FPF-1070
Evidence Grade B — Strong clinical evidence. 622 published studies, 319 human. 41 registered clinical trials.
Cerebrolysin is a mixture of peptide fragments derived from pig brain tissue, used in some countries (mainly Central/Eastern Europe, Asia, and Latin America) for stroke and dementia. Unlike most compounds in this database, it is not a single defined molecule — it is a complex biological mixture whose exact composition varies between batches.
622 published studies: 319 human, 202 animal, 45 in-vitro, 94 reviews
Cerebrolysin has been studied in over 200 clinical trials involving more than 15,000 patients, primarily for stroke and Alzheimer's disease. The largest stroke trial (CASTA, 1,070 patients) showed no significant benefit on its primary endpoint. A Cochrane systematic review concluded that evidence was insufficient to support its routine use in stroke or dementia.
Cerebrolysin is approved in some non-FDA/non-EMA jurisdictions for neurological conditions. Its clinical evidence base, despite being extensive in volume, has not met the standards required for FDA or EMA approval. The undefined molecular composition makes batch-to-batch consistency and quality standardisation inherently challenging compared to defined single-entity pharmaceuticals.
Research suggests the peptide mixture may interact with neurotrophic factor pathways. However, as an undefined mixture of unknown composition, the active component(s), their receptor targets, and their mechanism cannot be precisely characterised in the way that a defined single-entity drug can be. This is a fundamental limitation of mixture-based biologics.
Research suggests cerebrolysin has been studied in over 200 clinical trials involving more than 15,000 patients, primarily for stroke and Alzheimer's disease. However, the largest and most rigorous trials — particularly the CASTA stroke trial (1,070 patients) — failed their primary endpoints. Cochrane systematic reviews consistently rate the evidence as low to very low quality and have flagged a possible increase in non-fatal serious adverse events. Positive findings emerge mainly from smaller trials, post-hoc subgroup analyses, and meta-analyses partially associated with the manufacturer — patterns that do not meet the standards required for FDA or EMA approval. The undefined molecular composition makes batch-to-batch consistency inherently challenging compared to single-entity drugs. Despite extensive study, no positive Phase III trial on a primary endpoint exists for any indication.
Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial
Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study
Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study
Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
Pinealon has no marketing authorisation from any major regulatory agency. No controlled human clinical trials have been conducted. The evidence base consists of in vitro cell studies and animal experiments published primarily by the originating research group. As with other Khavinson bioregulator peptides, the proposed mechanisms and the underlying theoretical framework have not been evaluated through conventional Western regulatory processes. Products available through unregulated channels lack pharmaceutical quality assurance.
Selank is approved in Russia for anxiety-related conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies. The key clinical study (62 patients) compared Selank to a benzodiazepine in generalised anxiety disorder and reported comparable effects. Published clinical studies are predominantly Russian and have not undergone Western regulatory review. The evidence base does not meet FDA or EMA approval standards. Its regulatory status is limited to Russia and certain former Soviet states.
Semax is approved in Russia for stroke recovery and cognitive conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies, and the clinical evidence base has not undergone Western regulatory review. Published clinical studies are predominantly Russian. The largest published study (110 stroke patients) reported correlations between treatment and BDNF levels. The evidence does not meet the standards typically required for FDA or EMA approval. Its regulatory status is limited to Russia and certain former Soviet states.
