Cerebrolysin

Cerebrolysin^[1]
Clinical data
Other names	FPF-1070
AHFS/Drugs.com
Identifiers
CAS Number	12656-61-0;
DrugBank	DB16599;
UNII	37KZM6S21G;

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]

References

^ ^a ^b ^c ^d ^e ^f "Cerebrolysin". Unterach, Austria: Ever Pharma. 2024. Retrieved 10 July 2024.
^ "Cerebrolysin (International)". Drugs.com. 2024. Retrieved 10 July 2024.
^ Windisch M, Gschanes A, Hutter-Paier B (1998). "Neurotrophic activities and therapeutic experience with a brain derived peptide preparation". Ageing and Dementia. Journal of Neural Transmission. Supplementa. Vol. 53. pp. 289–98. doi:10.1007/978-3-7091-6467-9_25. ISBN 978-3-211-83114-4. PMID 9700665.
^ ^a ^b ^c ^d ^e ^f ^g ^h Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K, et al. (Cochrane Stroke Group) (October 2023). "Cerebrolysin for acute ischaemic stroke". The Cochrane Database of Systematic Reviews. 2023 (10): CD007026. doi:10.1002/14651858.CD007026.pub7. PMC 10565895. PMID 37818733.
^ ^a ^b Cui S, Chen N, Yang M, Guo J, Zhou M, Zhu C, He L (November 2019). "Cerebrolysin for vascular dementia". The Cochrane Database of Systematic Reviews. 2019 (11). doi:10.1002/14651858.CD008900.pub3. PMC 6844361. PMID 31710397.
^ Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z (March 2012). "Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial". Stroke. 43 (3): 630–636. doi:10.1161/STROKEAHA.111.628537. PMID 22282884. S2CID 26004422.
^ Woo PY, Ho JW, Ko NM, Li RP, Jian L, Chu AC, et al. (November 2020). "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. doi:10.1186/s12883-020-01908-9. PMC 7607674. PMID 33143640.
^ Fan F, Liu H, Shi X, Ai Y, Liu Q, Cheng Y (2022). "The Efficacy and Safety of Alzheimer's Disease Therapies: An Updated Umbrella Review". Journal of Alzheimer's Disease. 85 (3): 1195–1204. doi:10.3233/JAD-215423. PMID 34924395. S2CID 245311001.
^ Ghaffarpasand F, Torabi S, Rasti A, Niakan MH, Aghabaklou S, Pakzad F, et al. (2019). "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. doi:10.2147/NDT.S186865. PMC 6311329. PMID 30643411.
^ El Sayed I, Zaki A, Fayed AM, Shehata GM, Abdelmonem S (April 2018). "A meta-analysis of the effect of different neuroprotective drugs in management of patients with traumatic brain injury". Neurosurgical Review. 41 (2): 427–438. doi:10.1007/s10143-016-0775-y. PMID 27539610. S2CID 3980956.
^ Xiao S, Xue H, Li G, Yuan C, Li X, Chen C, et al. (February 2012). "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. doi:10.1177/0004867411433213. PMID 22311531. S2CID 206397952.
^ Khabirov FA, Khaybullin TI, Granatov EV, Shakirzianova SR (2016). "[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. doi:10.17116/jnevro201611612148-53. PMID 28139626.
^ Nasiri J, Safavifar F (June 2017). "Effect of cerebrolysin on gross motor function of children with cerebral palsy: a clinical trial". Acta Neurologica Belgica. 117 (2): 501–505. doi:10.1007/s13760-016-0743-x. PMID 28074392. S2CID 3805375.
^ Allam AF, Abotakia TA, Koptan W (July 2018). "Role of Cerebrolysin in cervical spondylotic myelopathy patients: a prospective randomized study". The Spine Journal. 18 (7): 1136–1142. doi:10.1016/j.spinee.2017.11.002. PMID 29155000. S2CID 23283518.
^ Menon PK, Muresanu DF, Sharma A, Mössler H, Sharma HS (February 2012). "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. doi:10.2174/187152712799960781. PMID 22229324.
^ Plosker GL, Gauthier S (2009). "Cerebrolysin: a review of its use in dementia". Drugs & Aging. 26 (11): 893–915. doi:10.2165/11203320-000000000-00000. PMID 19848437.
^ Wurzelmann M, Romeika J, Sun D (January 2017). "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. doi:10.4103/1673-5374.198964. PMC 5319242. PMID 28250730.
^ Rogers S (29 October 2020). "Nicholasville compounding pharmacy, owner plead guilty to distribution". ABC 36 News.
^ "Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs Unlawful Distribution of Prescription Drugs". www.justice.gov. 24 February 2021.