SoluneFit

Peptide library

Semax

Not FDA-approved Evidence grade C — small or uncontrolled human studies / case series Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: Семакс, Semaks, ACTH(4-10) analogue, Met-Glu-His-Phe-Pro-Gly-Pro, Semax acetate.

Regulatory status

Not FDA-approved. FDA staff proposed NOT adding Semax to the 503A bulk-substances list (no human PK, immunogenicity and characterisation concerns) [3]; Semax was on the Pharmacy Compounding Advisory Committee agenda on 24 July 2026 [2] and the committee voted to recommend inclusion (8-5 per press report; FDA minutes not yet posted, tally UNVERIFIED) [4] — non-binding, rulemaking pending. FDA lists Semax among bulk substances that may present significant safety risks [5] and named it in a 2020 warning letter to a compounder [7]. Registered in Russia (Peptogen) as 0.1 % and 1 % nasal drops [1].

What it is

Synthetic heptapeptide analogue of ACTH(4-10) without hormonal (corticotropic) activity.

A short synthetic peptide derived from a fragment of ACTH, registered in Russia as nasal drops (0.1 % and 1 %) for cognitive problems after cerebrovascular disease or brain injury and, at 1 %, for acute ischaemic stroke. It is not approved in the US.

What the published research shows

Human data are small, mostly Russian-language and non-randomised (e.g. 30 stroke patients vs 80 matched controls); FDA's 2026 review found no usable RCT and no human pharmacokinetic study.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

  • Cognitive disorders after cerebrovascular disease, TBI or surgery (Russian 0.1 % leaflet): 0.1 % drops (about 50 mcg per drop), 2-3 drops per nostril per dose; leaflet daily range 500-5000 mcg; course 3-5 days, up to 14 days. Optic-nerve atrophy: 2-3 drops per nostril 2-3 times daily (600-900 mcg/day) for 7-10 days. Children 5 and over: 1-2 drops per nostril twice daily (200-400 mcg/day) for 30 days.
  • Acute ischaemic stroke (Russian 1 % leaflet): 1 % drops (about 500 mcg per drop). Moderate stroke: 2-3 drops per nostril 3-4 times daily (6-12 mg/day); severe stroke: 3-4 drops per nostril 4-5 times daily (12-20 mg/day); 10-day course.
  • Acute hemispheric ischaemic stroke (Gusev et al. 1997, non-randomised): 30 patients given intranasal Semax added to standard therapy, compared with 80 patients with comparable strokes on standard therapy; daily doses of 12 mg (moderate) and 18 mg (severe) over 5- or 10-day courses were reported most effective. From the indexed abstract; randomisation and blinding not stated.

Mechanism, as reported

Described by the Russian leaflet as a nootropic and neuroprotective agent acting on brain metabolism and neurotrophic signalling; the molecular mechanism is not established in human studies.

Practical record

  • Studied routes: intranasal.
  • Typical supply: Russian Rx product: 3 mL dropper bottles of 0.1 % (1 mg/mL) or 1 % (10 mg/mL) solution with methylparaben; also sold unregulated online.
  • Reconstitution: Supplied as a ready solution; not reconstituted.
  • Storage: Leaflet: protect from light, at or below 10 °C, do not freeze; shelf life 2 years.

Safety signals on record

  • Reported adverse events: Leaflet: mild nasal-mucosa irritation with prolonged use. FDA's review found one FAERS report of eye pain and burning (hospitalisation) after online-bought 0.1 % drops, and noted adverse events were mostly not reported in the published studies.
  • Contraindications: Leaflet: hypersensitivity, pregnancy, breastfeeding, acute psychosis, anxiety disorders, history of seizures; 0.1 % form also under 5 years.
  • Interactions: Leaflet: none expected; avoid combining with intranasal vasoconstrictor drops. FDA noted an anti-thrombotic effect in rats (possible bleeding risk) and potentiation of amphetamine-induced dopamine release in mice.
  • Notes: No human half-life is published (leaflet gives intranasal bioavailability of 60-70 % and effect lasting 20-24 h, but no t1/2). FDA found no repeat-dose, reproductive or genotoxicity studies. Products bought online are unregulated.

Sources

  1. Семакс (Semax) 0.1 % / 1 % nasal drops — instruction for use (rlsnet.ru) (2026)
  2. FDA — July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (2026)
  3. FDA briefing document: Semax free base / Semax acetate — Pharmacy Compounding Advisory Committee, July 2026 (2026)
  4. RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list (vote tallies; FDA minutes not yet posted) (2026)
  5. FDA — Certain bulk drug substances for use in compounding that may present significant safety risks (2026)
  6. Gusev EI et al. Effectiveness of Semax in acute hemispheric ischemic stroke. 1997 (PMID 11517472) (1997)
  7. FDA Warning Letter — Tailor Made Compounding LLC (594743), 1 Apr 2020 (2020)

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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