NCT07678827 Viloxazine Hydrochloride Attention Deficit Disorder With Hyperactivity Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07678827 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07678827 is a hot trial to watch
Attention Deficit Disorder With Hyperactivity is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07678827 is notable because it evaluates Viloxazine Hydrochloride in a Phase 3 design sponsored by Alvogen Korea Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07678827 |
| Official title | A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD (AK-D101_BS) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Viloxazine Hydrochloride |
| Sponsor | Alvogen Korea Co., Ltd. |
| Geography | South Korea |
| Enrollment | 156 |
| Primary endpoint | Change From Baseline to Week 8 in K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) Total Score |
| Endpoint time frame | Baseline to Week 8, End of Treatment |
| Primary completion / readout proxy | 2027-09-01 |
Protocol design and endpoint interpretation
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter bridging clinical trial designed to evaluate the efficacy and safety of viloxazine extended-release capsules (AK-D101) compared with placebo in Korean children and adolescents aged 6 to 17 years with attention-deficit/hyperactivity disorder (ADHD). Eligible participants will be randomized in a 1:1 ratio to receive AK-D101 or placebo once daily for 8 weeks. Randomization will be stratified by study site and age group (children aged 6 to 11 years and adolescents aged 12 to 17 years). The primary efficacy endpoint is the change from baseline to Week 8, End of Treatment, in the Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score.
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of 156 participants across South Korea shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Change From Baseline to Week 8 in K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) Total Score (Baseline to Week 8, End of Treatment) — The Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score is used to assess ADHD symptoms. The total score ranges from 0 to 54, with higher scores indicating more severe ADHD symptoms. A negative change from baseline indicates improvement.
Readout outlook and evidence gap
The current protocol points to 2027-09-01 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Trial-sourced asset: Viloxazine Hydrochloride. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: Alvogen Korea Co., Ltd.. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07678827 provides a focused lens on Attention Deficit Disorder With Hyperactivity development. Its value will be determined by whether Viloxazine Hydrochloride can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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