Selank
Also sold as: Selank acetate, TP-7, Thr-Lys-Pro-Arg-Pro-Gly-Pro
Selank is not on FDA's 503A bulks list and cannot lawfully be compounded from bulk: FDA lists 'Selank acetate (TP-7)' among bulk drug substances previously in Category 2 whose nominations were withdrawn by the nominators, which moved its status sideways rather than toward legality. Selank has genuinely been administered to humans — three small Russian trials, none placebo-controlled and none replicated outside Russia — but FDA states it lacks important information regarding any safety issues raised by selank acetate administered to humans.
Which molecule this is. A synthetic heptapeptide: the tuftsin fragment Thr-Lys-Pro-Arg extended with the stabilising tripeptide Pro-Gly-Pro. FDA's withdrawn-nomination entry names the salt specifically — 'Selank acetate (TP-7)' — not the free base. Distinct from semax, which is an unrelated ACTH(4-7) analogue; the two are frequently sold as a combined product and are frequently conflated, including in their regulatory posture.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”Checked against the source on .
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
Absent from Categories 1, 2 and 3 of the bulks list updated 2026-05-14 — verified by fetching and text-extracting the document directly. Category 2 now contains exactly six substances, one of which is a peptide (kisspeptin-10). Absence alone does not distinguish 'withdrawn' from 'never nominated', so this status is taken from FDA's own nominated-but-withdrawn table, which lists 'Selank acetate (TP-7)' explicitly. It left Category 2 because the nominators withdrew the nominations — not because it moved toward legality. It did not enter Category 1, it is not on the 503A bulks list, and it remains non-compoundable. Note also that withdrawal is not the criminal line: the Watkins indictment (D. Utah, 1:26-cr-00015, 2026-04-01) charges misbranding under 352(b), which is why Category 1 substances sit in the same indictment as withdrawn ones.
“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
Administration check RUN AND PASSED, which is why this tier is not 'animal-or-in-vitro-only'. Each indexed human trial was opened and confirmed to ADMINISTER selank to patients rather than measure an endogenous peptide as a biomarker — the failure mode that reduces MOTS-c's apparent four human RCTs and TB-500's one to a real count of zero. Selank's human data is real. Three trials are indexed in PubMed, all Russian-language, all in Zh Nevrol Psikhiatr Im S S Korsakova: Zozulia et al. 2008 (PMID 18454096, n=62, selank 30 vs medazepam 32, generalized anxiety disorder and neurasthenia); Medvedev et al. 2014 (PMID 25176261, n=60, selank vs phenazepam); and Medvedev et al. 2015 (PMID 26356395, n=70, phenazepam 30 vs selank plus phenazepam 40). PubMed tags the 2008 and 2015 papers 'Randomized Controlled Trial'; the 2014 paper is tagged 'Clinical Trial'/'Comparative Study' only. Why 'promising' and not 'proven': not one of the three is placebo-controlled — 2008 and 2014 use an active benzodiazepine comparator, 2015 tests selank as an add-on. All are small (n=60-70), all trace to a single Russian research lineage, none is independently replicated outside Russia, none has been reviewed by FDA, and full texts were not read (Russian-language, not open access) so randomisation and blinding methods are unconfirmed beyond the PubMed publication-type tag. That is a real human signal, not established efficacy. Separately: ClinicalTrials.gov registers NO selank study at all — a term search returns only fuzzy-match noise on unrelated trials. Any vendor citing a 'registered selank trial' is citing something that does not exist.
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA lists 'Selank acetate (TP-7)' among bulk drug substances previously in Category 2 whose nominations were withdrawn by the nominators, and identifies immunogenicity risk and an information gap rather than a clean safety record.
