Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

Cerebrolysin: what the evidence says

At a glance

What it is: a mixture of small peptides and amino acids made from pig brain, given by injection or IV infusion. It is used for stroke and dementia in Russia, Eastern Europe, China and other Asian countries. ^R1

What the evidence says: mixed. A 2023 Cochrane review of 7 trials (1,773 people) found it probably does not reduce deaths after stroke. ^R1 The largest stroke trial (1,070 patients) was neutral ^R2; a smaller rehabilitation trial was positive. ^R3 Evidence for vascular dementia is very low quality. ^R5 There are no studies of healthy people using it as a nootropic.

Biggest risks: non-fatal serious adverse events were more common with Cerebrolysin in the Cochrane stroke review (moderate certainty). ^R1 Gray-market products made from animal brain add contamination risks.

Rating


Human Human evidence	Limited (mixed results) for stroke recovery ^R1–R3; small-to-medium effect in a brain-injury meta-analysis ^R4; very low-quality evidence in vascular dementia ^R5; No human data for nootropic use
Animal Animal / lab evidence	Reported (not reviewed for this page)
Regulatory	Not FDA-approved (no Drugs@FDA entry found) ^R8 · Austria: authorized, prescription-only (BASG label) ^R7 · Russia, Asia: UNVERIFIED · WADA: not named on the 2026 List ^R6
Established human dose	For approved uses: set by national labels UNVERIFIED; for nootropic use: none. Study details lists what trials used

Evidence verdict: Stroke recovery: Limited · Nootropic use: No human data Card verdict: Limited (stroke recovery, mixed results) · Nootropic use: No human data Card note: Varies by use, see page.

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the manufacturer supported 3 of the 7 stroke trials in the Cochrane review ^R1, and all vascular-dementia trials that reported funding were industry-funded. ^R5

What is it?

Cerebrolysin is made from pig brain tissue and contains low-molecular-weight peptides and amino acids. Its maker says it protects and supports nerve cells. ^{R1, R5} Gray-market sellers market it as a nootropic. Unknown Related pages: Cortexin (a similar calf/pig brain extract, included in the Cochrane review ^R1), Semax, P21.

Does it work?

Human Acute stroke (deaths): Cochrane, 7 RCTs, 1,773 participants: probably little or no difference in deaths (RR 0.96; moderate certainty). ^R1
Human Acute stroke (function): CASTA, 1,070 patients in Asia: no difference on the main outcome; a post hoc trend favored severe strokes. ^R2 CARS, a smaller exploratory trial with rehabilitation: better arm function at day 90. ^R3
Human Traumatic brain injury: CAPTAIN meta-analysis of 2 trials, 185 patients: small-to-medium benefit on a combined outcome. ^R4
Human Vascular dementia: Cochrane, 6 RCTs, 597 people: some benefit on cognition and global function, but very low-quality evidence with high risk of bias. ^R5
Unknown Memory or focus in healthy people: no studies found.

Is it safe?

Human Serious adverse events: Cochrane stroke review: non-fatal serious adverse events increased (RR 2.39; 3 trials, 1,335 people; moderate certainty), more so with the higher-intensity 10-day schedule (see Study details). Total serious adverse events: little or no difference. ^R1
Human Individual trials reported safety similar to placebo. ^{R3, R4}
Human Austrian label (BASG Fachinformation): do not use with status epilepticus, severe kidney impairment, or allergy to the product; use caution with allergic tendency, epilepsy or grand mal seizures, because seizures may become more frequent; watch for additive effects with antidepressants or MAO inhibitors. ^R7 Anaphylaxis wording: UNVERIFIED, not found in the label sections we read.
Unknown Long-term effects in healthy people unknown.

Gray-market "research use only" Cerebrolysin: extra risks

Animal-brain product outside drug controls. Gray-market Cerebrolysin may be counterfeit, mislabeled, or made without controls on sterility and prion/viral safety [UNVERIFIED: no testing data found]. Unknown IV or injected products of unknown quality carry infection risk. Unknown

What we don't know

Unknown Whether it improves recovery after stroke once trials not funded by the maker are weighed
Unknown Whether it does anything in healthy people
Unknown What is in gray-market ampoules

Is it legal?

