Otitis Media

6
Pipeline Programs
6
Companies
8
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
2
0
0
0
3
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
1100%
+ 7 programs with unclassified modality

Competitive Landscape

6 companies ranked by most advanced pipeline stage

GSK
GSKLONDON, United Kingdom
1 program
1
AugmentinPhase 41 trial
Active Trials
NCT04600752Completed310Est. Nov 2022
Pfizer
PfizerNEW YORK, NY
3 programs
1
ZmaxPhase 31 trial
PrevenarN/A1 trial
TympanocentesisN/A1 trial
Active Trials
NCT00195611Completed3,293Est. Jun 2006
NCT01199016Completed239Est. Jan 2016
NCT00360100Completed120Est. Dec 2006
M&
Merck & Co.RAHWAY, NJ
1 program
1
7-valent pneumococcal-CRM197 conjugate vaccinePhase 3Vaccine1 trial
Active Trials
NCT00378417Completed3,075Est. Mar 1999
DS
Daiichi SankyoChina - Shanghai
1 program
1
ofloxacin otic solution 0.3%Phase 31 trial
Active Trials
NCT00781521Completed96Est. Apr 2003
LP
Lee's PharmaceuticalChina - Guangzhou
1 program
1
0.1% Pazufloxacin Mesilate Ear DropsPhase 11 trial
Active Trials
NCT02592096Unknown32Est. Feb 2016
Alcon
AlconFORT WORTH, TX
1 program
1
AL-60371 otic suspensionPhase 11 trial
Active Trials
NCT01908764WithdrawnEst. Jan 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GSKAugmentin
PfizerZmax
Daiichi Sankyoofloxacin otic solution 0.3%
Merck & Co.7-valent pneumococcal-CRM197 conjugate vaccine
Lee's Pharmaceutical0.1% Pazufloxacin Mesilate Ear Drops
AlconAL-60371 otic suspension
PfizerTympanocentesis
PfizerPrevenar

Clinical Trials (8)

Total enrollment: 7,165 patients across 8 trials

NCT04600752GSKAugmentin

Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India

Start: May 2022Est. completion: Nov 2022310 patients
Phase 4Completed
NCT00360100PfizerZmax

Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

Start: Aug 2006Est. completion: Dec 2006120 patients
Phase 3Completed
NCT00781521Daiichi Sankyoofloxacin otic solution 0.3%

Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

Start: Nov 2002Est. completion: Apr 200396 patients
Phase 3Completed
NCT00378417Merck & Co.7-valent pneumococcal-CRM197 conjugate vaccine

Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

Start: Mar 1995Est. completion: Mar 19993,075 patients
Phase 3Completed
NCT02592096Lee's Pharmaceutical0.1% Pazufloxacin Mesilate Ear Drops

Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Start: Jul 2015Est. completion: Feb 201632 patients
Phase 1Unknown
NCT01908764AlconAL-60371 otic suspension

Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

Start: Nov 2014Est. completion: Jan 2015
Phase 1Withdrawn
NCT01199016PfizerTympanocentesis

Effect of Prevnar 13 on Ear Infections in Children

Start: Sep 2010Est. completion: Jan 2016239 patients
N/ACompleted
NCT00195611PfizerPrevenar

Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

Start: Sep 2005Est. completion: Jun 20063,293 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
6 companies competing in this space