Other psychostimulants and nootropics (local classification)
ATC code: N06BX-CORTEXIN (Cortexin (cattle brain cortex polypeptides) – local code)
The manufacturer claims nootropic, neuroprotective, and antioxidant effects via a complex of low-molecular-weight peptides isolated from the brain cortex of cattle (calves and piglets). The mechanism is not described in international pharmacological literature. The biological origin raises theoretical concerns about prion disease transmission. Independent multicenter RCTs by current standards are absent.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
2024 AMD PPP and EURETINA 2021 Guidelines recommend supplementation for dry AMD and intravitreal anti-VEGF (aflibercept, ranibizumab, brolucizumab, faricimab) for wet AMD. Cortexin is not mentioned. Peptide neuroprotection for AMD is not used outside Russia and a few CIS countries.
Sources
ICD-10: H35.3 · ICD-11: 9B75.0
Not recommended
For ASD, 2020, AACAP, and CG170 international guidelines recommend early behavioural intervention (ABA, ESDM) and management of comorbidities (epilepsy, sleep, anxiety). Peptide preparations and nootropics are not first-line. Massive Cortexin prescribing in Russian ASD practice lacks international support.
Sources
ICD-10: F84 · ICD-11: 6A02
Not recommended
Cortexin is not included in international guidelines for cognitive impairment and dementia ( NG97, 2018). The drug has no independent multicentre RCTs in international journals.
Sources
ICD-10: F06.7 · ICD-11: 6D71
Not recommended
In children with developmental and speech delay, Cortexin is not mentioned in international pediatric and neurological guidelines. and ESCAP do not include peptide «nootropics» in standards of care. Evidence-based approaches are early behavioral intervention, speech and special education therapy, and psychiatric care when indicated. Pharmacotherapy for specific symptoms (ADHD, autistic traits) uses agents with proven efficacy.
Sources
ICD-10: F80-F89 · ICD-11: 6A0Z
Not recommended
2024 Diabetic Retinopathy PPP and DRCR Retina Network protocols recommend glycaemic, blood pressure, and lipid control; intravitreal anti-VEGF for clinically significant macular edema and proliferative disease; retinal laser photocoagulation. Cortexin and other systemic peptide agents are absent from these documents. RCTs of Cortexin with outcomes on visual acuity, retinal thickness, or progression are not available in international journals.
Sources
ICD-10: H36.0 · ICD-11: 9B71.0
Not recommended
International guidelines 2020 Glaucoma PPP, EGS 2021, and ICO Guidelines for Glaucoma do not mention the drug. Glaucoma therapy rests on IOP reduction – drops, SLT laser, and surgery. Systemic peptide 'neuroprotection' is not used by the international ophthalmology community. A few Russian publications on peptide neuroprotection in glaucoma entered international databases, but independent multicentre RCTs have not been reproduced.
Sources
ICD-10: H40 · ICD-11: 9C61
Not recommended
International 2019 and 2021 stroke guidelines do not mention Cortexin or other «neuropeptide neuroprotectors» in acute ischemic stroke. Proven acute therapies are systemic thrombolysis with tPA within 4.5 hours of symptom onset and mechanical thrombectomy within 6–24 hours in selected patients.
Sources
ICD-10: I63 · ICD-11: 8B11
Not recommended
Cortexin is a peptide preparation derived from cattle cerebral cortex. It is not included in international clinical guidelines (, , ), and the and have not approved it. The diagnosis of dyscirculatory encephalopathy, which is the most common reason cortexin is prescribed in Russia, does not exist in international neurology or in ICD-11. There are no convincing independent clinical studies of efficacy in cognitive impairment. For prevention of vascular cognitive impairment: blood-pressure control, lipid management, smoking cessation, physical activity, cognitive training; for confirmed dementia: acetylcholinesterase inhibitors (donepezil, rivastigmine) and memantine. If cortexin was prescribed for memory improvement, after stress, or for dyscirculatory encephalopathy, consider seeking a second opinion.
Sources
Not recommended
Cortexin is not mentioned in Stroke Rehabilitation Guidelines 2016 or . Evidence-based rehabilitation rests on early mobilization, physical and occupational therapy, speech therapy, and psychological support. CIMT helps hemiparesis; intensive speech therapy helps dysphasia. Pharmacotherapy in rehabilitation is largely limited to antidepressants for post-stroke depression.
Sources
ICD-10: I69 · ICD-11: 8B25
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Direct links to regulator labels. Open in a new tab.
Contraindicated in pregnancy per manufacturer label. International sources have no recommendations.
Contraindicated during breastfeeding per manufacturer label.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Cortexin (bovine brain cortex polypeptides) is evaluated for the following indications with varying evidence strength: Diabetic retinopathy (evidence tier F), Memory and concentration enhancement (evidence tier F), Cognitive impairment (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Cortexin (bovine brain cortex polypeptides) (≥ 1 in 100): Allergic reactions, Pain and redness at the injection site. See the Safety section for uncommon and serious reactions.
FDA category N. Contraindicated in pregnancy per manufacturer label. International sources have no recommendations.
Contraindicated during breastfeeding per manufacturer label.
Cortexin (bovine brain cortex polypeptides) is contraindicated in: Pregnancy; Breastfeeding; Hypersensitivity. Full list in the Safety section.
international pediatric and neurological guidelines do not support peptide «nootropics» in developmental delay. Effective approaches are early behavioral intervention, speech and special education therapy.
international stroke and TBI rehabilitation guidelines do not mention Cortexin. Physical therapy, occupational therapy, and speech therapy are effective.
registration and inclusion in Russian Ministry of Health guidelines under the Russian evidence scale are not equivalent to an international evidence base.