At a glance
- Cerebrolysin is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 639 publications mentioning it, including 61 randomized controlled trials and 203 animal-only studies.
- ClinicalTrials.gov lists 43 registered studies testing it (9 active).
- FDA's adverse event system (FAERS) holds 80 reports mentioning it; 75 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- [Expert Council resolution: adjunctive pharmacotherapy for hyperkinetic disorders (attention deficit hyperactivity disorder) in children and adolescents].
- Adjunctive Cerebrolysin therapy following mechanical thrombectomy for tandem right internal carotid artery and middle cerebral artery occlusion with residual post-procedural perfusion deficit: a case report.
- Improvement of aphasia deficits following traumatic intracranial hemorrhage: a case report.
- An Adaptive, Time-Informed, Phenotype-Guided Pharmacological Framework for Severe Traumatic Brain Injury : A Hypothesis-Driven Narrative Review.
- Very Early Short-Course Cerebrolysin After Tenecteplase and Mechanical Thrombectomy: A Case Report.
- Post-endovascular thrombectomy perfusion imaging (CT and MR) as a prognostic biomarker and patient-selection tool for adjuvant therapy: A systematic review, meta-analysis, and clinical threshold framework.
- Adjunctive Cerebrolysin therapy following mechanical thrombectomy for acute basilar artery occlusion: a case report.
- Cerebrolysin as an adjunct to speech-language therapy in post-stroke Wernicke's aphasia: a case report.
- Research-Evidence-Practice Gaps in Post-stroke Neuro-recovery Pharmacological Therapies in Asia.
- Predictors of Psychoactive and Nootropic Substance Use Among Romanian University Healthcare Students: The Interplay Between Academic Anxiety and Educational Advancement.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 43
- Active
- 9
- With posted results
- 3
Conditions studied
Show 33 more studies
All 43 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 80
- Serious
- 75
- With death outcome
- 15
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.