Preclinical Safety Evaluation of BB106, a Novel Ketamine–Sulfobutylether-Beta-Cyclodextrin Salt, Following Subcutaneous Administration in Rats and Göttingen Minipigs

Yuval Ramot, Isabella Andreini, Giuseppe Sacco, Jeffrey Becker, Kevin Bruhn, Rosa Anna Manno, Abraham Nyska, Faculty of Medicine, Hebrew University of Jerusalem, Department of Dermatology, Hadassah Medical Center, AKROS Bioscience S, Bexson Biomedical, Santa Barbara, Consultant in Toxicologic Pathology, Yehuda HaMaccabi , Tel Aviv and Tel Aviv University, Tel Aviv

International Journal of Toxicology

Published online on January 20, 2026

Abstract

International Journal of Toxicology, Volume 45, Issue 3, Page 232-246, May-June 2026.
BackgroundConventional ketamine hydrochloride solutions are acidic and hyperosmotic, limiting their tolerability for subcutaneous (SC) delivery. BB106 is a novel ketamine formulation using the multitude of sulfobutylether-beta-cyclodextrin (SBECD) anionic ...