sertaconazole
Trade name: ertaczo
Approved
Dec 10, 2003
Sertaconazole is a azole antifungal that is FDA approved for the treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. Sertaconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Common adverse reactions include contact dermatitis, dry skin, burning skin and application site skin tenderness. — NCATS
Clinical trial activity
2 trials · 3 clinical orgs · 2 marketing orgs
Earliest trial started Mar 1, 2009 (NCT00856596)
Timeline
2000s
- Dec 10, 2003
Mylan — Earliest FDA Approval
- Dec 10, 2003
Bausch Health Companies — NDA Secondary Org
- Dec 10, 2003
Mylan — NDA Organization
- Jan 1, 2009
Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2013
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Cytochrome P450 51INHIBITOR
ERG11 inhibitor
Approval history
- approvedDec 10, 2003
Chemistry & pharmacology
SMILES
Clc1ccc(C(Cn2ccnc2)OCc2csc3c(Cl)cccc23)c(Cl)c1- Mol. weight
- 437.78 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL1201196 ↗
- WikipediaSertaconazole ↗
- NCATS72W71I16EG ↗
- ChEMBLCHEMBL1200725 ↗
Also known as
- demofix
- demofix
- demofix
- dermofix
- dermofix
- dermofix
- dermoseptic
- ertaczo
- ertaczo
- ertaczo
- fi 7045
- fi-7045
- ginedermofix
- mykosert
- sertaconazol
- sertaconazol
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole
- sertaconazole nitrate
- sertaconazole nitrate
- sertaconazole nitrate
- sertaconazole nitrate
- sertaconazole nitrate
- sertaconazolum
- sertaconazolum
- zalain
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01792713 | Phase 2 | Feb 1, 2013 | Spirig Pharma Ltd. |
| NCT00856596 | Phase 3 | Mar 1, 2009 | Jamaica Hospital Medical Center, Johnson and Johnson |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Jamaica Hospital Medical Center | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Johnson and Johnson | For profit | 1 | 0 | 1 | 2009 |
| Spirig Pharma Ltd. | For profit | 1 | 1 | 1 | 2013 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch Health Companies | For profit | NDA2 | Dec 10, 2003 |
| Bausch Health Companies | For profit | SYN | Dec 10, 2003 |
| Mylan | For profit | NDA | Dec 10, 2003 |