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Neuropeptides

Semax

Also known as ACTH(4-7)PGP, ACTH(4-10) analog Semax, Met-Glu-His-Phe-Pro-Gly-Pro, Semax acetate, N-acetyl Semax amidate (NA-Semax; distinct analog), Семакс

Limited human data

Synthetic ACTH(4-10)-derived heptapeptide; nootropic and neuroprotective melanocortin-derived peptide (Russian classification)

Not FDA-approved. Not on FDA's 503A category lists (May 14, 2026). Source, May 14, 2026

Identity. Semax here means the heptapeptide Met-Glu-His-Phe-Pro-Gly-Pro, the ACTH(4-7) fragment with a C-terminal Pro-Gly-Pro. This is the form covered by the human data and the Russian label. Three points of ambiguity apply. (1) The 10 mg formulary vial may be free base or acetate, and the July 2026 FDA advisory committee voted on free base and acetate forms. (2) N-acetyl Semax amidate is a chemically modified analog sold separately. No peer-reviewed human data or label exists for it, so Semax dosing must not be applied to it. (3) The Russian-literature name 'Semax acetyl' (PMID 23652441) may refer to a different form. Its abstract is unavailable, so this is not established. The 0.1% (1 mg/mL, 50 mcg/drop) and 1% (10 mg/mL, 500 mcg/drop) nasal solutions differ 10-fold. Endonasal electrophoresis products are not equivalent to nasal drops or spray. Take the exact active ingredient and salt form from the partner pharmacy's certificate of analysis.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

  1. Start

    6000 mcg/day (ischemic stroke trial, route not stated)1

    Human study
Frequency
Daily; per-day dose, administrations per day not stated1
Route
Not stated in the stroke trial; intranasal in the volunteer fMRI study12
Course
2 courses of 10 days with a 20 day interval1
No source supports injecting the 10 mg vial; sourced doses are intranasal or route-unstated, and 1% drops hold 10 times the mcg of 0.1%.
Calculate this dose

Dosing detail

Approved label

Approved label

  • Russian-registered Semax 0.1% nasal drops, general neurological indications (adults)

    Label text: 2-3 drops (not more than) per nostril, 50 mcg per drop; stated single dose 200-2000 mcg (3-30 mcg/kg); stated daily dose 500-5000 mcg (7-70 mcg/kg) мкг (mcg) per source; per-kg figures as stated: 3-30 mcg/kg single, 7-70 mcg/kg daily3

    Route
    intranasal drops
    Frequency
    not stated in this passage of the general-indication scheme
    Duration
    daily for 3-5 days, extended to 14 days if necessary
    n
    n/a (label)
    Design
    Label dosing (Russian manufacturer instruction as reproduced by RLS)
    Source quote
    «По 2–3 капли (не более) в каждый носовой ход.» «Разовая доза — 200–2000 мкг (3–30 мкг/кг), суточная — 500–5000 мкг (7–70 мкг/кг).» «ежедневно в течение 3–5 дней, при необходимости курс лечения продлевают до 14 дней.»

    Finding. Russian label range for the 0.1% solution in general neurological use (instruction dated 2003, source page updated 21.11.2018). The label is internally inconsistent. At 50 mcg/drop, 2-3 drops per nostril delivers only 200-300 mcg per administration, yet the same passage states a single dose up to 2000 mcg, which would take about 40 drops. Do not treat 2000 mcg as a per-administration dose for compounded products. The drop-based figure is what a patient can deliver. The discrepancy is not resolved.

  • Russian-registered Semax 0.1% nasal drops, optic nerve disorders (adults)

    2-3 drops per nostril; daily dose 600-900 мкг/сут (mcg/day)3

    Route
    intranasal drops
    Frequency
    2-3 times per day
    Duration
    7-10 days
    n
    n/a (label)
    Design
    Label dosing (Russian manufacturer instruction as reproduced by RLS)
    Source quote
    «По 2–3 капли в каждый носовой ход 2–3 раза в сутки. Суточная доза — 600–900 мкг/сут. Курс лечения — 7–10 дней.»

    Finding. Russian label regimen for optic nerve disease with the 0.1% solution.

