--- title: "Semax: What It Is, Evidence and Legal Status (2026)" description: "Semax: synthetic peptide approved as a medicine in Russia, not the US. Not yet graded. US status as of Oct 17, 2026: not approved. No dosing, no sellers." canonical: https://plainlygraded.com/peptides/semax/ last_updated: 2026-10-17 breadcrumb: "Home > Compounds > Semax" publisher: Plainly Graded policy: "No dosing, no sourcing, no vendor links. Every claim cites a public source." --- > We collect and compare information from public, cited sources. We cannot guarantee that it is complete, current or correct. This is not medical advice. Only a doctor can prescribe, and a doctor should confirm anything you read here before you act on it. # Semax - [FDA: not approved](https://plainlygraded.com/regulatory/#semax) - [503A compounding: under review](https://plainlygraded.com/regulatory/#semax) - [WADA: not named, ask USADA](https://plainlygraded.com/regulatory/#semax) STATUS AS OF 17 OCT 2026 FDA: not FDA-approved for any use · 503A: not on the 503A bulks list. FDA advisers recommended it on July 24, 2026; the vote is non-binding and no rule has been proposed · WADA: not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use · [tracker entry](https://plainlygraded.com/regulatory/#semax) **The short answer:** Semax is an unapproved peptide marketed online for focus, memory. As of October 17, 2026 it is not FDA-approved and not on the 503A bulks list, although FDA advisers voted on July 24, 2026 to recommend adding it. This page is a status-only draft until its evidence table is written. Written by [Maren Holt](https://plainlygraded.com/about/team/) 6 PUBLIC SOURCES · UPDATED 17 OCT 2026 · NO TIES TO SELLERS [How we source](https://plainlygraded.com/how-we-source/) ## What is Semax? Synthetic peptide approved as a medicine in Russia, not the US. Full section still to be written. ## What is Semax claimed to do, and what does the evidence show? **Overall grade** Not yet graded **Strongest evidence** To be graded The per-claim evidence table for Semax is still being written. ## What are the known risks and side effects of Semax? An unapproved product has no required quality testing. In July 2026 FDA staff told the agency's advisers they had concerns about impurities, bacterial toxins and unreliable certificates for several of these peptides, and that nobody knows how often they trigger an immune response. Who should be especially careful - **People who are pregnant, trying to get pregnant or breastfeeding.** There is no human data in pregnancy. - **Anyone under 18.** It has not been studied in young people. - **Tested athletes and service members.** Check with USADA or your service's rules first. A positive test counts whatever the label said. - **People taking prescription medicines.** Interactions have not been studied. Bring the product label to your clinician. Get medical help now if you have - Swelling of the face, lips or throat, trouble breathing, chest pain, a racing heart or fainting. **Call 911.** - Redness spreading from an injection site, warmth, pus or a fever. Get same-day care. - Unsure what you took or whether a reaction is serious: **Poison Control 1-800-222-1222** (free, 24 hours). - Thoughts of harming yourself: call or text **988**. ## Is Semax legal? Not FDA-approved for any use.[1,4] Not on the 503A bulks list. FDA advisers recommended it on July 24, 2026; the vote is non-binding and no rule has been proposed.[2,5,6] - **24 JUL 2026:** FDA's compounding advisory committee voted in favor of adding Semax to the 503A bulks list. Advisory only; no rule has been proposed.[2,5,6] - **15 APR 2026:** Removed from FDA's Category 2 because its nomination was withdrawn. It was not added to Category 1, so it is still not eligible for compounding.[1,4] Every status change for Semax is logged with its date and source in the [regulatory tracker entry for Semax](https://plainlygraded.com/regulatory/#semax). ## Is Semax banned in sport? Not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use.[3] Anti-doping rules work on strict liability: a positive test counts whatever the label said. ## What don't we know about Semax? Still unknown Still being written. Why this page has no dosing We don't publish doses, schedules or mixing instructions for Semax or any unapproved peptide. No human dose has been established for most of these uses, so we list what to ask a licensed prescriber instead. [Here's why, and who can legally answer](https://plainlygraded.com/why-we-dont-give-dosing/) ## What should you tell your doctor if you're using Semax? Tell them exactly what you took, for how long, and where it came from, and bring the label. These questions can help the conversation: - Is there an approved treatment for my goal that has been tested in people? - What should I watch for, and which symptoms mean I should stop and call you? - Could it interact with the medicines I already take? **Sources** 1. US Food and Drug Administration. 503A bulk drug substances: interim categories, updated April 15, 2026, 2026-04-15. 2. US Food and Drug Administration. Pharmacy Compounding Advisory Committee, meeting of July 23-24, 2026: briefing documents and vote record, 2026-07-23. 3. World Anti-Doping Agency. [2026 Prohibited List (sections S0 and S2)](https://www.wada-ama.org/en/prohibited-list), 2026-01-01. 4. Frier Levitt. [FDA peptides 'do not compound' list update 2026](https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/), 2026-04-16. (law-firm or secondary summary) 5. DLA Piper. [FDA AdComm recommends adding six peptides to bulk list](https://www.dlapiper.com/en-ae/insights/publications/2026/07/fda-adcomm-recommends-adding-six-peptides-to-bulk-list), 2026-07-31. (law-firm or secondary summary) 6. McDermott Will & Emery. [Bulk list bound? PCAC backs majority of peptides in two-day public meeting](https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/), 2026-07-27. (law-firm or secondary summary) **Changelog** 17 OCT 2026 Draft. Statuses read from the regulatory record dated 2026-10-17. Spotted an error? [Report it](https://plainlygraded.com/corrections/). We never change a page's updated date without changing its content. --- We collect and compare information from public, cited sources. We cannot guarantee that it is complete, current or correct. This is not medical advice. Only a doctor can prescribe, and a doctor should confirm anything you read here before you act on it. Canonical page: https://plainlygraded.com/peptides/semax/