Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPD465 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SPD465 (50 or 75 mg) | EXPERIMENTAL | - |
| Immediate Release Amphetamine salt (25 mg) | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SPD465 | DRUG | 50 or 75 mg once daily for 7 days |
| Immediate Release Amphetamine Salt | DRUG | 25 mg once daily for 7 days |
| Placebo | DRUG | Once daily for 7 days |
Inclusion Criteria: * Adult men and non-pregnant women between the ages of 18 and 55 * Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) * Baseline ADHD score of at least 24 Exclusion Criteria: * Weight l...
SPD465 is an investigational small molecule being studied for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
SPD465 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for ADHD.
SPD465 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and effectiveness for treating ADHD.
SPD465 has one completed Phase 2 clinical trial registered as NCT00928148, titled "The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)." The trial enrolled 86 participants and was a randomized, double-blind, placebo-controlled study.
SPD465 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Attention-Deficit/Hyperactivity Disorder. The drug has completed one clinical trial, but it has not received regulatory approval for any use.