OD-07656 hydrochloride

OD-07656 hydrochloride is an investigational chemical substance developed by Odyssey Therapeutics Inc. It is given as an oral capsule and is being studied in moderately to severely active ulcerative colitis. The substance has no marketing authorisation in the product records, meaning it is not yet approved as a medicine.^[1]

What is OD-07656 hydrochloride?

OD-07656 hydrochloride is a chemically synthesised substance that is taken by mouth as a capsule. It is classified under digestive system diseases in the trial registry, specifically for ulcerative colitis. The substance is also known simply as OD-07656. It is an investigational product with no marketing authorisation, and its development is led by Odyssey Therapeutics Inc.^[1]

How does OD-07656 hydrochloride work?

The available registry data do not describe the mechanism of action of OD-07656 hydrochloride. The trial focuses on measuring its safety and tolerability, as well as its effect on symptoms of ulcerative colitis using the modified Mayo Clinic Score.^[1]

Which conditions is it studied for?

• Moderately to severely active ulcerative colitis — a chronic inflammatory bowel disease affecting the large intestine, causing symptoms such as diarrhoea, rectal bleeding and mucosal inflammation. The trial tests whether OD-07656 can improve these symptoms.^[1]

How is OD-07656 hydrochloride given?

OD-07656 hydrochloride is given as an oral capsule. In the current trial, two oral doses are being tested: 20 mg and 40 mg. The comparison treatment, vedolizumab (Entyvio), is given as a 300 mg powder for concentrate for solution for infusion, administered by intravenous infusion.^[1]

What do the clinical trials show?

One clinical trial is registered for OD-07656 hydrochloride: a Phase 2a study in moderately to severely active ulcerative colitis. The trial is authorised and plans to enrol 109 participants. Its main goals are to evaluate safety and tolerability, and to measure efficacy using the 3-component modified Mayo Clinic Score, which combines stool frequency, rectal bleeding and endoscopic findings.^[1]

The study also records treatment-emergent adverse events, serious adverse events, and changes in laboratory parameters, electrocardiogram parameters and vital signs. Participants receive either OD-07656 orally or vedolizumab intravenously.^[1]

What side effects are known?

The registry record does not list specific side effects for OD-07656 hydrochloride. The trial is designed to collect information on treatment-emergent adverse events, including serious adverse events and those leading to treatment discontinuation, but no results are yet available.^[1]