The FDA has handed down a clinical hold to vTv Therapeutics’ lead diabetes program, halting a Phase 3 trial for the oral small molecule candidate.
The North Carolina-based company announced that it will pause patient enrollment in the Phase 3 after a “chromatographic signal” that couldn’t be “resolved by standard mass spectroscopy” was seen in a separate study of the drug.
vTv screened the first patient for the pivotal trial in June, but the company said no patient had been dosed yet. Its stock $VTVT took a tumble following the Friday announcement, trading down about 41% in premarket trading on Monday.
The FDA will need just a single in vitro study to “characterize” the signal and then the drug’s development can resume, according to the company, which added this signal hasn’t been seen in previous studies.
The company had originally planned to release data from this trial in the first quarter of 2026. It didn’t provide any updates on expected timelines.
Paul Sekhri“We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible,” vTv president and CEO Paul Sekhri wrote in a statement. “Cadisegliatin demonstrated compelling efficacy and a favorable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.”
vTv previously said in its first-quarter earnings release that it’s also planning two international registrational trials of cadisegliatin in type 1 diabetes which they expect to initiate in 2026, along with a Phase 2 trial in the Middle East in patients with type 2 diabetes.
Its drug works by activating glucokinase independently of insulin, offering an alternative way to control blood sugar levels.
The biotech raised a $51 million private placement with investors that included the JDRF T1D Fund. It had $52.3 million as of March 31, which was meant to fund its Phase 3 study through topline data.