Read this against the evidence tier rather than through it. Three Russian trials administered selank to roughly 190 patients in total, yet FDA still records that it 'lacks important information regarding any safety issues raised by selank acetate administered to humans.' Those are not contradictory: FDA's finding is about what was SUBMITTED AND REVIEWABLE for a compounding nomination, not about what exists in the world literature. Note too that FDA's concern is immunogenicity from aggregation and peptide-related impurities — a property of the COMPOUNDED PRODUCT and its manufacture, which no clinical trial of a well-characterised Russian formulation can speak to.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 22 April 2026“Compounded drugs containing selank acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA lacks important information regarding any safety issues raised by selank acetate administered to humans.”
Checked against the source on .Selank is NOT a subject of the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting. The seven substances before PCAC are BPC-157, emideltide (DSIP), epitalon, KPV, MOTS-c, semax and TB-500.
The single most likely error on this compound, and it comes from the neighbour. Semax IS before PCAC; selank is not, and FDA's semax briefing document explicitly rules selank out of scope when a selank paper appears in the semax nomination package. The two are nonetheless sold as one product — the same briefing document records vendors offering a '50:50' semax-and-selank combination nasal spray. Expect July 2026 PCAC coverage of semax to be reported as applying to selank. It does not. No PCAC briefing document for selank exists, and FDA has therefore published no staff proposal on it.
Semax-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nominations included an article describing the analgesic effects of a different peptide, selank (Meshavkin et al. 2006), which is out of the scope of this evaluation and is, therefore, not further discussed.”
Checked against the source on .FDA's safety-risk entry for selank acetate does NOT contain the 'has not identified any human exposure data' sentence that FDA applies to dihexa acetate, KPV, MOTs-C, PEG-MGF and Thymosin beta-4 fragment on the same page. Selank's entry instead refers to safety issues 'raised by selank acetate administered to humans'.
A finding about what the document does NOT say, which is why it is worth recording. The quoted sentence is FDA's KPV entry, reproduced here as the comparator — that two-part formula ('no human exposure data' + 'whether it would cause harm if administered to humans') is boilerplate FDA repeats across five other entries on this page: verbatim for dihexa acetate, KPV, MOTs-C and PEG-MGF, and near-verbatim for Thymosin beta-4 fragment, whose version drops 'on' and 'administered via any route of administration' and reads 'raised by this drug' rather than naming the substance. Selank's entry omits BOTH halves. It does not say no human exposure data exists, and it does not ask whether the substance would cause harm if administered to humans; it refers instead to issues 'raised by selank acetate administered to humans', a construction that presupposes administration has occurred. Both entries were read from the same fetch of the same page on 2026-07-16. Do not over-read this. It is a textual difference, not an FDA endorsement, and FDA has published no evaluation of the Russian trials — no PCAC briefing document for selank exists. FDA still records an immunogenicity risk and an information gap. The narrow, checkable point: the strongest negative sentence FDA has written about the peptides in this market is one it declined to write about selank.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 22 April 2026“FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration. FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans.”
Checked against the source on .Selank appears in none of the three categories of FDA's 503A bulks list updated May 14, 2026. Category 2 of that list contains six substances — cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration — and selank is not among them.
Recorded separately from legalStatus because absence and withdrawal are different facts with different sources, and collapsing them is how this gets reported wrong. This list establishes only that selank is in no category. On its own that is equally consistent with 'never nominated' and with 'approved drug that was never on the nomination track' — the reason bremelanotide is also absent. The withdrawal itself comes from FDA's nominated-but-withdrawn table, cited in legalStatus. What this list does establish, and it is the operative fact for anyone buying selank: it is not on the 503A bulks list, so a 503A pharmacy has no lawful basis to compound from it. The quoted sentence is the list's own pointer to the withdrawn table, which is what ties the two documents together.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026“Visit Safety Risks Associated with Certain Bulk Drug Substances for Use in Compounding for a summary of the identified safety risks for bulk drug substances in category 2, as well as other bulk drug substances that were previously in category 2 but were withdrawn.”
Checked against the source on .
