Cerebrolysin Explained

Drug Name:Cerebrolysin[1]
Drugs.Com:[2]
Cas Number:12656-61-0
Drugbank:DB16599
Unii:37KZM6S21G
Synonyms:FPF-1070

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).[3] [4] 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.[4] No clear benefit in the treatment of acute stroke has been found, and an increased rate of spontaneous adverse effects requiring hospitalization is reported.[4] Some positive effects have been reported when cerebrolysin is used to treat vascular dementia.[5]

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.[4] In addition, cerebrolysin might cause a higher rate of spontaneous adverse events requiring hospitalization.[4]

Studies of ischemic stroke in Asian subpopulations found an absence of benefit.[6] A 2020 study suggested a lack of benefit in hemorrhagic stroke related to cerebral aneurysm.[7]

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.[5] [8]

Other

Early studies have suggested potential use of cerebrolysin with a wide variety of neurodegenerative disorders, including traumatic brain injury,[9] [10] schizophrenia,[11] multiple sclerosis,[12] cerebral palsy[13] and spinal cord injury[14] [15] although research is still preliminary.

Adverse effects

Upon injection, adverse effects of cerebrolysin include nausea, dizziness, headache, and sweating.[1] It is not recommended for use in people with epilepsy, kidney disease, or hypersensitivity to the compound constituents.[1]

In trials studying the use of cerebrolysin after acute stroke, there was no increased risk of "serious adverse events" requiring hospitalization.[4] 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".[4]

Pharmacology

Laboratory studies indicate there may be neurotrophic effects of cerebrolysin similar to endogenous mechanisms, although its specific molecular effects are not clear.[16]

Cerebrolysin is given by injection.[1] Some of the peptides in cerebrolysin are short-lived once in the blood (for example, the half-life of BDNF is only 10 minutes).[17]

Regulatory

Although cerebrolysin is used in Russia, Eastern European countries, China, and other Asian countries, its status as a government-approved drug is unclear.[4] It is only available by prescription from a physician.[1] According to the manufacturer, the European Medicines Agency has declared cerebrolysin as safe.[1]

It is not an approved drug in the United States.[18] [19]

Notes and References

  1. Web site: Cerebrolysin . Ever Pharma . 10 July 2024 . Unterach, Austria . 2024.
  2. Web site: Cerebrolysin (International). Drugs.com. 2024. 10 July 2024.
  3. Book: Windisch M, Gschanes A, Hutter-Paier B . Ageing and Dementia . Neurotrophic activities and therapeutic experience with a brain derived peptide preparation . 53 . 289–98 . 1998 . 9700665 . 10.1007/978-3-7091-6467-9_25. Journal of Neural Transmission. Supplementa . 978-3-211-83114-4. https://link.springer.com/chapter/10.1007/978-3-7091-6467-9_25.
  4. Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K . Cerebrolysin for acute ischaemic stroke . The Cochrane Database of Systematic Reviews . 2023 . 10 . CD007026 . October 2023 . 37818733 . 10565895 . 10.1002/14651858.CD007026.pub7 . Cochrane Stroke Group .
  5. Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L . Cerebrolysin for vascular dementia . The Cochrane Database of Systematic Reviews . 2019 . 11 . November 2019 . 31710397 . 6844361 . 10.1002/14651858.CD008900.pub3 .
  6. Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z . Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial . Stroke . 43 . 3 . 630–636 . March 2012 . 22282884 . 10.1161/STROKEAHA.111.628537 . 26004422 . free .
  7. Woo PY, Ho JW, Ko NM, Li RP, Jian L, Chu AC, Kwan MC, Chan Y, Wong AK, Wong HT, Chan KY, Kwok JC . 6 . Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage . BMC Neurology . 20 . 1 . 401 . November 2020 . 33143640 . 7607674 . 10.1186/s12883-020-01908-9 . free .
  8. Fan F, Liu H, Shi X, Ai Y, Liu Q, Cheng Y . The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review . Journal of Alzheimer's Disease . 85 . 3 . 1195–1204 . 2022 . 34924395 . 10.3233/JAD-215423 . 245311001 .
  9. Ghaffarpasand F, Torabi S, Rasti A, Niakan MH, Aghabaklou S, Pakzad F, Beheshtian MS, Tabrizi R . 6 . Effects of cerebrolysin on functional outcome of patients with traumatic brain injury: a systematic review and meta-analysis . Neuropsychiatric Disease and Treatment . 15 . 127–135 . 2019 . 30643411 . 6311329 . 10.2147/NDT.S186865 . free .
  10. El Sayed I, Zaki A, Fayed AM, Shehata GM, Abdelmonem S . A meta-analysis of the effect of different neuroprotective drugs in management of patients with traumatic brain injury . Neurosurgical Review . 41 . 2 . 427–438 . April 2018 . 27539610 . 10.1007/s10143-016-0775-y . 3980956 .
  11. Xiao S, Xue H, Li G, Yuan C, Li X, Chen C, Wu HZ, Mitchell P, Zhang M . 6 . Therapeutic effects of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms . The Australian and New Zealand Journal of Psychiatry . 46 . 2 . 153–160 . February 2012 . 22311531 . 10.1177/0004867411433213 . 206397952 .
  12. Khabirov FA, Khaybullin TI, Granatov EV, Shakirzianova SR . [Effect of cerebrolysin on remyelination processes in multiple sclerosis patients in stage of relapse regression] . Zhurnal Nevrologii I Psikhiatrii imeni S.S. Korsakova . 116 . 12 . 48–53 . 2016 . 28139626 . 10.17116/jnevro201611612148-53 . free .
  13. Nasiri J, Safavifar F . Effect of cerebrolysin on gross motor function of children with cerebral palsy: a clinical trial . Acta Neurologica Belgica . 117 . 2 . 501–505 . June 2017 . 28074392 . 10.1007/s13760-016-0743-x . 3805375 .
  14. Allam AF, Abotakia TA, Koptan W . Role of Cerebrolysin in cervical spondylotic myelopathy patients: a prospective randomized study . The Spine Journal . 18 . 7 . 1136–1142 . July 2018 . 29155000 . 10.1016/j.spinee.2017.11.002 . 23283518 .
  15. Menon PK, Muresanu DF, Sharma A, Mössler H, Sharma HS . Cerebrolysin, a mixture of neurotrophic factors induces marked neuroprotection in spinal cord injury following intoxication of engineered nanoparticles from metals . CNS & Neurological Disorders Drug Targets . 11 . 1 . 40–49 . February 2012 . 22229324 . 10.2174/187152712799960781 .
  16. Plosker GL, Gauthier S . Cerebrolysin: a review of its use in dementia . Drugs & Aging . 26 . 11 . 893–915 . 2009 . 19848437 . 10.2165/11203320-000000000-00000 .
  17. Wurzelmann M, Romeika J, Sun D . Therapeutic potential of brain-derived neurotrophic factor (BDNF) and a small molecular mimics of BDNF for traumatic brain injury . Neural Regeneration Research . 12 . 1 . 7–12 . January 2017 . 28250730 . 10.4103/1673-5374.198964 . free . 5319242 .
  18. News: Rogers S . Nicholasville compounding pharmacy, owner plead guilty to distribution . ABC 36 News . 29 October 2020.
  19. Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs Unlawful Distribution of Prescription Drugs . www.justice.gov . 24 February 2021 . en.

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