peptides." It has no PubChem CID because it is a mixture, not a compound. Also indexed as FPF1070, Cerebrolysin Ebewe and Renacenz

Not a peptide, and not reconstituted

Supplied as a sterile aqueous solution for injection or concentrate for infusion, dosed in millilitres of solution and diluted in 0.9% saline. There is no lyophilised vial to dissolve and no syringe-unit conversion to make, so no reconstitution table on this page. (The solution does have a declared content per millilitre; what does not exist is any concentration for the reader to calculate.)

Researched for

Acute ischaemic stroke (the largest indication by trial volume), traumatic brain injury, vascular cognitive impairment and Alzheimer's dementia. Around 670 PubMed records and 62 randomised trials

Commonly reported range

The trial regimens, all intravenous: 30 mL/day in 100 mL saline for 10 days (stroke, the CASTA regimen); 50 mL/day for 10 days then two cycles of 10 mL/day (CAPTAIN, TBI); 10 mL/day five days a week for four weeks, repeated (Alzheimer's). These are hospital infusion protocols, not self-administered figures

Route reported

Intravenous infusion in essentially every controlled trial; intramuscular injection is used for smaller volumes in clinical practice. No trial has tested subcutaneous administration

What the largest trial found

CASTA, 1,070 patients, 30 mL daily for 10 days versus saline: the confirmatory endpoint showed no significant difference between groups (Stroke 2012, PMID 22282884). The positive claim from that trial comes from a post-hoc severity subgroup

Plasma half-life

Not established, and arguably not a well-formed question for a mixture. PubMed records pairing cerebrolysin with pharmacokinetics or half-life are few, and none reports a figure; the one that addresses the question does so qualitatively, describing a short half-life and poor stability as obstacles to its use (PMID 26108180). No number has a primary source we can trace

Regulatory status

Not FDA-approved — verified by absence on 2026-08-19: DailyMed returned zero labels against a database published 2026-08-18 and openFDA's Drugs@FDA returned no match. The Cochrane review records it as widely used in Russia, Eastern Europe, China and other Asian and post-Soviet countries; its manufacturer, EVER Neuro Pharma, is Austrian. Research use only here

Reported ranges from research/community — examples, not recommendations.

What it is / mechanism

Before any mechanism, the identity — because on this compound the identity is the story. Cerebrolysin is not a peptide. It is a hydrolysate: purified porcine brain tissue broken down enzymatically into free amino acids and low-molecular-weight peptides, then standardised and sold as a solution. The MeSH supplementary concept record for it (C006952) states this in seven words — a swine brain hydrolysate containing amino acids and small peptides — and lists cerebrolyzin, Cerebrolysin Ebewe, cerebrolysine, FPF1070 and Renacenz as the same thing. PubChem has no compound record for it at all, which is the correct outcome: a chemical database indexes molecules, and this is a mixture whose exact contents vary with the starting material and the manufacturing run. A related product, N-PEP-12, has its own MeSH record describing it as derived from cerebrolysin and "much less potent" but orally administrable. That matters for two practical reasons. First, there is no molecular weight, no sequence and no mass-spectrometry identity check for cerebrolysin. (A CAS Registry Number does exist, 12656-61-0 — but a registry number for a substance of biological origin names the preparation, it does not specify a structure, and nothing can be measured against it.) so a certificate of analysis cannot establish what a vial contains in the way it can for a defined peptide. Batch-to-batch consistency here is a claim about a manufacturing process, not a result you can verify from a number — and that is exactly the argument made in the clinical literature on the product, which states that strict process control ensures identity from batch to batch (PMID 36946392 — a single-author review in a Russian neurology journal, with no declared industry affiliation on the PubMed record). We located no independent published characterisation of the mixture's composition against which to check it. Second, everything measured in every trial was measured on one manufacturer's standardised preparation. Material sold under the same name from another source is not, in any verifiable sense, the same substance. The proposed mechanism is neurotrophic mimicry: the peptide fraction is described as crossing the blood-brain barrier and acting like endogenous neurotrophic factors, inducing neurogenesis, neuroplasticity and neuroprotection, with animal work pointing at PI3K/Akt signalling and reduced hippocampal apoptosis (for a closely related hydrolysate, PMID 34305399). Reviews describe the action as multimodal and pleiotropic (PMID 35268364, PMID 39832667). That framing is honest about what it is: a mechanism attributed to an uncharacterised mixture, inferred from what the mixture does rather than from a molecule binding a receptor. It is not comparable to the mechanistic evidence behind a single defined peptide, and the sections below are why that distinction has consequences.

