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zinc oxide

Small moleculeapproved

Approved

Feb 16, 2006

Zinc oxide is an inorganic compound with the formula ZnO. It is a white powder which is insoluble in water. ZnO is used as an additive in numerous materials and products including cosmetics, food supplements, rubbers, plastics, ceramics, glass, cement, lubricants, paints, sunscreens, ointments, adhesives, sealants, pigments, foods, batteries, ferrites, fire retardants, semi conductors, and first-aid tapes. Although it occurs naturally as the mineral zincite, most zinc oxide is produced synthetically. — Wikipedia

Clinical trial activity

16 trials · 16 clinical orgs · 2 marketing orgs

Phase 1
3
Phase 2
5
Phase 3
2
Phase 4
2

Earliest trial started Dec 1, 2012 (NCT02080247)

Timeline

2000s

  1. Feb 16, 2006

    Barrier Therapeutics — Earliest FDA Approval

  2. Feb 16, 2006

    Barrier Therapeutics — NDA Organization

  3. Feb 16, 2006

    Mylan — NDA Secondary Org

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Sunscreen/skin protectant

  • UnclearUnclear

    Unclear unclear

Combination products

Approval history

  • approvedFeb 16, 2006

Chemistry & pharmacology

Loading structure…

SMILES

[O-2].[Zn+2]
Mol. weight
81.39 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Black box warning

Sources

Also known as

  • calmoseptine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06854744N/AJan 15, 2024Tanta University
NCT06158451N/AJan 1, 2024Cairo University
NCT05901961Phase 4Jun 30, 2023Mahidol University
NCT05557812Early Phase 1 (Phase 1)Jan 28, 2023Virginia Commonwealth University
NCT05230797Early Phase 1 (Phase 1)Apr 30, 2022Cairo University
NCT05420805N/AApr 1, 2022Azienda Ospedaliera Universitaria Senese, University of Milan
NCT04505670Phase 2Aug 30, 2020University of Maryland
NCT04071977Phase 2Aug 31, 2019University of Guadalajara
NCT03702374Phase 3Sep 26, 2018Instituto Mexicano del Seguro Social, University of Guadalajara
NCT03561376Early Phase 1 (Phase 1)Sep 1, 2018University of Pittsburgh
NCT03650036Phase 2Jun 4, 2018Federal University of Piaui
NCT03478150N/AApr 1, 2018Cairo University
NCT05865431N/AMar 17, 2017University of California, Davis
NCT02714075N/AApr 30, 2016Swiss Federal Institute of Technology, University for Development Studies, Tamale, Ghana
NCT02716415Phase 4Mar 1, 2015Calmoseptine, Inc., University of the Philippines
NCT02080247Phase 3Dec 1, 2012Calmoseptine, Inc., University of the Philippines
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cairo UniversityAcademic/Hospital3322018
Calmoseptine, Inc.For profit2022012
University of GuadalajaraAcademic/Hospital2222018
University of the PhilippinesAcademic/Hospital2222012
Azienda Ospedaliera Universitaria SeneseAcademic/Hospital1112022
Federal University of PiauiAcademic/Hospital1112018
Instituto Mexicano del Seguro SocialGovernment1012018
Mahidol UniversityAcademic/Hospital1112023
Swiss Federal Institute of TechnologyAcademic/Hospital1112016
Tanta UniversityAcademic/Hospital1112024
University for Development Studies, Tamale, GhanaAcademic/Hospital1012016
University of California, DavisAcademic/Hospital1112017
University of MarylandAcademic/Hospital1112020
University of MilanAcademic/Hospital1012022
University of PittsburghAcademic/Hospital1112018
Virginia Commonwealth UniversityAcademic/Hospital1112023
16 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Barrier TherapeuticsFor profitNDAFeb 16, 2006
MylanFor profitNDA2Feb 16, 2006