Research peptides Selank and Semax identified in seized, unapproved pharmaceutical preparations
Background
The market for nootropics and cognitive enhancers includes substances sold as 'research peptides' which often lack comprehensive clinical trial data and regulatory approval. Compounds like Selank and Semax are promoted online for their supposed cognitive benefits but have not completed clinical trials to establish safety and efficacy. This creates a public health challenge, as these products are available as lyophilized powders for injection or as nasal sprays without oversight. Regulatory and controlling laboratories face a growing need to identify these potentially dangerous molecules in suspicious preparations, but may lack validated methods for a wide range of novel peptides with varying biochemical properties. This gap in analytical capability makes it difficult to monitor the market and protect consumers from unapproved and untested substances.
Study Design
Researchers analyzed two different unknown suspicious preparations seized at the end of 2017 and 2018. They employed a plethora of different analyses to identify any bioactive compounds present. Based on the findings, they developed a novel combined liquid chromatography tandem mass spectroscopy (LC-MS/MS) methodology. This new screening method was designed to be applicable to both hydrophilic and hydrophobic peptides. The method was then used to screen a total of 10 putative cognitive enhancing polypeptides being sold online. The screening rationale was validated in different matrices as required by ISO 17025, following recommendations from the General European Official Medicines Control Laboratory (OMCL) network.
Results
The two suspicious preparations seized in 2017 and 2018 were found to contain the research peptides Selank and Semax. To the authors' knowledge, these compounds have not completed any clinical trials. An online search, excluding the dark web, confirmed that these nootropic research peptides are freely available for purchase, sold as lyophilized powders for injection or in nasal spray formulations. This discovery served as the catalyst for developing a new analytical method.
The subsequent development yielded a novel combined liquid chromatography tandem mass spectroscopy (
LC-MS/MS) methodology capable of analyzing a total of 10 different putative cognitive enhancing polypeptides with variable biochemical characteristics. This screening tool was successfully validated according toISO 17025standards, demonstrating its reliability for identifying unknown peptides in various matrices. This provides a crucial tool for controlling agencies.
Key Findings
- Two suspicious pharmaceutical preparations seized in 2017 and 2018 were found to contain the research peptides Selank and Semax.
- Selank and Semax are sold online as lyophilized powders or nasal sprays despite not having completed any clinical trials.
- A new LC-MS/MS screening methodology was developed and validated to identify 10 different putative cognitive enhancing polypeptides.
- The screening rationale complies with the General European Official Medicines Control Laboratory (OMCL) network recommendations.
- The analytical method was validated in different matrices as required by ISO 17025 standards.
Why It Matters
The presence of unapproved research peptides like Selank and Semax in seized products highlights a significant regulatory blind spot and potential public health risk. For peptide users and biohackers, this serves as a critical warning about the contents of unregulated products, which may contain substances without established safety profiles. For controlling laboratories and regulatory agencies, this paper provides a validated analytical framework to address the rising tide of novel research chemicals. Controlling laboratories should adopt advanced screening methods like the described LC-MS/MS protocol to effectively identify and control the distribution of potentially dangerous, unapproved peptide preparations. This work is a direct step towards improving surveillance and enforcement, though widespread implementation is still needed to systematically police the online market for these substances.
TitrateLab articles covering Selank
Written by TitrateLab, separately from the study summarized above.
