Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI1341
TAK-341 · 1 trial · 1 indication
UMSARS Part I (historical review) is a 12-item scale that was adapted from the Unified Parkinson's Disease Rating Scale (UPDRS) and is used to assess activities related to motor disability and autonomic dysfunction. In this study, the UMSARS was modified to exclude the sexual function item. Thus, total 11 items were assessed. Each item was initially scored on a scale from 0 (normal) to 4 (severe); ratings of normal (0) and mild (1) were then combined and recorded as 0, making minimum score 0 and maximum score 3. The investigator rated the average functional situation for the past 2 weeks according to findings from the participant and caregiver interview and indicated the score that best fit with the participant's status. The total score is a sum of scores from all domains and range from 0 to 33. Higher scores indicate worse impairment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received TAK-341 matching placebo intravenous (IV) infusions, once every 4 weeks (Q4W) for 52 weeks. |
| TAK-341 | EXPERIMENTAL | Participants received TAK-341, IV Q4W for 52 weeks. An early set of participants initially received 2400 milligrams (mg) to determine pharmacokinetic (PK) parameters. Following the early participants, a dose of 2000 mg was given until the data from the PK participants became available. All participants then received 2400 mg until the end of treatment at 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TAK-341-matching placebo IV infusion |
| TAK-341 | DRUG | TAK-341 IV infusion |
Inclusion criteria: Diagnostic: 1. The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria. 2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator. 3. Evidence of MSA specifi...
TAK-341 is being developed for the treatment of Multiple System Atrophy, a rare neurological disorder. It is an investigational small molecule and has not been approved for any indication. Takeda Pharmaceutical Company Limited is evaluating it in a Phase 2 clinical program.
TAK-341 targets the orexin 2 receptor, also known as Orexin2R, a G protein-coupled receptor involved in sleep-wake regulation and other central nervous system functions. By acting on this receptor, TAK-341 is designed to modulate orexin signaling in patients with Multiple System Atrophy.
TAK-341 is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. Takeda is the sole sponsor of the clinical program for TAK-341 in Multiple System Atrophy.
TAK-341 is in Phase 2 clinical development for Multiple System Atrophy. The Phase 2 trial has been completed, and TAK-341 remains an investigational drug that has not received regulatory approval for any indication.
TAK-341 has been studied in one Phase 2 clinical trial, NCT05526391, titled A Study of TAK-341 in Treatment of Multiple System Atrophy. This completed trial enrolled 158 participants across the United States, Austria, Denmark, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
TAK-341 is the primary name used for this investigational compound. No alternative names have been established for it in the clinical development program.