# Cerebrolysin

Cerebrolysin has no approved use in the US, and no pharmacy may lawfully make it. It is a mixture of peptides from pig brain. The evidence grade is limited-human: trials abroad in stroke and dementia give mixed results, and one review found more serious harms.

Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | CBL | peer-reviewed | 2026-10-26 | [source](https://pubmed.ncbi.nlm.nih.gov/37220681/) |
| Class | neuro-and-cognitive | peer-reviewed | 2026-10-26 | [source](https://pubmed.ncbi.nlm.nih.gov/37818733/) |
| Regulatory status | no-approved-use | primary | 2026-10-26 | [source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020) |
| Status source read | 2026-10-25 | primary | 2026-10-26 | [source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020) |
| Evidence grade | limited-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) |

## Name

Cerebrolysin

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

## Summary

A mixture of small peptides and amino acids taken from pig brain, not one peptide. It is widely used after stroke in Russia, Eastern Europe and China.

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

## Short answer

Cerebrolysin has no approved use in the US, and no pharmacy may lawfully make it. It is a mixture of peptides from pig brain. The evidence grade is limited-human: trials abroad in stroke and dementia give mixed results, and one review found more serious harms.

Source: https://peptideindex.ai/methodology#short-answer

## Known risks

- A 2023 review of stroke trials found more people had serious harms on Cerebrolysin. These harms were not deadly [^5].
- In cells grown in a lab, large or repeated amounts of Cerebrolysin killed more cells [^11].
- A pharmacy that made Cerebrolysin drugs made its germ-free drugs in unclean conditions, FDA found [^1].
- FDA saw staff at a clinic fill syringes in an open room, in street clothes. Its letter names Cerebrolysin [^2].

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

## What nobody knows yet

- Nobody knows if Cerebrolysin helps recovery after stroke. A small trial found better arm movement, but a larger review found no change in deaths [^5] [^8].
- Any gain in vascular dementia may be too small to matter, and the trials had a high risk of bias [^6].
- Nobody knows which of the many peptides in the mixture do anything. That work is at an early stage [^12].
- The brain injury trial was small and just missed its main goal. A larger trial is needed [^9].
- The results in rats and in lab-grown cells may not hold in people [^10] [^11].

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

## What it is

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].

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

## Where it stands legally

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].

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

## What the evidence shows

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.

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

## Legitimate ways to get it

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.

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

## How people are getting it anyway

This section describes what happens and is not a recommendation.

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].

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

## Access routes

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

### None

Detail: There is no legal route to Cerebrolysin in the US today. It is in no approved drug and is not on the list pharmacies may use.

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

## Unofficial channels

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

### Compounding outside the rules

What it is: Made by a pharmacy from bulk Cerebrolysin, although it does not meet the rules for pharmacy compounding.

Legal position: FDA says drugs made from Cerebrolysin do not qualify for the compounding exemptions. It is in no approved drug and is not on the federal list. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)

Documented risks:

- FDA found that a pharmacy making drugs from Cerebrolysin made sterile drugs in unclean conditions. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
- A 2023 review of stroke trials found that Cerebrolysin probably raises the number of people with serious harms that are not deadly. (source: https://pubmed.ncbi.nlm.nih.gov/37818733/)

Enforcement:

- 2020-04-01: FDA warning letter to a Kentucky compounding pharmacy that made drugs from Cerebrolysin and other peptides. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
- 2020-10-29: The same pharmacy pleaded guilty in federal court to selling unapproved new drugs, Cerebrolysin among them. (source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

### Clinic or med spa

What it is: Made by a clinic that compounds its own drugs and ships them to patients.

Legal position: FDA says Cerebrolysin was not nominated for the list of substances pharmacies may use, so drugs made from it do not qualify for the compounding exemptions. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021)

Documented risks:

- FDA found the clinic filled sterile syringes outside a clean area, with staff in street clothes and no gloves. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021)

Enforcement:

- 2021-11-10: FDA warning letter to an Indiana clinic that compounded drugs; the letter names Cerebrolysin. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021

