Acute Otitis Media

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

AbbottABBOTT PARK, IL

3 programs

cefdinirPhase 41 trial

cefdinirPhase 2/31 trial

Active Trials

NCT00645203Completed447

NCT00644943Completed425

NCT00645112Completed357

MSDIreland - Ballydine

1 program

MontelukastPhase 41 trial

Active Trials

NCT00189462Completed99Est. Dec 2005

Sharp TherapeuticsPA - Pittsburgh

1 program

MontelukastPhase 4

AlconFORT WORTH, TX

6 programs

Moxidex otic solutionPhase 31 trial

AL-60371/AL-817 otic suspensionPhase 21 trial

Moxidex otic solutionPhase 21 trial

+1 more programs

Active Trials

NCT01027494Completed318Est. Nov 2012

NCT01908803Terminated84Est. Aug 2014

NCT00578773Completed303Est. Jan 2009

+3 more trials

Allergy TherapeuticsUK - West Sussex

1 program

Amoxicillin-Clavulanate, 10 daysPhase 21 trial

Active Trials

NCT01511107Terminated520Est. Oct 2015

Currax PharmaceuticalsTN - Brentwood

1 program

Antipyrine and Benzocaine otic solutionPhase 21 trial

Active Trials

NCT02037893Completed112Est. Sep 2014

GSKLONDON, United Kingdom

4 programs

Data collectionN/A1 trial

Middle ear fluid, nasopharyngeal aspirate and urine sample.N/A1 trial

Sample CollectionN/A1 trial

Active Trials

NCT02742753Completed1Est. Sep 2017

NCT02567747Completed1Est. Feb 2018

NCT01031082Completed265Est. May 2010

+1 more trials

ViiV HealthcareNC - Durham

4 programs

Data collectionN/A

Middle ear fluid, nasopharyngeal aspirate and urine sample.N/A

Sample CollectionN/A

SalvatFL - Miami

2 programs

DF289PHASE_31 trial

Active Trials

NCT01395966Completed331Est. Jun 2014

NCT01404611Completed331Est. Jun 2013

Integra LifeSciencesAustralia - Clayton

1 program

Iontophoresis SystemN/A1 trial

Active Trials

NCT00941993Completed109Est. Jan 2011

RecordatiFrance - Saint-Victor

1 program

Lactobacillus salivarius PS7 during 6 monthsN/A1 trial

Active Trials

NCT03614117Completed222Est. Jul 2020

Merck & Co.RAHWAY, NJ

1 program

MontelukastPHASE_41 trial

Active Trials

NCT00213252Completed130Est. Feb 2008

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

MSDMontelukast

Abbottcefdinir

SalvatDF289

AlconMoxidex otic solution

Abbottcefdinir

AlconAL-60371/AL-817 otic suspension

Currax PharmaceuticalsAntipyrine and Benzocaine otic solution

Allergy TherapeuticsAmoxicillin-Clavulanate, 10 days

AlconMoxidex otic solution

Merck & Co.Montelukast

RecordatiLactobacillus salivarius PS7 during 6 months

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 6,152 patients across 21 trials

NCT00189462 MSDMontelukast

A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

Start: Mar 2004Est. completion: Dec 200599 patients

Phase 4Completed

NCT00645112 Abbottcefdinir

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

Start: Nov 2003357 patients

Phase 4Completed

NCT00644943 Abbottcefdinir

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Start: Feb 2003425 patients

Phase 4Completed

NCT01404611 SalvatDF289

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Start: Jun 2011Est. completion: Jun 2013331 patients

Phase 3Completed

NCT01395966 SalvatDF289

Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Start: Jun 2011Est. completion: Jun 2014331 patients

Phase 3Completed

NCT01071902 AlconMoxidex otic solution

Safety and Efficacy of Moxidex Otic

Start: Feb 2010Est. completion: Oct 2011400 patients

Phase 3Terminated

NCT00579189 AlconMoxidex otic solution

Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Start: Jan 2006Est. completion: Jan 2009776 patients

Phase 3Completed

NCT00578474 AlconMoxidex otic solution

A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Start: Dec 2005Est. completion: Aug 2008911 patients

Phase 3Completed

NCT00645203 Abbottcefdinir

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Start: Jul 2002447 patients

Phase 2/3Completed

NCT01908803 AlconAL-60371/AL-817 otic suspension

Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

Start: Dec 2013Est. completion: Aug 201484 patients

Phase 2Terminated

NCT02037893 Currax PharmaceuticalsAntipyrine and Benzocaine otic solution

Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media

Start: Nov 2013Est. completion: Sep 2014112 patients

Phase 2Completed

NCT01511107 Allergy TherapeuticsAmoxicillin-Clavulanate, 10 days

Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance

Start: Jan 2012Est. completion: Oct 2015520 patients

Phase 2Terminated

NCT00578773 AlconMoxidex otic solution

A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Start: Nov 2007Est. completion: Jan 2009303 patients

Phase 2Completed

NCT00213252 Merck & Co.Montelukast

Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

Start: Sep 2005Est. completion: Feb 2008130 patients

Phase 2Completed

NCT03614117 RecordatiLactobacillus salivarius PS7 during 6 months

Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)

Start: Oct 2018Est. completion: Jul 2020222 patients

N/ACompleted

NCT02742753 GSKData collection

Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children

Start: Jun 2016Est. completion: Sep 20171 patients

N/ACompleted

NCT02567747 GSKData collection

Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age

Start: Oct 2015Est. completion: Feb 20181 patients

N/ACompleted

NCT01072227 GSKSample Collection

Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan

Start: Jul 2010Est. completion: Apr 201110 patients

N/ATerminated

NCT01027494 AlconCiprofloxacin 0.3% and dexamethasone 0.1% otic suspension

Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora

Start: Dec 2009Est. completion: Nov 2012318 patients

N/ACompleted

NCT01031082 GSKMiddle ear fluid, nasopharyngeal aspirate and urine sample.

Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children

Start: May 2009Est. completion: May 2010265 patients

N/ACompleted

NCT00941993 Integra LifeSciencesIontophoresis System

Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus

Start: Apr 2008Est. completion: Jan 2011109 patients

N/ACompleted

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

13 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.