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Cerebrolysin

Also known as FPF-1070

Peptide preparation from porcine brain, registered in several countries for stroke and dementia.

early-clinical Neuro & cognition approved drug

At a glance

Category
Neuro & cognition
Status
approved drug
Made from
animal-derived Manufactured by controlled enzymatic digestion of purified proteins from porcine (pig) brain tissue, yielding a mixture of low-molecular-weight peptides and free amino acids.
Route
up to 5 ml intramuscular, up to 10 ml intravenous, and from 10 ml an infusion diluted in 0.9% NaCl, Ringer's solution or 5% glucose over roughly 15-60 minutes
Half-life
Not meaningfully definable for a mixture. The Austrian SmPC states outright that direct measurement of pharmacokinetic parameters cannot be performed, and that indirect figures were inferred from the pharmacodynamic profile instead - on which basis it claims neurotrophic activity detectable in plasma for up to 24 hours after a single dose 8
Onset
No acute effect; the product is given in courses of 4 weeks (dementia) or 7-30 days (stroke, head injury) and assessed over weeks 8

The one registration that can be checked line by line is the Austrian one: 'Cerebrolysin - parenterale Lösung' holds Austrian marketing authorisation number 1-21380, granted on 25 March 1996 and last renewed on 25 March 2001, held by EVER Neuro Pharma GmbH of Unterach, and it is prescription-only 8. The approved Austrian indication is supportive treatment of cerebrovascular disorders, specifically senile dementia of the Alzheimer type and vascular dementia, post-stroke deficits, and traumatic brain injury (concussion and contusion), in adults and patients over 65 8. It is also registered in the Philippines, where in 2023 the national Health Technology Assessment Council recommended against public funding for post-ischaemic stroke 7. Registration in Russia, China and a range of other Eastern European, Asian and Latin American markets is asserted by the manufacturer; those individual national registers were not opened for this entry and the country count should be treated as the manufacturer's claim. A central EMA marketing authorisation has never been granted and there is no FDA approval; in the United States it is an unapproved drug.

Doping status: Not listed by WADA; S0 does not apply because it is approved in several countries

Checked against the WADA 2026 Prohibited List. For a specific product and country, Global DRO is the lookup athletes are expected to use — the List names substances, not brand names.

The starting material is central nervous tissue of pigs, which is what places the product in the class for which transmissible spongiform encephalopathy sourcing controls apply.

Mechanism of action

Cerebrolysin is not a single peptide but a standardised, enzymatically cleaved and purified low-molecular-weight protein extract of porcine brain. One millilitre contains 215.2 mg of concentrate, corresponding to roughly 5.8 mg of peptide nitrogen; broadly a quarter consists of peptides below 10 kDa and three quarters of free amino acids.

The manufacturer describes the action as 'neurotrophic-factor-like': promotion of neuronal survival, neurogenesis, synaptogenesis and dendritic branching, plus anti-excitotoxic and anti-apoptotic effects. Claims that it contains BDNF, GDNF, NGF or CNTF fragments refer to functional resemblance in laboratory assays, not to intact growth factors - those are far too large to survive the manufacturing process.

In humans, no mechanism has been demonstrated at all. There is no demonstrated target engagement in the central nervous system, no validated activity biomarker, and no convincing explanation of how intravenously administered peptides of 1-10 kDa would cross the blood-brain barrier in pharmacologically relevant quantities. For comparison: endogenous BDNF has a circulating half-life of about ten minutes.

What the research shows

For acute ischaemic stroke the best evidence points to no effect, with a signal of more non-fatal serious adverse events 6. For vascular dementia the evidence is nominally positive but small, heterogeneous, at high risk of bias and largely funded by the manufacturer; it has not been updated since 2013 4. For traumatic brain injury, Alzheimer's disease, developmental disorders in children and cognitive enhancement in healthy people the evidence is preliminary or absent.

Research in humans

Cochrane (ischaemic stroke, 2023 update): 7 studies with 1773 participants 6. All-cause mortality RR 0.96 (95% CI 0.65-1.41), moderate certainty - so probably no effect 6. Non-fatal serious adverse events were in fact increased: RR 2.39 (95% CI 1.10-5.23) 6. Strikingly, not one included study reported functional outcomes (mRS or Barthel) 6, even though the product is sold precisely for functional recovery. The largest study, CASTA (n=1070, 30 ml per day for 10 days), failed its primary endpoint: the combined test of NIHSS, mRS and Barthel at day 90 did not differ from placebo 1. The widely cited positive result in patients with an NIHSS above 12 is a post-hoc subgroup analysis 1 and is purely hypothesis-generating. Cochrane (vascular dementia, 2019 update): 6 studies with 597 participants, cognition SMD 0.36 (95% CI 0.13-0.58) and global function RR 2.69 (1.82-3.98), but the authors conclude that these data are not conclusive and that any effects may be too small to be clinically meaningful 4.

