Neuro & cognitive

Cerebrolysin

Also called Porcine brain-derived peptide preparation

Cerebrolysin is an injectable medicine made from pig brain proteins that have been broken down into small peptides and free amino acids. It is given by IV drip in some countries after stroke, brain injury or for dementia, but it is not approved in the United States. Large reviews by Cochrane found no clear survival benefit after stroke and only very-low-certainty evidence of benefit in vascular dementia.

Late-stage trialsTested in large human trials (phase 2b/3) but not yet approved in the US.

All printable flashcards

Illustrative chain. The exact sequence has not been published in a source we could verify.

Overview

How it works

Proposed, not established. Because it is a mixture, no single target is known. Supporters suggest its small peptides cross the blood-brain barrier and act somewhat like the brain's own growth factors (neurotrophic factors), for example by raising BDNF levels and influencing repair-related signaling such as the Sonic hedgehog pathway ⁶. These ideas come mainly from lab and animal work and industry-linked research; the authors of a 2025 review note that its mechanisms are not fully understood ⁶.

What research shows

Cochrane review, acute ischaemic stroke (Ziganshina et al., 2023 update; 6 RCTs, 1,689 participants for mortality): no clear effect on death up to 90 days (5.7% vs 6.1%; RR 0.96, moderate certainty); total serious adverse events were similar, but non-fatal serious adverse events were more common with Cerebrolysin/Cortexin (RR 2.39) ¹.
CASTA trial (Heiss et al., Stroke 2012; RCT n=1,070 in Asia): 30 mL/day IV for 10 days started within 12 hours of stroke did not beat placebo on the combined primary outcome; a post hoc subgroup with severe stroke showed lower mortality, which is exploratory only ³.
CARS-1 and CARS-2 meta-analysis (Guekht et al., 2017; 2 RCTs, n=448): 30 mL/day IV for 21 days plus rehabilitation improved arm motor function at day 90 versus placebo; trials were exploratory, heterogeneous and several authors had manufacturer ties ⁴.
Cochrane review, vascular dementia (Cui et al., 2019; 6 RCTs, 597 participants): small improvements in cognition and global function, but all evidence was very low certainty because of high risk of bias ².
Most trials were run in China, Russia and Eastern Europe, and many were funded by or linked to the manufacturer ²⁴.

Doses studied in people

Study or label	Dose used	Source
CASTA RCT in acute ischemic stroke (n=1,070)	30 mL/day by IV infusion for 10 days, started within 12 hours of symptom onset	³
CARS-1/CARS-2 RCTs in post-stroke motor recovery (n=448 total)	30 mL once daily by IV infusion for 21 days, started 24–72 hours after stroke	⁴
Trials pooled in the 2023 Cochrane stroke review	Ranged from 10–50 mL/day IV for 10 to 21 days across trials	¹

Doses listed are from hospital-based IV trials in stroke patients outside the US; they are not guidance for any other use.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Weekly protocol

How the schedule looks week by week. Each chart says where it comes from: a prescribing label, a clinical trial, or a protocol commonly reported online.

CASTA acute stroke trial

Clinical trial

One week

D1D2D3D4D5D6D7

Once daily · Intravenous infusion

Dose by week

30 mLwk 1–2

Course: 10 days, started within 12 hours of stroke
Note: Hospital trial in Asia (n=1,070). Week span covers the 10 days.
Source: Heiss WD et al. Cerebrolysin in patients with acute ischemic stroke in Asia (CASTA). Stroke 2012;43(3):630-636

CARS stroke-recovery trials

Clinical trial

One week

D1D2D3D4D5D6D7

Once daily · Intravenous infusion

Dose by week

30 mLwk 1–3

Course: 21 days, started 24–72 hours after stroke
Note: Combined analysis of the CARS-1 and CARS-2 trials (n=448), alongside standard rehabilitation.
Source: Guekht A et al. Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trials. Neurol Sci 2017;38(10):1761-1769

Reference only, not a recommendation. Label and trial schedules were set for specific patients under medical supervision. Use the calculator only to understand the arithmetic.

Vial math

Many research vials hold 5 or 10 mg of powder. This table shows how much ends up in each mark on a U-100 insulin syringe for common amounts of added liquid. It is arithmetic only, not a dose.

Vial	Liquid added	Concentration	Per unit (0.01 mL)
5 mg	1 mL	5 mg/mL	50 mcg	Open in calculator
5 mg	2 mL	2.5 mg/mL	25 mcg	Open in calculator
5 mg	3 mL	1.67 mg/mL	16.7 mcg	Open in calculator
10 mg	1 mL	10 mg/mL	100 mcg	Open in calculator
10 mg	2 mL	5 mg/mL	50 mcg	Open in calculator
10 mg	3 mL	3.33 mg/mL	33.3 mcg	Open in calculator

More sizes: all vial sizes · How this works: Syringes and units · Reconstitution guide.

Safety

2023 Cochrane review: no difference in total serious adverse events, but non-fatal serious adverse events were more frequent than with placebo (RR 2.39, 95% CI 1.10 to 5.23); moderate-certainty evidence ¹.
Reported serious non-fatal events in stroke trials include heart rhythm problems, heart failure, acute coronary syndrome, pneumonia and pulmonary embolism, as summarized in a 2025 review ⁶.
Vascular dementia trials did not show more adverse events than control, but the data were sparse and very low certainty ².
It is a biological product from animal tissue given by IV; products bought outside regulated pharmacies may be counterfeit or contaminated.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

Legal status

FDA: Not FDA-approved; it has never been registered for use in the United States ⁶.
Compounding: Not named on FDA's 503A Category 2 page or withdrawn-nominations table (current as of 04/22/2026), and not found on FDA's 503A nominations list as retrieved ⁷⁸.
Sports (WADA): Not named on the 2026 Prohibited List ⁵. Because it is approved as a medicine in several countries, S0 (non-approved substances) may not apply; athletes should confirm with their anti-doping organization.
Other: Approved/used as a prescription medicine in about 44 countries, mainly in Europe (especially Eastern Europe) and Asia ⁶. Not centrally approved by the EMA as far as found in this review.

Rules change often. See Legal status of peptides for how these categories work.

History

Cerebrolysin was first developed in 1949 in Innsbruck, Austria ⁶. It is now made by the Austrian company EVER Neuro Pharma ⁴ and is used in roughly 44 countries, mostly in Eastern Europe and Asia; it has never been registered by the US FDA ⁶. Large trials in stroke followed in the 2000s and 2010s, including the CASTA trial in Asia (n=1,070) and the CARS rehabilitation trials ³⁴. Cochrane reviews were published on acute stroke (latest update October 2023) and vascular dementia (2019 update) ¹².

Common questions

Is Cerebrolysin approved in the US?

No. It has never been registered by the FDA, though it is used as a prescription medicine in about 44 other countries ⁶.

Does Cerebrolysin help after a stroke?

The 2023 Cochrane review found it probably does not change the risk of death after ischaemic stroke ¹. Some trials reported better arm recovery during rehab, but they were exploratory and manufacturer-linked ⁴.

What are the known risks?

The Cochrane stroke review found more non-fatal serious adverse events with Cerebrolysin than with placebo ¹. Overall adverse-event data in dementia trials are sparse ².

Is Cerebrolysin banned in sport?

It is not named on the 2026 WADA Prohibited List ⁵; athletes should check with their anti-doping organization before use.

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Dihexa

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Sources

Last reviewed 2026-10-26 · How we research · Found an error? See our corrections policy.