  • Russian-registered Semax 0.1% nasal drops, pediatric minimal brain dysfunction incl. ADHD (children)

    1-2 drops per nostril; daily dose 200-400 мкг/сут (mcg/day)3

    Route
    intranasal drops
    Frequency
    2 times per day (morning and midday)
    Duration
    30 days
    n
    n/a (label)
    Design
    Label dosing (Russian manufacturer instruction as reproduced by RLS)
    Source quote
    «препарат закапывается по 1–2 капли в каждый носовой ход 2 раза в сутки (утром и днем). Суточная доза — 200–400 мкг/сут. Курс лечения — 30 дней.»

    Finding. Russian label pediatric regimen with the 0.1% solution. The Russian drug-reference entry lists age 5+ for this use.

  • Russian-registered Semax 1% nasal drops, acute ischemic stroke of moderate severity (adjunct to complex therapy)

    2-3 drops per nostril per administration (2,000-3,000 mcg per administration at 500 mcg/drop); daily total 6,000-12,000 mcg (12-24 drops, 0.6-1.2 mL) мкг (mcg) of active substance per drop4

    Route
    intranasal drops (bottle with plastic pipette stopper)
    Frequency
    3-4 times daily, 3-4 hours apart
    Duration
    daily for 10 days
    n
    n/a (label)
    Design
    Label dosing (Russian instruction as reproduced by medi.ru)
    Source quote
    «При инсульте средней тяжести за один прием вводится по 2-3 капли в каждую ноздрю» «Закапывание проводят 3-4 раза в день, с интервалом между закапываниями 3-4 часа.» «Суточная доза составляет 6000 мкг ( 12 капель или 0,6 мл ) - 12000 мкг ( 24 капли или 1,2 мл).» «Препарат назначают ежедневно в течение 10 дней.» «В одной капле стандартного раствора содержится 500 мкг активного вещества.»

    Finding. Russian label stroke regimen for the 1% solution. Each drop holds 500 mcg, ten times the 0.1% drop. The per-administration doses here are not daily doses.

  • Russian-registered Semax 1% nasal drops, severe acute ischemic stroke (adjunct to complex therapy)

    3-4 drops per nostril per administration (3,000-4,000 mcg per administration at 500 mcg/drop); daily total 12,000-20,000 mcg (24-40 drops, 1.2-2.0 mL) мкг (mcg) of active substance per drop4

    Route
    intranasal drops
    Frequency
    4-5 times daily, 2.5-3 hours apart
    Duration
    daily for 10 days
    n
    n/a (label)
    Design
    Label dosing (Russian instruction as reproduced by medi.ru)
    Source quote
    «При тяжелом инсульте за один прием вводится по 3 - 4 капли в каждую ноздрю» «Закапывание проводят 4-5 раз в день с интервалом между закапываниями 2,5-3 часа.» «Суточная доза составляет 12000 мкг ( 24 капли или 1,2 мл) - 20000 мкг ( 40 капель или 2,0 мл).» «Препарат назначают ежедневно в течение 10 дней.»

    Finding. Russian label regimen for severe stroke with the 1% solution. The upper daily dose is twice the 10 mg formulary vial.

Human studies

Human study

  • Adults after ischemic stroke, early (about 89 days) vs late (about 214 days) rehabilitation, semax+ vs semax- subgroups

    6000 mcg/day1

    Route
    not stated in abstract
    Frequency
    daily (per-day dose; administrations per day not stated)
    Duration
    2 courses of 10 days with a 20-day interval
    n
    110 patients total
    Design
    Clinical trial (PubMed type); randomization not reported in abstract; endpoints plasma BDNF, MRC motor scale, Barthel index
    Source quote
    Standard regimen of semax included 2 courses (6000 mcg/day) for 10 days with 20 day interval.

    Finding. Semax raised plasma BDNF, accelerated Barthel improvement and improved final outcome regardless of rehabilitation timing.

  • Adults with acute hemispheric ischemic stroke; semax added to combined intensive therapy vs conventional therapy

    12 mg/day (12,000 mcg) moderate stroke; 18 mg/day (18,000 mcg) severe stroke mg (daily dose, as stated)5

    Route
    not stated in abstract
    Frequency
    daily dose; administrations per day not stated
    Duration
    treatment course 5 and 10 days
    n
    30 semax, 80 controls
    Design
    Controlled clinical trial (PubMed type), clinical and EEG/evoked-potential endpoints
    Source quote
    The most effective daily doses were 12 mg for patients with strokes of moderate severity and 18 mg for patients with severe strokes (treatment course--5 and 10 days).

