Selank attracts attention as a calming or cognition-adjacent peptide, especially in anxiety and nootropic communities.
The main clinical signal comes from a small active-comparator study, while FDA says important human safety information is lacking for the compounded-drug context.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
4 names in this peptide family.
Selank acetate, Selank, and TP-7 resolve to one family for discovery, while exact salt, sequence, formulation, and route remain attached to each source.
4 evidence questions.
Human benefitLimited human evidenceDoes Selank acetate have established human clinical benefit for generalized anxiety disorder and neurasthenia (study context)?
FDA approvalNo FDA approval identifiedIs Selank acetate FDA approved?
503A statusRegulatory recordIs Selank acetate on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled Selank acetate automatically interchangeable?
See every Selank acetate evidence question →Open the machine-readable record ↗FDA's current safety page lists the withdrawn Selank acetate nomination
FDA says compounded Selank acetate may pose immunogenicity and product-quality risks and that important human safety information is lacking.
The public FDA record contains an unresolved safety concern.
This is not a committee vote, final 503A rule, or FDA approval decision.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
FDA's current safety page lists the withdrawn Selank acetate nomination
FDA says compounded Selank acetate may pose immunogenicity and product-quality risks and that important human safety information is lacking.
Read the source ↗FDA cited one compounder's Selank products
FDA said the firm's Selank products did not qualify for the claimed 503A exemptions under the circumstances described in the letter.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
A Russian-language study compared Selank in 30 patients with medazepam in 32 patients and reported similar anxiolytic effects. The small sample, active comparator, and limited methodological visibility leave benefit uncertain.
Read the study on PubMed ↗Mechanistic and animal findings do not resolve the lack of adequate human effectiveness and safety information for compounded Selank acetate.
Read the FDA review ↗Important unknowns.
- FDA identifies possible immunogenicity, aggregation, impurity, and active-ingredient characterization concerns.
- FDA says it lacks important human safety information for the proposed compounded-drug context.
- The small published clinical study used an active comparator rather than placebo and does not establish broad effectiveness or long-term safety.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
2 dated changes. 0 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.