PNB-0408
Evidence Grade D — Primarily preclinical. 17 published studies, mostly animal models. 0 registered clinical trials.
Dihexa is a modified peptide derivative with serious evidence integrity concerns. A key foundational paper received an expression of concern for image manipulation, and a second paper was retracted after an institutional investigation found falsified and fabricated data. No human clinical trials have been conducted. These integrity issues fundamentally undermine the evidence base.
17 published studies: 8 human, 4 animal, 3 in-vitro, 4 reviews
Dihexa has no marketing authorisation. No human clinical trials have been conducted. The foundational research by the originating laboratory faces serious integrity concerns: a key paper (McCoy et al., 2013) received an expression of concern for image manipulation, and a second paper (Benoist et al., 2014) was retracted after institutional investigation found falsified and fabricated data.
These integrity issues fundamentally undermine the evidence base for dihexa. Products available through unregulated channels are based on research that has been formally questioned or retracted by the scientific community. This compound carries unique evidence quality concerns beyond the standard limitations of other research compounds.
The originally proposed mechanism involved modulation of hepatocyte growth factor (HGF) signalling. However, the foundational publications describing this mechanism face severe scientific integrity concerns — one key paper received an expression of concern and another was retracted due to findings of falsified and fabricated data. The reliability of the proposed mechanism is therefore in question.
The evidence base for dihexa is severely compromised. The retraction and expression of concern on its two foundational papers mean the core claims about this compound cannot be relied upon. A related prodrug (fosgonimeton) from the same research programme was tested clinically but also failed and was discontinued. An additional safety concern is the mechanism itself: dihexa is proposed to work through the HGF/c-Met pathway, which is strongly associated with tumour growth and metastasis in many cancers. The extraordinarily long estimated half-life (8-12 days) raises accumulation concerns. Products from unregulated channels are based on research that has been formally questioned or retracted by the scientific community.
No trials registered on ClinicalTrials.gov for this compound.
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
Pinealon has no marketing authorisation from any major regulatory agency. No controlled human clinical trials have been conducted. The evidence base consists of in vitro cell studies and animal experiments published primarily by the originating research group. As with other Khavinson bioregulator peptides, the proposed mechanisms and the underlying theoretical framework have not been evaluated through conventional Western regulatory processes. Products available through unregulated channels lack pharmaceutical quality assurance.
Selank is approved in Russia for anxiety-related conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies. The key clinical study (62 patients) compared Selank to a benzodiazepine in generalised anxiety disorder and reported comparable effects. Published clinical studies are predominantly Russian and have not undergone Western regulatory review. The evidence base does not meet FDA or EMA approval standards. Its regulatory status is limited to Russia and certain former Soviet states.
Semax is approved in Russia for stroke recovery and cognitive conditions. It has not been approved by the FDA, EMA, or other major Western regulatory agencies, and the clinical evidence base has not undergone Western regulatory review. Published clinical studies are predominantly Russian. The largest published study (110 stroke patients) reported correlations between treatment and BDNF levels. The evidence does not meet the standards typically required for FDA or EMA approval. Its regulatory status is limited to Russia and certain former Soviet states.