Researched effects

Cerebrolysin has been studied more than almost anything else in this library — roughly 670 PubMed records and 62 randomised controlled trials — and the results are genuinely contested rather than simply thin. The useful thing this page can do is show which findings come from which kind of study. Start with the largest. CASTA randomised 1,070 patients with acute ischaemic hemispheric stroke within 12 hours of onset to 30 mL of cerebrolysin daily by intravenous infusion for 10 days or to saline, on top of aspirin, and followed them for 90 days. The primary endpoint was a combined global directional test of the modified Rankin Scale, Barthel Index and NIHSS. The published result is one sentence: the confirmatory endpoint showed no significant difference between the treatment groups (Stroke 2012, PMID 22282884). A post-hoc analysis stratified by severity then found a trend favouring cerebrolysin in patients with NIHSS above 12, and a mortality difference within that subgroup. Post-hoc subgroup findings from a null trial are hypothesis-generating; they are the weakest form of positive evidence a large trial can produce, and much of the confident language about this compound traces back to that subgroup. Then the systematic reviews, which disagree with each other in an informative way. The Cochrane review (2023 update, seven RCTs, 1,773 participants) concluded on moderate-certainty evidence that cerebrolysin probably has no beneficial effect on preventing all-cause death in acute ischaemic stroke, and flagged a probable increase in non-fatal serious adverse events (PMID 37818733). A 2025 meta-analysis of 14 RCTs and 2,884 patients found a statistically significant improvement in NIHSS change — the impairment scale — of 1.39 points (95% CI 0.53 to 2.25, p = 0.020), while functional independence on the modified Rankin Scale, the outcome that describes whether someone can live independently, showed only a non-significant trend (RR 1.31, 95% CI 0.90 to 1.91) (PMID 41018475). Those two results are compatible: the scale that moved measures neurological deficit, and the outcome that did not move is the one that matters to a patient. A network meta-analysis of 42 RCTs and 12,210 participants comparing nine neuroprotective agents against control ranked cerebrolysin top on none of the six outcomes assessed; butylphthalide and edaravone led (PMID 39834702). In traumatic brain injury the evidence is more favourable and much smaller. The CAPTAIN trial series, a prospective meta-analysis of two phase IIIb/IV randomised placebo-controlled trials, pooled 185 patients with admission Glasgow Coma Scores of 6 to 12 and reported a small-to-medium effect in favour of cerebrolysin on a multidimensional ensemble of functional and neuropsychological scales, significant at day 30 and day 90 (SMD 0.31 and 0.34; PMID 33620612). Note what that endpoint is: a composite analysed by directional multivariate tests, in 185 patients — a legitimate design, but not the same thing as moving a standard functional outcome in a large trial. In cognition, a 2025 systematic review of 173 vascular-cognitive-impairment trials covering 22,347 participants placed cerebrolysin among several interventions showing small-to-moderate cognitive improvement — behind Ginkgo biloba extracts — and its authors concluded that methodological heterogeneity across this literature undermined the strength of evidence for positive and negative findings alike (PMID 41198594). A phase 4 trial comparing cerebrolysin with donepezil in mild to moderate Alzheimer's disease, registered by the manufacturer as NCT01822951, was withdrawn with zero participants enrolled and no reason recorded. None of this is a guaranteed outcome and none of it is medical advice.

Dosage — reported ranges (overview)

Every cerebrolysin dosage figure worth quoting is a volume of a standardised solution given by intravenous infusion in a hospital, and the ones below are what the trials actually administered. They are stated here so the numbers in circulation can be checked against their source, not as a recommendation and not as something reproducible outside that setting. Acute ischaemic stroke, the CASTA regimen: 30 mL of cerebrolysin per day, diluted into 100 mL of 0.9% saline, infused intravenously for 10 consecutive days, started within 12 hours of stroke onset. That is the regimen the 1,070-patient trial used and the one most later trials copied (NCT00868283, NCT05124353, NCT02149875). Traumatic brain injury, the CAPTAIN regimen: 50 mL per day for 10 days, followed after intervals by two further treatment cycles of 10 mL per day for 10 days each (PMID 33620612). Alzheimer's dementia: 10 mL by intravenous infusion, five days a week for four consecutive weeks, the course repeated after a two-month treatment-free interval — 40 infusions in total (NCT00911807). CADASIL, in an ongoing trial: 40 mL per day with 60 mL saline for four days each month for a year (NCT05755997). Two things follow from that list, and they point in opposite directions from the way this compound is discussed as a cognitive enhancer. The first is that these are infusion volumes, not injection doses. Thirty millilitres diluted into a hundred more is a hospital procedure with a cannula, not something a syringe delivers. Where smaller volumes are given clinically they go intramuscularly, and no controlled trial of this compound has tested subcutaneous administration at all. The second is the dose-response relationship the Cochrane review found, which is the reason the regimen above is worth reading carefully rather than scaling up. Across the pooled trials, cerebrolysin produced no benefit on all-cause death at any dose. In the subgroup receiving 30 mL daily for 10 days — a cumulative 300 mL, the standard stroke course — non-fatal serious adverse events were 2.87 times as frequent as on placebo (95% CI 1.24 to 6.69), against 2.39 times across all dosing schedules pooled. A dose curve that is flat on the outcome and rising on harm is the single most useful thing this page carries, and it is visible only when the efficacy and safety results are read against each other instead of in separate sections.

