Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

PHASE3RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

July 31, 2030

Study Completion Date

January 31, 2031

Conditions
Familial Adenomatous Polyposis (FAP)
Interventions
DRUG

eRapa (encapsulated rapamycin)

0.5 mg capsules for oral use; white opaque capsule filled with off-white powder; Trial intervention will be provided in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.

DRUG

Placebo

Capsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.

Trial Locations (5)

37909

RECRUITING

GI Associates, Knoxville

43210

RECRUITING

Ohio State University, Columbus

48109

RECRUITING

University of Michigan, Ann Arbor

66160

RECRUITING

University of Kansas Medical Center, Kansas City

00935

RECRUITING

Hospital Oncologico - Puerto Rico Medical Center, Rio Piedras

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biodexa Pharmaceuticals

INDUSTRY

lead

Rapamycin Holdings Inc.

INDUSTRY

NCT06950385 - Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis | Biotech Hunter | Biotech Hunter