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.
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.
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.
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.
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.
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.
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.
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.
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.
Not recommended
— Chronic cerebral ischaemia / dyscirculatory encephalopathy: The term «dyscirculatory encephalopathy» is absent from international neurology and ICD-11. Cortexin for cognitive impairment and chronic cerebrovascular disease is not mentioned in or guidelines. Evidence-based management of vascular cognitive impairment relies on cardiovascular risk factor control, physical activity, cognitive training, and acetylcholinesterase inhibitors plus memantine in dementia.
Contraindicated in pregnancy per manufacturer label. International sources have no recommendations.
Contraindicated during breastfeeding per manufacturer label.
Cortexin (bovine brain cortex polypeptides) is evaluated for the following indications with varying evidence strength: Age-related macular degeneration (evidence tier F), Ischemic stroke (evidence tier F), Post-stroke recovery (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.
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.