Animal and lab research

The neurotrophic claims come from animal and cell culture models: neuroprotection in ischaemia models, reduced calpain activation, effects on APP processing and amyloid burden. These models form the basis of the mechanistic story but have never translated into demonstrable efficacy in humans.

Caveats. Three to four of the seven studies in the Cochrane review on ischaemic stroke were wholly or partly funded or supported by manufacturer EVER Neuro Pharma 6; in the vascular dementia review this applied to three of the six studies, with funding unclear in two others 4. In CASTA the protocol was published only after enrolment and a description of the randomisation procedure was missing; in another study the manufacturer itself supplied the randomisation codes. Cochrane flagged selective outcome reporting in all studies and loss to follow-up above 10% in four studies 6. A funnel plot analysis was not possible because of the small number of studies 6, but the authors noted that the manufacturer's involvement in design, conduct and reporting can in itself point to publication bias. A large number of Russian- and Chinese-language studies with uniformly positive outcomes is widely regarded as methodologically weak.

What it is used for

  • Acute ischaemic stroke (a registered indication; the best evidence does not support this 6)
  • Vascular dementia and senile dementia of the Alzheimer type - both named in the Austrian label 8
  • Traumatic brain injury, specified in the Austrian label as concussion and contusion 8
  • Developmental and cognitive disorders in children (in some countries)
  • There is no evidence whatsoever for use as a cognitive enhancer in healthy adults

Dosing

Dose
5-30 ml per day of the 215.2 mg/ml solution; maximum single and daily dose 50 ml. In stroke, 30 ml per day for 10 days has been used (CASTA), and in some studies 50 ml per day for 21 days. In dementia, 10-30 ml per day.
Frequency
Once daily, usually 5 days a week in dementia courses
Route
up to 5 ml intramuscular; 2-10 ml slow intravenous; 10-50 ml as an infusion over 15-60 minutes, diluted in 0.9% NaCl, Ringer's or 5% glucose
Duration
Courses of 10-20 days in stroke and traumatic brain injury; in dementia courses of 4 weeks, repeated 2-4 times a year
  • Cerebrolysin is dosed in millilitres, not milligrams. One millilitre contains 215.2 mg of a proteolytic peptide fraction from porcine brain protein 8.
  • The Austrian label's daily doses are indication-specific: 10-30 ml for 4 weeks in Alzheimer-type and vascular dementia, 20-50 ml for 10-21 days in ischaemic stroke, 30-50 ml for 10-21 days in haemorrhagic stroke, and 20-50 ml for 7-30 days in traumatic brain injury 8. A treatment cycle in dementia is 4 weeks at 5 applications per week, and from the second cycle onwards may drop to 2-3 applications per week 8.
  • The product is not given continuously but in defined courses. Use in anyone under 18 is not recommended for want of data 8.
  • Products of 60 mg per vial sold to consumers through the grey market are a different, unregulated form that does not correspond to the registered ampoule; dosing advice for these comes from sellers, not from a regulator.
  • Outside the registered indications, Cerebrolysin is self-administered as a nootropic 'course' by healthy people. That circulating pattern is described under Protocols; it diverges from the label by being for cognitive enhancement, for which there is no evidence at all.

These figures describe what the literature and published protocols report. They are not advice and not a dosing instruction.

Protocols

Acute ischaemic stroke (CASTA)

published trial

Source: Stroke, 2012 - CASTA, double-blind placebo-controlled randomised trial

Days 1-1030 ml per day of the 215.2 mg/ml solution, as an intravenous infusion

CASTA did not meet its primary endpoint. The schedule is reproduced because it is what was given, not because it worked. Cerebrolysin is measured in millilitres of a fixed-concentration solution, not in milligrams of powder.

Stroke rehabilitation (CARS)

published trial

Source: Stroke, 2016 - CARS, randomised, placebo-controlled, double-blind multicentre trial

Days 1-2130 ml per day of the 215.2 mg/ml solution, as an intravenous infusion, alongside standardised rehabilitation

CARS reported a benefit on motor function, but the Cochrane reviews of Cerebrolysin in acute stroke did not find a convincing effect on death or dependency. Grey-market 60 mg vials are a different, unregulated preparation and this schedule does not describe them.

Self-administered nootropic course (user-reported)

user protocol — not validated

Source: Nootropic forum reports and grey-market vendor labelling

This is not a validated schedule. It is a pattern that circulates among users and sellers, reproduced because it is what people actually follow — not because it has been tested. No trial established these doses, this interval or this duration, and nobody is checking what is in the vial. Treat every number below as an assertion, not a finding.