## Recruiting trials

Snapshot date: 2026-10-26.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- nct NCT07846488, url https://clinicaltrials.gov/study/NCT07846488, phase Not applicable, title Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke, status not-yet-recruiting, sponsor National Hospital of Acupuncture, Vietnam, countries Vietnam, us states none listed
- nct NCT06339411, url https://clinicaltrials.gov/study/NCT06339411, phase Phase 2, title Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy, status not-yet-recruiting, sponsor Chang Gung Memorial Hospital, countries none listed, us states none listed
- nct NCT06899464, url https://clinicaltrials.gov/study/NCT06899464, phase Phase 4, title Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial, status not-yet-recruiting, sponsor Cardinal Stefan Wyszynski University, countries none listed, us states none listed
- nct NCT07043686, url https://clinicaltrials.gov/study/NCT07043686, phase Not applicable, title Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study, status recruiting, sponsor University Medical Centre Ljubljana, countries Slovenia, us states none listed
- nct NCT06897176, url https://clinicaltrials.gov/study/NCT06897176, phase Phase 4, title Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study, status recruiting, sponsor Yonsei University, countries South Korea, us states none listed
- nct NCT05821075, url https://clinicaltrials.gov/study/NCT05821075, phase Phase 1/Phase 2, title Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy, status recruiting, sponsor October 6 University, countries Egypt, us states none listed
- nct NCT04427241, url https://clinicaltrials.gov/study/NCT04427241, phase Phase 4, title Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness, status recruiting, sponsor Konkuk University Medical Center, countries South Korea, us states none listed

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=Cerebrolysin&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

### 1. FDA warning letter to a compounding pharmacy that made drugs from Cerebrolysin and other peptides, 1 April 2020

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

### 2. FDA warning letter to a clinic that compounded drugs, naming Cerebrolysin, 10 November 2021

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021

### 3. US Attorney, Eastern District of Kentucky: a compounding pharmacy pleads guilty to selling unapproved new drugs, 2020

Type: regulatory

Tier: primary

Source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

### 4. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 5. Cochrane review: Cerebrolysin for acute ischaemic stroke, 2023

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/37818733/

### 6. Cochrane review: Cerebrolysin for vascular dementia, 2019

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/31710397/

### 7. Meta-analysis: Cerebrolysin in mild-to-moderate Alzheimer's disease, 2015

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/25832905/

### 8. CARS trial: Cerebrolysin and recovery after stroke, 2016

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/26564102/

### 9. CAPTAIN I trial: Cerebrolysin after traumatic brain injury, 2020

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/31494820/

### 10. Cerebrolysin and an enriched cage in rats after stroke, 2024

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/38048977/

### 11. Cerebrolysin on lab-grown motor-neuron-like cells, 2014

Type: in-vitro

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/24997385/

### 12. Finding the active peptides in Cerebrolysin by mass spectrometry, 2023

Type: in-vitro

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/37220681/

### 13. ClinicalTrials.gov NCT06897176: Cerebrolysin with speech therapy for aphasia after stroke

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06897176

### 14. ClinicalTrials.gov NCT06339411: Cerebrolysin after clot removal for stroke

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06339411

Last verified: 2026-10-26.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=Cerebrolysin&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://pubmed.ncbi.nlm.nih.gov/37220681/
- https://pubmed.ncbi.nlm.nih.gov/37818733/
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

[^1]: FDA warning letter to a compounding pharmacy that made drugs from Cerebrolysin and other peptides, 1 April 2020 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
[^2]: FDA warning letter to a clinic that compounded drugs, naming Cerebrolysin, 10 November 2021 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021
[^3]: US Attorney, Eastern District of Kentucky: a compounding pharmacy pleads guilty to selling unapproved new drugs, 2020 https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
[^4]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^5]: Cochrane review: Cerebrolysin for acute ischaemic stroke, 2023 https://pubmed.ncbi.nlm.nih.gov/37818733/
[^6]: Cochrane review: Cerebrolysin for vascular dementia, 2019 https://pubmed.ncbi.nlm.nih.gov/31710397/
[^7]: Meta-analysis: Cerebrolysin in mild-to-moderate Alzheimer's disease, 2015 https://pubmed.ncbi.nlm.nih.gov/25832905/
[^8]: CARS trial: Cerebrolysin and recovery after stroke, 2016 https://pubmed.ncbi.nlm.nih.gov/26564102/
[^9]: CAPTAIN I trial: Cerebrolysin after traumatic brain injury, 2020 https://pubmed.ncbi.nlm.nih.gov/31494820/
[^10]: Cerebrolysin and an enriched cage in rats after stroke, 2024 https://pubmed.ncbi.nlm.nih.gov/38048977/
[^11]: Cerebrolysin on lab-grown motor-neuron-like cells, 2014 https://pubmed.ncbi.nlm.nih.gov/24997385/
[^12]: Finding the active peptides in Cerebrolysin by mass spectrometry, 2023 https://pubmed.ncbi.nlm.nih.gov/37220681/
[^13]: ClinicalTrials.gov NCT06897176: Cerebrolysin with speech therapy for aphasia after stroke https://clinicaltrials.gov/study/NCT06897176
[^14]: ClinicalTrials.gov NCT06339411: Cerebrolysin after clot removal for stroke https://clinicaltrials.gov/study/NCT06339411