ORP-101 / OrphoMed - LARVOL DELTA

Drugs of the future for diarrhea-predominant irritable bowel syndrome: an overview of current investigational drugs. (PubMed, Expert Opin Investig Drugs) - "Clinical trial evidence has shown that loperamide, eluxadoline, alosetron, ramosetron, bile acid sequestrants, and rifaximin can modulate GI alterations and benefit patients with IBS-D. Among the potential therapies, ibodutant, ibudilast, blautix, BOS-589, solabegron, vibegron, olorinab, ebastine, and ORP-101 have demonstrated possible effects but remain confirmed...Therefore, we should focus on developing new, efficient, and affordable medications for IBS-D. The government, insurers, and society must recognize this need and collaborate to ensure its fulfillment."

Journal • Review • Gastrointestinal Disorder • Inflammation

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P2 | N=321 | Completed | Sponsor: OrphoMed, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2022 ➔ Oct 2021

Trial completion • Trial completion date • Gastrointestinal Disorder • Immunology

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P2; N=321; Active, not recruiting; Sponsor: OrphoMed, Inc.; Trial completion date: Dec 2021 ➔ Oct 2022

Clinical • Trial completion date • Gastrointestinal Disorder • Immunology

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P2; N=320; Active, not recruiting; Sponsor: OrphoMed, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gastrointestinal Disorder • Immunology

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P2; N=320; Recruiting; Sponsor: OrphoMed, Inc.; Trial completion date: Apr 2021 ➔ Oct 2021; Trial primary completion date: Apr 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date

PHASE 1 RESULTS OF ORP-101, A NOVEL PARTIAL μ AGONIST, FULL Κ ANTAGONIST WITHOUT OPIOID-LIKE ADVERSE EFFECTS, WHICH IS BEING DEVELOPED TO TREAT IBS-D (DDW 2020) - "Results of the animal and healthy human subject studies to date are consistent with the hypothesis that ORP-101 acts peripherally on intestinal opioid receptors to treat IBS-D without the risk of CNS effects."

Adverse events • P1 data • Addiction (Opioid and Alcohol) • CNS Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Psychiatry

"OrphoMed Pauses Recruitment for Phase 2 Adaptive Design Study of ORP-101 for Treatment of IBS-D https://t.co/US0Bm1DpLy" (@NewsFromBW)

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P2; N=320; Recruiting; Sponsor: OrphoMed, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P2; N=320; Not yet recruiting; Sponsor: OrphoMed, Inc.

Clinical • New P2 trial