What it is
Cortexin is a manufactured mixture of low-molecular-weight polypeptides extracted from the cerebral cortex of young cattle or pigs, developed in Russia by Vladimir Khavinson’s group and sold there as a registered prescription “peptide bioregulator” drug, typically as a lyophilized powder for intramuscular injection. Like Cerebrolysin, it is a biological mixture rather than a single defined peptide, and its manufacturer describes it as tissue-specific rather than acting through one identified receptor.
It has never been submitted for approval in the United States, the European Union or any other major regulatory jurisdiction outside the countries where Khavinson-group bioregulators circulate (principally Russia and some neighbouring states), and it has no FDA label or EMA authorisation.
The human trial record
A 1999 trial in 76 patients with stage I-II dyscirculatory encephalopathy (a Russian diagnostic category roughly corresponding to chronic cerebrovascular insufficiency) compared standard therapy alone (31 patients) against standard therapy plus adjuvant Cortexin delivered by nasal electrophoresis (45 patients), reporting improvement in psychoemotional state, attention, memory and EEG measures in the Cortexin group, described as a randomized comparative clinical trial in its own indexing.
A 2020 study in elderly university teachers combined breathing exercises with the Cortexin peptide bioregulator and reported improved measures of professional performance and functional state over two weeks, with the benefit lasting up to two months; this was framed as testing a combination intervention (breathing exercises plus Cortexin) rather than Cortexin alone.
Every trial located for this entry was published in Russian, conducted at Russian institutions, and used a delivery method, either nasal electrophoresis or combination with a behavioural intervention, that does not correspond to a simple systemic injection. No trial located for this entry reports a straightforward intramuscular dose in milligrams tested against a placebo in isolation, and no trial appears on ClinicalTrials.gov.
What is not known
Whether Cortexin given alone, by standard intramuscular injection, produces the effects reported when it was delivered by nasal electrophoresis or combined with breathing exercises. No trial located for this entry isolated the drug from its delivery method or its co-intervention.
Whether these results would replicate in a blinded, placebo-controlled Western trial. None was located.
Long-term human safety data outside these small Russian studies.