Terran Biosciences has developed TerXT, a combination of novel prodrugs of xanomeline and trospium, for treating schizophrenia. The prodrug approach aims to overcome the limitations of xanomeline and trospium, enabling fixed-dose combinations for once-daily oral administration and long-acting intramuscular injections.
Terran’s team of experts designed over 10,000 prodrugs using medicinal chemistry and PK modeling to optimize pharmacokinetic parameters and ratios. Preclinical testing involved synthesizing over 500 prodrugs and conducting 650 in vitro and in vivo studies.
Clinical trials of an oral, twice-daily combination of xanomeline and trospium have shown safety and efficacy in treating schizophrenia, and the combination is currently under FDA review for 505(b)(1) approval.
If the FDA approves the initial combination, Terran plans to pursue the 505(b)(2) approval pathway for TerXT and TerXT LAI, potentially bringing these long-acting formulations to market approximately five years after the first xanomeline/trospium approval.
The accelerated approval pathway will utilize pharmacokinetic bridging studies and leverage existing safety and efficacy data from completed trials to expedite the approval process. This approach aims to broaden patient access, improve the use profile, and enhance the affordability of these next-generation therapeutics.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
