Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00679601 | Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II) | PHASE2 | COMPLETED | 20 | — | — | Mar 31, 2007 | May 31, 2007 | Feb 20, 2018 | 1 | United States |
| NCT01278394 | Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail | PHASE2 | COMPLETED | 29 | — | — | Mar 1, 2007 | Jul 1, 2008 | Dec 6, 2018 | 2 | Mexico |
| NCT00680134 | Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis | PHASE2 | COMPLETED | 60 | — | — | Jun 30, 2006 | Aug 31, 2007 | Feb 20, 2018 | 7 | United States |
| NCT00680160 | Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I) | PHASE2 | COMPLETED | 15 | — | — | Apr 30, 2006 | May 9, 2007 | Feb 21, 2019 | 1 | United States |
| NCT00679523 | Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail | PHASE2 | COMPLETED | 60 | — | — | Nov 1, 2005 | Feb 1, 2007 | Nov 14, 2018 | 9 | Mexico |
| NCT00680095 | Cumulative Irritation Test | PHASE1 | COMPLETED | 37 | — | — | Jan 22, 2007 | Feb 19, 2007 | Apr 9, 2019 | 1 | United States |
Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | AN2690 Solution, 5.0% |
| Group/Cohort 1 | EXPERIMENTAL | AN2690 1% Solution (30 subjects) |
| Group/Cohort 2 | EXPERIMENTAL | AN2690 5% Solution (30 subjects) |
| Group 2 | EXPERIMENTAL | AN2690 Solution, 7.5% |
| A | EXPERIMENTAL | AN2690 Solution, 2.5% |
| B | EXPERIMENTAL | AN2690 Solution, 7.5% |
| C | EXPERIMENTAL | AN2690 Solution, 5.0% |
| D | ACTIVE_COMPARATOR | AN2690 Solution, Vehicle |
| E | ACTIVE_COMPARATOR | Sodium Lauryl Sulfate, 0.5% |
| Name | Type | Description |
|---|---|---|
| AN2690 | DRUG | AN2690 7.5% Solution, once daily for 28 days |
| AN2690 Solution, 5.0% | DRUG | Once daily application for 360 days |
| AN2690 Solution, 7.5% | DRUG | Once daily application for 180 days |
| AN2690 Solution, Vehicle | OTHER | AN2690 Solution, Vehicle, Daily for up to 21 days |
| Sodium Lauryl Sulfate, 0.5% | OTHER | Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days |
Inclusion Criteria: * Male or female ≥18 and ≤65 * BMI between 18.5 and 35 inclusive * Moderate to severe onychomycosis involving ≥80% of both great toenails, as determined by visual inspection after the nail has been trimmed * Combined thickness of the nail plate and nail bed of each great toenail...