Page data last changed: . Registry refreshes and identity assessments are separate from scientific content review.
Not one peptide but a standardised digest of pig brain — which is why it has no sequence, no formula and no registry entry, and why its evidence is judged by trial reviews rather than chemistry.
Also known as: FPF-1070 · FPF1070 · Cere
Part of the Neuropeptides & signaling cluster
Overview
Cerebrolysin is not a single peptide: it is a mixture of low-molecular-weight peptides and amino acids derived from porcine brain, given as daily intravenous infusions, and widely used for acute ischaemic stroke and dementia in Russia, Eastern Europe, China and other post-Soviet and Asian countries. Cochrane reviews have assessed it repeatedly; it is not approved in North America or the European Union.
Source & context
Biological / chemical source: Enzymatic digest of porcine brain tissue
Primary research or clinical context: Marketed and used clinically in Russia, Eastern Europe, China and other Asian and post-Soviet countries for stroke and dementia; not approved by the FDA, Health Canada or the EMA
What Cerebrolysin is — and why it has no sequence
Cerebrolysin is a mixture, not a molecule. The Cochrane reviews that have assessed it describe it as “a mixture of low-molecular-weight peptides and amino acids derived from porcine brain” with potential neuroprotective properties (Ziganshina et al., Cochrane Database of Systematic Reviews 2023). Because it is an enzymatic digest rather than a synthetic peptide, it has no defined amino-acid sequence, no molecular formula and no entry in PubChem or the IUPHAR Guide to Pharmacology. That is unusual for this directory, where almost every profile carries a verified structure block, and it is the first thing to understand about the product: its identity is a manufacturing process and a batch specification, not a chemical structure.
What is actually in it
A mass-spectrometric analysis of the peptide composition reported that Cerebrolysin “contains considerable amounts of Leu- and Met-enkephalins, partial analogues of enkephalins, peptide fragments of beta-lipotropin” (Torshin et al., Zhurnal Nevrologii i Psikhiatrii 2019), and proposed that these fragments act on the endorphin system and raise brain-derived neurotrophic factor. The same analysis used bioinformatics to suggest inhibition of several kinases by the peptide components. These are composition and mechanism hypotheses from one group; the directory's enkephalin profiles cover the opioid peptides themselves. What the mixture does in a patient cannot be inferred from its ingredient list, which is why the clinical trial literature, not the chemistry, carries the evidential weight here.
Where it is used
Cerebrolysin is “widely used in the treatment of acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries” (Ziganshina et al., Cochrane Database of Systematic Reviews 2023), and “in many parts of the world … given as a series of daily intravenous infusions, is used as a potential intervention for vascular dementia” (Cui et al., Cochrane Database of Systematic Reviews 2019). A 2025 review notes it “is most widely used in Eastern European countries” and examines proposed psychiatric uses (Florek et al., Biomedicines 2025). ClinicalTrials.gov listed 42 registered studies naming it as an intervention at the September 2026 snapshot, including phase 3 and phase 4 trials in stroke, disorders of consciousness and Bell's palsy.
The trial evidence: stroke
The Cochrane review of Cerebrolysin in acute ischaemic stroke has been updated repeatedly. The 2015 version included one trial of 146 participants; the 2016–2017 versions six randomised trials with 1,501 participants; the 2020 version seven trials with 1,601 participants; and the 2023 update seven trials with 1,773 participants, adding a trial of the Cerebrolysin-like agent Cortexin that contributed 272 participants (Ziganshina et al., Cochrane Database of Systematic Reviews 2015, 2016, 2017, 2020, 2023). Across those updates the reviewers repeatedly judged risk of bias unclear or high for several domains — allocation concealment, incomplete outcome data and selective reporting among them. The growth in participant numbers has not been matched by growth in the quality of the trials, which is the point the review series keeps making.