A printable reference sheet and log comes with All-Access Lifetime.

Reconstitution — not applicable

This page deliberately has no reconstitution table, and that is not an omission — it is what the product is. Cerebrolysin is not supplied as a lyophilised powder. It is a sterile aqueous solution, described in trial registrations as a "solution for injection / concentrate for solution for infusion," and it is dosed in millilitres of that solution rather than in milligrams of a substance. Preparing it means drawing the prescribed volume and diluting it into 0.9% sodium chloride — 30 mL of cerebrolysin into 100 mL of saline is the regimen written into trial after trial — and infusing it. There is no vial to dissolve, no mcg/mL concentration to calculate, no U-100 insulin-syringe unit conversion, and therefore no bacteriostatic water in the process at any point. Every other injectable compound covered on this site is reconstituted and drawn up, and it would be natural to assume the same arithmetic applies here. It does not, and the assumption is worth naming because of what it implies about material bought under this name. Cerebrolysin has no molecular weight, no sequence and no reference standard, so if what arrives is a lyophilised powder in a peptide vial, there is no calculation that turns it into the product the trials studied and no analytical result that could confirm it is the same mixture. That is a limit of the substance, not of this page. Our reconstitution calculator and the bacteriostatic water it assumes apply to the defined peptides in this library. They do not apply to this one.

Injection / administration basics

Administration in every controlled trial of cerebrolysin was intravenous infusion, and that is not an incidental design choice. The regimens are consistent across indications and across sponsors: the prescribed volume is diluted into 0.9% saline and infused, typically over 15 to 60 minutes depending on volume, once daily for a course of days or weeks. CASTA infused 30 mL daily for 10 days; the CAPTAIN TBI trials infused 50 mL daily for 10 days and then two cycles of 10 mL; the Alzheimer's trial infused 10 mL five days a week for four weeks, twice. Intramuscular injection is used clinically for smaller volumes. Subcutaneous administration — the route almost every other compound in this library is discussed in — has not been tested in any registered trial of this substance. The reason the route is fixed is worth stating: this is a biological derived from animal tissue, given in volumes measured in tens of millilitres, in populations that are usually acutely unwell. The adverse-event signal that Cochrane picked up sits in that setting, and a 2024 case report documents a laboratory-confirmed, life-threatening anaphylactic reaction following an intravenous administration in an 85-year-old stroke patient (PMID 39055722). Anaphylaxis to a protein-derived biological is an infusion-setting risk, and the settings the trials used are equipped for it. None of this is instruction for human use. It is a description of how the substance was administered in the studies whose numbers this page quotes.

Half-life & frequency rationale

There is no established plasma half-life for cerebrolysin, and it is worth being clear that this is partly a category problem rather than only a gap in the data. A half-life describes the elimination of a defined molecule. Cerebrolysin is a mixture of free amino acids and assorted small peptides whose components would each clear at their own rate, and no published work identifies which component is responsible for any measured effect. What exists is qualitative and consistent. PubMed searches pairing cerebrolysin with pharmacokinetics or half-life return only a handful of records — the count varies with how the query is phrased — and none of them reports a figure. The most direct statement comes from a drug-delivery study developing PLGA nanoparticle carriers for it, whose stated rationale is that administering cerebrolysin in humans is criticised for its short half-life, poor stability and the high doses required to achieve an effect (Molecular Neurobiology 2015, PMID 26108180). The trial designs say the same thing structurally: the courses run for ten days to four weeks of daily infusions rather than as single doses, which is what investigators do when a substance does not persist. The practical reading is that any specific half-life figure you encounter for cerebrolysin should be treated as unsourced until someone names the study and states which component of the mixture was measured. We could not find one.

