Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AN2690 · 10 trials · 3 indications
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
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 |
|---|---|---|
| AN2690 Topical Solution, 5% | EXPERIMENTAL | AN2690 Topical Solution, 5% |
| Solution Vehicle | PLACEBO_COMPARATOR | Solution Vehicle |
| Group 1 | EXPERIMENTAL | AN2690 Solution, 5.0% |
| Group 2 | EXPERIMENTAL | AN2690 Solution: 5% |
| Group 3 | EXPERIMENTAL | AN2690 Solution: 7.5% |
| Group 4 | PLACEBO_COMPARATOR | AN2690 Solution Vehicle |
| Group/Cohort 1 | EXPERIMENTAL | AN2690 1% Solution (30 subjects) |
| Group/Cohort 2 | EXPERIMENTAL | AN2690 5% Solution (30 subjects) |
| 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 Topical Solution, 5% | DRUG | AN2690 Topical Solution, 5%, applied once daily for 48 weeks |
| Solution Vehicle | DRUG | AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks |
| AN2690 | DRUG | AN2690 7.5% Solution, once daily for 28 days |
| AN2690 Solution, 5.0% | DRUG | Once daily application for 360 days |
| AN2690, 2.5% | DRUG | Once daily application for 90 days and 3 x weekly for 90 days |
| AN2690, 5% | DRUG | Once daily application for 90 days and 3 x weekly for 90 days |
| AN2690, 7.5% | DRUG | Once daily application for 90 days and 3 x weekly for 90 days |
| Vehicle | DRUG | Once daily application for 90 days and 3x weekly for 90 days |
| AN2690 Solution Vehicle | DRUG | Once daily application for 90 days and 3x weekly for 90 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: * Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail * KOH positive at screening * Willingness not to use any other products including nail polish applied to the toenails during the study * Women of childbearing potential who are currently ...
AN2690 is an investigational topical treatment being studied for onychomycosis, a fungal infection of the nails. The development program focuses on distal, subungual onychomycosis and onychomycosis of the toenails, including the great toenail. It is applied as a topical solution rather than taken orally.
AN2690 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer has sponsored the clinical trial program evaluating the topical solution in patients with toenail onychomycosis across multiple study sites in the United States, Canada, and Mexico.
AN2690 is in Phase 2 development for onychomycosis, and it is investigational rather than approved. The program includes completed Phase 2 and Phase 3 trials, but the drug has not been cleared for marketing. All six of its registered trials are listed as completed, with none currently active.
Six completed trials have evaluated AN2690, including NCT01302119 and NCT01270971, two Phase 3 studies of the topical solution in toenail onychomycosis that together enrolled about 1,198 patients. Earlier studies include NCT01278394 in Mexico and NCT00680160, a Phase 2 absorption study in moderate to severe onychomycosis.
Yes. AN2690 Topical Solution is the same investigational product as AN2690. The names AN2690 Solution, 5.0%, AN2690, 5.0%, AN2690, 2.5%, AN2690 Topical Solution, 5%, and AN2690, 5% refer to the same topical solution formulations and strengths studied in the onychomycosis program.
The AN2690 trials were randomized, double-blind, and placebo-controlled, enrolling adults 18 years and older with onychomycosis. The largest studies were Phase 3 trials of the topical solution in toenail onychomycosis conducted in the United States and Canada, while a smaller Phase 2 study was run in Mexico.