| Review year | Randomised trials | Participants |
|---|---|---|
| 2015 | 1 | 146 |
| 2016 / 2017 | 6 | 1,501 |
| 2020 | 7 | 1,601 |
| 2023 | 7 (incl. one Cortexin trial) | 1,773 |
The trial evidence: vascular dementia
The 2013 Cochrane review of Cerebrolysin in vascular dementia pooled six randomised trials with 597 participants and reported a benefit on general cognition: a weighted mean difference of 1.10 points on the Mini-Mental State Examination (95% CI 0.37 to 1.82) and −4.01 points on the extended ADAS-cog (95% CI −5.36 to −2.66), with improved global clinical response (relative risk 2.71, 95% CI 1.83 to 4.00) and only non-serious adverse events reported (Chen et al., Cochrane Database of Systematic Reviews 2013). The 2019 update was undertaken because the earlier review “yielded inconsistent results” and to apply contemporary methods for appraising the strength of the evidence (Cui et al., Cochrane Database of Systematic Reviews 2019). A one-point MMSE difference is statistically detectable; whether it is clinically meaningful is the question the updated review set out to weigh.
Regulatory status
Cerebrolysin is a licensed medicine in the countries where the Cochrane reviews describe it as widely used, and it is administered there as a course of intravenous infusions. It is not approved by the FDA, Health Canada or the EMA, and no application appears in the evidence pack. As a biological product derived from animal tissue with no defined structure, it also sits outside the “research peptide” category this site normally discusses: it cannot be synthesised to a specification, and a certificate of analysis for a vial sold online cannot verify identity against a reference sequence because there is none.
Relation to other peptides on this site
The enkephalins identified in its composition have their own profile (Met-enkephalin), as does β-endorphin, the β-lipotropin fragment that the composition study relates to. Semax and Selank, two synthetic neuropeptides developed in Russia and used in the same clinical culture, are the nearest comparators among defined molecules; Cerebrolysin differs from them in being undefined. Readers comparing “nootropic peptides” should note that Cerebrolysin is the only one of the group with a systematic-review evidence base at all, and that this base is itself contested.
Structure & chemistry
Molecular identity & reference confidence
Reference mass unavailable
Reference values are taken from the cited molecular record or curated profile. A database match is not independent laboratory verification; modifications, counter-ions, and formulations can change the measured mass.
- Molecular form
- No defined sequence — a heterogeneous digest of porcine brain proteins; mass-spectrometry has identified enkephalins, partial enkephalin analogues and β-lipotropin fragments among its peptides
- Species
- Not established by this molecular identity audit
- Termini (N / C)
- Not specified / Not specified
Average reference mass
Reference policy updated: 2026-10-05
- Backbone
- No defined sequence — a heterogeneous digest of porcine brain proteins; mass-spectrometry has identified enkephalins, partial enkephalin analogues and β-lipotropin fragments among its peptides
- Status
- Used clinically in Russia, Eastern Europe, China and other Asian and post-Soviet countries; not approved by the FDA, Health Canada or the EMA as of September 2026
Chemistry values: curated profile.
Clinical development snapshot
ClinicalTrials.gov lists 43 registered studies with “Cerebrolysin” as an intervention (snapshot 2026-10-01). A registry footprint is not evidence of efficacy or approval.
| NCT | Title | Phase | Status | Updated |
|---|---|---|---|---|
| NCT07846488 | Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke | Not applicable | not yet recruiting | 2026-09-29 |
| NCT06339411 | Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy | Phase 2 | not yet recruiting | 2026-08-11 |
| NCT04427241 | Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness | Phase 4 | recruiting | 2026-05-11 |
| NCT06052787 | Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the IC | Phase 3 | completed | 2025-11-19 |
| NCT05821075 | Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy | Phase 2 | recruiting | 2025-07-31 |
| NCT07043686 | Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study | Not applicable | recruiting | 2025-07-09 |
Change log
Dated observations from the data pipeline (registry flags, trial footprints, identifiers) and editorial reviews of this profile.
- Trials1 registered study added on ClinicalTrials.gov (now 43).
- EditorialProfile content reviewed and updated by the editorial team.