US: not FDA-approved; no application found in Drugs@FDA data (Oct 25, 2026). ^R8 Austria: authorized as a prescription medicine (holder EVER Neuro Pharma) for cerebrovascular disorders, including dementia, after-stroke deficits and head injury. ^R7 Russia, China and other countries: UNVERIFIED, not checked with national regulators. WADA: Cerebrolysin is not named on the 2026 Prohibited List ^R6; whether S0 (non-approved substances) applies depends on its approvals elsewhere, which we have not checked UNVERIFIED.

Study details

These are amounts researchers used, not recommendations.

R1 Human Cochrane review: acute ischemic stroke (Ziganshina 2023)

Study	People / model	Route	Amount used	Follow-up	Reported	Side effects / limitations	Citation
Ziganshina 2023	7 RCTs, 1,773 people with acute ischemic stroke	IV	Varied; subgroup 30 mL/day for 10 days	Trial-dependent	No difference in deaths; more non-fatal SAEs	Manufacturer supported 3 trials; risk of bias often unclear	PMID 37818733

R2 Human RCT: CASTA, acute stroke in Asia (Heiss 2012)

Study	People / model	Route	Amount used	Follow-up	Reported	Side effects / limitations	Citation
Heiss 2012	1,070 patients within 12 h of stroke	IV	30 mL/day for 10 days, plus aspirin	90 days	Neutral primary endpoint; post hoc trend in severe stroke	Post hoc subgroup only	PMID 22282884

R3 Human RCT: CARS, stroke rehabilitation (Muresanu 2016)

Study	People / model	Route	Amount used	Follow-up	Reported	Side effects / limitations	Citation
Muresanu 2016	Stroke patients starting rehabilitation (number not in abstract)	IV	30 mL/day for 21 days	90 days	Better arm function (ARAT) vs placebo	Exploratory, small; authors ask for a large confirmatory trial	PMID 26564102

R4 Human Meta-analysis: CAPTAIN, traumatic brain injury (Vester 2021)

Study	People / model	Route	Amount used	Follow-up	Reported	Side effects / limitations	Citation
Vester 2021	185 patients, moderate-severe TBI (2 RCTs)	IV	50 mL/day for 10 days, then 2 cycles of 10 mL/day for 10 days	90 days	Small-to-medium benefit at days 30 and 90	Two trials only	PMID 33620612

R5 Human Cochrane review: vascular dementia (Cui 2019)

Study	People / model	Route	Amount used	Follow-up	Reported	Side effects / limitations	Citation
Cui 2019	6 RCTs, 597 people	IV	Varied	15 days to 3 years	Some benefit on cognition and global function	Very low-quality evidence; high risk of bias; industry-funded	PMID 31710397

Full reference list (PubMed entries checked Oct 25, 2026)

^R1 Ziganshina LE, et al. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023. PMID 37818733
^R2 Heiss WD, et al. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012. PMID 22282884
^R3 Muresanu DF, et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016. PMID 26564102
^R4 Vester JC, et al. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series. Neurol Sci. 2021. PMID 33620612
^R5 Cui S, et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019. PMID 31710397
^R6 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/en/prohibited-list
^R7 BASG (Austrian Federal Office for Safety in Health Care). Cerebrolysin Fachinformation (SmPC), sections 4.3–4.5; and Packungsbeilage (patient leaflet). Checked Oct 25, 2026. https://medikamente.basg.gv.at/documents/1-21380__DOTC_FACH_INFO.pdf · https://medikamente.basg.gv.at/documents/1-21380__DOTC_GEBR_INFO.pdf (national label, German)
^R8 FDA. Drugs@FDA data (openFDA drugsfda endpoint), searched "cerebrolysin" Oct 25, 2026: no application found. https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:cerebrolysin · Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/ (a no-match search; Orange Book not separately checked)

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Cerebrolysin. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).

Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.