Stacking — overview

Cerebrolysin is not a compound that belongs in a stack in the sense the rest of this library uses the word. It is an infused hospital preparation studied as an add-on to standard care, and the combinations with evidence behind them are combinations with medical treatments, not with other research peptides. Those studied combinations are worth knowing because of what they show. Added to donepezil in Alzheimer's disease, cerebrolysin was tested against each agent alone in a three-arm trial (NCT00911807). Added to mechanical thrombectomy in acute stroke, it has been examined in observational studies pooled into a 294-patient meta-analysis (PMID 41880098) — observational, so confounding by indication is the obvious limit. Added to speech and language therapy for post-stroke aphasia, it was tested in the randomised ESCAS pilot (Stroke 2025, PMID 39957612). Added to alteplase, in NCT00840671. We are aware of no controlled study of cerebrolysin combined with any research peptide, and no pharmacological basis for predicting how an uncharacterised mixture would interact with one. Our cross-compound stacking guide covers where pairings are redundant rather than additive; here the honest answer is that the question has never been asked.

For how combinations are grouped by research context, the named blends, and why a pre-mixed blend vial cannot be calculated from its total milligrams, see the peptide stacks guide.

Storage & handling

• Cerebrolysin is a solution, not a powder, so the handling questions are different from every other compound in this library. Manufacturer instructions for the marketed product govern storage; it is typically kept below 25°C and protected from light, and it is not frozen.
• Once diluted into saline for infusion, the prepared solution is used promptly — a diluted parenteral preparation is not a multi-dose stock, and nothing about it is preserved for re-entry.
• Bacteriostatic water has no role here. The preservative in bacteriostatic water exists to make a reconstituted lyophilised vial safe to enter repeatedly; cerebrolysin is neither lyophilised nor reconstituted, and adding a preserved diluent to a ready-made parenteral solution is not part of any published protocol.

Evidence File

The Cerebrolysin Evidence File: The Trials That Stopped

Cerebrolysin has one of the largest trial records in this library, and also one of the most selectively quoted. The free page covers the null result in the largest stroke trial and the Cochrane safety signal. This file works the other direction: it reads the registry rather than the journals, follows the trials that were terminated, withdrawn or stopped at interim analysis, and traces the figures that circulate in marketing back to the paper each one came from. It also names the exact searches run to establish what has never been studied, and maps which authors and which statistical contractor sit behind the positive headline endpoints.

• 42 registered studies read end to end
• 4 registry entries terminated or withdrawn, all four manufacturer-sponsored
• 5 circulating claims traced back to the paper each came from
• 1 headline trial that missed its own intention-to-treat primary

Sourcing File

The Cerebrolysin Sourcing File: A Certificate That Cannot Establish Identity

For a defined peptide, a certificate of analysis answers two questions: is this the right molecule, and how much of it is there. Cerebrolysin breaks the first question rather than merely failing it, which the free page already explains. This file supplies what follows from that: the two quantitative declarations a certificate could legitimately be checked against and where they are published, the gram-scale arithmetic of an actual trial course, how the FDA's own substance registry defines a material with no structure, where published descriptions of the composition contradict each other, and the one peer-reviewed study that put marketed look-alikes through a chromatograph.

• 2 label-declared quantities a certificate can be checked against
• 11 look-alike preparations named in one published bioassay
• 2 incompatible published figures for the peptide fraction, 15% and 25%
• 413.2 g of concentrate in one registered year-long regimen

Benefit & Outcome Review

Cerebrolysin Benefit Review: Thirteen Claims Against Their Measurements

Marketing for cerebrolysin describes a general-purpose neuro-repair agent: stroke recovery, brain injury, memory, focus, neurogenesis. The clinical record describes something narrower and stranger - a hospital infusion tested almost entirely in acutely ill or demented patients, on composite endpoints, largely by one sponsor. This review takes each circulating claim, names the study meant to support it, states the species it was measured in, gives the effect size against its comparator rather than against baseline, and records where a claim has no measurement behind it at all. Several survive as plausible but unproven, and more than one is contradicted by the trial designed to test it.

• 13 marketed claims graded against their source studies
• 1 claim with no human evidence of any kind
• 3 claims whose own trial's primary endpoint ran against the marketing
• 1 healthy-volunteer study, published in 1998

Guide FAQ

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