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Semax regulatory status

Current status of Semax in the United States: Under FDA review. In sport: WADA status unclear. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Semax?

Regulatory: Under FDA reviewWADA: WADA status unclearVerified: Verified Sep 22, 2026
FDA and compounding
Semax was placed on the FDA 503A Category 2 list (substances with significant safety risks) in 2023 and removed from it on April 15, 2026. On July 23 to 24, 2026 the Pharmacy Compounding Advisory Committee recommended adding semax to the 503A bulks list. As of the last verification date FDA has not published a final rule, so compounding pharmacies and state boards vary in whether they will fill it. It is not an FDA approved drug and is not eligible for 503B outsourcing. It is a registered prescription drug in Russia.
WADA
WADA status unclear
Access path
  1. No lawful compounded access path yet: PCAC recommended it for the 503A bulks list in July 2026, but until FDA publishes a final rule a 503A pharmacy has no federal basis to compound it from bulk.
  2. Not available as an FDA approved product; registered prescription drug in Russia.
  3. Products labeled research use only are not lawful for human use and are not verified for purity.

Full Semax page: evidence, dosing in the literature, and sources

Is semax FDA approved?

No. Semax is not an FDA approved drug, although it is a registered prescription drug in Russia. FDA placed it on the 503A Category 2 list in 2023 and removed it on April 15, 2026, and the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list on July 23 to 24, 2026. That vote is advisory and is not a U.S. approval. [1] [2] [3]

What is the FDA status of semax in 2026?

Under FDA review. As of September 2026 FDA has not published a final rule adding semax to the 503A bulks list, so a 503A pharmacy has no federal basis to compound it from bulk yet. It is not eligible for 503B outsourcing. [2] [3]

Is semax legal in the US?

There is no lawful U.S. source of semax for human use today. It is not FDA approved, it is not yet on the 503A bulks list, and products labeled research use only are not lawful for human use. Its Russian registration does not carry over to the United States. [2] [3]

Is semax banned by WADA?

Unclear. Semax is not named on the WADA Prohibited List, and because it is an approved drug in Russia it does not automatically fall under section S0 for non-approved substances. Athletes should confirm with their anti-doping organization before use. [4]

How has the status of Semax changed over time?

  1. PCAC

    PCAC recommends six peptides for the 503A bulks list

    At its July 23 to 24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted to recommend that BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon be added to the 503A bulk drug substances list. A committee recommendation is advisory; FDA must still issue a rule before the substances are formally listed.

    Regulatory: Under FDA reviewSource: Pharmacy Compounding Advisory Committee
  2. FDA

    FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2

    FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.

    Regulatory: Removed from Category 2 (Apr 2026)Source: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)
  3. FDA

    FDA places a batch of nominated peptides in 503A Category 2

    In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.

    Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Semax and the source of each dated event.

  1. [1]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (503A Category 2 list and nominated but withdrawn substances, current as of April 22, 2026)FDA, 2026
  2. [2]FDA Pharmacy Compounding Advisory Committee meetings (July 2026 meeting on peptide nominations)FDA, 2026
  3. [3]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
  4. [4]WADA Prohibited ListWADA, 2026

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