econazole
Trade name: spectazole
Approved
Dec 23, 1982
Econazole (commonly used as the nitrate salt) is an antifungal medication of the imidazole class. It is a broad spectrum antimycotic with some action against Gram positive bacteria. It is used topically in dermatomycoses also orally and parenterally. Sold under the brand name Ecoza among others, it is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Econazole 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. Econazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis. — NCATS
Clinical trial activity
8 trials · 8 clinical orgs · 13 marketing orgs
Earliest trial started Sep 1, 2006 (NCT00385502)
Timeline
1980s
2000s
- Nov 26, 2002
CASI Pharmaceuticals, Inc. — Marketing Organization
- Nov 26, 2002
Taro Pharmaceuticals — Marketing Organization
- Nov 26, 2002
Chartwell Pharmaceuticals — Marketing Organization
- Jun 23, 2004
Perrigo — Marketing Organization
- Jun 23, 2004
Padagis Us — Marketing Organization
- Dec 17, 2004
Pharmaceutical Associates — Marketing Organization
- Dec 17, 2004
Teligent Pharmaceuticals — Marketing Organization
- Dec 17, 2004
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2011
Earliest Phase 3 Sponsor(trial)
- Oct 24, 2013
Glenmark Pharmaceuticals — NDA Secondary Org
- Oct 24, 2013
Resilia Pharms — Marketing Organization
- Oct 24, 2013
Resilia Pharms — NDA Secondary Org
- Jan 1, 2015
Earliest Phase 1 Sponsor(trial)
- Apr 18, 2018
Mylan — Marketing Organization
- Apr 18, 2018
Aurobindo Pharma — Marketing Organization
Indications
Approved for
Mechanism of action
- Cytochrome P450 51INHIBITOR
ERG11 inhibitor
Approval history
- approvedDec 23, 1982
Chemistry & pharmacology
SMILES
Clc1ccc(COC(Cn2ccnc2)c2ccc(Cl)cc2Cl)cc1- Mol. weight
- 381.69 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
- ChEMBLCHEMBL808 ↗
- WikipediaEconazole ↗
- NCATS6Z1Y2V4A7M ↗
- ChEMBLCHEMBL1201049 ↗
Also known as
- 1-(2,4-dichloro-beta-((p-chlorobenzyl)oxy)phenethyl)imidazole
- 1-(2,4-dichloro-beta-((p-chlorobenzyl)oxy)phenethyl)imidazole
- econazole
- econazole
- econazole
- econazole
- econazole
- econazole
- econazole
- econazole
- econazole
- econazole
- (+-)-econazole
- (+-)-econazole
- econazole nitrate
- econazole nitrate
- econazole nitrate
- econazole nitrate
- econazole nitrate
- econazole nitrate
- ecostatin
- ecostatin
- ecostatin
- ecostatin-1
- ecostatin twin pack
- gyno-pevaryl
- gyno-pevaryl
- gyno-pevaryl 150
- gyno-pevaryl 150
- gyno-pevaryl 1 cp pack
- gyno-pevaryl once
- micofugal
- pevaryl
- pevaryl
- r-14827
- r-14827
- spectazole
- spectazole
- spectazole
- sq-13050
- sq-13050
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03129321 | Phase 3 | Mar 15, 2016 | DPT Laboratories, Mylan |
| NCT02720783 | Phase 1 | Mar 4, 2016 | Angelini, Cross Research S.A. |
| NCT02713893 | Phase 1 | Sep 1, 2015 | Angelini, Cross Research S.A. |
| NCT01696799 | Phase 2 | Sep 1, 2011 | AmDerma |
| NCT01358240 | Phase 3 | Jun 1, 2011 | AmDerma, Therapeutics, Inc. |
| NCT01353976 | Phase 3 | May 1, 2011 | AmDerma, Therapeutics, Inc. |
| NCT00768599 | Phase 2 | Mar 1, 2008 | AmDerma |
| NCT00385502 | Phase 2 | Sep 1, 2006 | BioStrategics Consulting Ltd, MacroChem Corporation |
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AmDerma | For profit | 4 | 4 | 2 | 2008 |
| Angelini | For profit | 2 | 2 | 1 | 2015 |
| Cross Research S.A. | For profit | 2 | 0 | 1 | 2015 |
| Therapeutics, Inc. | For profit | 2 | 0 | 1 | 2011 |
| BioStrategics Consulting Ltd | For profit | 1 | 0 | 1 | 2006 |
| DPT Laboratories | For profit | 1 | 0 | 1 | 2016 |
| MacroChem Corporation | For profit | 1 | 1 | 1 | 2006 |
| Mylan | For profit | 1 | 1 | 1 | 2016 |
Marketing (19)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alvogen | For profit | NDA2 | Dec 23, 1982 |
| Alvogen | For profit | NDA | Dec 23, 1982 |
| Alvogen | For profit | SYN | Dec 23, 1982 |
| Aurobindo Pharma | For profit | MKTG | Apr 18, 2018 |
| CASI Pharmaceuticals, Inc. | For profit | MKTG | Nov 26, 2002 |
| Chartwell Pharmaceuticals | For profit | MKTG | Nov 26, 2002 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Dec 17, 2004 |
| Glenmark Pharmaceuticals | For profit | NDA2 | Oct 24, 2013 |
| Mylan | For profit | MKTG | Apr 18, 2018 |
| Mylan | For profit | SYN | Apr 18, 2018 |
| Padagis Us | For profit | MKTG | Jun 23, 2004 |
| Perrigo | For profit | MKTG | Jun 23, 2004 |
| Perrigo | For profit | SYN | Jun 23, 2004 |
| Pharmaceutical Associates | For profit | MKTG | Dec 17, 2004 |
| Resilia Pharms | For profit | MKTG | Oct 24, 2013 |
| Resilia Pharms | For profit | NDA2 | Oct 24, 2013 |
| Taro Pharmaceuticals | For profit | MKTG | Nov 26, 2002 |
| Teligent Pharmaceuticals | For profit | MKTG | Dec 17, 2004 |
| Teligent Pharmaceuticals | For profit | SYN | Dec 17, 2004 |