Xifaxan EIR (rifaximin extended intestinal release) / Bausch Health, Alfa Wassermann, Alfasigma - LARVOL DELTA

Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea (clinicaltrials.gov) - P2 | N=216 | Completed | Sponsor: Alfasigma S.p.A. | Phase classification: P2a ➔ P2

Phase classification • Dermatology • Rosacea

Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea (clinicaltrials.gov) - P2a | N=216 | Completed | Sponsor: Alfasigma S.p.A. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Rosacea

Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea (clinicaltrials.gov) - P2a | N=216 | Active, not recruiting | Sponsor: Alfasigma S.p.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ Oct 2022 | Trial primary completion date: Jul 2022 ➔ Oct 2022

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Rosacea

Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea (clinicaltrials.gov) - P2a; N=171; Recruiting; Sponsor: Alfasigma S.p.A.

Clinical • New P2a trial • Dermatology • Rosacea

ROAD: Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. (clinicaltrials.gov) - P2/3; N=193; Terminated; Sponsor: Alfasigma S.p.A.; Active, not recruiting ➔ Terminated; Trial primary completion date: Jul 2020 ➔ Dec 2020; Sponsor's decision

Clinical • Trial primary completion date • Trial termination • Gastrointestinal Disorder

ROAD: Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. (clinicaltrials.gov) - P2/3; N=193; Active, not recruiting; Sponsor: Alfasigma S.p.A.; Recruiting ➔ Active, not recruiting; N=882 ➔ 193

Clinical • Enrollment change • Enrollment closed

One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease (clinicaltrials.gov) - P3; N=80; Terminated; Sponsor: Bausch Health Americas, Inc.; N=660 ➔ 80; Active, not recruiting ➔ Terminated; The study was terminated early due to difficulty in enrollment and lack of clinical study drug access.

Clinical • Enrollment change • Trial termination

One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease (clinicaltrials.gov) - P3; N=81; Terminated; Sponsor: Bausch Health Americas, Inc.; N=660 ➔ 81; Active, not recruiting ➔ Terminated; The study was terminated early due to difficulty in enrollment and lack of clinical study drug access.

Clinical • Enrollment change • Trial termination

ROAD: Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. (clinicaltrials.gov) - P2/3; N=882; Recruiting; Sponsor: Alfasigma S.p.A.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open