Cognitive · Dosing reference

Cerebrolysin dosage

Dosing as quoted from non-US labeling, study durations and vial arithmetic.

Approved outside the USAHuman trial evidenceEx-US label

Full research page Cycle-length evidence Compare Prefer Amiravo on Google

Regulatory status: Approved outside the US
Human amounts: Austrian label: 10 to 50 mL daily depending on indication; trials used 10 to 60 mL per administration
Route studied: Intravenous infusion or injection; intramuscular up to 5 mL (Austrian label)
Frequency: Daily courses of 7 to 30 days; dementia cycles 5 administrations per week for 4 weeks (Austrian label)
Half-life: Not directly measurable (peptide mixture)
Evidence grade: Grade A · Human trial evidence
Vial sizes on the market: 60 mg
Other forms seen: Liquid ampoules/vials 215.2 mg/mL (clinical product)

What Cerebrolysin is

Cerebrolysin is a porcine brain-derived preparation of low-molecular-weight peptides and amino acids given by intravenous infusion or injection. It is authorised in Austria and used in Russia, Eastern Europe, China and other Asian countries for supportive treatment after stroke and head injury and in dementia, but it is not approved by the FDA. Randomized trials and Cochrane reviews report mixed results, including no clear effect on death after acute ischaemic stroke; this entry summarizes them for research reference only.

Cerebrolysin is described as a mixture of low-molecular-weight peptides and amino acids derived from porcine brain with potential neuroprotective properties ^3, and as a preparation said to have neurotrophic and neuroprotective activity ^4. Pharmacology The Austrian SmPC states that direct pharmacokinetic measurement is not possible because the product is a mixture of short-chain peptides similar or identical to… How it works →

Key evidence

Ziganshina et al., Cochrane Database Syst Rev (acute ischaemic stroke) · 2023 · Humans (adults with acute ischaemic stroke)
All-cause death RR 0.96 (95% CI 0.65 to 1.41; moderate certainty); total serious adverse events RR 1.16; non-fatal serious adverse events RR 2.39 (95% CI 1.10 to 5.23); the authors concluded that Cerebrolysin probably does not reduce all-cause death ^3. ³
Heiss et al., Stroke (CASTA) · 2012 · Humans (patients with acute ischaemic hemispheric stroke in Asia)
The confirmatory endpoint showed no significant difference between groups; a post hoc analysis suggested a trend favouring Cerebrolysin in patients with NIHSS above 12 ^6. ⁶
Muresanu et al., Stroke (CARS) · 2016 · Humans (patients after ischaemic stroke in early rehabilitation)
Action Research Arm Test at day 90 favoured Cerebrolysin (Mann-Whitney estimator 0.71); premature discontinuation was 3.8%; the authors called for confirmation in a larger trial ^5. ⁵

All studies on the research page

Dosing as stated on non-US labeling

Austrian SmPC (Zulassungsnummer 1-21380, March 2021) posology: daily doses of 10 to 30 mL for 4 weeks in dementia; 20 to 50 mL for 10 to 21 days in ischaemic stroke; 30 to 50 mL for 10 to 21 days in haemorrhagic stroke; 20 to 50 mL for 7 to 30 days in craniocerebral trauma; given intramuscularly (up to 5 mL), intravenously (up to 10 mL) or, from 10 mL, by slow infusion after dilution; one treatment cycle is 4 weeks with 5 administrations per week, and in dementia cycles may be repeated after 2 months ^1. Not recommended under 18 years ^1.
In CASTA (NCT00868283), patients with acute ischaemic stroke were randomized within 12 hours of onset to Cerebrolysin 30 mL daily or saline placebo by intravenous infusion for 10 days, in addition to aspirin 100 mg daily, with 90-day follow-up ^6.
In CARS, patients received Cerebrolysin 30 mL/day or saline placebo once daily for 21 days, starting 24 to 72 hours after stroke onset, alongside a standardized 21-day rehabilitation programme ^5.
In the Alzheimer's disease trial, 279 patients received intravenous infusions of Cerebrolysin 10, 30 or 60 mL or placebo 5 days per week for 4 weeks, then two infusions per week for 8 weeks, with assessment to week 24 ^7.
In CAPTAIN I, patients with traumatic brain injury received 50 mL of Cerebrolysin or saline daily for 10 days, followed by two further treatment cycles of 10 mL daily for 10 days, added to standard care ^8.

How long did human studies run?

Austrian label: courses of 4 weeks in dementia (repeatable after 2 months), 10 to 21 days after stroke, 7 to 30 days after head trauma ^1.
Trials: 10 days (CASTA), 21 days (CARS), 12 weeks of infusions with assessment to 24 weeks (Alzheimer's disease) ^5,6,7.

Cycle-length evidence for Cerebrolysin

Who was excluded from the studies

Austrian label contraindications: hypersensitivity to the active substance or excipients, status epilepticus, severe renal impairment ^1.
Not recommended in children and adolescents under 18 because of insufficient data ^1.

Side effects reported in studies

Non-fatal serious adverse events
RR 2.39 (95% CI 1.10 to 5.23) vs placebo; RR 2.87 in the subgroup with 10-day courses · Acute ischaemic stroke, 3 trials, 1,335 participants (Cochrane) ³
Any adverse event
RR 1.03 (95% CI 0.92 to 1.14) vs placebo · Acute ischaemic stroke, 4 trials, 1,607 participants (Cochrane) ³
Allergic or hypersensitivity reactions (skin and local vascular reactions, fever, dyspnoea, chills, shock-like states)
Very rare (label category) · Austrian SmPC ¹
Isolated grand mal seizures
Very rare (label category) · Austrian SmPC ¹
Palpitations or arrhythmia with rapid administration
Very rare (label category) · Austrian SmPC ¹
Agitation, insomnia or confusion; dizziness, warmth, sweating or itching with rapid administration; loss of appetite
Rare (label category) · Austrian SmPC ¹

Full adverse-event data

Cerebrolysin draw calculator

Pick the vial strength and the water added, enter an amount, and see the concentration, the units to draw and how many draws the vial holds. Arithmetic only.

