Dignify Therapeutics, a Research Triangle Park, North Carolina-based biopharmaceutical company focused on restoring bowel and bladder control for people with neurological conditions, announced on October 7, 2026 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DTI-117. The clearance allows Dignify to begin first-in-human testing of DTI-117, an on-demand therapy being developed to restore controlled evacuation in people with neurogenic bowel dysfunction (NBD), and marks the company’s transition from preclinical to clinical-stage development.
“FDA clearance of our IND allows us to begin evaluating DTI-117 in the clinic and represents an important milestone for Dignify,” said Anthony DiTonno, Chief Executive Officer of Dignify Therapeutics. “We are on track to dose the first participant in the Phase 1 healthy volunteer trial in November and anticipate preliminary topline data from the first few cohorts in early 2027.”
Inside the Phase 1 Study
The NIH-funded Phase 1 trial is a randomized, double-blind, placebo-controlled, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics of single intramuscular doses of DTI-117 in healthy volunteers. Dosing is expected to begin in November 2026, with preliminary topline data from the initial cohorts anticipated in early 2027.
Designed for Control and Dignity
People with NBD often have substantial difficulty initiating bowel movements, which can require significant time, effort, and caregiver assistance. Current approaches, including laxatives, enemas, and manual evacuation, can lack predictable timing and may be invasive or stigmatizing.
DTI-117 is a short-acting peptide and neurokinin-2 receptor agonist designed to induce rapid, on-demand defecation within minutes, potentially giving people greater control over the timing and location of evacuation. In preclinical studies, it demonstrated rapid, controlled bladder and bowel emptying across multiple animal models.
“Through extensive interactions with people with spinal cord injury and personal experience with my son, who has a C2 spinal cord injury, we designed DTI-117 around the attributes that matter most for a drug-induced defecation therapy: predictable start and stop timing, brief duration, efficient emptying, and tolerability,” said Karl Thor, Ph.D., Chief Scientific Officer of Dignify Therapeutics. “As a small peptide designed for short-acting exposure, we believe DTI-117 has the potential to deliver on these attributes and give people greater control over bowel care.”
Built With Federal and North Carolina Support
Dignify has received 18 NIH awards and more than $20 million in NIH funding. DTI-117 development is supported by the National Institute of Neurological Disorders and Stroke under Award Number U44NS129628. The company has also been supported by its founders, venture capital firms, the North Carolina Biotechnology Center, and the One NC Small Business Program.
About Dignify Therapeutics
Founded by a team of serial entrepreneurs and internationally recognized scientists, Dignify Therapeutics develops practical, convenient treatments for bladder and bowel voiding dysfunction, especially in people with neurogenic conditions. The company is located at the First Flight Venture Center in Research Triangle Park, North Carolina.
