Cerebrolysin

Cerebrolysin is not one peptide. It is a mixture of small peptides and amino acids taken from pig brain ^[5]. Amino acids are the building blocks of proteins. Researchers are still trying to find which of its many peptides do anything ^[12].

It is given by drip into a vein ^[6]. Doctors in Russia, Eastern Europe, China and other parts of Asia use it widely after stroke ^[5]. No drug approved in the US contains it ^[1].

Cerebrolysin has no approved use in the US: FDA says it is in no approved drug and is not on the list pharmacies may use ^[1]. That means no pharmacy may lawfully make it. Its use after stroke in other countries does not change its US status ^[5]. Checked 25 October 2026.

A pharmacy may make a drug from a bulk substance only in certain cases. One case is a substance on a list FDA keeps under section 503A of the law ^[4]. FDA letters of 2020 and 2021 say nobody had nominated Cerebrolysin for that list ^{[1] [2]}. FDA says drugs made from it are new drugs that need its approval ^[1].

In 2020, a Kentucky pharmacy pleaded guilty in federal court to selling unapproved new drugs ^[3]. Cerebrolysin was one of them ^[3].

The evidence grade is limited-human: trials in people with stroke, dementia and brain injury give mixed results, and many were small or at risk of bias ^{[5] [6] [8] [9]}.

A 2023 Cochrane review pooled seven stroke trials with 1,773 people ^[5]. It found that Cerebrolysin, or a similar mixture, probably makes little or no difference to deaths ^[5]. It also found a possible rise in serious harms that were not deadly ^[5]. The maker of Cerebrolysin supported three of the trials ^[5]. In the CARS trial, people in early stroke rehab who got Cerebrolysin moved their arms better at 90 days than people given salt water ^[8]. Its authors called it a small, early trial ^[8].

Vascular dementia is memory loss from poor blood flow in the brain. A 2019 Cochrane review of six trials with 597 people found small gains in thinking scores ^[6]. The quality of that evidence was very low, and any gain may be too small to matter ^[6]. A 2015 analysis of six trials in mild-to-moderate Alzheimer's disease found gains over a dummy treatment ^[7]. In 46 people with a brain injury, the CAPTAIN I trial just missed its main goal ^[9].

In 40 rats with a stroke, Cerebrolysin and a cage full of objects each helped movement and memory ^[10]. In lab-grown nerve-like cells, it gave brief protection, but high or repeated amounts harmed the cells ^[11]. These are animal and lab results, not results in people.

No approved drug in the US contains Cerebrolysin, and no pharmacy may lawfully make it ^{[1] [4]}. There is no legal route to it in the US today.

Trials abroad are testing it after stroke. One in South Korea is recruiting, and one in Taiwan has not yet started ^{[13] [14]}. Any open trial appears in the trials block below, with the date the official registry was last checked.

Two ways of getting Cerebrolysin show up in federal records ^{[1] [2]}. The first is pharmacies that make it although the law does not allow it. In 2020, FDA sent a warning letter to a Kentucky pharmacy that made drugs from Cerebrolysin and other peptides ^[1]. That pharmacy later pleaded guilty to selling unapproved new drugs, Cerebrolysin among them ^[3].

The second is clinics that make their own drugs. In 2021, FDA sent a warning letter to a clinic, and the letter says Cerebrolysin was not nominated for the pharmacy list ^[2]. FDA found the clinic made sterile drugs in unclean conditions ^[2].

FDA says products like these are new drugs that need its approval, and Cerebrolysin has none ^[1].