Compounds / Cerebrolysin
Cerebrolysin
Also known as: Cerebrolysin concentrate; porcine brain peptide preparation; EVER Pharma neuropeptide preparation
Primary research focus: Neurorecovery (ischemic stroke, traumatic brain injury, vascular dementia, Alzheimer disease)
Last updated July 2026 · Reviewed against FDA labeling and published research.
What is Cerebrolysin?
Cerebrolysin is a standardized preparation of low-molecular-weight peptides and free amino acids produced by enzymatic breakdown of purified porcine brain proteins. It is not a single molecule but a defined mixture (roughly 15 percent peptides and 85 percent free amino acids). Manufactured by EVER Pharma (Austria), it is an approved prescription drug in more than 50 countries for stroke, traumatic brain injury, and dementia, but it is not FDA-approved and is not available in the US.
Cerebrolysin is proposed to act by neurotrophic factor mimicry, with effects resembling BDNF, NGF, and GDNF, supporting neuronal survival and plasticity. Additional proposed actions include modulation of glutamate-mediated excitotoxicity and effects on endogenous protein-clearance pathways. Because it is a complex mixture rather than a single receptor ligand, its action is broad rather than target-specific.
How it’s supplied
Brand / trade names: Cerebrolysin (EVER Pharma)
Supplied as a sterile, ready-to-use amber solution in ampoules and vials for intravenous infusion or intramuscular injection (each mL contains about 215.2 mg of the porcine-brain peptide concentrate). It is an approved prescription product abroad; in the US it is not approved and is handled as a research substance or accessed through import, outside FDA oversight.
Dosage Chart
| Phase | Dose | Frequency | Notes |
|---|---|---|---|
| Stroke | 20-50mL | 1x Daily | 10-21 Days |
| Traumatic Brain Injury | 20-50mL | 1x Daily | 7-30 Days |
| Vascular Dementia | 10-30mL | 1x Daily | 4 Weeks, 2-4 Cycles Per Year |
| Alzheimers Disease | 10-30mL | 1x Daily | 4 Weeks, 2-4 Cycles Per Year |
- The IV or IM injection has to be administered immediately after opening the ampoule
Potential Benefits and Side Effects
Effects reported in published research. Not a promise of results, and not medical advice.
- Reported in international clinical trials and use; independent evidence is mixed.
- Used abroad as an adjunct in acute ischemic stroke recovery and rehabilitation.
- Reported cognitive benefits in vascular dementia and Alzheimer disease (meta-analyses suggest a modest effect).
- Reported functional benefit in traumatic brain injury (CAPTAIN meta-analysis).
- Proposed neurotrophic, neuroprotective, and neuroplasticity support.
- Generally mild and transient in individual trials.
- Injection-site irritation with intramuscular use.
- Infusion-related dizziness, warmth, or sweating, reduced by slower infusion.
- Headache or dizziness, uncommon and usually transient.
- Rare allergic-type reactions; the independent Cochrane stroke review noted a possible increase in non-fatal serious adverse events.
Warnings and contraindications
Important safety information. This is not exhaustive — read the full prescribing information and consult your prescriber or pharmacist.
- The following reflect the approved foreign label and independent evidence; there is no FDA label.
- Use caution in patients with epilepsy or a history of seizures, as it may lower the seizure threshold; the label contraindicates status epilepticus and grand mal epilepsy.
- Allergic and anaphylactoid reactions can occur; it is contraindicated in known porcine-protein allergy.
- Rapid intravenous infusion may cause dizziness, warmth, sweating, or palpitations; infuse slowly.
- Use caution in severe renal impairment.
- Independent Cochrane review of acute ischemic stroke found no benefit on death and signaled a possible increase in non-fatal serious adverse events; the independent evidence is more cautious than industry-sponsored trials.
- Do not combine in the same infusion with balanced amino acid solutions or incompatible medications.
- Based on the approved foreign label:
- Known hypersensitivity to the product or to porcine protein.
- Status epilepticus or grand mal epilepsy.
- Severe renal impairment.
Reconstitution Steps
How to prepare the lyophilized vial. Confirm specifics with your pharmacist or prescriber.
- Cerebrolysin is supplied as a ready-to-use sterile solution in ampoules or vials, not as a powder to reconstitute; the steps below describe preparing an infusion.
- Confirm the ampoule or vial volume and the amount ordered before starting.
- Wash your hands and gather supplies: the Cerebrolysin ampoule(s) or vial, a compatible infusion solution (for example, normal saline), an alcohol swab, and a sterile syringe.
- Inspect the solution: it should be clear and amber-colored with no particles. Do not use if cloudy or discolored.
- Wipe the ampoule neck or vial stopper with a fresh alcohol swab.
- Draw the ordered volume of Cerebrolysin into the syringe.
- Add it to the compatible infusion solution as directed; do not mix Cerebrolysin in the same infusion with amino acid solutions or with incompatible medications.
- Protect the prepared infusion from prolonged light and administer within the time specified.
- Note the resulting concentration for reference on this page.
US regulatory status
Classifications are public record but can change. For reference only, not legal advice.
Development: Cerebrolysin was developed by EVER Pharma (originally Ebewe Pharma) in Austria and has been used clinically for decades. It is registered in more than 50 countries (including Austria, Russia, China, and South Korea) for acute ischemic stroke, traumatic brain injury, vascular dementia, and Alzheimer disease. It has been studied in numerous randomized trials, including Phase 3 stroke trials (CASTA, CARS) and TBI meta-analysis (CAPTAIN). Independent Cochrane systematic reviews across three decades have concluded there is insufficient evidence for routine use in acute ischemic stroke, with no mortality benefit and a possible harm signal, while dementia and TBI data are described as suggestive but not definitive. It has never been FDA-approved and there is no US regulatory pathway as of mid-2026.
Notes: Cerebrolysin is an approved prescription drug in more than 50 countries but is not FDA-approved and is not legally marketed in the US or the UK. As a proprietary biological extract it is not a bulk drug substance on the FDA 503A list and is not eligible for 503A or 503B compounding; US access occurs through import or travel, outside FDA oversight. It is not currently on the WADA Prohibited List. It is not a controlled substance. (Status current as of mid-2026.)
International status
Pharmacokinetics
Storage and handling
Important Notes
Practical considerations for consistency and safety.
- Cerebrolysin is a mixture of many peptides and free amino acids, not a single defined compound.
- It is an approved prescription drug abroad but is not FDA-approved and is not available in the US through legal pharmaceutical channels.
- Industry-sponsored trials are more favorable than independent Cochrane reviews; the honest reading sits in between and leans cautious for stroke.
- It is given by IV infusion or IM injection under medical supervision in countries where it is approved.
Lifestyle Factors
- Administered as short treatment courses (commonly 10 to 21 days), sometimes repeated a few times per year, under medical supervision where approved.
- Not a self-administered lifestyle supplement.
References
Related compounds
Important disclaimer
This page is an educational reference, not medical advice, a diagnosis, or a treatment recommendation, and not a substitute for your prescriber or pharmacist. Approval and regulatory status varies by compound and can change. Always confirm against current prescribing information and consult a qualified healthcare professional before making any decision about a medication.