    Finding. Adding Semax increased regression of general cerebral and focal, especially motor, disorders. These are mg-scale doses, 20-70x the practice ceiling (250-600 mcg/day) and more than a whole 10 mg vial per day. The abstract does not state the route. It is presumed intranasal. This is not a vial-scale regimen and should not be used to set injectable ranges.

  • Narrative review, species not separated (humans and animals); dose may derive from animal work

    0.015-0.050 mg/kg6

    Route
    intranasal
    Frequency
    not stated in abstract; abstract says effects persist 20-24 h after intranasal administration
    Duration
    not stated
    n
    not stated
    Design
    Narrative review of experience (not a trial)
    Source quote
    it has been demonstrated that this peptide is capable to stimulate operative memory and attention, to increase resistance to hypoxia and to improve brain circulation in experimental animals and human beings over prolonged period (20-24 h after intranasal administration in doses 0.015-0.050 mg/kg).

    Finding. The authors state that memory, attention and brain circulation improved for 20-24 h after intranasal administration in experimental animals and humans. 0.015-0.050 mg/kg equals 15-50 mcg/kg, about 1,050-3,500 mcg for a 70 kg adult. The top end exceeds the Russian label maximum single dose of 30 mcg/kg. The review does not separate animal from human doses, so it is not a human dosing reference.

  • Healthy adult volunteers, resting-state fMRI before and 5 and 20 min after a single dose

    1% solution (dose volume not stated in abstract) % intranasal solution2

    Route
    intranasal
    Frequency
    single administration
    Duration
    single dose; scans at 5 and 20 min
    n
    24 volunteers (14 Semax, 10 placebo)
    Design
    Placebo-controlled volunteer fMRI study (allocation method not stated in abstract)
    Source quote
    Resting state fMRI was carried out 3 times: directly before and 5 and 20 min after intranasal 1% Semax (14 subjects) or placebo (10 subjects).

    Finding. Semax group showed a larger rostral (medial frontal) default-mode-network subcomponent than controls; no clinical endpoint.

  • Adults with diabetes and non-proliferative diabetic retinopathy; endonasal electrophoresis vs intranasal instillations vs standard therapy

    0.1% preparation (amount not stated in abstract) % solution7

    Route
    endonasal electrophoresis (main group); intranasal instillation (comparison group)
    Frequency
    not stated in abstract
    Duration
    benefit followed up to 12 months
    n
    114 patients (228 eyes)
    Design
    Comparative study (PubMed type); three groups
    Source quote
    The patients in main group underwent endonasal electrophoresis of 0.1% semax preparation. Patients of the comparison group were treated with intranasal instillations of semax and those of the control group received only standard hypoglycemic therapy and treatment with Doxy-Hem.

    Finding. Both Semax groups improved visual, perimetric and electrophysiological measures; electrophoresis showed the most pronounced, longest-lasting effect.

What clinics and vendors publish

These ranges come from clinic and vendor publications, not studies.

Community-reported

All practice figures come from one clinic web page (Klearmind) with no named author, no credentials and no cited studies. No peer-reviewed or professional-education source with dosing exists. The page covers intranasal use only, and its dose chart does not state whether figures are per dose or per day. The practice figures (100-600 mcg) overlap or fall below the low end of the 0.1% label range. They are far below the 1% stroke regimens, which are a different product and indication. Concentration per spray varies by product, so dose by the labeled mcg per actuation from the partner pharmacy. A 10 mg vial (10,000 mcg) lasts about 17 days at 600 mcg per day. Giving the whole vial in one dose (10,000 mcg) exceeds every sourced single dose (largest 4,000 mcg, severe stroke, 1% label) and is a dosing error.