1 · Vial strength

sizes on the market

2 · Water added

3 · Amount per draw

4 · Syringe

Your mix

60 mg + 2 mL water = 30 mg/mL

10 units holds 3 mg

Draw toEnter an amount in step 3

U-100 syringe · 100 units = 1 mL

Computed from your inputs. Not a dose or a recommendation.

Compare water volumes for this vialShow

More water = lower concentration = a larger, easier-to-measure draw. Tap a row to use it.

Water	mg/mL	Draw
0.5 mL	120	—
1 mL	60	—
1.5 mL	40	—
2 mL	30	—
2.5 mL	24	—
3 mL	20	—
5 mL	12	—

Supplies and handling

Lyophilized vial
Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
Sterile diluent
The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
Graduated syringes
Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
Alcohol prep pads
For wiping vial stoppers before each puncture.
Nitrile gloves
Clean gloves for aseptic handling.
Sharps container
Puncture-resistant container for used needles.

Step-by-step reconstitution guide Storage and transport accessories

Storage

The Austrian SmPC states: store below 25 degrees C, do not refrigerate or freeze, and keep in the original packaging to protect from light ^1.

Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent: The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed: Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles: Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution: This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed: Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status: Authorised in Austria (Zulassungsnummer 1-21380, EVER Neuro Pharma GmbH) as a prescription-only parenteral solution for supportive treatment of cerebrovascular disorders, including Alzheimer-type senile dementia, vascular dementia, post-stroke deficits and craniocerebral trauma, in adults and patients over 65 ^1. A 2023 Cochrane review states that it is widely used for acute ischaemic stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries ^3. Not approved by the FDA; an openFDA query returned no application record ^9.
United States (FDA): Not approved; an openFDA Drugs@FDA query for cerebrolysin returned no application record ^9. Cerebrolysin does not appear in any category of FDA's May 14, 2026 list of bulk drug substances nominated for compounding under section 503A ^10.
Sport (WADA): Cerebrolysin is not named on the WADA 2026 Prohibited List ^11. Class S0 applies to substances with no current approval by any governmental regulatory health authority for human therapeutic use ^11; Cerebrolysin holds a national authorisation in Austria ^1.

Status varies by country and changes over time. How we describe regulatory status.

Cerebrolysin compared with related compounds

Compound	Status	Evidence	Human amounts	Half-life
Cerebrolysin	Approved outside the US	A	Ex-US label	Not directly measurable (peptide mixture
Semax	Approved outside the US	B	None established	—
Selank	Approved outside the US	B	None established	—
Dihexa	Not approved — research use only	C	None established	—
DSIP	Not approved — research use only	B	None established	—
Oxytocin	FDA-approved	A	FDA label	The Pitocin label states a plasma half-l

Frequently asked questions

What doses of Cerebrolysin have been studied in humans?

Cerebrolysin is approved outside the US; this page quotes that labeling as a regulatory record.

Is there an established Cerebrolysin cycle length?

No cycle length or break has been established. Human studies administered Cerebrolysin for the periods listed on this page; those are study durations, not a recommended course.

How much bacteriostatic water should be added to a Cerebrolysin vial?

There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.

How many units is a given amount on an insulin syringe?

On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.

What is the half-life of Cerebrolysin?

Not directly measurable (peptide mixture)

Is Cerebrolysin FDA-approved?

Approved outside the US. Authorised in Austria (Zulassungsnummer 1-21380, EVER Neuro Pharma GmbH) as a prescription-only parenteral solution for supportive treatment of cerebrovascular disorders, including Alzheimer-type senile dementia, vascular dementia, post-stroke deficits and craniocerebral trauma, in adults and patients over 65 ^1. A 2023 Cochrane review states that it is widely used for acute ischaemic stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries ^3. Not approved by the FDA; an openFDA query returned no application record ^9.

References

Cerebrolysin parenterale Loesung, Fachinformation (summary of product characteristics), Zulassungsnummer 1-21380, EVER Neuro Pharma GmbH, Stand Maerz 2021 BASG (Austrian Federal Office for Safety in Health Care). 2021
Cerebrolysin parenterale Loesung, Gebrauchsinformation (patient leaflet), EVER Neuro Pharma GmbH, Stand Maerz 2021 BASG (Austrian Federal Office for Safety in Health Care). 2021
Cerebrolysin for acute ischaemic stroke Cochrane Database Syst Rev. 2023
Cerebrolysin for vascular dementia Cochrane Database Syst Rev. 2019
Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial Stroke. 2016
Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial Stroke. 2012
A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease Eur J Neurol. 2006
Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial Neurol Sci. 2020
Drugs@FDA application data queried through openFDA for cerebrolysin (no matching application record returned on 23 October 2026) openFDA / Drugs@FDA. 2026
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (categories 1, 2 and 3; updated May 14, 2026) FDA. 2026
International Standard: Prohibited List 2026 World Anti-Doping Agency. 2026

Last reviewed October 23, 2026 by the Amiravo editorial team. Editorial policy · Report an error