Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GR68755 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| GR68755 (Alosetron hydrochrolide) group | EXPERIMENTAL | GR68755 1 mg tablets QD in the morning every day for 28 days |
| Name | Type | Description |
|---|---|---|
| GR68755 (Alosetron hydrochloride) 1 mg tablet | DRUG | 1 tablet (1 mg) once a day |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Disease to be treated: Has been diagnosed with severe d-IBS (at least 6 months of d-IBS symptoms as defined by the Rome II Criteria), and failed conventional IBS therapy. ...
GR68755 is being studied for the treatment of irritable colon, specifically severe diarrhea-predominant irritable bowel syndrome (IBS). It is an investigational small molecule developed by GSK plc and has been evaluated in a Phase 2 clinical trial in adult women with this condition.
GR68755 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating GR68755 for irritable colon, including the Phase 2 trial NCT01855711 that studied the drug in severe diarrhea-predominant IBS.
GR68755 is in Phase 2 clinical development. One Phase 2 trial, NCT01855711, has been completed. The drug is investigational and has not been approved by the FDA for any indication. No active trials are currently listed for GR68755.
GR68755 has been evaluated in one completed Phase 2 trial, NCT01855711, titled "Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)." The trial enrolled 32 female participants aged 20 years and older and was an uncontrolled study.
Yes, GR68755 is also known as alosetron hydrochloride. The 1 mg tablet formulation is referred to as GR68755 (alosetron hydrochloride) 1 mg tablet. This is the same investigational drug candidate being studied by GSK for irritable colon.