titanium
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
Earliest trial started Sep 1, 2001 (NCT00152217)
Timeline
2000s
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
- Oct 5, 2006
Sanofi-Aventis — Earliest FDA Approval
- Oct 5, 2006
L'Oreal — NDA Secondary Org
- Oct 5, 2006
Sanofi-Aventis — NDA Secondary Org
- Oct 5, 2006
Sanofi-Aventis — NDA Organization
Indications
Approved for
Studied for
- Biliary Tract Neoplasms · Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma, Hepatocellular · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 1/Phase 2
- Colorectal Neoplasms · Phase 3
- Dental Caries · Phase 3
- Dentin Sensitivity · Phase 1
- Dermatology · Phase 2/Phase 3
- Fracture Dislocation · Phase 2
- Melanosis · Phase 4
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 1
- Nerve Sheath Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 3
- Pulpitis · Phase 3
- Rectal Neoplasms · Phase 2
- Stomach Neoplasms · Phase 3
- Sunburn · Phase 4
- Tumor Suppressor Protein p53 · Phase 2
- Urticaria · Phase 2
Mechanism of action
- Unspecified targetUnclear
Unclear
Combination products
anthelios
with octocrylene, avobenzone, ecamsule
Approval history
- approvedOct 5, 2006
Chemistry & pharmacology
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
- WikipediaTitanium oxide ↗
- NCATSD1JT611TNE ↗
- ChEMBLCHEMBL1201136 ↗
- WikipediaTitanium dioxide ↗
- WikipediaTitanium ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05890469 | N/A | Dec 1, 2023 | QMUL, University of London, University of Zurich |
| NCT06025084 | Phase 1 | Dec 1, 2022 | Al Azhar University |
| NCT04365270 | Phase 3 | Jan 15, 2019 | Ain Shams University, British University In Egypt |
| NCT03666195 | N/A | Oct 15, 2018 | Cairo University |
| NCT05574751 | N/A | Sep 1, 2018 | Damanhour University |
| NCT03060655 | Phase 2 | Aug 1, 2016 | Hebei University |
| NCT02754180 | Phase 2 | Mar 1, 2016 | Tsinghua University |
| NCT01761461 | Phase 3 | Feb 6, 2013 | Sungkyunkwan University |
| NCT01695356 | Phase 4 | Sep 1, 2012 | Universidad Autonoma de San Luis Potosi |
| NCT01874678 | N/A | Mar 1, 2011 | TTY Biopharm |
| NCT01228045 | Phase 2 | Feb 1, 2011 | Government of Singapore, National University of Singapore |
| NCT01100801 | Phase 2 | Jul 1, 2010 | Government of Singapore, National University of Singapore, Yonsei University |
| NCT01736410 | Phase 2 | May 1, 2010 | Government of Singapore |
| NCT01096199 | Phase 1 | Mar 29, 2010 | National University of Singapore |
| NCT01021787 | Phase 4 | Dec 1, 2009 | L'Oreal |
| NCT01269255 | Phase 1 | Dec 1, 2009 | Yonsei University |
| NCT01131689 | Phase 1 | Sep 1, 2009 | Sungkyunkwan University |
| NCT01286766 | Phase 2 | Sep 1, 2009 | Yonsei University |
| NCT00874328 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2008 | Jeil Pharmaceutical Co., Ltd., National Cancer Center, Korea, The National Cancer Center |
| NCT01269216 | Phase 2 | Oct 1, 2008 | Yonsei University |
Organizations
Research & Development (37)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sungkyunkwan University | Academic/Hospital | 5 | 4 | 3 | 2006 |
| Yonsei University | Academic/Hospital | 5 | 3 | 2 | 2007 |
| Government of Singapore | Government | 3 | 1 | 1 | 2010 |
| Hokkaido University | Academic/Hospital | 3 | 3 | 2 | 2004 |
| L'Oreal | For profit | 3 | 3 | 2 | 2006 |
| National Cancer Center, Korea | Government | 3 | 2 | 1 | 2007 |
| National University of Singapore | Academic/Hospital | 3 | 3 | 2 | 2010 |
| Otsuka | For profit | 3 | 3 | 1 | 2001 |
| Hyogo Medical University | Academic/Hospital | 2 | 0 | 1 | 2001 |
| Seoul National University | Academic/Hospital | 2 | 1 | 1 | 2006 |
| TTY Biopharm | For profit | 2 | 1 | 2 | 2007 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Al Azhar University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| British University In Egypt | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Cairo University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Damanhour University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Government of Japan | Government | 1 | 0 | 1 | 2005 |
| Hebei University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Hill Top Research | For profit | 1 | 0 | 1 | 2006 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| L'Oreal | For profit | NDA2 | Oct 5, 2006 |
| Sanofi-Aventis | For profit | NDA2 | Oct 5, 2006 |
| Sanofi-Aventis | For profit | NDA | Oct 5, 2006 |