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Compound · clinical trials

Viloxazine clinical trials

Also listed in trial records as SPN-812
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our USA register that name Viloxazine as an intervention. Synced 3 Oct 2026
2Current trials
1Recruiting now
1Lead sponsor
1Country register
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov registry records · Last verified · Editorial standards
At a glance

Viloxazine is named as an intervention in 2 current clinical trials in our USA register. 1 is recruiting patients now. The most common phase is Phase 3. The lead sponsor is Supernus Pharmaceuticals, Inc. The most-studied condition is Attention-Deficit/Hyperactivity Disorder.

Where Viloxazine is approved

All regulators →

Of the three regulators tracked here, the first to approve Viloxazine was the US, on 2 Apr 2021.

USUnited States (FDA)
2 Apr 2021
Qelbree
NDA211964 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Viloxazine patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Viloxazine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Qelbree
  • 6 listed patents; the last listed expires 2 Apr 2035 (US 9662338).
See the Orange Book listing for NDA 211964

Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Viloxazine

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$224.5m
461,158 prescriptions in 2025 · Qelbree
+39% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Viloxazine works

All drug targets →

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2106483, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 11502, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Trials by status

  • Recruiting150%
  • Active, closed150%

Trials by phase

  • Phase 3150%
  • Phase 4150%
01

Clinical trials of Viloxazine

2 trials
StudyPhaseStatusLead sponsorRegisters

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Viloxazine

1 condition
Attention-Deficit/Hyperactivity Disorder2
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Supernus Pharmaceuticals, Inc2
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA21

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Viloxazine trials

How many clinical trials are testing Viloxazine?

2 current trials in our USA register name Viloxazine (also registered as SPN-812) as a drug or biological intervention, as of the registry sync on 3 October 2026. Completed and withdrawn studies are not counted.

Are Viloxazine trials recruiting patients?

Yes. 1 of the 2 trials is recruiting: 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Viloxazine clinical trials?

The lead sponsor is Supernus Pharmaceuticals, Inc. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Viloxazine works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Viloxazine works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Viloxazine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 3 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.