Last reviewed · How we verify
SPN-812
At a glance
| Generic name | SPN-812 |
|---|---|
| Also known as | viloxazine extended-release capsules (Qelbree), viloxazine extended-release capsules, Qelbree, Viloxazine extended-release capsules |
| Sponsor | Supernus Pharmaceuticals, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms (PHASE4)
- Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD (PHASE4)
- Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) (PHASE3)
- Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women (PHASE4)
- Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD (PHASE4)
- Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD (PHASE3)
- Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD (PHASE3)
- Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD (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:
- SPN-812 CI brief — competitive landscape report
- SPN-812 updates RSS · CI watch RSS
- Supernus Pharmaceuticals, Inc. portfolio CI