Onset
Not established as a precise figure; clinical and community descriptions suggest same-day to short-term effects.
Protocol / Research Dosing Guide
Semax Dosage Guide: Russian Clinical Ranges, Route Boundaries and Safety
An evidence-organized Semax reference separating the Russian clinical and intranasal literature from the sparser subcutaneous research-community reports, without transferring numbers across routes.
Last reviewed September 16, 202617 minute readResearch information only
Level 3 — Foreign clinical approval, no US approvalRegistered only in RussiaNot FDA approved
Semax Quick Start
Semax is a Russian-designed ACTH-fragment peptide used clinically in Russia for stroke recovery, cognitive disorders, and optic nerve disease. It has never been FDA approved in the United States. Its clinical evidence base is almost entirely intranasal; subcutaneous injection is reported far less often and has sparse direct human data, so intranasal figures should not be assumed to apply to an injected dose.
Why researchers care
Cognitive performance, post-stroke recovery, and optic nerve disease research
Class
Synthetic ACTH(4–7)-derived heptapeptide with a Pro-Gly-Pro stabilizing tail
Route reported
Intranasal solution in most published research; subcutaneous injection is a less-studied community format
Cycle length
10–14 day short courses or 4–6 week cognitive courses reported, sometimes cycled with 2–4 weeks off
Regulatory status
Registered as a medicine in Russia (on the Vital and Essential Drugs List); not FDA approved in the United States; removed from FDA's 503A Category 2 nominations list on April 23, 2026
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Semax Dosing Protocol and Schedule
The supplied source reports intranasal cognitive-research amounts of about 0.6–1.5 mg per day split into two administrations, higher supervised amounts in acute stroke care, and a single-dose healthy-volunteer study at about 1.2 mg. For subcutaneous use it reports sparse sub-milligram community figures and notes that a rodent pharmacology figure of up to about 1 mg/kg is not human-applicable.
| Phase or study | Amount | Frequency / evidence |
|---|---|---|
| Cognitive/nootropic intranasal | About 0.6–1.5 mg/day, split into 2 administrations | Russian clinical literature |
| Acute ischemic stroke (clinical, Russia) | Higher daily amounts under hospital supervision | Clinical study context |
| Healthy-volunteer single-dose study | About 1.2 mg, one-time intranasal administration | Human research |
| Subcutaneous community reports | Sub-milligram per administration | Community reported, sparse human data |
| Animal pharmacology reference | Up to about 1 mg/kg in rodent models | Not human-applicable |
| Rest period | 2–4 weeks off after a 4–6 week course is reported | Community reported |
Intranasal and subcutaneous figures are not interchangeable. A given milligram amount produces different exposure by each route, and the published literature does not provide a conversion.
Semax Supplies Needed
Neutral research-material planning only. This does not establish an appropriate amount or route.
Research planning item
Exact labeled research vial or nasal bottle
Research planning item
Bacteriostatic water at a measured volume (injectable format only)
Research planning item
U-100 insulin syringes (injectable format only)
Research planning item
Alcohol prep swabs
Research planning item
Sharps container (injectable format only)
Research planning item
Written concentration label with the preparation date
Semax Reconstitution Calculator
Vial-format concentration math
Concentration
5 mg/mL
Draw volume
0.1 mL
U-100 units
10
Mathematical draws
10
Arithmetic only. The entered amount is not a recommendation and does not establish suitability.
Best Time to Take Semax: Morning or Night?
Morning or evening?
Morning and early afternoon administration is the commonly reported pattern, to avoid late-day stimulation.
Once daily or split?
Cognitive-research reports describe splitting the daily amount into two administrations.
With food?
Not established for either route.
Missed amount?
No validated replacement procedure exists for either route.
Semax Route Comparison
| Format | What is reported | Evidence limit |
|---|---|---|
| Intranasal solution | 0.1% or 1% concentrations, metered spray or drops | The most-studied route in the published Russian literature |
| Subcutaneous injection | Reconstituted research vial, sub-milligram community reports | Sparse direct human data; not the primary studied route |
| Route conversion | Not established | Intranasal and subcutaneous amounts are not interchangeable |
Routes and amounts are not interchangeable unless a verified study explicitly establishes a conversion.
