Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AN2690 · 6 trials · 1 indication
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...
AN2690 is an investigational small molecule being developed for the treatment of onychomycosis, a fungal infection of the nail. It is specifically studied for distal, subungual onychomycosis and onychomycosis of the toenails. The drug is administered as a topical solution.
AN2690 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored clinical trials evaluating the drug's safety and efficacy in patients with onychomycosis of the toenail.
AN2690 is in Phase 2 clinical development. While some completed trials were Phase 1 and Phase 3, the current development stage is Phase 2. The drug is investigational and has not been approved by regulatory authorities.
AN2690 has been studied in six completed clinical trials with a total enrollment of 1,198 participants. Key trials include NCT00679523, a Phase 2 study in Mexico, and NCT01270971 and NCT01302119, both Phase 3 studies in the United States and Canada.
AN2690 is the investigational code name for the drug also known as tavaborole. Pfizer has studied this topical antifungal under both names in clinical trials for onychomycosis of the toenails.