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TEV-56286 · 4 trials · 2 indications
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).
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).
| Arm | Type | Description |
|---|---|---|
| TEV-56286 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Orally administered capsules once daily |
| Cohort 1 | EXPERIMENTAL | Random sequence of test and reference formulations |
| Cohort 2 | EXPERIMENTAL | Random sequence of test and reference formulations |
| Name | Type | Description |
|---|---|---|
| TEV-56286 | DRUG | administered orally |
| Placebo | DRUG | Matching placebo administered orally |
| TEV-56286 Test | DRUG | Administered orally |
| TEV-56286 Reference | DRUG | Administered orally |
| [14C]-TEV-56286 | DRUG | Oral capsule |
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 *...
TEV-56286 is an investigational small molecule being studied for the treatment of Multiple System Atrophy (MSA) in adult patients aged 30 years and older. It is also being evaluated in healthy participants for early-phase clinical trials, including mass balance and formulation studies. The drug is currently in clinical development and is not approved by regulatory authorities.
The specific molecular target of TEV-56286 has not been disclosed in available clinical trial information. As a small molecule, it is being investigated for its potential to modify the course of Multiple System Atrophy, a rare neurodegenerative disorder. Its mechanism of action remains under evaluation in ongoing and completed clinical studies.
TEV-56286 is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol TEVA. Teva is conducting clinical trials for this drug across multiple countries, including the United States, France, Germany, Israel, Italy, Japan, and Spain.
TEV-56286 is in Phase 1 and Phase 2 clinical development. The Phase 1 trials, which include mass balance and formulation studies in healthy participants, have been completed. Two Phase 2 trials in patients with Multiple System Atrophy are currently recruiting participants. The drug is investigational and has not received FDA approval.
TEV-56286 is being studied in four clinical trials. NCT06568237 is a Phase 2 trial in Multiple System Atrophy with 350 participants, currently recruiting. NCT07197866 is a Phase 2 extension trial with 200 participants, also recruiting. NCT06627231 and NCT06911567 are completed Phase 1 trials in healthy participants.
No alternative names for TEV-56286 have been disclosed in the available clinical trial information. The drug is identified solely by its development code, TEV-56286, in all registered trials. It is a distinct investigational compound being developed by Teva Pharmaceutical Industries for Multiple System Atrophy.