Developing a Mitragynine Formulation to Conduct Rigorously Controlled Clinical Trials with a Kratom Alkaloid Extract

National Center For Advancing Translational Sciences

Investigators

Abstract

To date, a purification process has been developed to isolate MG from kratom alkaloid extract as a bioactive salt, and the synthesis of the Good Manufacturing Practice (GMP)-grade active pharmaceutical ingredient (API) is complete. Pharmacokinetic and toxicokinetic parameters have been evaluated in multiple species, and further in vitro PK studies to assess drug interactions and metabolism are complete. A capsule formulation suitable for clinical testing was developed, and the formulated GMP drug product has been manufactured to support ongoing preclinical Good Laboratory Practice (GLP) toxicology studies and eventual clinical trials. Regulatory meetings with the FDA are scheduled to inform further IND-directed development plans.