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New hope for IBD sufferers: two experimental drugs enter Mid-Stage trial

NCT ID NCT07113522

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 study is testing two new drugs, MT-501 and MT-201, in 140 adults with moderate-to-severe Crohn's disease or ulcerative colitis. The goal is to see if these treatments are safe and can improve symptoms and gut healing. Researchers will monitor side effects and measure how well the drugs control disease activity over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT-501 and MT-201 (investigational drugs)
What this could lead to
If successful, these drugs could offer new, more effective options for controlling moderate-to-severe Crohn's disease and ulcerative colitis with fewer side effects.
What could go wrong
This is an early Phase 2 trial with only 140 participants, so results may not apply to everyone. The drugs may not work better than existing treatments or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria-Crohn's Disease: * Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology * Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD) * Meets drug stabilization requirements Inclusion Criteria-Ulcerative Colitis: * Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology * Moderately to severely active UC as defined by a 3-component MMCS * Meets drug stabilization requirements Exclusion Criteria-Crohn's Disease: * Diagnosis of indeterminate colitis * Suspected or diagnosed intra-abdominal or perianal abscess at Screening * Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments * CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement Exclusion Criteria-Ulcerative Colitis: * Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation * Current stoma or impending need for colostomy or ileostomy * Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase * Previous total proctocolectomy or subtotal colectomy

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Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn's disease are added.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    66 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mirador Therapeutics Selected Site

    RECRUITING

    Birmingham, Alabama, 35235, United States

  • Mirador Therapeutics Selected Site

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    Scottsdale, Arizona, 85258, United States

  • Mirador Therapeutics Selected Site

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    Sun City, Arizona, 85351, United States

  • Mirador Therapeutics Selected Site

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    Little Rock, Arkansas, 72205, United States

  • Mirador Therapeutics Selected Site

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    Little Rock, Arkansas, 72211, United States

  • Mirador Therapeutics Selected Site

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    Colorado Springs, Colorado, 80921, United States

  • Mirador Therapeutics Selected Site

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    Littleton, Colorado, 80120, United States

  • Mirador Therapeutics Selected Site

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    Miami, Florida, 33134, United States

  • Mirador Therapeutics Selected Site

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    Miami, Florida, 33165, United States

  • Mirador Therapeutics Selected Site

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    Miami, Florida, 33176, United States

  • Mirador Therapeutics Selected Site

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    Orlando, Florida, 32825, United States

  • Mirador Therapeutics Selected Site

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    Palmetto Bay, Florida, 33176, United States

  • Mirador Therapeutics Selected Site

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    Pensacola, Florida, 32504, United States

  • Mirador Therapeutics Selected Site

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    Atlanta, Georgia, 30342, United States

  • Mirador Therapeutics Selected Site

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    Snellville, Georgia, 30078, United States

  • Mirador Therapeutics Selected Site

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    Glenview, Illinois, 60026, United States

  • Mirador Therapeutics Selected Site

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    Gurnee, Illinois, 60031, United States

  • Mirador Therapeutics Selected Site

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    Lafayette, Louisiana, 70503, United States

  • Mirador Therapeutics Selected Site

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    Marrero, Louisiana, 70072, United States

  • Mirador Therapeutics Selected Site

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    Shreveport, Louisiana, 71105, United States

  • Mirador Therapeutics Selected Site

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    Ypsilanti, Michigan, 48197, United States

  • Mirador Therapeutics Selected Site

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    Bridgeton, Missouri, 63044, United States

  • Mirador Therapeutics Selected Site

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    Kansas City, Missouri, 64114, United States

  • Mirador Therapeutics Selected Site

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    Liberty, Missouri, 64068, United States

  • Mirador Therapeutics Selected Site

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    Las Vegas, Nevada, 89128, United States

  • Mirador Therapeutics Selected Site

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    New York, New York, 10016, United States

  • Mirador Therapeutics Selected Site

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    Rochester, New York, 14618, United States

  • Mirador Therapeutics Selected Site

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    High Point, North Carolina, 27262, United States

  • Mirador Therapeutics Selected Site

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    Raleigh, North Carolina, 27612, United States

  • Mirador Therapeutics Selected Site

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    Cincinnati, Ohio, 45219, United States

  • Mirador Therapeutics Selected Site

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    Liberty Township, Ohio, 45044, United States

  • Mirador Therapeutics Selected Site

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    Providence, Rhode Island, 02904, United States

  • Mirador Therapeutics Selected Site

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    Greenville, South Carolina, 29607, United States

  • Mirador Therapeutics Selected Site

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    Cordova, Tennessee, 38018, United States

  • Mirador Therapeutics Selected Site

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    Dallas, Texas, 75230, United States

  • Mirador Therapeutics Selected Site

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    Garland, Texas, 75044, United States

  • Mirador Therapeutics Selected Site

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    Georgetown, Texas, 78628, United States

  • Mirador Therapeutics Selected Site

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    Houston, Texas, 77090, United States

  • Mirador Therapeutics Selected Site

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    Lubbock, Texas, 79424, United States

  • Mirador Therapeutics Selected Site

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    Southlake, Texas, 76092, United States

  • Mirador Therapeutics Selected Site

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    Tyler, Texas, 75701, United States

  • Mirador Therapeutics Selected Site

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    Webster, Texas, 77598, United States

  • Mirador Therapeutics Selected Site

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    Bellevue, Washington, 98004, United States

  • Mirador Therapeutics Selected Site

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    Silverdale, Washington, 98383, United States

  • Mirador Therapeutics Selected Site

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    Tacoma, Washington, 98405, United States

  • Mirador Therapeutics Selected Site

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    Milwaukee, Wisconsin, 53215, United States

  • Mirador Therapeutics Selected Site

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    Toronto, Canada

  • Mirador Therapeutics Selected Site

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    Kutaisi, Georgia

  • Mirador Therapeutics Selected Site

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    Marneuli, Georgia

  • Mirador Therapeutics Selected Site

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    Tbilisi, 0102, Georgia

  • Mirador Therapeutics Selected Site

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    Tbilisi, 0144, Georgia

  • Mirador Therapeutics Selected Site

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    Tbilisi, 0159, Georgia

  • Mirador Therapeutics Selected Site

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    Tbilisi, 0178, Georgia

  • Mirador Therapeutics Selected Site

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    Tbilisi, 0180, Georgia

  • Mirador Therapeutics Selected Site

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    Tbilisi, 4600, Georgia

  • Mirador Therapeutics Selected Site

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    Chisinau, Moldova

  • Mirador Therapeutics Selected Site

    RECRUITING

    Chisinau, Moldova

    Contact Email: •••••@•••••

  • Mirador Therapeutics Selected Site

    RECRUITING

    Ivano-Frankivsk, Ukraine

  • Mirador Therapeutics Selected Site

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    Kyiv, 02002, Ukraine

  • Mirador Therapeutics Selected Site

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    Kyiv, 02091, Ukraine

  • Mirador Therapeutics Selected Site

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    Kyiv, 03037, Ukraine

  • Mirador Therapeutics Selected Site

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    Kyiv, Ukraine

  • Mirador Therapeutics Selected Site

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    Lutsk, Ukraine

  • Mirador Therapeutics Selected Site

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    Lviv, Ukraine

  • Mirador Therapeutics Selected Site

    RECRUITING

    Poltava, Ukraine

  • Mirador Therapeutics Selected Site

    RECRUITING

    Vinnytsia, Ukraine

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Other studies related to the condition(s) this trial covers.