Documented safety signals
FDA identifies potential immunogenicity risk from aggregation and peptide-related impurities, and states it lacks important information about any safety issues raised by selank acetate administered to humans.
This is an information gap, not a clean bill of health, and it is not a documented adverse event either. Unlike BPC-157 (three FAERS reports) no FAERS signal for selank was identified in the sources read for this record — which reflects what we checked, not a demonstrated absence of harm. The Russian trials reported tolerability outcomes on the UKU scale, but their full texts were not read, so no adverse-event profile is recorded here. A blank is honest.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 22 April 2026Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Did Selank become legal again when FDA removed it from Category 2?
No. Selank left FDA's Category 2 because the nominators withdrew the nominations, not because FDA cleared it — FDA's own table of substances 'previously in category 2' states they 'were withdrawn by the nominators,' and lists 'Selank acetate (TP-7)' among them. Withdrawal moved selank off the evaluation track entirely rather than toward approval: it did not enter Category 1, it is not on the 503A bulks list, and it remains non-compoundable. FDA continues to record an immunogenicity risk for compounded selank acetate on that same page.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 22 April 2026“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”
Checked against the source on .- Can I get Selank from a compounding pharmacy?
Not lawfully. Selank appears in none of the three categories of FDA's 503A bulks list updated May 14, 2026, and a 503A compounding pharmacy has no lawful basis to compound from a bulk drug substance that is not on that list. Category 2 of the list contains six substances — cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration — and selank is not among them. Selank is nonetheless marketed in the United States, including as a combined product with semax, which FDA documented in its semax briefing document.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .- Is there any human evidence that Selank works?
Yes, but it is small, Russian, and not placebo-controlled. Three trials indexed in PubMed administered selank to patients — in a 2008 trial published in Zh Nevrol Psikhiatr Im S S Korsakova, researchers studied 62 patients with generalized anxiety disorder and neurasthenia, comparing selank in 30 patients against the benzodiazepine medazepam in 32, and reported that 'the anxiolytic effects of both drugs were similar.' None of the three trials uses a placebo control, all are small, all trace to a single Russian research lineage, none has been independently replicated outside Russia, and FDA has published no evaluation of any of them. ClinicalTrials.gov registers no selank study at all.
[Efficacy and possible mechanisms of action of a new peptide anxiolytic selank in the therapy of generalized anxiety disorders and neurasthenia] — PubMed, 1 January 2008“Sixty-two patients with generalized anxiety disorder (GAD) and neurasthenia were studied. The effect of selank (30 patients) was compared to that of medazepam (32 patients). ... The anxiolytic effects of both drugs were similar but selank had also antiasthenic and psychostimulant effects.”
Checked against the source on .- Is Selank part of the July 2026 FDA advisory committee meeting?
No. Selank is not a subject of the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting; the seven substances before that committee are BPC-157, emideltide (DSIP), epitalon, KPV, MOTS-c, semax and TB-500. Semax is on that list and selank is not, despite the two being sold together as a combination product — and FDA's semax briefing document says so explicitly, ruling a selank paper 'out of the scope of this evaluation' when it appeared in the semax nomination package. No PCAC briefing document for selank exists and FDA has published no staff proposal on it.
Semax-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nominations included an article describing the analgesic effects of a different peptide, selank (Meshavkin et al. 2006), which is out of the scope of this evaluation and is, therefore, not further discussed.”
Checked against the source on .- Is Selank safe?
FDA says it does not know. FDA's safety-risk page states that compounded drugs containing selank acetate 'may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities,' and that FDA 'lacks important information regarding any safety issues raised by selank acetate administered to humans.' That is an information gap rather than either a clean record or a documented harm. Note what FDA's concern attaches to: aggregation and peptide-related impurities are properties of how a compounded product is made, which no clinical trial of a different, well-characterised formulation can answer.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 22 April 2026“Compounded drugs containing selank acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA lacks important information regarding any safety issues raised by selank acetate administered to humans.”
Checked against the source on .