FDA places vTv's lead diabetes drug on hold over chromatographic signal

The FDA has placed vTv Therapeutics’ phase 3 trial for cadisegliatin on hold more than two years after the biotech stacked its remaining chips on the Type 1 diabetes drug.

The regulator placed the clinical hold across the cadisegliatin program “based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy,” vTv explained in a post-market update July 26.