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

Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU (clinicaltrials.gov) - P3 | N=150 | Completed | Sponsor: Ain Shams University | Trial primary completion date: Mar 2025 ➔ May 2025 | Recruiting ➔ Completed

Trial completion • Trial primary completion date • CNS Disorders • Hematological Disorders • Vascular Neurology

Comparative effects of Cerebrolysin and Erythropoietin in dendritic spines and memory in an animal model of aging (Neuroscience 2025) - "In these groups, a recovery in the proportion of mushroom spines and a decrease in stubby spines were observed, suggesting maintenance of functional synaptic properties. These findings support the therapeutic potential of CBL and EPO in the prevention and treatment of structural and functional alterations associated with brain aging."

Preclinical • CNS Disorders

Cerebrolysin ameliorates ketamine-mediated anxiety and cognitive impairments via modulation of mitochondrial function and CREB/PGC-1α pathway. (PubMed, Mol Brain) - "Furthermore, CBL therapy upregulated the hippocampal expression of the proteins CREB, p-CREB, and PGC-1α compared with the ketamine-treated animals. It is speculated that treatment with CBL can attenuate ketamine-induced cognitive deficits and anxiety-like behaviors through the upregulation of the CREB/PGC-1α pathway and the improvement of mitochondrial function."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Therapeutic strategies in vascular cognitive impairment: A systematic review and meta-analysis. (PubMed, Alzheimers Dement) - "Considerable methodological heterogeneity across VCI trials undermined the strength of evidence for both positive and negative findings, ultimately decreasing confidence in the possibility of treating VCI. Ginkgo biloba extracts have shown the greatest cognitive and functional benefits, though their clinical significance remains uncertain, and certainty of evidence is overall low. Future trials should focus on a single VCI subtype, prioritize interventions with a strong mechanistic rationale, standardize diagnostic criteria, ensure adequate power for chosen outcomes, test against placebo, and implement FAIR data sharing to accelerate therapeutic discovery."

Clinical • Journal • Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Vascular Neurology

Cerebrolysin treatment in a case of post-herpes simplex encephalitis with neuropsychiatric symptoms. (PubMed, J Med Life) - "The patient was treated with acyclovir and dexamethasone in the acute phase, followed by Cerebrolysin administration in the post-acute phase. This case highlights the potential therapeutic role of Cerebrolysin in managing post-encephalitic cognitive dysfunction, underscoring the need for further studies."

Journal • CNS Disorders • Cognitive Disorders • Epilepsy • Herpes Simplex • Infectious Disease • Psychiatry

Safety and feasibility of cerebrolysin in treatment of primary intracerebral hemorrhage (CLINCH)-a prospective, randomized, open-label, blinded endpoint pilot trial. (PubMed, Front Neurol) - "The restrictive eligibility criteria may limit generalizability but enhance the likelihood of detecting treatment effects. If positive, results would support a larger confirmatory trial and inform the sample size."

Journal • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

EFFICACY OF CEREBROLYSIN TREATMENT AS AN ADD-ON THERAPY TO MECHANICAL THROMBECTOMY IN PATIENTS WITH ACUTE ISCHEMIC STROKE: FINAL RESULTS OF A PROSPECTIVE, OPEN LABEL STUDY. (WSC 2025) - "Cerebrolysin improved functional outcomes at 90 days and 12 months, 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 evaluation in randomized trials."

Clinical • Cardiovascular • Diabetes • Ischemic stroke • Metabolic Disorders

CEREBROPROTECTION IN ACUTE ISCHEMIC STROKE: PERSPECTIVES ON COMBINING CEREBROLYSIN WITH RECANALIZATION THERAPY (WSC 2025) - "These recent findings support Cerebrolysin as a promising adjunctive treatment in AIS. Its multimodal cerebroprotective profile, including blood–brain barrier stabilization, may reduce reperfusion-associated complications and enhance recovery. Further confirmatory trials are warranted to validate its integration into standard AIS management."

Cardiovascular • Hematological Disorders • Ischemic stroke

CEREBROLYSIN IN LATERAL MEDULLA INFARCTION FROM VERTEBRAL ARTERY DISSECTION: A PILOT RETROSPECTIVE ANALYSIS (WSC 2025) - "This pilot study found no significant recovery benefit from Cerebrolysin in VAD-induced LMI, possibly due to small sample size. However, it provides novel insights into a rare stroke subtype, highlighting the need for larger trials to evaluate Cerebrolysin's role in targeted stroke populations. These findings may guide future research in personalized stroke rehabilitation."

Retrospective data • Cardiovascular • Ischemic stroke

CEREBROLYSIN AND INTRAVENOUS THROMBOLYSIS IN ISCHEMIC STROKE: A PROSPECTIVE BRAIN IMAGING ANALYSIS FROM THE CEREHETIS TRIAL (WSC 2025) - "Cerebrolysin was associated with favorable brain imaging dynamics, supporting its potential cytoprotective effects in AIS."

Clinical • Cardiovascular • Ischemic stroke

EFFICACY OF CEREBROLYSIN COMBINED WITH EXTENDED REHABILITATION ON UPPER LIMB RECOVERY IN SEVERE SUBACUTE STROKE: AN ONGOING RANDOMIZED CLINICAL TRIAL (WSC 2025) - "Cerebrolysin led to greater improvement in post-stroke upper limb motor function compared to placebo, as measured by ARAT and FMA-UE, with significant effects observed after three weeks and sustained at 90 days. This effect may be attributed to Cerebrolysin's multimodal impact on long-term neuroregeneration mechanisms, enhanced by extended neurorehabilitation."

