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SEP-225289
SEP-225289 is a Small molecule drug developed by Sumitomo Pharma America, Inc.. It is currently in Phase 2 development. Also known as: Dasotraline.
Dasotraline, also known as SEP-225289, is a small molecule serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), Binge Eating Disorder, and other related conditions. It is being investigated in clinical trials, including a 6-week study in children aged 6 to 12 years, in comparison to a placebo.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Frequently asked questions about SEP-225289
What is SEP-225289?
Who makes SEP-225289?
Is SEP-225289 also known as anything else?
What development phase is SEP-225289 in?
Related
- Manufacturer: Sumitomo Pharma America, Inc. — full pipeline
- Also known as: Dasotraline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing