Cerebrolysin

{{Short description|Experimental drug for neurodegenerative disorders}}

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| drug_name = Cerebrolysin{{cite web |title=Cerebrolysin |url=https://www.cerebrolysin.com/cerebrolysin/about-cerebrolysin |publisher=Ever Pharma |access-date=10 July 2024 |location=Unterach, Austria |date=2024}}

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| tradename = 速利清

| Drugs.com = {{cite web|url=https://www.drugs.com/international/cerebrolysin.html|publisher=Drugs.com|title=Cerebrolysin (International)|date=2024|accessdate=10 July 2024}}

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| CAS_number = 12656-61-0

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| DrugBank = DB16599

| UNII = 37KZM6S21G

| synonyms = FPF-1070, 脑蛋白水解物 [cerebroprotein hydrolysate]

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Cerebrolysin (developmental code name FPF-1070) is an experimental mixture of enzymatically-treated peptides derived from pig brain whose constituents can include brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), and ciliary neurotrophic factor (CNTF).{{cite book | vauthors = Windisch M, Gschanes A, Hutter-Paier B | title = Ageing and Dementia | chapter = Neurotrophic activities and therapeutic experience with a brain derived peptide preparation | volume = 53 | pages = 289–98 | year = 1998 | pmid = 9700665 | doi = 10.1007/978-3-7091-6467-9_25| series = Journal of Neural Transmission. Supplementa | isbn = 978-3-211-83114-4|chapter-url=https://link.springer.com/chapter/10.1007/978-3-7091-6467-9_25}}{{cite journal | vauthors = Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K | title = Cerebrolysin for acute ischaemic stroke | journal = The Cochrane Database of Systematic Reviews | volume = 2023 | issue = 10 | pages = CD007026 | date = October 2023 | pmid = 37818733 | pmc = 10565895 | doi = 10.1002/14651858.CD007026.pub7 | collaboration = Cochrane Stroke Group }} 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.

Cerebrolysin has been studied for potential treatment of several neurodegenerative diseases, with only preliminary research, as of 2023. No clear benefit in the treatment of acute stroke has been found, and an increased rate of spontaneous adverse effects requiring hospitalization is reported. Some positive effects have been reported when cerebrolysin is used to treat vascular dementia.{{cite journal | vauthors = Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L | title = Cerebrolysin for vascular dementia | journal = The Cochrane Database of Systematic Reviews | volume = 2019 | issue = 11 | date = November 2019 | pmid = 31710397 | pmc = 6844361 | doi = 10.1002/14651858.CD008900.pub3 }}

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.{{cite journal | vauthors = Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z | title = Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial | journal = Stroke | volume = 43 | issue = 3 | pages = 630–636 | date = March 2012 | pmid = 22282884 | doi = 10.1161/STROKEAHA.111.628537 | s2cid = 26004422 | doi-access = free }} A 2020 study suggested a lack of benefit in hemorrhagic stroke related to cerebral aneurysm.{{cite journal | vauthors = Woo PY, Ho JW, Ko NM, Li RP, Jian L, Chu AC, Kwan MC, Chan Y, Wong AK, Wong HT, Chan KY, Kwok JC | display-authors = 6 | title = Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage | journal = BMC Neurology | volume = 20 | issue = 1 | pages = 401 | date = November 2020 | pmid = 33143640 | pmc = 7607674 | doi = 10.1186/s12883-020-01908-9 | doi-access = free }}

=Dementia=

Reviews of preliminary research indicate a possible improvement in cognitive function using cerebrolysin for vascular dementia and Alzheimer's disease, although further high-quality research is needed.{{cite journal | vauthors = Fan F, Liu H, Shi X, Ai Y, Liu Q, Cheng Y | title = The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review | journal = Journal of Alzheimer's Disease | volume = 85 | issue = 3 | pages = 1195–1204 | date = 2022 | pmid = 34924395 | doi = 10.3233/JAD-215423 | s2cid = 245311001 }}

=Other=

Early studies have suggested potential use of cerebrolysin with a wide variety of neurodegenerative disorders, including traumatic brain injury,{{cite journal | vauthors = Ghaffarpasand F, Torabi S, Rasti A, Niakan MH, Aghabaklou S, Pakzad F, Beheshtian MS, Tabrizi R | display-authors = 6 | title = Effects of cerebrolysin on functional outcome of patients with traumatic brain injury: a systematic review and meta-analysis | journal = Neuropsychiatric Disease and Treatment | volume = 15 | pages = 127–135 | date = 2019 | pmid = 30643411 | pmc = 6311329 | doi = 10.2147/NDT.S186865 | doi-access = free }}{{cite journal | vauthors = El Sayed I, Zaki A, Fayed AM, Shehata GM, Abdelmonem S | title = A meta-analysis of the effect of different neuroprotective drugs in management of patients with traumatic brain injury | journal = Neurosurgical Review | volume = 41 | issue = 2 | pages = 427–438 | date = April 2018 | pmid = 27539610 | doi = 10.1007/s10143-016-0775-y | s2cid = 3980956 }} schizophrenia,{{cite journal | vauthors = Xiao S, Xue H, Li G, Yuan C, Li X, Chen C, Wu HZ, Mitchell P, Zhang M | display-authors = 6 | title = Therapeutic effects of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms | journal = The Australian and New Zealand Journal of Psychiatry | volume = 46 | issue = 2 | pages = 153–160 | date = February 2012 | pmid = 22311531 | doi = 10.1177/0004867411433213 | s2cid = 206397952 }} multiple sclerosis,{{cite journal | vauthors = Khabirov FA, Khaybullin TI, Granatov EV, Shakirzianova SR | title = [Effect of cerebrolysin on remyelination processes in multiple sclerosis patients in stage of relapse regression] | journal = Zhurnal Nevrologii I Psikhiatrii imeni S.S. Korsakova | volume = 116 | issue = 12 | pages = 48–53 | date = 2016 | pmid = 28139626 | doi = 10.17116/jnevro201611612148-53 | doi-access = free }} cerebral palsy{{cite journal | vauthors = Nasiri J, Safavifar F | title = Effect of cerebrolysin on gross motor function of children with cerebral palsy: a clinical trial | journal = Acta Neurologica Belgica | volume = 117 | issue = 2 | pages = 501–505 | date = June 2017 | pmid = 28074392 | doi = 10.1007/s13760-016-0743-x | s2cid = 3805375 }} and spinal cord injury{{cite journal | vauthors = Allam AF, Abotakia TA, Koptan W | title = Role of Cerebrolysin in cervical spondylotic myelopathy patients: a prospective randomized study | journal = The Spine Journal | volume = 18 | issue = 7 | pages = 1136–1142 | date = July 2018 | pmid = 29155000 | doi = 10.1016/j.spinee.2017.11.002 | s2cid = 23283518 }}{{cite journal | vauthors = Menon PK, Muresanu DF, Sharma A, Mössler H, Sharma HS | title = Cerebrolysin, a mixture of neurotrophic factors induces marked neuroprotection in spinal cord injury following intoxication of engineered nanoparticles from metals | journal = CNS & Neurological Disorders Drug Targets | volume = 11 | issue = 1 | pages = 40–49 | date = February 2012 | pmid = 22229324 | doi = 10.2174/187152712799960781 }} although research is still preliminary.

Adverse effects

Upon injection, adverse effects of cerebrolysin include nausea, dizziness, headache, and sweating. It is not recommended for use in people with epilepsy, kidney disease, or hypersensitivity 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, [was] life-threatening, required inpatient hospitalisation or resulted in prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, [was] a congenital anomaly/birth defect, or [was] a medically important event or reaction".

Pharmacology

Laboratory studies indicate there may be neurotrophic effects of cerebrolysin similar to endogenous mechanisms, although its specific molecular effects are not clear.{{cite journal | vauthors = Plosker GL, Gauthier S | title = Cerebrolysin: a review of its use in dementia | journal = Drugs & Aging | volume = 26 | issue = 11 | pages = 893–915 | date = 2009 | pmid = 19848437 | doi = 10.2165/11203320-000000000-00000 }}

Cerebrolysin is given by injection. Some of the peptides in cerebrolysin are short-lived once in the blood (for example, the half-life of BDNF is only 10 minutes).{{cite journal | vauthors = Wurzelmann M, Romeika J, Sun D | title = Therapeutic potential of brain-derived neurotrophic factor (BDNF) and a small molecular mimics of BDNF for traumatic brain injury | journal = Neural Regeneration Research | volume = 12 | issue = 1 | pages = 7–12 | date = January 2017 | pmid = 28250730 | doi = 10.4103/1673-5374.198964 | doi-access = free | pmc = 5319242 }}

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 has declared cerebrolysin as safe.

As of October 2020, cerebrolysin was not an approved drug in the United States.{{cite news | vauthors = Rogers S |title=Nicholasville compounding pharmacy, owner plead guilty to distribution |url=https://www.wtvq.com/2020/10/29/nicholasville-compounding-pharmacy-owner-plead-guilty-to-distribution/ |work=ABC 36 News |date=29 October 2020}}{{cite journal |title=Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs Unlawful Distribution of Prescription Drugs |website=www.justice.gov |date=24 February 2021 |url=https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-sentenced-unlawful-distribution |language=en}}{{better source|date=June 2025}}

References