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TEV-56286

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment550
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07197866An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System AtrophyPHASE2 RECRUITING 200 — — Sep 30, 2025May 17, 2029May 12, 202618 United States, France +5
NCT06568237A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System AtrophyPHASE2 RECRUITING 350 — — Oct 2, 2024Sep 15, 2027May 4, 202654 United States, France +5
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Study Endpoints
Primary Endpoints
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
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).

Secondary Endpoints
Number of participants with potentially clinically significant vital sign values
Baseline to Week 96
Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)
Baseline to Week 96
Number of participants with potentially clinically significant 12-lead ECG measurements
Baseline to Week 96
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TEV-56286EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOROrally administered capsules once daily
Interventions
NameTypeDescription
TEV-56286DRUGadministered orally
PlaceboDRUGMatching placebo administered orally
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

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 *...

Countries:United StatesFranceGermanyIsraelItalyJapanSpain
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07197866studyFirstPostDate: changed
LOWMay 24, 2026NCT06568237studyFirstPostDate: changed