MT-501

MT-501 is an investigational substance being studied for inflammatory bowel disease. It is a chemically synthesised substance, supplied by Mirador Therapeutics, Inc., and has no marketing authorisation in the product records.^[1] The name MT-501 is also the product name used in the trial records.^[1]

Table of contents

• What is MT-501?
• How does MT-501 work?
• Which conditions is MT-501 studied for?
• How is MT-501 given?
• What do the clinical trials show?
• What side effects are known?

What is MT-501?

MT-501 is an investigational, chemically synthesised substance. It appears in the trial records as a test substance in two trial arms, which means the study investigates this substance directly.^[1] The product records describe it as a film-coated tablet for oral use, with no marketing authorisation.^[1] The authorisation holder named in the records is Mirador Therapeutics, Inc.^[1]

How does MT-501 work?

The trial records and registry data do not describe a mechanism of action for MT-501. The study is designed to evaluate safety and tolerability, as well as endoscopic and clinical measures of response in inflammatory bowel disease.^[1]

Which conditions is MT-501 studied for?

• Crohn’s disease — a long-term inflammatory condition of the digestive tract. The trial measures endoscopic response at the end of the induction phase.^[1]
• Ulcerative colitis — a long-term inflammatory condition affecting the large bowel. The trial measures endoscopic improvement at the end of the induction phase.^[1]

How is MT-501 given?

MT-501 is given as a film-coated tablet by mouth, which is described in the records as oral use.^[1] The trial also includes a placebo for MT-501 as film-coated tablets, used as a comparison.^[1] The dose of MT-501 is not reported in the trial record.^[1]

What do the clinical trials show?

One authorised Phase 2 platform study is listed for MT-501. It plans to enrol 55 participants with Crohn’s disease or ulcerative colitis.^[1] The trial is interventional and includes both MT-501 and a placebo for MT-501, as well as another substance called MT-201 given by parenteral use.^[1] The primary outcomes include the proportion of participants reporting treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values. For Crohn’s disease, the study also measures the proportion with endoscopic response at the end of the induction phase. For ulcerative colitis, it measures the proportion with endoscopic improvement at the end of the induction phase. In the randomised placebo-controlled parts, the study measures the proportion of participants with clinical remission at the end of the induction phase.^[1]

What side effects are known?

The trial records do not report side effects for MT-501 from completed data. The study is designed to measure treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values.^[1]