Reported daily amountcommonly 5-10 ml of the 215.2 mg/ml ampoule solution intramuscularly, sometimes toward the label's higher figures
Reported course lengthroughly 10 to 30 days, echoing the clinical course, repeated a few times a year
Reported stackingfrequently combined with cortexin, semax, selank or noopept in the same course

The label directs millilitres of a fixed-concentration solution, in defined courses, given by or under a clinician for stroke, dementia and traumatic brain injury; what circulates in nootropic communities is self-injection of the same ampoules, or of unregistered grey-market vials, at home by healthy people for cognitive enhancement — an indication for which there is no evidence at all. The millilitre figures are copied from the label and repurposed. A specific hazard is the milligram/millilitre confusion: the registered ampoule is measured in millilitres of a 215.2 mg/ml solution, but grey-market '60 mg' vials invite dosing in milligrams, and nobody reconciles the two. There is no published basis for nootropic use; reports are subjective, unblinded and usually confounded because several compounds are run at once. Absence of bad reports from this unmonitored, self-selected group is not evidence of safety, and the porcine-brain origin and the increase in non-fatal serious adverse events seen in the stroke trials both still apply.

Schedules are reproduced as their source states them. Units, IU and milligrams explains why the figures are not interchangeable between products.

Reconstitution

Vial sizes
1 ml, 2 ml, 5 ml, 10 ml, 20 ml, 30 ml (ampoules with ready-to-use solution 215.2 mg/ml)
Solvent
Not applicable - it is a solution, not a lyophilised powder. For infusion, dilute with 0.9% NaCl, Ringer's solution or 5% glucose.
Storage
Store below 25 °C, protected from light in the outer carton. Do not freeze. Draw up from the ampoule immediately before use; the product contains no preservative and any remainder is discarded.

Worked example

10 ml ampoule diluted in 100-250 ml physiological saline, given as an infusion over about 30 minutes.

Do not mix with amino acid solutions in the same infusion, and do not combine with solutions that alter the pH or contain lipids.

Safety

Side effects

  • Rate-related, listed as rare in the Austrian label: dizziness on too-rapid administration, and a moderate sensation of heat or sweating especially on rapid injection 8
  • Rare in the label: loss of appetite, and agitation - described there as the intended activating effect shading into aggressiveness, confusion and insomnia 8
  • Very rare in the label: dyspepsia, diarrhoea, constipation, vomiting and nausea; palpitations or arrhythmia on too-rapid administration; local reactions at the injection site such as redness, itching and burning 8
  • Very rare in the label: allergic and hypersensitivity reactions, described as tingling, skin and local vascular reactions, neck, head and limb pain, fever, mild back pain, dyspnoea, chills and a shock-like state 8
  • Very rare in the label: isolated grand mal seizures and one case of convulsion have been associated with Cerebrolysin 8
  • Reported as rare in one study cited by the label: hyperventilation, hypertension, hypotension, fatigue, tremor, depression, apathy or drowsiness, and influenza-like symptoms - the label notes these are also common complaints in the elderly population the product is given to, with or without medication 8
  • The most important safety signal in the literature is the increase in non-fatal serious adverse events in the Cochrane review on ischaemic stroke (RR about 2.4), which is generally left unmentioned in promotional material

Do not use if

  • The Austrian label lists exactly three contraindications: hypersensitivity to the active substance or excipients, status epilepticus, and severe renal impairment 8
  • Epilepsy itself is a warning rather than a contraindication in that label: caution is advised in allergic diathesis, in epileptic disorders and in grand mal seizures, because seizure frequency may increase 8
  • Pregnancy - the label says Cerebrolysin must not be used during pregnancy unless the woman's clinical condition requires it; animal reproduction studies showed no signal 8. In breastfeeding, a choice must be made between stopping the feed and stopping the treatment 8
  • It is a biological product of porcine origin; theoretical concerns about transmissible agents and immunogenicity remain, and it may be objectionable to those with religious or dietary objections to porcine products

Interactions

The Austrian label advises watching for additive effects when Cerebrolysin is given with antidepressants or MAO inhibitors, and recommends dosing the antidepressant lower in that case; at 30-40 ml of Cerebrolysin combined with high doses of MAO inhibitors a rise in blood pressure may occur 8. It must not be given in the same infusion as balanced amino acid solutions, and it is incompatible with solutions that shift the pH outside 5.0-8.0 and with lipid-containing solutions 8. Vitamins and cardiovascular agents may be given concurrently but not in the same syringe 8. Caution with agents that lower the seizure threshold follows from the seizure warning rather than from a studied interaction.

Sources