StartCommunity-reported
Start low; no figure given (Klearmind)
TitrationCommunity-reported
Adjust gradually based on response; no step sizes given (Klearmind).
TypicalCommunity-reported
100-300 mcg 'low' and 300-600 mcg 'moderate' (Klearmind)
FrequencyCommunity-reported
1-2 times daily (Klearmind)
RouteCommunity-reported
Intranasal spray (Klearmind). No source found for injectable dosing of the 10 mg formulary vial.
TimingCommunity-reported
Morning favored, evening usually avoided (Klearmind).
CycleCommunity-reported
10-20 days on, 1-2 weeks off (Klearmind). Russian label courses vary by indication: 3-5 days (extendable to 14), 7-10 days (optic nerve), 10 days (stroke, 1%) and 30 days (pediatric).
  • Community-reportedVendor page8
    Low: 100–300 mcg / Moderate: 300–600 mcg / Daily use: 1–2 times / Cycle length: 10–20 days / Break period: 1–2 weeks

Safety

Serious warnings

  • No FDA label or boxed warning exists, and Semax is not FDA-approved. The FDA page (current as of 04/22/2026) states: 'Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.'9
  • Russian 1% label contraindication: «Острые психические состояния, расстройства, сопровождаемые тревогой, беременность, период лактации, судороги в анамнезе.» (acute psychiatric states, anxiety-accompanied disorders, pregnancy, lactation, seizure history). The 0.1% label lists a different, partly broader set; see contraindications.4
  • The authors of a review note that the absence of serious adverse events in the published Russian literature is encouraging but insufficient for conclusive safety determinations, given publication bias and differences in pharmacovigilance standards.10
  • FDA staff recommended against adding the substances discussed at the July 2026 advisory committee meeting. The 8-5 committee vote on Semax is non-binding. Removal from Category 2 (April 2026) does not automatically confer Category 1 status.11

Contraindications

  • Semax 1% label: «Повышенная чувствительность к компонентам препарата.» «Острые психические состояния, расстройства, сопровождаемые тревогой, беременность, период лактации, судороги в анамнезе.» (hypersensitivity; acute psychiatric states; anxiety-accompanied disorders; pregnancy; lactation; seizure history)4
  • Semax 0.1% label: «Гиперчувствительность, острые психотические состояния; расстройства, сопровождающиеся тревогой; заболевания эндокринной системы, беременность, кормление грудью, возраст до 5 лет.» (hypersensitivity; acute psychotic states; anxiety-accompanied disorders; endocrine system disease; pregnancy; breastfeeding; age under 5). The two Russian labels differ: seizure history appears only on the 1% label, and endocrine disease and age under 5 appear only on the 0.1% label. Apply the union of both lists when screening. No US label exists.3

Adverse effects

  • 0.1% label: «Возбуждение, бессонница.» (agitation, insomnia). This is relevant for a stimulating nootropic with morning-dosing advice and an anxiety-disorder contraindication.3
  • Label: «При длительном применении возможно слабое раздражение слизистой оболочки носа.» (with long use, mild nasal mucosal irritation is possible)4
  • Label overdose statement: «Явлений передозировки препаратом до настоящего времени не удавалось выявить»4
  • Trial report (187 patients with cerebrovascular insufficiency): 'The drug is featured by minor percent of side-effects and is well tolerated by patients, including those of older age groups.' The abstract gives no event rates.12
  • Authors' review: 'in no case it produced negative side actions or complications connected with its administration' (company-affiliated Russian review, no event data).6

Monitoring

  • No published monitoring protocol exists, and no source specifies lab monitoring. The following is derived from the label contraindications and adverse effects, not from a monitoring source. Before treatment, screen for seizure history, anxiety or psychotic disorder, endocrine disease, pregnancy or lactation, and age. During follow-up, watch for agitation, insomnia, anxiety, mood change, new neurological symptoms, nasal mucosal irritation (intranasal), and injection-site reaction or hypersensitivity if a parenteral form is dispensed.4

Interactions

  • Label: «нежелательно введение средств, обладающих местным сосудосуживающим действием при их интраназальном введении.» (intranasal local vasoconstrictors undesirable)4

Handling

Reconstitution

No reconstitution or dilution instructions are established. The Russian labels cover ready-made nasal solutions, not a lyophilized vial. Dose volume must be calculated from the pharmacy's labeled mg/mL. Reference point: 10 mg = 10,000 mcg.

Storage before mixing

Russian 1% label: «В защищенном от света месте при температуре не выше +10°С, не допускать замораживания.» (protect from light, at or below +10 C, do not freeze); shelf life 2 years. This applies to the finished nasal solution, not the compounded vial. The 0.1% label reproduction states 8-10 C.

