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Acute Otitis Externa

3
Pipeline Programs
4
Companies
6
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
3
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Alcon
AlconFORT WORTH, TX
3 programs
3
AL-60371, 0.3% Otic SuspensionPhase 31 trial
AL-60371, 0.3% otic suspensionPhase 31 trial
Moxidex otic solutionPhase 31 trial
Active Trials
NCT01535599Completed768Est. May 2013
NCT01535560Completed589Est. Oct 2012
NCT00750633Completed990Est. Jan 2009
Lee's Pharmaceutical
Lee's PharmaceuticalChina - Guangzhou
1 program
Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic SolutionPHASE_31 trial
Active Trials
NCT04636957Unknown600Est. Jul 2022
Salvat
SalvatFL - Miami
1 program
DF289 plus DF277PHASE_31 trial
Active Trials
NCT03196973Completed493Est. Sep 2018
Takeda
TakedaTOKYO, Japan
1 program
FST201PHASE_31 trial
Active Trials
NCT00961675Completed70Est. Jun 2010

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
AlconAL-60371, 0.3% Otic Suspension
TakedaFST201
AlconMoxidex otic solution

Clinical Trials (6)

Total enrollment: 3,510 patients across 6 trials

NCT04636957Lee's PharmaceuticalCiprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution

A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)

Start: Nov 2020Est. completion: Jul 2022600 patients
Phase 3Unknown
NCT03196973SalvatDF289 plus DF277

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

Start: Jul 2017Est. completion: Sep 2018493 patients
Phase 3Completed
NCT01535560AlconAL-60371, 0.3% otic suspension

Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

Start: Apr 2012Est. completion: Oct 2012589 patients
Phase 3Completed
NCT01535599AlconAL-60371, 0.3% Otic Suspension

Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

Start: Mar 2012Est. completion: May 2013768 patients
Phase 3Completed
NCT00961675TakedaFST201

FST-201 in the Treatment of Acute Otitis Externa

Start: Aug 2009Est. completion: Jun 201070 patients
Phase 3Completed
NCT00750633AlconMoxidex otic solution

A Phase III Study of an Otic Formulation in Acute Otitis Externa

Start: Jun 2008Est. completion: Jan 2009990 patients
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

3 late-stage (Phase 3) programs, potential near-term approvals
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.