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New drug emrusolmin tested for Long-Term safety in rare brain disease

NCT ID NCT07197866

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 10 times

Summary

This study is testing the long-term safety of an oral drug called Emrusolmin (TEV-56286) in 200 adults with multiple system atrophy (MSA), a rare and serious brain disorder. Participants who completed a prior trial will take the drug for about 100 weeks. The main goal is to see how many people have side effects or drop out due to side effects.

What this could mean

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

Active substance
Emrusolmin (TEV-56286) taken orally
What this could lead to
If successful, this study could show that Emrusolmin is safe enough to use long-term for multiple system atrophy, potentially slowing disease progression.
What could go wrong
This is an early-phase, open-label extension trial focused on safety, not effectiveness. It is small (200 participants) and may not prove the drug works or is safe for everyone.

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 200 people

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

Started

Sep 2025

Expected to finish

May 2029

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

30 years and older

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: * Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements * Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit * Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP * Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product NOTE - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial * Is of a vulnerable population (eg, people kept in detention or jail) * Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial Note - Additional criteria apply, please contact the investigator for more information

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Conditions

The condition(s) this trial relates to.

multiple system atrophy

As listed by the trial registrant

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

Multiple system atrophy

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

    36 sites in 7 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Teva Investigational Site 15543

    RECRUITING

    Spokane, Washington, 99202, United States

  • Teva Investigational Site 15544

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Teva Investigational Site 15546

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Teva Investigational Site 15548

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Teva Investigational Site 15549

    RECRUITING

    New York, New York, 10016, United States

  • Teva Investigational Site 15551

    RECRUITING

    New York, New York, 10032-3726, United States

  • Teva Investigational Site 15554

    RECRUITING

    La Jolla, California, 92037, United States

  • Teva Investigational Site 15555

    RECRUITING

    Tampa, Florida, 33613, United States

  • Teva Investigational Site 30295

    RECRUITING

    Salerno, 84131, Italy

  • Teva Investigational Site 30296

    RECRUITING

    Roma, 00163, Italy

  • Teva Investigational Site 30297

    RECRUITING

    Catania, 95123, Italy

  • Teva Investigational Site 30298

    RECRUITING

    Milan, 20132, Italy

  • Teva Investigational Site 30299

    RECRUITING

    Bologna, 40139, Italy

  • Teva Investigational Site 31319

    RECRUITING

    Valencia, 46026, Spain

  • Teva Investigational Site 31320

    RECRUITING

    Pamplona, 31008, Spain

  • Teva Investigational Site 31321

    RECRUITING

    Barcelona, 08036, Spain

  • Teva Investigational Site 31322

    RECRUITING

    Seville, 41013, Spain

  • Teva Investigational Site 31323

    RECRUITING

    Barcelona, 08035, Spain

  • Teva Investigational Site 31324

    RECRUITING

    Barcelona, 08025, Spain

  • Teva Investigational Site 32818

    RECRUITING

    Dresden, 01307, Germany

  • Teva Investigational Site 32819

    RECRUITING

    Münster, 48149, Germany

  • Teva Investigational Site 32820

    RECRUITING

    München, 81377, Germany

  • Teva Investigational Site 32822

    RECRUITING

    Düsseldorf, 40225, Germany

  • Teva Investigational Site 32824

    RECRUITING

    Marburg, 35033, Germany

  • Teva Investigational Site 32825

    RECRUITING

    Kassel, 34128, Germany

  • Teva Investigational Site 35289

    NOT_YET_RECRUITING

    Marseille, 13385, France

  • Teva Investigational Site 35290

    RECRUITING

    Bordeaux, 33400, France

  • Teva Investigational Site 35291

    RECRUITING

    Paris, 75651, France

  • Teva Investigational Site 35292

    RECRUITING

    Toulouse, 31059, France

  • Teva Investigational Site 80203

    RECRUITING

    Haifa, 31999, Israel

  • Teva Investigational Site 80204

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Teva Investigational Site 84135

    RECRUITING

    Sendai, 982-8555, Japan

  • Teva Investigational Site 84137

    RECRUITING

    Niigata, 951-8520, Japan

  • Teva Investigational Site 84138

    RECRUITING

    Sagamihara, 252-0392, Japan

  • Teva Investigational Site 84139

    RECRUITING

    Fuchū, 183-0042, Japan

  • Teva Investigational Site 84141

    RECRUITING

    Sanda-shi, 669-1592, Japan

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