A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Phase 2 Completed 321 enrolled OrphoMed, Inc. PPD Development, LP · collab

RandomizedSequentialTriple-blindTreatment

Summary

This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D.

Timeline

Start: 2019-11-22
Primary completion: 2021-10-04
Completion: 2021-10-04

Outcome

Missed primary endpoint

paper ORP-101 100 mg did not achieve a statistically significant difference vs placebo for the primary endpoint PMID 41887552 ↗

paper P = .12 for ORP-101 100 mg vs placebo PMID 41887552 ↗

Publications

Singh P, Nee JW, Ballou S, Lee A, Loesch J, Iturrino J, Rangan V, Lembo A. ORP-101 in Irritable Bowel Syndrome With Diarrhea: A Phase II Randomized, Controlled Trial. Clin Gastroenterol Hepatol. 2026 Mar 24:S1542-3565(26)00216-8. doi: 10.1016/j.cgh.2026.03.012. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ORP-101	Small molecule	50 mg	Oral
Subject	ORP-101	Small molecule	100 mg	Oral