Cerebrolysin (porcine brain-derived proteolytic peptide fraction) / EVER Pharma - LARVOL DELTA

Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: October 6 University | Trial completion date: Dec 2024 ➔ Feb 2026 | Trial primary completion date: Oct 2024 ➔ Jan 2026

Trial completion date • Trial primary completion date • CNS Disorders

Is Cerebrolysin Useful in Psychiatry Disorders? (PubMed, Biomedicines) - " The results show that this specific substance could have a relatively small application in psychiatry. The limited amount of available research on the use of cerebrolysin suggests that it may have some significance in supporting the treatment of depression and autism spectrum disorders and alleviating adverse effects during treatment with neuroleptics."

Journal • Autism Spectrum Disorder • Bipolar Disorder • CNS Disorders • Depression • Genetic Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Effects of cerebrolysin on behavioral changes and the tryptophan-kynurenine pathway in the prefrontal cortex of male mice in the ketamine model of schizophrenia. (PubMed, Mol Biol Rep) - "These findings demonstrate the neuroprotective properties of CBL, which are likely due to its modulatory action on the TRP/KYN pathway and improvement in spatial memory, anxiety, and depression-like behaviors in schizophrenia mice."

Journal • Preclinical • CNS Disorders • Cognitive Disorders • Depression • Inflammation • Mood Disorders • Psychiatry • Schizophrenia • IL1B • NLRP3

Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: University Medical Centre Ljubljana

New trial • Cardiovascular • Ischemic stroke • Vascular Neurology

Cerebrolysin with reperfusion therapy in ischemic stroke: a prospective analysis of multimodal brain imaging data from the CEREHETIS trial (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Cerebrolysin treatment was associated with favorable changes in quantitative imaging biomarkers, indicating better preservation of brain microstructure, stabilization of BBB permeability, and a reduction in infarct volume in patients with AIS. These findings support the potential cytoprotective effects of Cerebrolysin and highlight the utility of DTI and PCT for evaluating therapeutic efficacy and guiding individualized neuroprotective strategies."

Clinical • Journal • Cardiovascular • Ischemic stroke

Cerebrolysin-loaded platelet-rich plasma exosomes: Restoring immune homeostasis via TNF-α/IL-10 modulation and apoptosis targeting for spinal cord injury repair. (PubMed, J Spinal Cord Med) - "Histological assessment revealed improved tissue organization, and motor function recovery was significantly enhanced as measured by BBB scores. CLE showed neuroprotective and anti-inflammatory effects, reducing apoptosis and inflammation while promoting tissue repair and motor function recovery in SCI, making it a promising therapeutic candidate."

IO biomarker • Journal • CNS Disorders • Inflammation • Orthopedics • BAX • BCL2 • IL10 • TNFA

Cost-effectiveness of Cerebrolysin as an add-on treatment for neurorecovery after traumatic brain injury. (PubMed, J Med Life) - "A model-based approach is needed to account for potential sources of bias beyond the 90-day observation period of this clinical trial. Furthermore, economic evaluations incorporating patients diagnosed with all TBI severities are needed."

HEOR • Journal • CNS Disorders • Depression • Psychiatry • Vascular Neurology

Influence of Exogenous Neuropeptides on the Astrocyte Response Under Conditions of Continuous and Cyclic Hypoxia and Red Blood Cell Lysate. (PubMed, Int J Mol Sci) - "Its ability to lower harmful mediators like IL-1β and IL-6 while enhancing protective factors such as IL-10 suggests a promising therapeutic strategy in stroke, traumatic brain injury, and subarachnoid hemorrhage. Alongside other mechanisms such as neurotrophic factor enhancement and glial cell regulation, this cytokine modulation underscores the therapeutic potential of Cerebrolysin in a variety of central nervous system disorders."

