Research Triangle Park, North Carolina, U.S., October 7, 2026
Dignify Therapeutics, a biopharmaceutical development company focused on restoring bowel and bladder control in people with neurological conditions, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DTI-117, enabling the investigational therapy to advance into first-in-human clinical evaluation. DTI-117 is being developed as an on-demand treatment for neurogenic bowel dysfunction (NBD), a condition that can make voluntary bowel movements difficult or unpredictable for people with spinal cord injuries and other neurological disorders. The company plans to initiate a Phase 1 clinical trial in healthy volunteers in November 2026, with preliminary topline data from the initial study cohorts expected in early 2027. Supported by funding from the National Institutes of Health (NIH), the randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of single ascending intramuscular doses of DTI-117. The IND clearance marks an important milestone for Dignify Therapeutics as it transitions the candidate from preclinical research into clinical development.
DTI-117 Targets Neurogenic Bowel Dysfunction
DTI-117 is a short-acting peptide and neurokinin-2 (NK2) receptor agonist designed to induce rapid, controlled bowel evacuation on demand. The investigational candidate is intended to provide greater control over the timing and location of bowel movements, potentially helping patients manage a challenging aspect of daily life. Neurogenic bowel dysfunction can occur when neurological damage disrupts the normal communication between the nervous system and the gastrointestinal tract. People affected by the condition may experience difficulty initiating bowel movements, prolonged bowel-care routines and a need for assistance from caregivers. Existing management approaches include laxatives, enemas and manual evacuation, which may be time-consuming, invasive or difficult to schedule predictably. Dignify is developing DTI-117 to address these limitations through a treatment designed to produce rapid, transient emptying with a brief duration of action. According to the company, preclinical studies demonstrated rapid, controlled bladder and bowel emptying across multiple animal models. These findings provide the rationale for clinical investigation, although the therapy’s safety, effectiveness and potential benefits in humans have not yet been established. The upcoming Phase 1 study will represent the first clinical evaluation of DTI-117 in humans.
Phase 1 Trial to Assess Safety and Pharmacokinetics
Following FDA clearance, Dignify Therapeutics expects to begin dosing healthy volunteers in November 2026. The Phase 1 study will use a randomized, double-blind, placebo-controlled, single-ascending-dose design to investigate the effects of progressively evaluated single intramuscular doses. Its primary objectives are to assess safety and tolerability, while pharmacokinetic assessments will examine how the investigational compound behaves in the body. The study is supported by the National Institutes of Health, including the National Institute of Neurological Disorders and Stroke, under award number U44NS129628. Dignify anticipates reporting preliminary topline results from the first few cohorts in early 2027. These initial findings are expected to provide an early assessment of the candidate’s clinical profile and help guide subsequent development decisions. As the study is being conducted in healthy volunteers, it is not designed to establish therapeutic benefit in people with neurogenic bowel dysfunction. Further clinical studies in appropriate patient populations would be needed to determine whether DTI-117 can deliver predictable bowel evacuation and meaningful improvements in daily functioning. The company has identified predictable onset and offset, brief treatment duration, efficient emptying and tolerability as key attributes guiding its development strategy.
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NIH-Supported Development Advances Patient-Centered Care
Dignify Therapeutics aims to develop practical treatments for bowel and bladder voiding disorders, particularly those associated with neurological conditions. The company’s approach focuses on addressing functional challenges that can affect independence, dignity and quality of life. DTI-117’s proposed on-demand mechanism could potentially offer an alternative to conventional bowel-management strategies if clinical studies confirm its safety and effectiveness. The company reports receiving 18 NIH awards and more than $20 million in NIH funding, supporting its research and development activities. FDA IND clearance allows the clinical investigation to proceed but does not represent FDA approval of DTI-117 for marketing or patient use. The candidate remains investigational, and its future development will depend on clinical findings and applicable regulatory requirements. The planned Phase 1 study is a critical first step in determining whether DTI-117 can progress toward a treatment option for people living with neurogenic bowel dysfunction. Results expected in early 2027 should provide initial information to inform the next stage of development.
Source: Dignify Therapeutics press release
