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Cerebrolysin (developmental code name FPF-1070) is an experimental mixture of
enzymatically An enzyme () is a protein that acts as a biological catalyst by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as produc ...
-treated
peptide Peptides are short chains of amino acids linked by peptide bonds. A polypeptide is a longer, continuous, unbranched peptide chain. Polypeptides that have a molecular mass of 10,000 Da or more are called proteins. Chains of fewer than twenty am ...
s derived from pig brain whose constituents can include
brain-derived neurotrophic factor Brain-derived neurotrophic factor (BDNF), or abrineurin, is a protein found in the and the periphery. that, in humans, is encoded by the ''BDNF'' gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the can ...
(BDNF),
glial cell line-derived neurotrophic factor Glial cell line-derived neurotrophic factor (GDNF) is a protein that, in humans, is encoded by the ''GDNF'' gene. GDNF is a small protein that potently promotes the survival of many types of neurons. It signals through GFRα receptors, particul ...
(GDNF),
nerve growth factor Nerve growth factor (NGF) is a neurotrophic factor and neuropeptide primarily involved in the regulation of growth, maintenance, proliferation, and survival of certain target neurons. It is perhaps the prototypical growth factor, in that it was ...
(NGF), and
ciliary neurotrophic factor Ciliary neurotrophic factor is a protein that in humans is encoded by the ''CNTF'' gene. The protein encoded by this gene is a polypeptide hormone and neurotrophic factor whose actions have mainly been studied in the nervous system where it pro ...
(CNTF). Although it is under preliminary study for its potential to treat various brain diseases, it is used as a therapy in dozens of countries in
Eurasia Eurasia ( , ) is a continental area on Earth, comprising all of Europe and Asia. According to some geographers, Physical geography, physiographically, Eurasia is a single supercontinent. The concept of Europe and Asia as distinct continents d ...
. Cerebrolysin has been studied for potential treatment of several
neurodegenerative disease A neurodegenerative disease is caused by the progressive loss of neurons, in the process known as neurodegeneration. Neuronal damage may also ultimately result in their death. Neurodegenerative diseases include amyotrophic lateral sclerosis, mul ...
s, with only preliminary research, as of 2023. No clear benefit in the treatment of acute
stroke Stroke is a medical condition in which poor cerebral circulation, blood flow to a part of the brain causes cell death. There are two main types of stroke: brain ischemia, ischemic, due to lack of blood flow, and intracranial hemorrhage, hemor ...
has been found, and an increased rate of spontaneous
adverse effect An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term compli ...
s requiring hospitalization is reported. Some positive effects have been reported when cerebrolysin is used to treat
vascular dementia Vascular dementia is dementia caused by a series of strokes. Restricted blood flow due to strokes reduces oxygen and glucose delivery to the brain, causing cell injury and neurological deficits in the affected region. Subtypes of vascular dement ...
.


Research


Stroke

A 2023 review indicated that cerebrolysin or cerebrolysin-like peptide mixtures from cattle brain likely provide no benefit for preventing all-cause death in acute ischemic stroke, and that higher quality studies are needed. In addition, cerebrolysin might cause a higher rate of spontaneous adverse events requiring hospitalization. Studies of ischemic stroke in Asian subpopulations found an absence of benefit. A 2020 study suggested a lack of benefit in
hemorrhagic stroke Stroke is a medical condition in which poor blood flow to a part of the brain causes cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. Both cause parts of the brain to stop ...
related to
cerebral aneurysm An intracranial aneurysm, also known as a cerebral aneurysm, is a Cerebrovascular disease, cerebrovascular disorder characterized by a localized dilation or ballooning of a blood vessel in the brain due to a weakness in the vessel wall. These a ...
.


Dementia

Reviews of preliminary research indicate a possible improvement in
cognitive function Cognitive skills are skills of the mind, as opposed to other types of skills such as motor skills, social skills or life skills. Some examples of cognitive skills are literacy, self-reflection, logical reasoning, abstract thinking, critical th ...
using cerebrolysin for
vascular dementia Vascular dementia is dementia caused by a series of strokes. Restricted blood flow due to strokes reduces oxygen and glucose delivery to the brain, causing cell injury and neurological deficits in the affected region. Subtypes of vascular dement ...
and
Alzheimer's disease Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems wit ...
, although further high-quality research is needed.