Semax Half-Life and Dosing Frequency
| Measure | Finding | Evidence limit |
|---|---|---|
| Human plasma half-life | Not established in the sources reviewed | The Pro-Gly-Pro tail is reported to slow breakdown relative to the bare ACTH fragment |
| Animal half-life | Not established as a specific figure in the sources reviewed | Context only |
| Frequency logic | Twice-daily splitting is a reported clinical/community pattern | Not tied to a published pharmacokinetic study in the sources reviewed |
| Route-specific exposure | Not established | No comparative bioavailability study across routes was identified |
Semax Dosage Chart
| Route | Amount | Frequency | Source | Human validation |
|---|---|---|---|---|
| Intranasal | 0.6–1.5 mg/day | Split into 2 administrations | Russian clinical literature | Cognitive/nootropic research context |
| Intranasal | About 1.2 mg | Single administration | Human research (healthy-volunteer study) | One-time research context |
| Intranasal | Higher supervised amounts | Multiple daily administrations | Clinical study (acute stroke) | Hospital-supervised only |
| Subcutaneous | Sub-milligram per administration | Not established frequency | Community reported | No |
Published study values describe those studies. Community-reported values are not validated dosing recommendations.
Semax Reconstitution Guide
Concentration: 5 mg/mL
| Entered amount | Volume | U-100 units |
|---|---|---|
| 0.5 mg | 0.1 mL | 10 units |
| 1 mg | 0.2 mL | 20 units |
| 1.5 mg | 0.3 mL | 30 units |
- 1.Confirm the exact quantity printed on the vial label.
- 2.Choose and record the measured bacteriostatic water volume.
- 3.Clean the vial stopper with an alcohol swab.
- 4.Add the liquid slowly down the vial wall.
- 5.Swirl gently until clear; never shake.
- 6.Inspect for cloudiness, discoloration, or particles and discard anything that is not clear.
- 7.Label the vial with the calculated concentration and preparation date.
- 8.Use only the calculated concentration for syringe unit arithmetic; intranasal products should be dosed from the printed bottle label instead.
Reconstitution does not establish identity, purity, sterility, stability, or an appropriate amount.
How Semax Works
Structural basis
Semax is derived from ACTH(4–7), stabilized with an added Pro-Gly-Pro tail to slow enzymatic breakdown.
Semax Human Trials and FDA Status
Current status · verified September 16, 2026
Registered as a medicine in Russia (on the Vital and Essential Drugs List); not FDA approved in the United States; removed from FDA's 503A Category 2 nominations list on April 23, 2026
- A 1997 Russian clinical study administered intranasal Semax during the acute period of hemispheric ischemic stroke.
- Russian clinical literature (including Kaplan 1996 and Voronina 2023 as cited in the supplied source) reports intranasal cognitive and post-stroke use in the Vital and Essential Drugs List context.
- A healthy-volunteer cognitive-attention study reported a single intranasal administration of about 1.2 mg.
- No published human trial of subcutaneous or injected Semax was identified in the sources reviewed.
Who Should Avoid Semax?
This is an evidence-gap and precaution list, not an approved prescribing label.
Pregnancy or breastfeeding
No safety data
Children or adolescents outside Russian clinical indications
No established protocol for general use
Anxiety disorders or acute agitation
Stimulating effects are reported in community and clinical descriptions
Uncontrolled hypertension or seizure history
Not evaluated in the sources reviewed
Concurrent stimulant use
No interaction studies
Reliance on subcutaneous dosing to reproduce intranasal clinical results
Route conversion is not established
Semax Side Effects, Risks and Safety
Nasal irritationReported with intranasal use
Important limitation: Route-specific.
Anxiety or overstimulation, especially late in the dayAnecdotal and clinical description
Important limitation: Basis for morning/early-afternoon timing pattern.
HeadacheAnecdotal
Important limitation: No controlled incidence data.
Injection-site reaction (subcutaneous)Anecdotal
Important limitation: Sparse human data for this route.
Allergic responseUnknown
Important limitation: No large characterized safety dataset.
Long-term use effectsUnknown
Important limitation: No long-duration published follow-up identified.
Semax Timeline and Monitoring
Course length
10–14 days for short clinical-context courses; 4–6 weeks for cognitive-research courses, per the supplied source.
Cycling pattern
2–4 weeks off is reported after a 4–6 week course.
Monitoring
No validated Semax-specific monitoring schedule was identified.