Storage after mixing

Not established.34

Evidence

Semax has been used in Russia since the 1990s for stroke, optic nerve disease and cognitive disorders. Human evidence comes from small Russian clinical trials. The abstracts do not report randomization, route, frequency or event rates. There is no Western randomized trial and no FDA label. Animal data support most mechanism claims. Tier C applies to intranasal Russian-registered products only. Injectable or vial use rests on practice alone, with no human data. The only US-style practice dosing comes from one clinic web page: 100-600 mcg, with the per-dose or per-day basis not stated. This overlaps or falls below the low end of the 0.1% label range (500-5000 mcg/day). It is far below the 1% stroke regimens (6000-20000 mcg/day), which are a different product and indication.

Mechanism

Semax is a synthetic heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro, and an ACTH(4-10) analog. In rodents, hippocampal BDNF protein rose 1.4-fold, BDNF mRNA rose 3-fold, trkB was activated, and immune and vascular gene expression changed after cerebral ischemia. Human mechanistic data are limited to raised plasma BDNF after stroke and a resting-state fMRI difference in the default mode network.121013

Availability

Amounts offered

  • 10 mg

Custom strengths on request.

Blends that include Semax

References

According to PubMed

  1. 1[The efficacy of semax in the treatment of patients at different stages of ischemic stroke]Zh Nevrol Psikhiatr Im S S Korsakova 2018;118(3 Pt 2):61-68, 2018
  2. 2Effects of Semax on the Default Mode Network of the BrainBull Exp Biol Med 2018;165(5):653-656, 2018
  3. 3Semax (Семакс) nasal drops 0.1% - Russian drug-reference reproduction of manufacturer instruction (approved 2003, updated 21.11.2018 per page)RLS Encyclopedia (rlsnet.ru), 2018
  4. 4Семакс капли назальные 1% - instruction textmedi.ru (drug-instruction aggregator)
  5. 5[Effectiveness of semax in acute period of hemispheric ischemic stroke (a clinical and electrophysiological study)]Zh Nevrol Psikhiatr Im S S Korsakova 1997;97(6):26-34, 1997
  6. 6[A nootropic adrenocorticotropin analog 4-10-semax (15 years experience in its design and study)]Zh Vyssh Nerv Deiat Im I P Pavlova 1997;47(2):420-30, 1997
  7. 7[The results of the application of the pre-formed physical factors and neuroprotective therapy for the rehabilitative treatment of the patients with diabetic retinopathy]Vopr Kurortol Fizioter Lech Fiz Kult 2013;(5):29-32, 2013
  8. 8Semax Dosing Guide (Klearmind clinic blog, March 26, 2026; no named author or credentials)klearmindclinics.com, 2026
  9. 9FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (page content current as of 04/22/2026; Semax listed in the nominated-but-withdrawn table)U.S. FDA, 2026
  10. 10Therapeutic peptides in gerontology: mechanisms and applications for healthy agingFront Aging 2026 (PMC13095733), 2026
  11. 11Compounding at the crossroads: FDA AdComm recommends adding six peptides to the 503A Bulk Drug Substances List (31 July 2026)DLA Piper (law-firm summary), 2026
  12. 12[Semax in prevention of disease progress and development of exacerbations in patients with cerebrovascular insufficiency]Zh Nevrol Psikhiatr Im S S Korsakova 2005;105(2):35-40, 2005
  13. 13The peptide semax affects the expression of genes related to the immune and vascular systems in rat brain focal ischemia: genome-wide transcriptional analysisBMC Genomics 2014;15:228, 2014
  14. 14[Evaluation of therapeutic effect of new Russian drug semax in optic nerve disease]Vestn Oftalmol 2000;116(1):15-8, 2000
  15. 15Stability of Semax acetyl to proteolysis in various biological mediaDokl Biol Sci 2013;449:110-2, 2013
  16. 16Семакс (Semax) nasal drops 0.1% and 1% - Russian drug-reference reproduction of manufacturer instruction (approved 2008 per page)RLS Encyclopedia (rlsnet.ru), 2008
  17. 17Bulk-list bound? PCAC backs majority of peptides in two-day public meeting (client alert dated July 27, 2026)McDermott Will & Schulte (law-firm summary of FDA PCAC meeting July 23-24, 2026), 2026

Last reviewed 2026-10-14. 43 figures checked against their sources. How this works