Dignify Therapeutics has secured U.S. Food and Drug Administration (FDA) clearance to begin human testing of an experimental drug designed to help people with neurological conditions regain greater control over bowel movements.

 

The FDA’s clearance of the company’s Investigational New Drug (IND) application for DTI-117 moves the drug candidate into clinical development, marking a key milestone in the effort to develop an on-demand treatment for neurogenic bowel dysfunction (NBD).

 

Dignify expects to begin dosing healthy volunteers in November 2026 in a National Institutes of Health (NIH)-funded Phase 1 trial. Preliminary topline data from the initial study cohorts are anticipated in early 2027.

 

DTI-117 is being developed to trigger rapid, controlled bowel evacuation within minutes, potentially giving patients greater control over when and where they empty their bowels. The short-acting drug candidate is designed to address a significant challenge for people with NBD, who may struggle to initiate bowel movements voluntarily.

 

For many, bowel care can be time-consuming, physically demanding and dependent on caregiver assistance. Existing approaches, including laxatives, enemas and manual evacuation, may offer limited predictability and can be invasive or stigmatizing.

 

Dignify aims to change that with a treatment designed around speed, predictability and patient control.

 

“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, 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.”

 

Preclinical studies have demonstrated rapid, controlled bladder and bowel emptying across multiple animal models. The upcoming Phase 1 trial will assess the safety, tolerability and pharmacokinetics of single intramuscular doses of DTI-117 in healthy volunteers.

 

The randomized, double-blind, placebo-controlled, single-ascending-dose study will provide the first clinical assessment of the drug candidate in humans.

 

“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.”

 

DTI-117 is a short-acting peptide and neurokinin-2 receptor agonist being developed as an on-demand treatment for neurogenic bowel dysfunction and other bladder and bowel voiding disorders.

 

Its intended short duration of action is designed to support patient-controlled evacuation rather than prolonged effects. However, its safety and effectiveness in humans remain to be established through clinical trials.

 

Dignify Therapeutics, based at the First Flight Venture Center in Research Triangle Park, North Carolina, focuses on developing practical treatments for bladder and bowel dysfunction, particularly in people with neurological conditions.

 

The company says it has received 18 NIH awards and more than $20 million in NIH funding. Development of DTI-117 is supported by the National Institute of Neurological Disorders and Stroke under NIH Award No. U44NS129628.

 

The Phase 1 study represents the first clinical step for DTI-117. Its results will help determine whether the drug can advance toward further testing as a potential option for people whose neurological conditions make bowel management difficult.