Journal • Astrocytoma • Brain Cancer • Cardiovascular • CNS Disorders • Glioblastoma • Hematological Disorders • Oncology • Solid Tumor • Subarachnoid Hemorrhage • Vascular Neurology • CCL2 • CXCL10 • CXCL8 • CXCL9 • IL10 • IL1B • IL6

Effect of Cerebrolysin on Cognitive Function and Delirium in Coronary Artery Bypass Graft Patients. (PubMed, Med Sci Monit) - "CONCLUSIONS Patients maintained their cognitive status. The lack of delirium in the study group prompts us to develop a plan for a large-scale multicenter study assessing the potential ability of CER to reduce the risk of delirium in cardiac surgery patients."

Clinical • Journal • Anesthesia • Cardiovascular • CNS Disorders

Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study. (PubMed, Transl Stroke Res) - P3 | "Cerebrolysin improved functional outcomes at 90 days, accelerated neurological recovery, and reduced complications post-MT in patients with small ischemic core, good collateral circulation, and effective recanalization at baseline. These findings warrant further randomized trials to validate its efficacy and explore its long-term benefits.Registration: URL: https://www.clinicaltrials.gov ; unique identifier: NCT04904341."

Journal • Cardiovascular • Diabetes • Ischemic stroke • Metabolic Disorders

Neurotropic Effects of Cortexin on Models of Mental and Physical Developmental Delay. (PubMed, Biomedicines) - "In a separate series of experiments in mice, the concentration of the test drug cortexin and the reference drug cerebrolysin was determined in blood and brain tissue samples using radioactive iodine (Na125I) labeling of these preparations... The results indicate that brain polypeptides (cortexin), administered either intramuscularly or rectally, can reach the systemic circulation and cross the blood-brain barrier, as demonstrated by our distribution studies using radiolabeled preparations. These polypeptides exert comparable neurotropic effects in models of mental and physical developmental delays in offspring caused by neonatal trauma or the toxic effect of ethanol in late pregnancy in rats."

Journal • Cardiovascular • Developmental Disorders • Mood Disorders

Conservative and newer drug treatment for degenerative cervical myelopathy. (PubMed, J Clin Orthop Trauma) - "Riluzole did not replicate its promising animal results in human trials, using the modified Japanese Orthopaedic Association (mJOA) score as an outcome measure. Cerebrolysin is promising but needs more RCTs to define its role in the management algorithm. Limaprost Alfadex provided inconclusive evidence, however, is in an ongoing phase III trial...Anti-Fas ligand antibody has not been studied in humans but demonstrated benefit in animal models. Research should focus on large-scale RCTs for these drugs with careful attention to long-term effects, side effects, and finding the most effective doses."

Journal • CNS Disorders • Infectious Disease • Inflammation • Orthopedics • FASLG

CLINCH: Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Cardinal Stefan Wyszynski University

New P4 trial • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Yonsei University

New P4 trial • Cardiovascular

Cerebrolysin and the optimal timing of anticoagulation resumption in stroke: combined post hoc survival analysis of the CEREHETIS trial (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "AT may be safely resumed within 48 h in low-risk patients (HTI=0), on days 3-5 in high-risk patients (HTI=1-4), and on day 10 in very-high-risk patients (HTI=5-8) without symptomatic HT. Cerebrolysin mitigates the compounding effect, reduces HT risk, and facilitates earlier, safer AT resumption in high-risk patients (HTI=1-4) by day 2 post-stroke, supporting its role in personalized stroke management."

Clinical • Journal • Retrospective data • Cardiovascular • Hematological Disorders

Cerebrolysin Induces Dendritic Tree Plastic Changes and BDNF Increase in the Amygdala of Male Rats with Maternal Deprivation. (PubMed, Neurochem Res) - "Our results show that CBL could be part of the treatment in case of a traumatic or stressful event in neurodevelopment, especially in the youth age. According to this preclinical study, CBL could help reverse symptoms of different psychopathologies caused by stress or trauma, with neurobiological changes underlying its effect."

