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Inclusion of a compound does not constitute endorsement. Information sourced from published research and regulatory filings.

Semax

Cat 2 → Pending Cat 1

Neuropeptide · Research peptide (approved in Russia as Semax)

Synthetic analog of ACTH (4-10) fragment researched for neuroprotective and cognitive-enhancing effects. Approved in Russia; not FDA-approved in the US.

About

Mechanism
Synthetic analog of ACTH (4-10) fragment. Enhances BDNF expression, modulates dopaminergic and serotonergic systems, provides neuroprotective effects. Does not affect adrenal cortex function despite ACTH origin.
Half-Life
Approximately 3-5 minutes (intranasal bioavailability extends effective duration)
Route
subcutaneous
Frequency
Once daily (intranasal or SC)

Clinical Dosing

200-600 mcgonce daily (intranasal or sc)

Not FDA-approved. Approved in Russia for cognitive enhancement and stroke recovery. Currently FDA Category 2 (restricted) in US. Pending return to Category 1.

Dosing based on small human studies or early-phase trials. Not established by Phase 3 evidence.

Regulatory Status

FDA Category
Research peptide in US (approved in Russia)
Reclassification
pending
Date Restricted
2023-09-29
Announced Return
2026-02-27

Status based on publicly available FDA communications. Verify at FDA.gov for authoritative guidance.

View full regulatory timeline →

Titration Protocols

Research Protocol

Source: Ashmarin et al., Doklady Biological Sciences, 2005

DoseDurationDraw (3 mg vial in 2mL)Notes
300 mcgMaintenance0.20 mL (20 units)Standard research dose

Available Vial Sizes

3 mg

3 mg vial

5 mg

5 mg vial

Citations

  1. [1]ACTH/MSH-like Peptide Semax: Mechanisms of Action and Clinical Applications. Doklady Biological Sciences, 402(1), 195-197. Link(Reviewed: 2026-02-27)