TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)

This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating gastrointestinal recovery following major abdominopelvic surgery. TU-100 will be evaluated in 2 surgical populations under a Master Protocol: 1. Subjects undergoing Radical Cystectomy (RC), 2.subjects undergoing Complex Abdominal Wall Reconstruction (CAWR).

NCT Number	NCT07765589
Lead Sponsor	Tsumura USA
Conditions	Delay in GI Recovery/Postoperative Ileus (POI)
Enrollment	240 participants
Start Date	2026-12
Primary Completion	2028-06 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-14