Pipeline
DTI-117 is Dignify’s lead clinical-stage program and a novel, short-acting neurokinin-2 receptor agonist being developed to produce rapid, controlled bowel emptying on demand.
The U.S. Food and Drug Administration has cleared Dignify’s IND for DTI-117, allowing the program to advance into first-in-human clinical development. Dignify is initiating an NIH-funded Phase 1 single-ascending-dose study of intramuscular DTI-117 in healthy volunteers to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamic activity.
The clinical program is designed to establish a foundation for subsequent evaluation in people with neurogenic bowel dysfunction and to support the development of a convenient sublingual formulation for later-stage use. DTI-117 is being developed under a 505(b)(1) regulatory pathway.
DTI-301 is a TRPV1 receptor agonist formulated as a rectal suppository and designed to produce rapid, predictable bowel emptying on demand.
Dignify is advancing DTI-301 toward Phase 1 clinical development in Australia, beginning with evaluation in healthy volunteers. The program is intended to establish safety, tolerability and pharmacodynamic activity before progressing into people with neurogenic bowel dysfunction.
Because DTI-301 is administered locally in the colorectum, the approach is designed to limit systemic exposure while providing a rapid and transient therapeutic effect. DTI-301 is being developed under a 505(b)(2) regulatory pathway, with the goal of supporting an efficient path toward later-stage clinical development and registration.