FAQ about Cerebrolysin
What is Cerebrolysin?+
Cerebrolysin is not a single peptide: it is a mixture of low-molecular-weight peptides and amino acids derived from porcine brain, given as daily intravenous infusions, and widely used for acute ischaemic stroke and dementia in Russia, Eastern Europe, China and other post-Soviet and Asian countries. Cochrane reviews have assessed it repeatedly; it is not approved in North America or the European Union.
What Canadian product status is recorded for Cerebrolysin?+
Canadian product status for Cerebrolysin has not been verified in this profile. No verified record here does not mean no authorization exists. Status depends on the product, formulation and use; consult Health Canada's product records.
What is the typical length of Cerebrolysin?+
Cerebrolysin is not a classic amino-acid chain peptide in the same sense; see the profile for classification details.
What is Cerebrolysin?+
A mixture of low-molecular-weight peptides and amino acids derived from porcine brain, given as intravenous infusions and used for stroke and dementia mainly in Russia, Eastern Europe and Asia. It is not a single peptide and has no defined sequence.
Is Cerebrolysin FDA-approved?+
No. It is not approved by the FDA, Health Canada or the EMA. It is licensed and widely used in Russia, Eastern Europe, China and other Asian and post-Soviet countries.
Does Cerebrolysin work for stroke?+
Cochrane has reviewed the randomised trials repeatedly (seven trials, 1,773 participants in the 2023 update) and has consistently flagged unclear or high risk of bias across several domains. The evidence has grown in size more than in quality.
Does Cerebrolysin help dementia?+
A 2013 Cochrane meta-analysis of six trials (597 participants) found a 1.10-point MMSE benefit and improved global response; the 2019 update was undertaken because earlier results were inconsistent.
What peptides are in Cerebrolysin?+
Mass spectrometry has identified Leu- and Met-enkephalins, partial enkephalin analogues and fragments of β-lipotropin, among others. The full composition is a batch property, not a fixed formula.
Related peptides
References & further reading
- 1.Jarosz et al. (2023). Cerebrolysin in Patients with TBI: Systematic Review and Meta-Analysis. Brain Sci
- 2.Trimmel et al. (2024). Life-Threatening Anaphylaxis due to Cerebrolysin®. Case Rep Neurol Med
- 3.Bogolepova (2023). [Cerebrolysin in the treatment of cognitive impairment]. Zh Nevrol Psikhiatr Im S S Korsakova
- 4.Aguilar-Hernández et al. (2025). Cerebrolysin Ameliorates Age-Induced Dendritic Spine Degeneration and Memory Decline in C57BL6 Mice. Neurochem Res
- 5.Ozkizilcik et al. (2019). Nanodelivery of cerebrolysin reduces pathophysiology of Parkinson's disease. Prog Brain Res
- 6.Mafikandi et al. (2025). Effects of cerebrolysin on behavioral changes and the tryptophan-kynurenine pathway in the prefrontal cortex of male mice in the ketamine model of schizophrenia. Mol Biol Rep
- 7.iganshina et al. (2013). [Cerebrolysin for acute ischemic stroke]. Vestn Ross Akad Med Nauk
- 8.Kojder et al. (2023). Cerebrolysin in Patients with Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis. J Clin Med
- 9.Ziganshina et al. (2023). Cerebrolysin for acute ischaemic stroke. Cochrane Database of Systematic Reviews
- 10.Ziganshina et al. (2020). Cerebrolysin for acute ischaemic stroke. Cochrane Database of Systematic Reviews
- 11.Cui et al. (2019). Cerebrolysin for vascular dementia. Cochrane Database of Systematic Reviews
- 12.Chen et al. (2013). Cerebrolysin for vascular dementia. Cochrane Database of Systematic Reviews
- 13.Torshin et al. (2019). Cerebrolysin peptides as mood stabilizers. Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova
- 14.Florek et al. (2025). Is Cerebrolysin Useful in Psychiatry Disorders? Biomedicines