Reviewed evidence dossier / SLK-01
Selank evidence:
active comparator, no shortcuts.
One older, Russian-language human study compared Selank with an active medicine in 62 participants; it did not include a placebo. A separate plasma enzyme assay addresses a possible mechanism outside an intact organism. This dossier keeps those records distinct from broad mental-health, cognition, safety, and catalog claims.
Protocol-bound observations in one older comparison.
The cited human report establishes that 62 participants were randomized between Selank and medazepam and assessed with psychometric scales and serum-enkephalin measurements. The assay paper establishes an observation about enkephalin degradation in plasma outside an intact organism.
Placebo-confirmed effects, broad cognition, or settled safety.
The record does not establish a placebo-separated effect, outcomes in healthy people, broad mental-health or cognitive conclusions, long-term safety, in vivo mechanism, equivalence between Selank and Selank acetate, or catalog-vial identity.
What kind of answer can this dossier provide?
Selank has a human publication, but not a broad or modern clinical evidence base. The cited randomized study is an older Russian-language report with 62 participants, an active comparator, and no placebo group. The second research record is an enzyme assay using plasma. These sources can support precise statements about their own designs and measurements—not general conclusions about effectiveness, cognition, mechanism in people, or long-term safety.
A sequence record cannot verify a separate material.
PubChem CID 11765600 describes Selank as H-Thr-Lys-Pro-Arg-Pro-Gly-Pro-OH, sequence TKPRPGP. FDA’s public safety-risk page refers specifically to Selank acetate (TP-7). Those names and forms should not be treated as analytically equivalent without evidence establishing the exact sequence, salt form, formulation, and material identity.
PubChem can anchor a reference identity. It cannot establish the identity, purity, strength, stability, sterility, biological equivalence, safety, or intended use of a supplier’s vial. The Selank identity record also cannot, by itself, stand in for a Selank acetate safety record.
Finding, model, limitation, source.
ACTIVE COMPARATOR
Older 62-person randomized comparison
A 2008 Russian-language report randomized 62 participants with generalized anxiety disorder or neurasthenia to Selank (30 participants) or medazepam (32 participants). The record includes Hamilton, Zung, and Clinical Global Impression assessments and serum-enkephalin measurements. The indexed abstract reports changes in the assessed measures.
Limit: Medazepam was an active comparator; there was no placebo arm. The study is small, older, and represented by one region- and language-specific report. It does not resolve placebo-separated effects, uncommon harms, long-term safety, or generalizability.
ENZYME ASSAY
Plasma enkephalin-degradation observation
A 2001 paper examined enkephalin degradation and enkephalin-degrading enzyme activity in plasma and reported dose-dependent inhibition in the assay.
Limit: This experiment occurred outside an intact organism. It does not establish exposure at a human tissue, an effect in the human brain, the mechanism behind a clinical observation, or a clinical outcome.
PUBLIC RECORD
Reference sequence TKPRPGP
PubChem records Selank under CID 11765600 and identifies the heptapeptide sequence as TKPRPGP.
Limit: A public compound entry identifies a reference record. It does not test or verify a commercial material and does not establish equivalence to Selank acetate.
SAFETY GAP
Human safety and quality questions remain open
FDA’s public safety-risk page says compounded Selank acetate (TP-7) may pose immunogenicity risk because of potential aggregation and peptide-related impurities and that the agency lacks important human safety information.
Limit: This is an identified risk and information gap for the substance and context FDA names. It is neither proof that every Selank-related material causes harm nor evidence that a separate material is safe.
Questions the cited record does not answer.
The human study compared Selank with medazepam. Independent, adequately powered, placebo-controlled replication is not represented in this source ledger.
The cited record does not establish effects in healthy people, broad cognitive outcomes, or generalizability across different populations and care settings.
A small, older study and a plasma assay cannot resolve uncommon harms, immunogenicity, impurities, interactions, or long-term safety.
Inhibition in a plasma enzyme assay does not establish distribution, target engagement, brain activity, causal mechanism, or a clinical endpoint in people.
Selank, Selank acetate, formulation, and supplier material cannot be treated as interchangeable without analytical evidence.
No cited source verifies the identity, purity, stability, safety, efficacy, approval, or intended use of PSC or another supplier’s material.
What the cited record can—and cannot—answer.
What is Selank?
PubChem describes Selank as the heptapeptide TKPRPGP. That reference identity does not verify a separate vial, and the Selank record cannot be assumed equivalent to Selank acetate without analytical evidence.
What human evidence is represented in this dossier?
One older Russian-language randomized study enrolled 62 participants and compared Selank in 30 participants with medazepam in 32. The record is small, has no placebo arm, and does not resolve broad effectiveness, generalizability, uncommon harms, or long-term safety.
Did the 62-person study include a placebo group?
No. It used medazepam as an active comparator. Without a placebo or untreated control, the study cannot separate treatment-associated change from expectation, natural history, regression to the mean, or other shared influences.
What did the human study measure?
The indexed record identifies Hamilton, Zung, and Clinical Global Impression assessments and serum-enkephalin measurements. Those measures belong to the study’s defined population and protocol; they do not establish broad cognition or effects in healthy people.
Does the enzyme assay establish Selank’s mechanism in people?
No. The cited record examined enkephalin degradation and enzyme activity in a plasma assay. An ex vivo assay does not establish what occurs in an intact human organism, in the brain, or at a clinical endpoint.
What does FDA’s safety-risk page say about Selank acetate?
FDA says compounded Selank acetate may pose immunogenicity risk because of potential aggregation and peptide-related impurities and that important human safety information is lacking. This identifies unresolved risk and information gaps; it does not prove that every material is harmful or safe.
Does this dossier evaluate any PSC catalog vial?
No. Published, database, or regulatory records for a named material do not establish the identity, equivalence, purity, safety, efficacy, approval, or intended use of a separate catalog material.
Open the source and preserve its boundary.
- Seredenin et al. · Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova · 2008Older Russian-language randomized active-comparator report: 62 participants, with 30 assigned to Selank and 32 to medazepam; no placebo group.PubMed 18454096 ↗
- Kost et al. · Bulletin of Experimental Biology and Medicine · 2001Plasma enkephalin-degradation and enzyme-activity assay; an ex vivo mechanistic record, not a clinical outcome study.PubMed 11550013 ↗
- PubChem · Compound CID 11765600Public identity record for Selank, sequence TKPRPGP. A database identity does not verify a supplier’s material or establish equivalence to Selank acetate.PubChem record ↗
- FDA compounded-substance safety-risk pageLive agency record describing aggregation, peptide-related impurity, immunogenicity, and missing human-safety information for compounded Selank acetate (TP-7).FDA safety-risk record ↗
Versioned, not silently rewritten.
Version 1.0 published. Added claim-linked human, ex vivo, identity, FDA, and FAQ records; made the active-comparator design, absence of placebo, source age, language, material-form, catalog-equivalence, and safety gaps explicit.
A substantive correction records the date, changed statement, reason, and supporting source. Send a precise citation or correction request through the PSC policies and contact page.