Cerebrolysin
Cerebrolysin — the most-studied nootropic peptide: 50 countries, contested evidence, no FDA approval

Class: peptide
Synonyms: Cerebrolysin
a porcine brain-derived neuropeptide preparation
Function tags: neuroprotection
stroke recovery
TBI
vascular dementia / Alzheimer's
(nootropic, in gray-market framing)
Overall evidence grade: C
WADA prohibited: no
Last updated: 2026-07-13

In brief: Cerebrolysin is a pig-brain-derived mixture of neuropeptides and amino acids (not a single molecule), given by IV/IM, that mimics the brain's own neurotrophic factors (BDNF, NGF, GDNF) to support neuron survival and synaptic plasticity. It's the most clinically-studied "cognitive peptide" by a wide margin — 160+ trials, 8000+ patients, and approval in 50+ countries for stroke, TBI, and dementia — with individual RCTs (e.g. CASTA in stroke; several Alzheimer's trials) showing real cognitive/functional benefits, and the vascular-dementia evidence among its strongest. But the evidence is genuinely contested: Cochrane reviews across three decades rate it low-quality (small samples, high bias, heavily manufacturer-funded), there's no independent confirmation, a 2023 Cochrane found no mortality benefit and a significant rise in serious adverse events in acute stroke, and it is not FDA-approved. So the honest read is unusual for this register: lots of human data and real-world approval — but quality and independence problems keep Western academic neurology cautious. Big evidence base ≠ settled evidence.

## Identity unlike every other entry here, Cerebrolysin is **not one molecule**. It's a **proprietary extract from purified pig-brain tissue**, produced by **controlled enzymatic hydrolysis**, yielding a **standardized mixture of low-molecular-weight neuropeptides and free amino acids**. The low-MW fragments are small enough to **cross the blood-brain barrier**. It is given **only by IV infusion or IM injection** (peptides would be digested if taken orally). Made **exclusively by EVER Neuro Pharma** (Austria). ## Mechanism (as proposed) Cerebrolysin's low-molecular-weight peptide fragments are thought to **cross the blood-brain barrier** and **mimic endogenous neurotrophic factors** — **BDNF, NGF and GDNF** — thereby supporting **neuronal survival, synaptic plasticity, neurogenesis**, and reducing secondary injury processes (astrogliosis, axonal injury in animal models). Because it's a **mixture**, the effect is described as **multimodal** (neurotrophic-like + neuroprotective + possibly synaptogenic) rather than a single receptor action. This "brain-cocktail mimicking growth factors" framing is biologically plausible and animal-supported — but the **clinical translation is exactly what remains contested**.

Evidence grades by outcome:
outcome: Vascular dementia
grade: C
base: Multiple RCTs + 2020 systematic review (J Neural Transm); often cited as its strongest indication
caveat: Among the better-supported uses — but Cochrane still cautious; manufacturer funding pervasive
outcome: Alzheimer's disease (cognition)
grade: C
base: Meta-analysis of 6 double-blind placebo-controlled trials: significant vs placebo at 4 wk, effect size ~ cholinesterase inhibitors
caveat: Positive signal, but short follow-up, small trials, industry-sponsored; Cochrane "very low" quality
outcome: Stroke recovery (cognitive/functional)
grade: C
base: CASTA (1,070 pts): improved 90-day cognition; several rehab RCTs
caveat: Individual trials positive; 2023 Cochrane: no mortality benefit + ↑ serious AEs (RR ~2.39); 2012 trial doubted benefit except severe cases
outcome: Traumatic brain injury (TBI)
grade: C
base: RCTs + 2025 mechanistic work on secondary-injury modulation
caveat: Suggestive; smaller/heterogeneous evidence
outcome: Nootropic use in healthy adults (the gray-market use)
grade: F
base: Essentially none — trials are in disease populations
caveat: No evidence it helps healthy cognition or prevents dementia; extrapolation from patient data is unjustified
outcome: Independent replication / overall quality
base: Three decades of Cochrane appraisal
caveat: The core problem: predominantly manufacturer-funded, high risk of bias, no independent confirmation. Large ≠ high-quality
outcome: Safety
base: Large exposure across trials/clinical use
caveat: Generally described as safe short-term; porcine allergy = absolute contraindication; rare seizure reports (causality unclear); caution with serotonergic antidepressants; 2023 Cochrane flagged ↑ non-fatal serious AEs

Legal status:
region: EU
status: Status varies
note: status varies by country; it is a prescription medical product where registered, not a cosmetic and not a self-administered supplement.

Cosmetic claims:

Note: The most-studied cognitive "peptide" — approved in 50+ countries, yet its evidence is genuinely contested. Three points define this entry: (1) it's not a single peptide but a porcine (pig) brain extract — a mixture of neuropeptides and amino acids; (2) it has by far the largest human evidence base of any nootropic peptide (160+ trials, 8000+ patients) and is approved/registered in 50+ countries — but not FDA-approved; (3) despite that, Cochrane reviews across three decades keep finding the evidence weak (small samples, bias, manufacturer funding), and a 2023 Cochrane review flagged a rise in serious adverse events. It's the register's cleanest "widely used, still unproven" case.
Status note: watch for the updated 2025 Cochrane vascular-dementia review and any independent, non-industry RCT — that would be decisive

Sources:
Cochrane reviews — Cerebrolysin for vascular dementia (2013; updated 2025) and for acute ischemic stroke (2023, 7 RCTs / 1,773 participants: no mortality benefit; ↑ non-fatal serious AEs RR ~2.39).
Heiss WD, et al. Cerebrolysin in acute ischemic stroke in Asia (CASTA). Stroke. 2012.
Alvarez XA, Cacabelos R, et al. — Alzheimer's RCTs (24-week dose-ranging; combination with donepezil).
2020 systematic review, J Neural Transm (vascular dementia); Thome & Doppler (2012) safety profile.
EVER Neuro Pharma (manufacturer) — composition/administration. (Note: evidence base is large but predominantly manufacturer-funded; no independent confirmation as of 2026.)