Semax side effects and results in studies
The Semax studies here say little about adverse events: one Russian study of 187 cerebrovascular patients describes a minor percentage of side effects and good tolerability, including in older patients, without giving rates. The measured outcomes are mostly plasma BDNF, stroke recovery scales, ulcer healing and brain imaging, in small Russian clinical studies and in rodents.
Adverse events reported
| Event | As reported | Source |
|---|---|---|
| Side effects, overall | Described as a minor percentage of side effects; well tolerated, including by older age groups. Rates and event types not stated in the abstract (n=187, cerebrovascular insufficiency) | Gusev EI et al. |
| Adverse events | Not reported in the abstract of the 110-patient stroke rehabilitation study | Gusev EI et al. |
| Adverse events | Not reported in the abstract of the healthy-volunteer fMRI study | Lebedeva IS et al. |
Outcomes measured
| Outcome | Result as reported | Source |
|---|---|---|
| Plasma BDNF after ischaemic stroke | Increased with Semax regardless of rehabilitation timing, and stayed high throughout the study period | Gusev EI et al. |
| Barthel index (daily function) after stroke | Semax and high BDNF accelerated improvement and improved the final Barthel score | Gusev EI et al. |
| Neurological recovery in acute ischaemic stroke | Some influence on the rate of recovery of general, focal and especially motor deficits versus conventional therapy | Gusev EI et al. |
| Stroke and TIA in cerebrovascular insufficiency | Clinical improvement, stabilisation of disease progress and reduced risk of stroke and transient ischaemic attack | Gusev EI et al. |
| Healing of refractory peptic ulcer at day 14 | 89.5% with intranasal Semax added to standard drugs versus 30.8% in controls | Ivanikov IO et al. |
| Default mode network on resting-state fMRI | Greater volume of the rostral (medial frontal) subcomponent than placebo, 5 and 20 min after intranasal 1% Semax | Lebedeva IS et al. |
| Amygdala functional connectivity on fMRI (52 healthy participants) | General and specific effects of Semax and Selank on connectivity between the right amygdala and right temporal cortex | PMID 32342318 |
| Brain gene expression after rat cerebral ischaemia | 394 genes changed versus saline; inflammation genes suppressed and neurotransmission genes activated | Filippenkov IB et al. |
| Functional recovery after mouse spinal cord injury | Improved, with reduced pyroptosis and oxidative stress | Liu R et al. |
What the studies don't show
None of these abstracts give adverse-event rates, so the safety picture rests on one general statement of tolerability. The 'benefits' reported are outcomes measured in small Russian clinical studies, healthy-volunteer imaging and animal models, not results from large blinded trials. There are no long-term human data in these records.