Semax: where it stands with the FDA, and what it costs
Registered as a medicine in Russia, not approved in the US.
Go to clinicLowest per monthSemax nasal spray
PepScribe · from $79/mo
Go to clinicLowest at a clinic we link toSemax injection (5ml)
Pepti · $229/mo (≈ $245 per 30 days with its fees)
Where Semax stands today
No FDA-approved drug contains semax. FDA had it in 503A Category 2 from September 29, 2023 until April 22, 2026 (nominations withdrawn). On July 24, 2026 the advisory committee voted 8-5 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers semax free base for intranasal use only, single-ingredient, under ten conditions; it does not cover 503B facilities.
For pharmacies compounding one patient's prescription (section 503A)
Not on the 503A bulks list and in no FDA category (removed from Category 2 on April 22, 2026 after its nominations were withdrawn). Since Oct 30, 2026 it is one of six peptides in HHS's interim enforcement discretion policy for 503A compounding, limited to the form and routes below and ten conditions.
“Bulk drug substances nominated but withdrawn ... Semax (heptapeptide) Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities.”
““Semax (heptapeptide)” has been removed from category 2 because the nominations were withdrawn by the nominators.”
HHS interim enforcement discretion policy (Office of the Secretary, not FDA)
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A.”
Form and routes HHS covers
“Based on the identified updated information, enforcement discretion for semax free base is appropriate for intranasal use that is compounded from API accompanied by a CoA meeting the conditions of this policy.”
“Semax was in Category 2 from September 29, 2023, until April 22, 2026, and neither the placement nor the removal changed its status under section 503A; CDER recommended against listing either form, and the PCAC voted in favor of both forms.”
One of the ten conditions: single-ingredient products only (no blends)
“The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.”
The Federal Register notice calls the policy a draft; written comments closed two weeks after publication
“HHS is announcing the availability of a draft”
21 CFR 216.23(a), the 503A bulks list itself: six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester, thymol iodide); none of the compounds in this file
“The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The HHS policy names 503A compounders only; it does not cover 503B outsourcing facilities
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician”
The FDA's compounding advisory committee
24 July 2026: Should semax (free base) and semax acetate be placed on the 503A bulks list? (use FDA reviewed: cerebral ischemia, migraine and trigeminal neuralgia). Vote: 8 yes, 5 no, 1 abstention (both forms), per law-firm reports. Committee recommended inclusion, against FDA staff's proposal; no FDA rule yet; HHS cited the vote in its Oct 30, 2026 interim policy
“VOTE: Should Semax (free base) be placed on the list? ... VOTE: Should Semax acetate be placed on the list?”
Our reading
A 503A pharmacy can compound semax (free base) nasal spray for a patient-specific prescription under HHS's enforcement discretion if every condition is met; injectable semax, semax acetate, 'N-acetyl semax amidate' and blends fall outside it.
Every source above was checked again on 14 November 2026.
What 39 clinics charge
- PepScribeSemax nasal sprayfrom $79/mo
- EnhancedSemax nasal sprayfrom $109/mo
- Bon HealthSemax nasal spray (10ml)$114/mo
- System LabsSemax nasal spray (10ml)$119/mo
- YuviaSemax nasal spray (15ml)$119/mo
What Semax is
- What it is
- Synthetic peptide (ACTH 4-10 analog)
- How it works
- A synthetic analog of a fragment of adrenocorticotropic hormone, developed in Russia.
- How it is given
- Nasal spray
Semax side by side
About Semax
Is Semax FDA-approved?
No. No FDA-approved drug contains Semax. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Semax legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains semax. FDA had it in 503A Category 2 from September 29, 2023 until April 22, 2026 (nominations withdrawn). On July 24, 2026 the advisory committee voted 8-5 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers semax free base for intranasal use only, single-ingredient, under ten conditions; it does not cover 503B facilities.
How much does Semax cost?
39 clinics publish a price. The lowest that compares per month is from $79/mo at PepScribe, and the middle of 28 clinics' lowest monthly prices is about $177. What a month buys differs by clinic, so each price lists what it includes. every Semax price
What forms does Semax come in?
Clinics sell it as nasal spray (41 prices), injection (2 prices), other (1 price).