Other

Early studies have suggested potential use of cerebrolysin with a wide variety of neurodegenerative disorders, including
traumatic brain injury A traumatic brain injury (TBI), also known as an intracranial injury, is an injury to the brain caused by an external force. TBI can be classified based on severity ranging from mild traumatic brain injury (mTBI/concussion) to severe traumati ...
,
schizophrenia Schizophrenia () is a mental disorder characterized variously by hallucinations (typically, Auditory hallucination#Schizophrenia, hearing voices), delusions, thought disorder, disorganized thinking and behavior, and Reduced affect display, f ...
,
multiple sclerosis Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit ...
,
cerebral palsy Cerebral palsy (CP) is a group of movement disorders that appear in early childhood. Signs and symptoms vary among people and over time, but include poor coordination, spasticity, stiff muscles, Paresis, weak muscles, and tremors. There may b ...
and
spinal cord injury A spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in its function. It is a destructive neurological and pathological state that causes major motor, sensory and autonomic dysfunctions. Symptoms of ...
although research is still preliminary.


Adverse effects

Upon injection, adverse effects of cerebrolysin include
nausea Nausea is a diffuse sensation of unease and discomfort, sometimes perceived as an urge to vomit. It can be a debilitating symptom if prolonged and has been described as placing discomfort on the chest, abdomen, or back of the throat. Over 30 d ...
, dizziness, headache, and sweating. It is not recommended for use in people with
epilepsy Epilepsy is a group of Non-communicable disease, non-communicable Neurological disorder, neurological disorders characterized by a tendency for recurrent, unprovoked Seizure, seizures. A seizure is a sudden burst of abnormal electrical activit ...
,
kidney disease Kidney disease, or renal disease, technically referred to as nephropathy, is damage to or disease of a kidney. Nephritis is an Inflammation, inflammatory kidney disease and has several types according to the location of the inflammation. Infla ...
, or
hypersensitivity Hypersensitivity (also called hypersensitivity reaction or intolerance) is an abnormal physiological condition in which there is an undesirable and adverse immune response to an antigen. It is an abnormality in the immune system that causes Imm ...
to the compound constituents. In trials studying the use of cerebrolysin after acute stroke, there was no increased risk of "serious adverse events" requiring hospitalization. These were specifically defined as "...any untoward medical occurrence that, at any dose, resulted in death, aslife-threatening, required inpatient hospitalisation or resulted in prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, asa congenital anomaly/birth defect, or asa medically important event or reaction".


Pharmacology

Laboratory studies indicate there may be neurotrophic effects of cerebrolysin similar to
endogenous Endogeny, in biology, refers to the property of originating or developing from within an organism, tissue, or cell. For example, ''endogenous substances'', and ''endogenous processes'' are those that originate within a living system (e.g. an ...
mechanisms, although its specific molecular effects are not clear. Cerebrolysin is given by injection. Some of the peptides in cerebrolysin are short-lived once in the blood (for example, the
half-life Half-life is a mathematical and scientific description of exponential or gradual decay. Half-life, half life or halflife may also refer to: Film * Half-Life (film), ''Half-Life'' (film), a 2008 independent film by Jennifer Phang * ''Half Life: ...
of BDNF is only 10 minutes).


Regulatory

Although cerebrolysin is used in Russia, Eastern European countries, China, and other Asian countries, its status as a government-approved drug is unclear. It is only available by prescription from a physician. According to the manufacturer, the
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
has declared cerebrolysin as safe. As of October 2020, cerebrolysin was not an
approved drug An approved drug is a Medicine, medicinal preparation that has been validated for a therapeutic use by a Regulation of therapeutic goods, ruling authority of a government. This process is usually specific by country, unless specified otherwise. ...
in the United States.


References

{{Growth factor receptor modulators Antidementia agents Neuroprotective agents Nootropics Peptides Management of stroke