URG101

URG101 is combination of lidocaine and heparin instilled directly into the bladder via catheter. Lidocaine provides immediate symptom relief, while high dose heparin (also a GAG) helps to mechanically repair the damaged bladder lining.

The individual components of this combination therapy, Lidocaine HCl and heparin sodium, are FDA-approved products for use as a local anesthetic and an anticoagulant, respectively. It was demonstrated that when these components were mixed together and buffered by the addition of sodium bicarbonate, the resultant solution reduced symptoms of pelvic pain and urgency upon instillation into a subject’s bladder. Most subjects exhibit both an acute benefit as well as sustained benefit from single and multiple treatments.

Clinical Efficacy

Our Phase II data shows the greatest separation from placebo ever published in IC/BPS.

Key Findings

• Immediate relief with first URG101 dose
• Many patients experienced > 24hr symptom relief following only one dose
• Significant reduction of daytime symptoms
• Many patients experienced fewer night time voiding episodes

Mechanism of Action

Intravesical URG101 has a dual action mechanism: reducing pain and repairing the GAG layer.

Clinical Trials

• Recruiting: Engage-24
• Completed: Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
• Completed: Study of U101 for Bladder Pain and/or Urgency