titanium

Small moleculeapproved

Approved

Oct 5, 2006

Titanium dioxide, also known as titanium(IV) oxide or titania, is the naturally occurring oxide of titanium, chemical formula TiO 2. When used as a pigment, it is called titanium white, Pigment White 6 (PW6), or CI 77891. Generally it is sourced from ilmenite, rutile and anatase. It has a wide range of applications, from paint to sunscreen to food coloring. When used as a food coloring, it has E number E171. World production in 2014 exceeded 9 million metric tons. Titanium dioxide has excellent ultraviolet (UV) resistant qualities and acts as a UV absorbent. In the pharmaceutical industry, titanium dioxide is used in most sunscreens to block UVA and UVB rays, similar to zinc oxide. It is also commonly used as pigment for pharmaceutical products such as gelatin capsules, tablet coatings and syrups. In the cosmetics industry, it is used in toothpaste, lipsticks, creams, ointments and powders. It can be used as an opacifier to make pigments opaque. The FDA has approved the safety of titanium dioxide for use as a colorant in food, drugs and cosmetics, including sunscreens. However, controversy exists as to the safety of titanium dioxide nanoparticles used in the cosmetics industry, for example in sunscreens. Titanium and zinc oxides may be made into the nanoparticle size (0.2-100 nanometers) to reduce the white appearance when applied topically, but retain the UV blocking properties. Recent studies suggest titanium dioxide nanoparticles may be toxic, although further research is needed. — NCATS

Clinical trial activity

38 trials · 37 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
26
Phase 3
10
Phase 4
2

Earliest trial started Sep 1, 2001 (NCT00152217)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  4. Oct 5, 2006

    Sanofi-Aventis — Earliest FDA Approval

  5. Oct 5, 2006

    L'Oreal — NDA Secondary Org

  6. Oct 5, 2006

    Sanofi-Aventis — NDA Secondary Org

  7. Oct 5, 2006

    Sanofi-Aventis — NDA Organization

Indications

Mechanism of action

  • Unspecified targetUnclear

    Unclear

Combination products

Approval history

  • approvedOct 5, 2006

Chemistry & pharmacology

Loading structure…

SMILES

[Ti]
Mol. weight
47.867 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • anatase
  • anatase titanium dioxide
  • brookite
  • dundee
  • e171
  • e171
  • e45 sun
  • nano-anatase
  • nano-tio2
  • reflectant
  • rutile
  • siccolam
  • ti(5)si(3)
  • titania
  • titanium
  • titanium
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium dioxide
  • titanium disilicide
  • titanium oxide
  • titanium oxide
  • titanium silicate
  • titanium silicide
  • titanium white
  • ts-1
  • ts-1
  • ts-1

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05890469N/ADec 1, 2023QMUL, University of London, University of Zurich
NCT06025084Phase 1Dec 1, 2022Al Azhar University
NCT04365270Phase 3Jan 15, 2019Ain Shams University, British University In Egypt
NCT03666195N/AOct 15, 2018Cairo University
NCT05574751N/ASep 1, 2018Damanhour University
NCT03060655Phase 2Aug 1, 2016Hebei University
NCT02754180Phase 2Mar 1, 2016Tsinghua University
NCT01761461Phase 3Feb 6, 2013Sungkyunkwan University
NCT01695356Phase 4Sep 1, 2012Universidad Autonoma de San Luis Potosi
NCT01874678N/AMar 1, 2011TTY Biopharm
NCT01228045Phase 2Feb 1, 2011Government of Singapore, National University of Singapore
NCT01100801Phase 2Jul 1, 2010Government of Singapore, National University of Singapore, Yonsei University
NCT01736410Phase 2May 1, 2010Government of Singapore
NCT01096199Phase 1Mar 29, 2010National University of Singapore
NCT01021787Phase 4Dec 1, 2009L'Oreal
NCT01269255Phase 1Dec 1, 2009Yonsei University
NCT01131689Phase 1Sep 1, 2009Sungkyunkwan University
NCT01286766Phase 2Sep 1, 2009Yonsei University
NCT00874328Phase 1/Phase 2 (Phase 2)Oct 1, 2008Jeil Pharmaceutical Co., Ltd., National Cancer Center, Korea, The National Cancer Center
NCT01269216Phase 2Oct 1, 2008Yonsei University
Showing 20 of 38 trials
Page 1 / 2

Organizations

Research & Development (37)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Sungkyunkwan UniversityAcademic/Hospital5432006
Yonsei UniversityAcademic/Hospital5322007
Government of SingaporeGovernment3112010
Hokkaido UniversityAcademic/Hospital3322004
L'OrealFor profit3322006
National Cancer Center, KoreaGovernment3212007
National University of SingaporeAcademic/Hospital3322010
OtsukaFor profit3312001
Hyogo Medical UniversityAcademic/Hospital2012001
Seoul National UniversityAcademic/Hospital2112006
TTY BiopharmFor profit2122007
Ain Shams UniversityAcademic/Hospital1112019
Al Azhar UniversityAcademic/Hospital1012022
British University In EgyptAcademic/Hospital1012019
Cairo UniversityAcademic/Hospital1112018
Cornell UniversityAcademic/Hospital1112008
Damanhour UniversityAcademic/Hospital1112018
Government of JapanGovernment1012005
Hebei UniversityAcademic/Hospital1112016
Hill Top ResearchFor profit1012006
37 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
L'OrealFor profitNDA2Oct 5, 2006
Sanofi-AventisFor profitNDA2Oct 5, 2006
Sanofi-AventisFor profitNDAOct 5, 2006