Cerebrolysin

evidence score

nootropic

Gray Market

167 studies

FPF 1070cerebrolysin injectionporcine brain hydrolysate

Cerebrolysin is a standardized porcine brain-derived peptide mixture containing low molecular weight neuropeptides and amino acids. Widely used in Eastern Europe, China, and Latin America for stroke recovery, traumatic brain injury, Alzheimer's disease, and vascular dementia — with regulatory approval in many countries outside the US/UK. Phase III trials have been conducted for acute ischemic stroke (CASTA trial) with mixed but generally positive results. Mechanism involves neurotrophic factor-like activity mimicking BDNF and NGF, promoting neuronal survival, dendritic sprouting, and neuroplasticity. Injectable only (IV/IM). Gray-market in the US — not FDA approved but widely imported. Legitimate clinical use context in stroke neurology.

Evidence

Moderate evidence

Safety

Unknown safety profile

Clinical Status

Phase III

Last Sync

Feb 19, 2026

Last Reviewed

Not reviewed yet

Physician Notes

Expect 1-2 day mood depression post-infusion. This is common and transient. Approved in 40+ countries. Used in courses (10-20 daily infusions) rather than ongoing.

FDA Status:Not FDA-approved in the US. Approved in 40+ countries for neurological indications.

Monitoring

Neurological assessment
Mood monitoring post-infusion

Contraindications

Epilepsy (may lower seizure threshold)
Severe renal failure

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Dosing

Typical

20 ml

5 mlRange60 ml

FrequencyIV infusion or IM injection, typically in 10–20 day courses

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Pharmacology

Half-lifeUnknown (peptide mixture with variable components)

OnsetIV: effects within 1–2 weeks of treatment course; IM similar but slower

DurationBenefits from treatment courses may persist weeks to months

Routes

intravenous

intramuscular

Evidence Score

Level B — Moderate

167 studies indexed · 14 meta-analyses

Scoring Factors

Volume(24%)~45/100

Quality(24%)~57/100

Sample Size(12%)~94/100

Consistency(14%)~94/100

Replication(8%)~94/100

Recency(18%)~94/100

Scores estimated from study counts. Exact breakdown computed after research sync.

Evidence Levels

AScore ≥75 with at least 1 meta-analysis and 3+ RCTs

BScore ≥50 with at least 1 RCT or meta-analysis

CScore ≥25 — observational or animal evidence only

DScore <25 — very limited or preclinical data

Plain-English Snapshot

Cerebrolysin is currently categorized as a nootropic compound.

Evidence is moderate (74/100): promising signal from 167 indexed studies, but context and population still matter.

Safety scoring is incomplete. Start conservatively and monitor carefully.

Core mechanism

Porcine brain peptide mixture with neurotrophic factor-like activity; activates BDNF/NGF signaling pathways; promotes neuroplasticity, neuronal survival, and synaptogenesis

Practical Context

Strongest current signals

Level B: Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study.
Level B: Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study.
Level C: Cerebroprotection in acute ischemic stroke: Perspectives on combining cerebrolysin with recanalization therapy.