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

On Market (1)

Approved therapies currently available

CEFDINIRApproved

cefdinir

Unknown Company

Cephalosporin Antibacterial [EPC]oral2021

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

AbbottABBOTT PARK, IL

2 programs

cefdinirPhase 41 trial

cefdinirPhase 2/35 trials

Active Trials

NCT00234949Completed380

NCT00645073Completed271

NCT00644943Completed425

+3 more trials

Merck & Co.RAHWAY, NJ

1 program

MontelukastPhase 45 trials

Active Trials

NCT01618929Completed113Est. May 2016

NCT01621386Completed34Est. Mar 2016

NCT01404013Unknown99Est. Aug 2014

+2 more trials

AlconFORT WORTH, TX

5 programs

Moxidex otic solutionPhase 31 trial

Moxidex otic solutionPhase 21 trial

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspensionN/A1 trial

Active Trials

NCT01027494Completed318Est. Nov 2012

NCT00578773Completed303Est. Jan 2009

NCT00579189CompletedEst. Jan 2009

+2 more trials

SalvatFL - Miami

2 programs

DF289Phase 31 trial

Active Trials

NCT01395966CompletedEst. Jun 2014

NCT01404611CompletedEst. Jun 2013

RecordatiFrance - Saint-Victor

1 program

Lactobacillus salivarius PS7 during 6 monthsN/A1 trial

Active Trials

NCT03614117Completed222Est. Jul 2020

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Merck & Co.Montelukast

Abbottcefdinir

Merck & Co.Montelukast

Abbottcefdinir

SalvatDF289

Showing 15 of 32 trials with date data

Clinical Trials (32)

Total enrollment: 4,534 patients across 32 trials

NCT01618929 Merck & Co.Montelukast

Effects of Montelukast in Asthmatic Children With and Without Food Allergy

Start: Mar 2013Est. completion: May 2016113 patients

Phase 4Completed

NCT01404013 Merck & Co.Montelukast

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

Start: Feb 2012Est. completion: Aug 201499 patients

Phase 4Unknown

NCT01027806 Merck & Co.Montelukast

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

Start: Jul 2010Est. completion: Aug 201464 patients

Phase 4Terminated

NCT00559546 Merck & Co.Montelukast

Montelukast as a Controller of Atopic Syndrome

Start: Mar 2007Est. completion: Jul 200761 patients

Phase 4Completed

NCT00721240 Merck & Co.Montelukast

Investigation to Identify Predictors of Response to a Treatment With Montelukast

Start: Feb 2006Est. completion: Jun 200950 patients

Phase 4Completed

NCT00234949 Abbottcefdinir

A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

Start: Mar 2005380 patients

Phase 4Completed

NCT00934713 Merck & Co.Montelukast

The Effect of Montelukast Treatment in Wheezy Infants

Start: Sep 2004Est. completion: Apr 2008112 patients

Phase 4Completed

NCT00189462 Merck & Co.Montelukast

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

NCT00645073 Abbottcefdinir

Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis

Start: Nov 2003271 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

NCT00645125 Abbottcefdinir

A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications

Start: Jan 2003154 patients

Phase 4Completed

NCT00644891 Abbottcefdinir

Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Start: Jan 2003158 patients

Phase 4Completed

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 2014

Phase 3Completed

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 2013

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 2009

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 2008

Phase 3Completed

NCT00116324 Merck & Co.Montelukast

Predicting the Response to Montelukast by Genetic Variation in Asthmatics

Start: Apr 2003Est. completion: Dec 2006150 patients

Phase 3Completed

NCT00162864 Merck & Co.Montelukast

A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease

Start: Dec 1999Est. completion: Apr 2002200 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

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 2008

Phase 2Completed

NCT01621386 Merck & Co.Montelukast

Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

Start: Jan 2013Est. completion: Mar 201634 patients

Phase 1Completed

NCT01086527 Merck & Co.Montelukast

Genotype Stratified Pharmacokinetic Study of Montelukast

Start: Mar 2010Est. completion: Dec 20142 patients

Phase 1Completed

NCT00492102 Merck & Co.Montelukast

Montelukast in Very Low Birthweight Infants

Start: Mar 2007Est. completion: Jun 20119 patients

Phase 1Completed

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

NCT01230437 Merck & Co.Montelukast

Montelukast and Nasal Epithelial Cell Inflammatory Responses in Asthma and Rhinitis

Start: Jan 2011Est. completion: Dec 201140 patients

N/AUnknown

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

NCT00710450 Merck & Co.Montelukast

Effect of Montelukast on Basophils, In-vitro

Start: May 2008Est. completion: Sep 201115 patients

N/AUnknown

NCT00513760 Merck & Co.Montelukast

Transporter Mediated Uptake of Montelukast

Start: Jun 2007Est. completion: Dec 201427 patients

N/ACompleted

NCT00148603 Merck & Co.Montelukast

Montelukast in the Treatment of Duodenal Eosinophilia

Start: Sep 2005Est. completion: Dec 200624 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

5 late-stage (Phase 3) programs — potential near-term approvals

5 companies competing in this space