CDEK
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viloxazine

Trade name: Qelbree

Small moleculeapproved

Approved

Apr 2, 2021

Viloxazine, sold under the brand name Qelbree among others, is a selective norepinephrine reuptake inhibitor medication that is indicated in the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. It was marketed for almost 30 years as an antidepressant for the treatment of depression before being discontinued and subsequently repurposed as a treatment for ADHD. Viloxazine is taken orally. It was used as an antidepressant in an immediate-release form and is used in ADHD in an extended-release form, although current evidence indicates that it is significantly less effective at reducing ADHD symptoms compared to stimulant medications like methylphenidate. — Wikipedia

Clinical trial activity

15 trials · 4 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
10
Phase 3
8
Phase 4
4

Earliest trial started Oct 1, 2009 (NCT01000870)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Supernus Pharmaceuticals — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2016

    Supernus Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

2020s

  1. Apr 2, 2021

    Supernus Pharmaceuticals — Earliest FDA Approval

  2. Apr 2, 2021

    Supernus Pharmaceuticals — Marketing Organization

  3. Apr 2, 2021

    Supernus Pharmaceuticals — NDA Secondary Org

  4. Apr 2, 2021

    Supernus Pharmaceuticals — NDA Organization

  5. Apr 28, 2026

    Appco Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 2, 2021

Chemistry & pharmacology

Loading structure…

SMILES

CCOc1ccccc1OCC1CNCCO1
Mol. weight
237.3 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 2-((2-ethoxyphenoxy)methyl)morpholine
  • 2-((2-ethoxyphenoxy)methyl)morpholine
  • emovit
  • ici 58834
  • ici 58,834
  • ici-58834
  • ici-58834
  • mni-513-01
  • spn-812
  • viloxazin
  • viloxazina
  • viloxazina
  • viloxazine
  • viloxazine
  • viloxazine
  • viloxazine
  • viloxazine
  • viloxazine
  • viloxazine hcl
  • viloxazine hcl
  • viloxazine hcl
  • viloxazine hydrochloride
  • viloxazine hydrochloride
  • viloxazine hydrochloride
  • viloxazine hydrochloride
  • viloxazine hydrochloride
  • viloxazine hydrochloride
  • viloxazinum
  • viloxazinum
  • vivalan
  • vivalan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06185985Phase 4Jan 31, 2024Supernus Pharmaceuticals
NCT06259331Phase 4May 23, 2023PPD, Supernus Pharmaceuticals
NCT04786990Phase 4Jul 27, 2021Supernus Pharmaceuticals, University of California, San Francisco
NCT04781140Phase 4May 31, 2021Supernus Pharmaceuticals
NCT04143217Phase 3Dec 31, 2019Supernus Pharmaceuticals, University of California, San Francisco
NCT04016779Phase 3Aug 31, 2019Supernus Pharmaceuticals, University of California, San Francisco
NCT04016792Phase 3Aug 31, 2019Supernus Pharmaceuticals, University of California, San Francisco
NCT03247556Phase 3Nov 1, 2017Supernus Pharmaceuticals
NCT03247543Phase 3Oct 31, 2017Supernus Pharmaceuticals
NCT03247530Phase 3Oct 20, 2017Supernus Pharmaceuticals
NCT03247517Phase 3Oct 20, 2017Supernus Pharmaceuticals
NCT02736656Phase 3Apr 1, 2016Supernus Pharmaceuticals
NCT02633527Phase 2Feb 1, 2016Supernus Pharmaceuticals
NCT01107496Phase 1/Phase 2 (Phase 2)Jun 1, 2010Supernus Pharmaceuticals
NCT01000870Early Phase 1 (Phase 1)Oct 1, 2009Institute for Neurodegenerative Disorders
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Supernus PharmaceuticalsFor profit141432010
University of California, San FranciscoAcademic/Hospital4022019
Institute for Neurodegenerative DisordersAcademic/Hospital1112009
PPDFor profit1012023
4 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Appco PharmaFor profitMKTGApr 28, 2026
Supernus PharmaceuticalsFor profitMKTGApr 2, 2021
Supernus PharmaceuticalsFor profitNDA2Apr 2, 2021
Supernus PharmaceuticalsFor profitNDAApr 2, 2021