Semax Benefits and Results: What the Evidence Shows
| Claim | Evidence level | What research shows | Important limitation |
|---|---|---|---|
| Post-stroke recovery support | Clinical use in Russia | Russian clinical literature | Not FDA approved; not established in a US regulatory context |
| Cognitive performance | Human research | Cognitive-attention and Russian clinical studies | Effect sizes and consistency vary by source |
| Optic nerve disease | Clinical use in Russia | Listed clinical indication | Not independently detailed in the sources reviewed |
| Subcutaneous performance benefits | Not established | Community claims | No direct human injectable study identified |
Semax Storage and Handling
Lyophilized vial
Refrigerated or frozen storage is the commonly reported condition; follow the exact product label.
Intranasal bottle
Follow the manufacturer or supplier label; no universal condition is established in the sources reviewed.
Prepared injectable vial
No validated Semax-specific prepared-vial stability duration was identified.
Appearance
A clear solution is expected; cloudiness, discoloration, or particles mean discard.
Semax Troubleshooting
Nasal spray amount is unclear
Read the bottle label for mcg per spray or per drop; do not estimate by counting drops.
Solution appears cloudy
Discard it and do not administer by any route.
Calculated syringe units look wrong
Recheck vial quantity, diluent volume, target amount, and unit conversion.
Late-day overstimulation
Community and clinical descriptions favor morning/early-afternoon dosing to avoid this.
A scheduled amount is missed
No validated missed-amount procedure was identified in the sources reviewed.
Semax Comparisons
| Compound | Class or mechanism | Evidence | FDA status |
|---|---|---|---|
| Semax | ACTH(4–7)-derived heptapeptide | Russian clinical registration; intranasal human literature | Not FDA approved |
| N-Acetyl Semax | Modified Semax form | Not interchangeable with Semax | Not FDA approved |
| Selank | ACTH-fragment-family anxiolytic peptide | Russian clinical registration | Not FDA approved |
| Adamax | Vendor-created Semax analogue | No direct published studies | Not FDA approved |
Semax Frequently Asked Questions
What is Semax?
A synthetic seven-amino-acid peptide derived from ACTH(4–7) with a stabilizing Pro-Gly-Pro tail, registered as a medicine in Russia.
Is Semax FDA approved?
No. It is not approved in the United States.
What is its regulatory status in Russia?
It is on Russia's Vital and Essential Drugs List, used for stroke recovery, cognitive disorders, and optic nerve disease.
What is the 503A status update?
It was removed from FDA's 503A Category 2 bulk substances nominations list on April 23, 2026 because the underlying nominations were withdrawn; a PCAC review was scheduled for July 24, 2026.
Which route has the most human evidence?
Intranasal. Subcutaneous human data is sparse by comparison.
Can intranasal amounts be converted to an injectable dose?
No. The two routes are not interchangeable and no conversion is established.
What is a typical intranasal cognitive-research amount?
The Russian clinical literature reports roughly 0.6–1.5 mg/day split into two administrations, per the supplied source.
Is there a validated cycle length?
No single validated cycle exists; 10–14 day and 4–6 week courses are reported, sometimes with a 2–4 week break.
What is its half-life?
Not established in the sources reviewed.
Is long-term safety established?
No large long-term safety dataset was identified.
What does the calculator do?
It converts entered vial and liquid values into concentration and syringe-unit arithmetic only; it does not establish a dose.
Sources and Research
Coverage source
1. Semax protocol coverage source
Route-specific schedules, reconstitution math, and page coverage; not primary evidence.
Open direct sourceHuman research
2. Gusev EI et al., acute ischemic stroke Semax study (1997)
Russian clinical study of intranasal Semax administered during the acute period of hemispheric ischemic stroke.
Open direct sourceAnimal research
3. Semax rapidly increases BDNF expression in rat hippocampus
Animal research context on a proposed neurotrophic mechanism.
Open direct sourceAnimal research
4. Effects of Semax on BDNF/TrkB expression
Rat pharmacology study relevant to mechanism context.
Open direct sourceMissing information flagged for review
- Human subcutaneous dosage and pharmacokinetics: Not established
- Human plasma half-life: Not established
- Route-conversion data between intranasal and subcutaneous use: Not established
- Validated cycle and rest period: Not established
- Long-term safety data: Not established
- US regulatory pathway outcome following the 503A review: Not established