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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 weeklyPartial data

NA-Semax

N-Acetyl Semax

Acetylated Semax analog with improved stability and bioavailability.

§ 01   Overview

Overview

Acetylated Semax analog with improved stability and bioavailability.

Limited independent data beyond Semax literature.

§ 02   Mechanism

Mechanism of action

NA-Semax is N-acetylated, improving proteolytic stability while retaining the BDNF-upregulating and ACTH-derived neurotrophic profile of Semax.

  • 01Similar nootropic profile to Semax
  • 02Longer half-life

§ 03   Dosing

Dosing protocol

Standard Protocol

Dose Range
250 – 1000 mcg per dose
Route
Intranasal
Timing
AM
Frequency
Daily or 2x weekly

§ 04   Evidence

Evidence & research

Preclinical

Limited independent data beyond Semax literature.

FDA Status

Not FDA-approved.

§ 05   Stacks

Common stacks

§ 06   News

In the news

1 article 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 · 2

International

Cosmic Nootropic

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

Visit
International

Rupharma

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

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
  • 02Nasal irritation

Contraindications

None specified.

§ 10   Questions

NA-Semax FAQ

What is NA-Semax?
Acetylated Semax analog with improved stability and bioavailability. NA-Semax is N-acetylated, improving proteolytic stability while retaining the BDNF-upregulating and ACTH-derived neurotrophic profile of Semax.
What is NA-Semax used for?
Reported uses include similar nootropic profile to semax and longer half-life. Evidence strength is rated Preclinical — see the evidence section for detail.
How is NA-Semax dosed?
Commonly referenced dosing is 250 – 1000 mcg per dose, typically daily or 2x weekly, administered Intranasal. This is educational reference only; consult a licensed clinician before use.
What are the side effects of NA-Semax?
Commonly reported side effects include mild headache and nasal irritation. This list is not exhaustive.
Is NA-Semax legal?
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. FDA status: Not FDA-approved..

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.