Chitosans and chitosan derivatives in pharmaceuticals that reached clinical trials.

Chitosans and chitosan derivatives have potential for pharmaceutical uses. To the author, it has seemed that only one product containing such a carbohydrate had received marketing approval as a medicine. This work aims to offer possible explanations by identification and evaluation of clinical trials and reports. Known or possible structures of chitosan and chitosan derivatives were determined. Searches were conducted to gather regulatory and clinical information. Relevant clinical trials and reports were selected by applying eligibility criteria. Characteristics of corresponding drug products and ingredients were inspected. The selected trials and reports were evaluated via a new scale covering control, randomisation and blinding. Requirements and recommendations of regulatory bodies are discussed. Numerous relevant medicines were found to have been clinically investigated. Most natural sources of the corresponding chitosans and chitosan derivatives were not explicitly stated. Various dosage forms, compositions, and molecular parameters were observed for drug products. Ten areas of investigational uses are delineated. Some carbohydrates could be active ingredients, while others could function as excipients. Numerical scores were obtained by evaluating the clinical trials and reports. Parts of the information regarding carbohydrate properties or study design are not available. The limited data reporting, relatively small trial sizes, and some unfavourable findings may help explain the landscape.