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TEV-56286

Phase 2

Multiple System Atrophy | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Trials Updated: May 12, 2026

TEV-56286 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since Oct 2024

TEV-56286 target and mechanism

ModalitySmall molecule

Also known as TEV-56286 Test, Emrusolmin

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment550

FDA Designations

No designations recorded

TEV-56286 clinical trials

TEV-56286 · 2 trials · 1 indication

Phase 2 2
NCT06568237A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System AtrophyMultiple System Atrophy
RECRUITING350 Analytics
NCT07197866An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System AtrophyMultiple System Atrophy
RECRUITING200 Analytics
PHASE2RECRUITING
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System AtrophyUnlock trial analytics
PHASE2RECRUITING
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
Multiple System AtrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
Baseline to Week 48

The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).

For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined
Baseline to Week 48

The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).

Number of participants experiencing an adverse event
Baseline to Week 100
Number of participants who withdrew from the trial due to an adverse event
Baseline to Week 100

Secondary Endpoints

For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
Baseline to Week 48
For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)
Baseline to Week 48
Change From Baseline in the UMSARS Part 1 Score
Baseline to Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TEV-56286EXPERIMENTALOrally administered capsules once daily
PlaceboPLACEBO_COMPARATOROrally administered capsules once daily

Interventions

NameTypeDescription
TEV-56286DRUGTEV-56286 capsules administered orally
PlaceboDRUGMatching placebo administered orally
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Eligibility Criteria

Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria * is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination * Females of child bearing p...

Countries:United StatesFranceGermanyIsraelItalyJapanSpain
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Frequently asked questions about TEV-56286

What is TEV-56286 used for?

TEV-56286 is an investigational small molecule being studied for the treatment of Multiple System Atrophy, a rare neurological disorder. It is in Phase 2 clinical development and is not yet approved for any indication. Teva Pharmaceutical Industries Limited is developing the drug.

Who makes TEV-56286?

TEV-56286 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the drug in Multiple System Atrophy.

What phase is TEV-56286 in?

TEV-56286 is in Phase 2 clinical development for Multiple System Atrophy. Both of its trials are Phase 2 studies and both are currently recruiting participants. The drug is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is TEV-56286 in?

TEV-56286 is being evaluated in two Phase 2 trials: NCT06568237, which has an enrollment of 350 participants, and NCT07197866, an extension trial with an enrollment of 200 participants. Both are recruiting and are being conducted in the United States, France, Germany, Israel, Italy, Japan, and Spain.

Is TEV-56286 the same as TEV-56286 Test or TEV-56286 Dose A?

Yes. TEV-56286 Test and TEV-56286 Dose A are alternative names used for TEV-56286, the same investigational small molecule developed by Teva Pharmaceutical Industries Limited for Multiple System Atrophy. Searches using any of these names refer to the same Phase 2 drug candidate.

How is TEV-56286 studied in its clinical trials?

Both Phase 2 trials of TEV-56286 in Multiple System Atrophy are randomized, double-blind, and placebo-controlled. Together they plan to enroll 550 participants aged 30 years and older, across seven countries. The trials do not use biomarker selection, and healthy volunteers are not eligible to participate.