Selank
A Russian-developed anxiolytic heptapeptide, not FDA-approved, in FDA Category 2, and among the peptides slated for the July 2026 PCAC review.
What it is
Selank is a synthetic heptapeptide derived from the immune peptide tuftsin, developed at a Russian research institute and studied as an anxiolytic / nootropic agent.S3
Marketed as
Selank is promoted for anxiety, stress, and focus. Outside its Russian approval these are marketing claims, not effects established to Western regulatory standards.S1S3
Regulatory status (US)
Selank is not FDA-approved.S1 It appears among the peptides in FDA's Category 2 compounding review (the "nominated but withdrawn" group) and is on the agenda for the July 2026 Pharmacy Compounding Advisory Committee.S1S2 In the US it is otherwise treated as a research peptide, not a medicine.S3
Around the world
Selank has regulatory approval in Russia as a prescription anxiolytic/nootropic, but is not approved in the US, Canada, or most of Europe, where it circulates as a research peptide.S3
Evidence
Reported mechanisms involve GABAergic, serotonergic, and related pathways, and Russian studies describe anxiolytic effects.S3 The evidence base is largely Russian with limited independent replication (see caveat), so its effects should not be presented as established to Western standards.S3
The clinical evidence base for Selank is predominantly from Russian research institutions, with limited independent international replication and long-term safety data. S3
Anti-doping
Selank is an anxiolytic peptide rather than a GH secretagogue; it is not part of the GH-secretagogue class, and its specific anti-doping status should be checked against the current WADA List rather than assumed.S1
Safety
As an unapproved research peptide in the US, Selank has limited independent long-term safety data, and use falls outside FDA finished-drug oversight; FDA's general Category 2 concerns (characterization, purity, limited safety information) apply.S1S3
What's changing
The near-term item is the July 2026 PCAC review and any subsequent FDA decision on Selank's compounding status.S1S2
Sources
Every reference below is a primary source cited in this entry, drawn from the approved corpus.
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01
FDA — Certain Bulk Drug Substances for Use in Compounding (Category 2)fda.gov · Federal regulatory listing
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02
FDA — July 23–24, 2026: Meeting of the Pharmacy Compounding Advisory Committeefda.gov · Federal advisory-committee notice
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03
Selank (Wikipedia — tuftsin-derived heptapeptide, Russian regulatory status, mechanism)en.wikipedia.org · Tertiary reference
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