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Peptide.Guide

FDA Category 2 · restricted from compounding

This compound is on the FDA’s interim Section 503A Category 2 bulks list and cannot be legally compounded by US pharmacies. An HHS announcement in February 2026 signaled intent to restore several peptides to Category 1, but no Federal Register action has been published. Check the FDA PCAC schedule for updates.

Read the full regulatory context
PreclinicalCognitiveIntranasalDaily or 2x per week

Semax

Synthetic ACTH(4-10) analog developed in Russia for stroke rehabilitation and cognitive enhancement.

§ 01   Overview

Overview

Synthetic ACTH(4-10) analog developed in Russia for stroke rehabilitation and cognitive enhancement.

Approved in Russia since the 1990s. Limited Western trial data. Strong preclinical and Russian clinical body.

§ 02   Mechanism

Mechanism of action

Semax upregulates BDNF and NGF expression, enhances dopaminergic and serotonergic signaling, and modulates enkephalin degradation. It crosses the blood-brain barrier and has well-documented nootropic effects in Russian clinical use.

  • 01Improved focus and mental clarity
  • 02Reduced mental fatigue under stress
  • 03Neuroprotective effects after ischemia (preclinical)
  • 04Adjunct in stroke rehabilitation (Russia)

§ 03   Dosing

Dosing protocol

Standard Protocol

Vial
5 mg
BAC Water
1 ml BAC water (intranasal) or per protocol
Dose Range
250 – 1000 mcg per dose
Starting Dose
300 mcg intranasal
Route
Intranasal
Timing
AM
Frequency
Daily or 2x per week
Cycle
4–8 weeks

§ 04   Evidence

Evidence & research

Preclinical

Approved in Russia since the 1990s. Limited Western trial data. Strong preclinical and Russian clinical body.

FDA Status

Not FDA-approved.

§ 05   Stacks

Common stacks

§ 06   News

In the news

8 articles from the last 12 months · updates hourly

§ 07   Sourcing

Sourcing & supply

Regulatory status

Restricted from compounding

Placed on the FDA's 503A Category 2 list and cannot be lawfully compounded in the US. No brand pharmacy alternative exists. US buyers encounter only research-use-only (RUO) channels, which the FDA's Intended Use Doctrine treats as unapproved drug sales.

International · 3

International

Cosmic Nootropic

The most credible Russian / Khavinson source for US buyers. Sources authentic bioregulators through 'Peptides Company' (ex-NPCRIZ).

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International

Rupharma

12+ year Russian pharmacy reseller. Reviews.io 4.84/5 (81+). Has a genuine US warehouse for common peptides.

Visit
International

Trident Peptides

1,299+ Trustpilot reviews (5-star). Strongest review base in UK research peptides. No visible ISO/GMP; COAs not posted.

1 flag on record
Visit

Research-use-only · 5

Research-use-only

Swiss Chems

Established SARMs/peptide vendor. FDA warning letter Dec 2024 for GLP-1s. Weaker peptide QC than SARMs QC.

Third-Party Testing1 flag on record
Visit
Research-use-only

Limitless Life Nootropics

'Only BBB-accredited peptide company' (since 2020). Claims three-lab third-party testing. Broad catalog.

BBB Accredited +1
Visit
Research-use-only

Core Peptides

Broad catalog, widest payment range. Mid-credibility: Knoji 2.5/5 and one scam-impersonation report.

Third-Party Testing1 flag on record
Visit
Research-use-only

Modern Aminos

Multi-vial batch third-party testing. 5-star Trustpilot (1,400+ reviews). US- and EU-facing.

Third-Party Testing
Visit
Research-use-only

Peptide Warehouse

US-made, independent third-party testing including endotoxin and heavy-metal panels. Distinct from similar-sounding copycat domains.

Third-Party Testing1 flag on record
Visit

Listings are informational, not endorsement. Verify credentials and flags against FDA and PCAB databases before purchasing. Full directory & how to verify →

§ 09   Safety

Safety & side effects

Side effects

  • 01Mild headache
  • 02Irritation at intranasal application

Contraindications

None specified.

This site is for educational and research purposes only. It does not constitute medical advice. Always consult a qualified healthcare provider before using any peptide or supplement.