talc
Trade name: sclerosol
Approved
Dec 24, 1997
Talc, or talcum, is a clay mineral composed of hydrated magnesium silicate, with the chemical formula Mg3Si4O10(OH)2. Talc in powdered form, often combined with corn starch, is used as baby powder. This mineral is used as a thickening agent and lubricant. It is an ingredient in ceramics, paints, and roofing material. It is a main ingredient in many cosmetics. It occurs as foliated to fibrous masses, and in an exceptionally rare crystal form. It has a perfect basal cleavage and an uneven flat fracture, and it is foliated with a two-dimensional platy form. — Wikipedia
Clinical trial activity
12 trials · 19 clinical orgs · 3 marketing orgs
Earliest trial started Dec 1, 1994 (NCT00002622)
Timeline
1990s
- Jan 1, 1994
Earliest Phase 3 Sponsor(trial)
- Sep 18, 1995
Orphan Drug Designation
- Dec 24, 1997
Lymol Medical — Earliest FDA Approval
- Dec 24, 1997
Lymol Medical — NDA Organization
- Dec 24, 1997
Lymol Medical — NDA Secondary Org
- Dec 24, 1997
Sciarra Labs — Marketing Organization
- Dec 24, 1997
Sciarra Labs — NDA Secondary Org
2000s
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2016
Earliest Phase 1 Sponsor(trial)
- May 1, 2017
Novatech SA — NDA Secondary Org
Indications
Approved for
Mechanism of action
- UnclearUnclear
Unclear unclear
Approval history
- approvedPriority reviewDec 24, 1997
Chemistry & pharmacology
SMILES
O=[Mg].O=[Mg].O=[Mg].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O- Mol. weight
- 361.25 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- Yes
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3990276 ↗
- WikipediaTalc ↗
- ChEMBLCHEMBL3989756 ↗
- ChEMBLCHEMBL1200568 ↗
Also known as
- e553b
- e553b
- sclerosol
- sclerosol
- talc
- talc
- talc
- talc
- talc
- talc
- talcum
- talcum
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04806373 | Phase 4 | Jun 15, 2021 | Genentech, Memorial Healthcare System |
| NCT04792970 | Phase 4 | Mar 18, 2021 | Duke University |
| NCT03973957 | N/A | May 27, 2019 | Cooper Human Systems |
| NCT02825095 | Early Phase 1 (Phase 1) | Aug 1, 2016 | Technion University |
| NCT02674243 | Phase 3 | Nov 1, 2015 | Chiangmai University |
| NCT02839408 | Phase 2 | Jun 1, 2015 | University of Chile |
| NCT01017315 | Phase 3 | Jul 1, 2009 | Prince of Songkla University |
| NCT00530452 | Phase 2 | Oct 1, 2007 | CrystalGenomics, Inc., IQVIA |
| NCT00821860 | Phase 3 | Sep 30, 2003 | Papworth Hospital NHS Foundation Trust |
| NCT00042770 | Phase 3 | May 31, 2002 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT00002872 | Phase 3 | Nov 1, 1996 | Eastern Cooperative Oncology Group, Mayo Clinic, National Cancer Institute (NCI), North Central Cancer Treatment Group, University of South Florida |
| NCT00002622 | Phase 3 | Dec 1, 1994 | Eastern Cooperative Oncology Group, National Cancer Institute (NCI), North Central Cancer Treatment Group, Radiation Therapy Oncology Group, University of California, Los Angeles |
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 3 | 2 | 1 | 1994 |
| Eastern Cooperative Oncology Group | Academic/Hospital | 2 | 1 | 1 | 1994 |
| North Central Cancer Treatment Group | Academic/Hospital | 2 | 0 | 1 | 1994 |
| Chiangmai University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Cooper Human Systems | For profit | 1 | 1 | 1 | 2019 |
| CrystalGenomics, Inc. | For profit | 1 | 1 | 1 | 2007 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Genentech | For profit | 1 | 0 | 1 | 2021 |
| IQVIA | For profit | 1 | 0 | 1 | 2007 |
| Mayo Clinic | Academic/Hospital | 1 | 0 | 1 | 1996 |
| Memorial Healthcare System | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Papworth Hospital NHS Foundation Trust | Academic/Hospital | 1 | 1 | 1 | 2003 |
| Prince of Songkla University | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Radiation Therapy Oncology Group | Academic/Hospital | 1 | 0 | 1 | 1994 |
| State University of New York, Buffalo | Academic/Hospital | 1 | 0 | 1 | 2002 |
| Technion University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| University of California, Los Angeles | Academic/Hospital | 1 | 0 | 1 | 1994 |
| University of Chile | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of South Florida | Academic/Hospital | 1 | 0 | 1 | 1996 |
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Lymol Medical | For profit | NDA | Dec 24, 1997 |
| Lymol Medical | For profit | NDA2 | Dec 24, 1997 |
| Novatech SA | For profit | NDA2 | May 1, 2017 |
| Sciarra Labs | For profit | MKTG | Dec 24, 1997 |
| Sciarra Labs | For profit | NDA2 | Dec 24, 1997 |