Emoxypine (Mexidol)

Ischemic stroke

• MIR 2025, 304 patients, 17 centres in Russia, Kazakhstan and Uzbekistan, double-blind, placebo-controlled. Adults aged 40 to 75 with a first hemispheric ischemic stroke within 48 hours, an NIHSS score of 9 to 15 and no clot-dissolving or clot-removal treatment received standard care plus Mexidol 500 mg intravenously twice a day for 10 days and then 250 mg by mouth three times a day for 60 days, or standard care plus placebo. The primary endpoint was met: modified Rankin scale scores fell by 2.45 points with Mexidol and 2.01 points with placebo (p=0.003) among the 279 patients analysed per protocol, and 85 of 141 against 57 of 138 reached a score of 0 or 1 (PMID: 41456191, PMID: 40898634; ClinicalTrials.gov NCT06437626). The paper reports a significant difference in NIHSS change (p<0.001), while the ClinicalTrials.gov results give a median NIHSS change of -7 points in both groups, with interquartile ranges of -9 to -6 on Mexidol and -8 to -5 on placebo (PMID: 40898634; ClinicalTrials.gov NCT06437626).
• EPICA 2017, 150 patients randomized, double-blind, placebo-controlled. Patients aged 40 to 79 with hemispheric ischemic stroke received Mexidol 500 mg a day intravenously for 10 days and then 125 mg three times a day by mouth for 8 weeks, or placebo. At the end of treatment the mean modified Rankin score was lower with Mexidol (p=0.04), and the share scoring 0 to 2 and NIHSS scores also favored Mexidol; side effect frequency did not differ (PMID: 28665371). ClinicalTrials.gov lists the end-of-treatment modified Rankin score as the primary outcome, at 1.10 with Mexidol and 1.46 with placebo among 61 and 63 completers (ClinicalTrials.gov NCT02793687).
• Skvortsova 2006, 78 patients, double-blind, placebo-controlled. Fifty-one patients admitted within 24 hours of stroke received Mexidol 300 mg a day for 14 days and 27 received placebo; NIHSS scores improved more with Mexidol by day 14 (p<0.05), and Barthel scores improved more by day 21 in patients treated within 6 hours (PMID: 39320346).
• Meta-analysis 2023, St. Petersburg. Eleven Russian-language studies, only 2 of them randomized and 9 non-randomized, unblinded cohort studies, gave lower NIHSS and modified Rankin scores with Mexidol, with significant statistical heterogeneity (PMID: 38148698).

Chronic brain ischemia and cognition

• MEMO 2021, 318 patients aged 40 to 90, 15 centres in Russia and Uzbekistan, double-blind, placebo-controlled. Patients received Mexidol 500 mg intravenously for 14 days and then 250 mg three times a day by mouth for 60 days, or placebo. The primary endpoint, change in MoCA score, favored Mexidol (p<0.000001), with a lower 95 percent confidence limit of 1.51 points for the difference (PMID: 34932280); ClinicalTrials.gov gives mean MoCA gains of 4.22 points with Mexidol and 2.17 points with placebo (ClinicalTrials.gov NCT06834490). Secondary measures of processing speed, fatigue, anxiety, autonomic symptoms, balance, the mental component of quality of life and global impression also favored Mexidol (PMID: 34932280).
• Meta-analysis 2024, Sechenov University. Ten prospective randomized trials with 482 patients on Mexidol and 455 on basic therapy alone gave MoCA scores 2.06 points higher with Mexidol (95 percent CI 0.98 to 3.14) (PMID: 38261288). The first author, V. V. Zakharov, is also a MEMO author (PMID: 34932280).
• Smaller studies. In an unblinded study, 45 patients given Mexidol had better movement, quality of life and screening cognition scores at day 74 than 30 matched patients who were not given Mexidol (PMID: 26081329).

ADHD in children

• MEGA 2022, 333 children aged 6 to 12, 14 Russian centres, double-blind, placebo-controlled, 6 weeks. Children took Mexidol 125 mg twice daily, Mexidol 125 mg once daily plus placebo, or placebo. Both Mexidol groups beat placebo on the primary endpoint, the change in total SNAP-IV inattention and hyperactivity-impulsivity score, and the twice-daily regimen did best (PMID: 35485068). ClinicalTrials.gov gives mean score changes of -9.33 points (twice daily), -7.31 points (once daily) and -3.93 points (placebo) (ClinicalTrials.gov NCT06854601).

Other conditions

• Diabetic peripheral neuropathy. A 2016 systematic review of 27 randomized trials by an Erasmus Medical Centre group in Rotterdam listed Mexidol among treatments with significant symptom improvement (PMID: 26822889).
• Alcohol withdrawal. A double-blind, placebo-controlled study in Chelyabinsk reported faster reduction of some anxiety symptoms with Mexidol; the abstract does not give the number of patients (PMID: 34693691).

In the EPICA stroke trial, the frequency of side effects did not differ significantly between groups (PMID: 28665371); its posted results list serious adverse events in 1 of 75 patients on Mexidol and 3 of 75 on placebo (ClinicalTrials.gov NCT02793687).

In the MEMO trial in chronic brain ischemia, no deaths or serious adverse events occurred among 318 patients. Other adverse events were recorded in 19 of 159 patients on Mexidol and 32 of 159 on placebo; itchy throat (4 against 0), itchy nose (2 against 0) and altered taste (2 against 0) were among those recorded more often on Mexidol (ClinicalTrials.gov NCT06834490).

In the MEGA trial in children with ADHD, adverse events were recorded in 26 of 111 children on 125 mg twice daily, 14 of 111 on 125 mg once daily and 20 of 111 on placebo (ClinicalTrials.gov NCT06854601), and the authors reported no significant differences in the main safety measures (PMID: 35485068).

Who reported the safety data

These four trials were sponsored by Pharmasoft, the Russian company named in the MEGA trial report as the maker of the Mexidol tablets tested (PMID: 35485068), and each ClinicalTrials.gov record was submitted after the trial's primary completion date (ClinicalTrials.gov NCT02793687, NCT06834490, NCT06854601, NCT06437626).

Pregnancy

The MIR trial excluded pregnant and breastfeeding women and required contraception during treatment (ClinicalTrials.gov NCT06437626). A PubMed search on 25 October 2026 found no study of Mexidol or emoxypine in pregnant women.