Clinical • Cardiovascular

CEREBROLYSIN AMELIORATES NEUROCOGNITIVE IMPAIRMENT AND REDUCES INFLAMMATION IN A MURINE MODEL OF VASCULAR DEMENTIA (WSC 2025) - "Cerebrolysin demonstrates therapeutic potential for VaD by improving neurocognitive function, promoting white matter integrity, and reducing neuroinflammation in a BCAS-induced VaD mouse model. These findings suggest that Cerebrolysin may be a promising therapeutic agent for VaD and warrant further investigation in clinical trials."

Preclinical • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Inflammation • Vascular Neurology • GFAP • MBP

CEREBROLYSIN AS ADD-ON THERAPY IN PATIENTS WITH HIGH HUNT-HESS GRADE SUBARACHNOIDAL HEMORRHAGE (WSC 2025) - "According to preliminary results Ccerebrolysin as an add-on drug may improve the 90-day functional outcome in patients with aSAH and initial Hunt-Hess grade III and higher."

Clinical • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

CREGS-2 - A MULTINATIONAL, HIGH-QUALITY COMPARATIVE EFFECTIVENESS TRIAL OF CEREBROLYSIN IN MODERATE ACUTE ISCHEMIC STROKE (WSC 2025) - "Safety profiles were comparable between groups. Data integrity was high (90.9% valid mRS at day 90), with a dropout rate of 5.7%.ConclusionsThe HQCER design of CREGS-2 confirms that well-designed real-world studies can generate reliable evidence on Cerebrolysin's effectiveness and safety in moderate acute ischemic stroke patients."

HEOR • Cardiovascular • Diabetes • Ischemic stroke • Metabolic Disorders

CIRCULATING TIGHT JUNCTION PROTEINS IN ACUTE ISCHEMIC STROKE PATIENTS AFTER REPERFUSION THERAPY COMBINED WITH CEREBROLYSIN (WSC 2025) - No abstract available

Clinical • Cardiovascular • Ischemic stroke

Left atrial occlusion in intracerebral hemorrhage with atrial fibrillation, herpes zoster, and stroke, improving stroke outcomes in China, and Cerebrolysin as a treatment for acute stroke. (PubMed, Int J Stroke) - No abstract available

Journal • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Herpes Zoster • Varicella Zoster

Safety and Efficacy of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of 14 Randomized Controlled Trials. (PubMed, Cureus) - "These findings suggest that Cerebrolysin significantly enhances early neurological recovery after ischemic stroke, with a comparable safety profile. Further high-quality trials are warranted to confirm its impact on long-term functional outcomes."

Journal • Retrospective data • Review • Cardiovascular • Hematological Disorders • Ischemic stroke

Evaluating the Effect of Cerebrolysin as an Adjuvant to Standard Therapy in Patients with Acute Ischemic Stroke: A Prospective Observational Study. (PubMed, Medicina (Kaunas)) - "However, the short follow-up, single-center setting, and lack of randomization limit generalizability. Larger multicenter randomized trials with longer follow-up are needed to confirm these findings."

Journal • Observational data • Cardiovascular • Ischemic stroke

Microglial Polarization and Therapeutic Strategies in Post-stroke Neuroinflammation. (PubMed, Neurol Ther) - "Emerging pharmacological interventions, such as the free radical scavenger edaravone, the neurotrophic factor cerebrolysin, and the excitotoxicity modulator citicoline, demonstrate promising neuroprotective potential when strategically timed. Findings on neuroinflammation, mechanism, or interventions in ischemic stroke were narratively synthesized through thematic analysis. This review summarizes current insights into post-stroke neuroinflammatory mechanisms, with a focus on the dual role of microglial polarization."

Journal • Review • Cardiovascular • Inflammation • Ischemic stroke • Oncology • IL6 • TNFA

A clinical case of treating a patient with severe ischemic stroke and cancer (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Despite the high risk of hemorrhagic complications associated with underlying malignancy, systemic thrombolysis with alteplase was successfully administered; however, hemorrhagic transformation subsequently occurred. Early comprehensive rehabilitation and adjunctive therapy with Cerebrolysin (30 ml/day) significantly reduced neurological deficits. One month after the stroke, the patient exhibited near-complete motor recovery and substantial improvement in speech function without complications during anticoagulant therapy with apixaban. This case highlights the importance of early diagnosis and an integrated approach to the management of stroke in oncological patents."

Journal • Cardiovascular • Colon Cancer • Colorectal Cancer • Hematological Disorders • Ischemic stroke • Oncology • Solid Tumor • Thrombosis

CREGS-2 - A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke. (PubMed, Int J Stroke) - "The ordinal MoCA showed superiority for Cerebrolysin in the TP (MW 0.5530; CI 0.5282-0.5778; P<0.0001) with more pronounced effects in the subgroup with cognitive impairments at baseline (Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) ≥3.3). No differences in safety measures were recorded.The study is notable for its robust data integrity, with valid entries of 90.9% for the primary 90-day mRS assessment with multilevel case mix standardisation and an overall dropout rate to the final visit of only 5.7%.ConclusionThe results of the CREGS-2 study showed the effectiveness and safety of Cerebrolysin treatment for moderate acute IS in real world clinical practice."

HEOR • Journal • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Ischemic stroke

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

Neuroprotective Agents With Reperfusion Therapies in Ischemic Stroke: Evidence From Recent Randomized Trials. (PubMed, Cureus) - "Interventions included nerinetide, edaravone (and its derivatives), nelonemdaz, cerebrolysin, minocycline, glyceryl trinitrate, and normobaric hyperoxia. Quality assessment using the Cochrane Risk of Bias (RoB) 2.0 tool revealed low to moderate risk of bias across most studies. Although the evidence remains heterogeneous, this review highlights the potential role of neuroprotective agents as adjuncts to reperfusion therapy and identifies promising directions for future clinical trials."

Journal • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

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