Acute Otitis Externa
5
Pipeline Programs
4
Companies
5
Clinical Trials
0
Approved Products
Pipeline by Development Stage
Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
5
0
Early DiscoveryClinical DevelopmentMarket
Competitive Landscape
4 companies ranked by most advanced pipeline stage
AlconFORT WORTH, TX
2 programs2
AL-60371, 0.3% otic suspensionPhase 31 trial
Moxidex otic solutionPhase 31 trial
Active Trials
LP
Lee's PharmaceuticalChina - Guangzhou
1 program1
Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic SolutionPhase 31 trial
Active Trials
Trial Timeline
Clinical trial activity over time
2021
2022
2023
2024
2025
2026
Lee's PharmaceuticalCiprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution
SalvatDF289 plus DF277
AlconAL-60371, 0.3% otic suspension
TakedaFST201
AlconMoxidex otic solution
Clinical Trials (5)
Total enrollment: 670 patients across 5 trials
A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)
Start: Nov 2020Est. completion: Jul 2022600 patients
Phase 3Unknown
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Start: Jul 2017Est. completion: Sep 2018
Phase 3Completed
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Start: Apr 2012Est. completion: Oct 2012
Phase 3Completed
FST-201 in the Treatment of Acute Otitis Externa
Start: Aug 2009Est. completion: Jun 201070 patients
Phase 3Completed
A Phase III Study of an Otic Formulation in Acute Otitis Externa
Start: Jun 2008Est. completion: Jan 2009
Phase 3Completed
Phase Legend
Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available
Key Insights
5 late-stage (Phase 3) programs — potential near-term approvals
4 companies competing in this space