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AN2690, 5%

Phase 3

Onychomycosis of Toenails | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Apr 3, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,198

FDA Designations

No designations recorded

Clinical trial landscape

AN2690, 5% · 2 trials · 1 indication

Phase 3 2
NCT01302119Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the ToenailOnychomycosis of Toenails
COMPLETED604 Analytics
NCT01270971Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the ToenailOnychomycosis of Toenails
COMPLETED594 Analytics
PHASE3COMPLETED
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Onychomycosis of ToenailsUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Onychomycosis of ToenailsUnlock trial analytics

Study Endpoints

Primary Endpoints

Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Week 52

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.

Secondary Endpoints

Completely Clear or Almost Clear Target Great Toenail at Week 52
Week 52
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Week 52
Negative Mycology of Target Great Toenail at Week 52
Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AN2690 Topical Solution, 5%EXPERIMENTALAN2690 Topical Solution, 5%
Solution VehiclePLACEBO_COMPARATORSolution Vehicle

Interventions

NameTypeDescription
AN2690 Topical Solution, 5%DRUGAN2690 Topical Solution, 5%, applied once daily for 48 weeks
Solution VehicleDRUGAN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

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 ...

Countries:United StatesCanada
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Frequently asked questions about AN2690, 5%

What is AN2690 used for?

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.

Who makes AN2690?

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.

What phase is AN2690 in?

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.

What clinical trials is AN2690 in?

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.

Is AN2690 the same as tavaborole?

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.