Journal • Preclinical • Mood Disorders • BDNF

Update on Neuroprotection after Traumatic Brain Injury. (PubMed, CNS Drugs) - "New strategies and pharmacotherapy options for neuroprotection continue to be evaluated, including tranexamic acid, progesterone, cerebrolysin, cyclosporin A, citicholine, memantine, and lactate. The spectrum of TBI severity has also gained increasing attention as it relates to mild TBI or concussion, blast injury, and subacute or chronic subdural hematomas. In this review, we review the pathophysiology, recent clinical trials, and future directions for acute TBI."

Journal • Review • CNS Disorders • Vascular Neurology

Retraction Note: Neuroprotective effects of Cerebrolysin in triple repeat Tau transgenic model of Pick's disease and fronto-temporal tauopathies. (PubMed, BMC Neurosci) - No abstract available

Journal • Frontotemporal Lobar Degeneration

Drug-Induced Alteration of Hair Pigmentation: a clinical review and update (AAD 2025) - " Hypopigmentation of the hair, including graying/whitening has been reported with anticonvulsants, interferons, retinoids, tyrosine kinase inhibitors, chemotherapy agents, chloroquine, and hydroxychloroquine. Hair darkening has been reported with cholinesterase inhibitors, retinoids, minoxidil, hormone analogs, prostaglandin analogs, immunomodulatory and immunosuppressive medications. Repigmentation of previously gray hair has been associated with monoclonal antibodies, tyrosine kinase inhibitors, retinoids, tamoxifen, cerebrolysin, and topical pseudocatalase...Three cases of permanent/persistent hair color change have been reported with brentuximab, dupilumab, and a cholinesterase inhibitor. A wide range of medications can induce permanent or temporary alterations of hair pigmentation, and subsequently impact medication adherence and quality of life. Updated knowledge and comprehensive understanding of the medications associated with drug-induced hair color changes is..."

Clinical • Review • CAT

Cerebrolysin as an adjuvant therapy after mechanical thrombectomy in large vessel occlusion cardioembolic stroke: a propensity score matching analysis. (PubMed, Front Neurol) - "The administration of Cerebrolysin was safe and well tolerated. Further studies are required to confirm these results."

Journal • Cardiovascular • Hematological Disorders • Ischemic stroke

C-REGS2: Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness (clinicaltrials.gov) - P=N/A | N=1851 | Completed | Sponsor: Ever Neuro Pharma GmbH | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jul 2024

HEOR • Trial completion • Trial completion date • Cardiovascular • Ischemic stroke

CERICA: CERebrolysin in CADASIL (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Ever Neuro Pharma GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed

Effect of neurofeedback training on relative α variant score monitored by bedside continuous electroencephalography and optic nerve sheath diameter evaluated by ultrasound in patients with ischemic hypoxic encephalopathy (PubMed, Zhonghua Wei Zhong Bing Ji Jiu Yi Xue) - "Both ONDS determined by ultrasound and relative α variation score monitored by electroencephalography changed significantly in the patients with ischemic hypoxic encephalopathy. Neurofeedback training can effectively improve brain function in patients with ischemic hypoxic encephalopathy."

Journal • Observational data • Cardiovascular • CNS Disorders • Critical care • Depression • Psychiatry • BDNF

Speech Therapy Combined With Cerebrolysin in Enhancing Nonfluent Aphasia Recovery After Acute Ischemic Stroke: ESCAS Randomized Pilot Study. (PubMed, Stroke) - "Further research with larger cohorts is needed to fully establish the efficacy of this combination therapy. URL: https://www.isrctn.com; Unique identifier: ISRCTN54581790."

Journal • Cardiovascular • Ischemic stroke

Correction to: Sonic Hedgehog Signaling Pathway Mediates Cerebrolysin-Improved Neurological Function After Stroke. (PubMed, Stroke) - No abstract available

Journal • Cardiovascular