K4 Elite
K4 Elite
Semax is a synthetic ACTH(4-10) fragment analogue developed in Russia and used there as an intranasal preparation. The human evidence consists of Russian-language, PubMed-indexed clinical studies from the 1990s-2010s in acute ischaemic stroke, chronic cerebrovascular insufficiency, motor neuron disease and other neurological conditions, most of them open-label or with non-randomised control groups; mechanistic work is largely in rat ischaemia models. No Western, placebo-controlled replication of the stroke findings has been published in the indexed literature, and only English abstracts of most trials are available.
Each row records what a published study did: who it enrolled, the regimen it administered to those subjects, and what it reported. These are historical study descriptions, not protocols to follow.
| Study | Population | Regimen as reported | Primary findings |
|---|---|---|---|
| Gusev et al., Zh Nevrol Psikhiatr Im S S Korsakova 1997 (open comparative study; Russian-language) | 30 patients in the acute period of hemispheric ischaemic stroke, compared with 80 conventionally treated controls matched for severity and lesion location | Patients received Semax added to combined intensive therapy; the daily doses reported as most effective were 12 mg for moderate stroke and 18 mg for severe stroke, given over treatment courses of 5 and 10 days. | The authors reported faster regression of general cerebral and focal (especially motor) deficits in the Semax group, assessed by clinical rating scales, EEG mapping and somatosensory evoked potentials. |
| Gusev, Skvortsova & Chukanova, Zh Nevrol Psikhiatr Im S S Korsakova 2005 (Russian-language) | 187 patients with different stages of chronic cerebrovascular insufficiency | Patients received Semax alongside standard management; dose and course length are not stated in the English abstract. | The authors reported clinical improvement and stabilisation of disease course in treated patients, and described the drug as well tolerated with a minor percentage of side effects, including in older age groups. |
| Gusev et al., Zh Nevrol Psikhiatr Im S S Korsakova 2018 (Russian-language) | 110 patients after ischaemic stroke (43 men, 67 women; mean age 58 years) in early (~89 days) or late (~214 days) rehabilitation, subdivided into Semax+ and Semax- subgroups | Patients in the Semax subgroups received two 10-day courses of 6000 mcg/day (6 mg/day) separated by a 20-day interval. | Plasma BDNF levels rose and remained elevated in Semax-treated subgroups regardless of rehabilitation timing, and Barthel index improvement was reported to be faster in these subgroups. |
| Serdiuk et al., Zh Nevrol Psikhiatr Im S S Korsakova 2007 (open-label; Russian-language) | 27 patients with definite, probable or possible motor neuron disease | Semax 1% solution was administered intranasally in two 10-day courses with a 2-week break, at a daily dose of 12 mg. | Serial needle EMG showed a fluctuating (forward-backward) course of chronic partial denervation, which the authors concluded made short-interval EMG unsuitable for monitoring drug efficacy; functional scales (Norris, ALSFRS, ALSAQ-40) were recorded. |
| Ivanikov et al., Bull Exp Biol Med 2002 (open study) | Patients with refractory peptic ulcers receiving standard anti-ulcer therapy (omeprazole, De-Nol, solcoseryl) | Patients received intranasal Semax 1% solution, 2-4 drops three times daily for 10 days, in addition to standard therapy. | Ulcer healing at day 14 was reported in 89.5% of Semax-treated patients versus 30.8% of controls. |
| Panikratova et al., Dokl Biochem Biophys 2020 (placebo-controlled resting-state fMRI study) | 52 healthy participants | Participants received a single administration of Semax, Selank or placebo; resting-state fMRI was acquired before and 5 and 20 minutes after administration (dose not stated in the abstract). | Between-group differences in functional connectivity between the right amygdala and right temporal cortex were reported after Semax or Selank compared with placebo. |
| Filippenkov et al., Genes 2020 (rat model) | Rats subjected to transient middle cerebral artery occlusion (tMCAO) | In a rat tMCAO model, animals were treated with Semax or saline and brain transcriptomes were profiled by RNA-Seq at 24 h. | 394 differentially expressed genes were identified; Semax-treated animals showed suppressed inflammation-related and increased neurotransmission-related gene expression relative to saline. |
Effects recorded in the cited reports. Frequencies are those the source reported, in the population that source studied.
| Effect | Frequency / context | Source |
|---|---|---|
| Episodes of paroxysmal EEG activity after administration | Observed in some patients with posthypoxic encephalopathy (n=73 studied); the authors advised EEG monitoring during the first administration (Alekseeva et al. 1999; Russian-language, frequency not stated). | [Use of semax at a follow-up of patients with posthypoxic encephalopathy] ↗ |
| Overall tolerability | Described as a minor percentage of side effects and good tolerability, including in older patients, in a 187-patient cerebrovascular insufficiency study (Gusev 2005); specific event rates are not given in the English abstract. | [Semax in prevention of disease progress and development of exacerbations in patients with cerebrovascular insufficiency] ↗ |
No interactions with a verifiable citation have been indexed for this compound.
No contraindications with a verifiable citation have been indexed for this compound.