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Telehealth Clinic Expands Selank Program, But the Evidence Is Mostly Russian and Small

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A press release issued through EZ Newswire says Bowery Clinic, a concierge telehealth practice specializing in physician-led peptide care, has expanded its Selank program for eligible patients in 27 states and the District of Columbia. The announcement is paired with an educational overview of the compound, which the clinic frames as a response to rising patient interest in nootropic and anxiolytic peptides.

Selank is a synthetic heptapeptide, an analog of tuftsin, a naturally occurring immunomodulatory tetrapeptide with the sequence Thr-Lys-Pro-Arg. Selank extends that core with three more amino acids, Pro-Gly-Pro, for the full sequence TKPRPGP. It was developed through Russian peptide-research programs tied to the Russian Academy of Sciences, and a 2022 Russian review cited in the release lists it among products registered in that country and classifies it as an anxiolytic.

Where the human data comes from

The published evidence is largely Russian preclinical work plus a small number of human studies with modest sample sizes. One study of 62 patients with generalized anxiety disorder or neurasthenia compared Selank with medazepam and reported similar anxiolytic effects between groups, with additional antiasthenic and psychostimulant effects reported in the Selank arm. A separate 60-patient study comparing Selank with phenazepam reported anxiolytic effects and mild nootropic effects.

Further research evaluating Selank alongside phenazepam reported reductions in several phenazepam-associated adverse effects, including sedation and impairment of attention and memory. The release itself cautions that this does not establish Selank as equivalent to, safer than, or a replacement for FDA-approved anxiety treatments, which is a more careful sentence than most peptide marketing manages.

Not approved, and not cleared

Selank is not FDA-approved for any indication in the United States. The release is explicit that its removal from the FDA's Category 2 list reflects a withdrawn bulk substance nomination and signals nothing about clearance or approval for compounding. Compounded medications are not FDA-approved.

Limitations

Much of the mechanistic evidence remains preclinical, and the clinic acknowledges that no large multicenter development program has been run. Long-term safety, adverse event and toxicity profiles have not been established in large-scale U.S. trials, formal drug-interaction studies are limited, and safety has not been adequately established in pregnancy, breastfeeding or pediatric populations.

Bottom line

This is a company announcement, not a study, and the interesting part is what it concedes. A clinic selling access to a compound saying out loud that the trials are small, foreign and unreplicated sets a bar the research-chemical vendors it criticizes will not clear.

Source: RSS.app — Peptides bundle. Read the original.

Filed under: safety, fda, supply

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