Last reviewed · How we verify
SEP-225289
At a glance
| Generic name | SEP-225289 |
|---|---|
| Also known as | Dasotraline |
| Sponsor | Sumitomo Pharma America, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Dasotraline Pediatric ADHD Study (PHASE2, PHASE3)
- A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting. (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting. (PHASE3)
- Open-label Safety Study in Adults With ADHD (PHASE3)
- Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction (PHASE1)
- Dasotraline SEP360-105 Pediatric PK/PD Study (PHASE1)
- Adult Attention Deficit Hyperactivity Disorder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SEP-225289 CI brief — competitive landscape report
- SEP-225289 updates RSS · CI watch RSS
- Sumitomo Pharma America, Inc. portfolio CI