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

Drug Modality Breakdown

Vaccine

3100%

+ 20 programs with unclassified modality

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

ViiV HealthcareNC - Durham

1 program

AugmentinPhase 4

Colorado TherapeuticsCO - Louisville

1 program

dornase alfaPhase 4

PfizerNEW YORK, NY

2 programs

ZmaxPhase 31 trial

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis MediaN/A1 trial

Active Trials

NCT00768534Completed2,138Est. Oct 2015

NCT00360100Completed120Est. Dec 2006

Sharp TherapeuticsPA - Pittsburgh

1 program

7-valent pneumococcal-CRM197 conjugate vaccinePhase 3Vaccine

MSDIreland - Ballydine

1 program

7-valent pneumococcal-CRM197 conjugate vaccinePhase 3Vaccine1 trial

Active Trials

NCT00378417Completed3,075Est. Mar 1999

UNION therapeuticsDenmark - Hellerup

1 program

Triamcinolone AcetonidePhase 31 trial

Active Trials

NCT07189572Not Yet Recruiting168Est. Oct 2027

AlconFORT WORTH, TX

1 program

AL-60371 otic suspensionPhase 11 trial

Active Trials

NCT01908764Withdrawn0Est. Jan 2015

Integra LifeSciencesAustralia - Clayton

6 programs

Acclarent Tympanostomy Tube Delivery SystemN/A1 trial

Acclarent Tympanostomy Tube Delivery systemN/A1 trial

Iontophoresis System With EarsetN/A1 trial

Tube Delivery SystemN/A1 trial

Tympanostomy Tube Delivery SystemN/A1 trial

+1 more programs

Active Trials

NCT02150044Completed29Est. Nov 2010

NCT01324271Completed85Est. May 2012

NCT01611246Completed22Est. Aug 2012

+3 more trials

Preceptis MedicalMN - Golden Valley

2 programs

Ear tube placement with the Hummingbird TTSN/A1 trial

Hummingbird Tympanostomy Tube SystemN/A1 trial

Active Trials

NCT02165384Completed199Est. Mar 2018

NCT03503591Completed109Est. Aug 2021

Human BioSciencesWV - Martinsburg

1 program

Insertion of tympanostomy tubesN/A1 trial

Active Trials

NCT00365092Completed400Est. Mar 2005

PhotoniCareNC - Durham

1 program

OtoSight Middle Ear ScopeN/A1 trial

Active Trials

NCT03890107Completed110Est. Apr 2022

Lee's PharmaceuticalChina - Guangzhou

1 program

0.1% Pazufloxacin Mesilate Ear DropsPHASE_11 trial

Active Trials

NCT02592096Unknown32Est. Feb 2016

Merck & Co.RAHWAY, NJ

1 program

7-valent pneumococcal-CRM197 conjugate vaccinePHASE_3Vaccine

Daiichi SankyoChina - Shanghai

1 program

ofloxacin otic solution 0.3%PHASE_31 trial

Active Trials

NCT00781521Completed96Est. Apr 2003

IQVIADURHAM, NC

1 program

AugmentinPHASE_4

GSKLONDON, United Kingdom

1 program

AugmentinPHASE_41 trial

Active Trials

NCT04600752Completed310Est. Nov 2022

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

GSKAugmentin

UNION therapeuticsTriamcinolone Acetonide

PfizerZmax

Daiichi Sankyoofloxacin otic solution 0.3%

MSD7-valent pneumococcal-CRM197 conjugate vaccine

Lee's Pharmaceutical0.1% Pazufloxacin Mesilate Ear Drops

AlconAL-60371 otic suspension

PhotoniCareOtoSight Middle Ear Scope

Preceptis MedicalHummingbird Tympanostomy Tube System

Preceptis MedicalEar tube placement with the Hummingbird TTS

Integra LifeSciencesIontophoresis System With Earset

Integra LifeSciencesTube Delivery System

Integra LifeSciencesTympanostomy tube placement

Integra LifeSciencesAcclarent Tympanostomy Tube Delivery system

Integra LifeSciencesAcclarent Tympanostomy Tube Delivery System

Showing 15 of 18 trials with date data

Clinical Trials (18)

Total enrollment: 7,030 patients across 18 trials

NCT04600752 GSKAugmentin

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

NCT07189572 UNION therapeuticsTriamcinolone Acetonide

Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma

Start: Oct 2025Est. completion: Oct 2027168 patients

Phase 3Not Yet Recruiting

NCT00360100 PfizerZmax

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

Start: Aug 2006Est. completion: Dec 2006120 patients

Phase 3Completed

NCT00781521 Daiichi 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

NCT00378417 MSD7-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

NCT02592096 Lee's Pharmaceutical0.1% Pazufloxacin Mesilate Ear Drops

Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Start: Jul 2015Est. completion: Feb 201632 patients

Phase 1Unknown

NCT01908764 AlconAL-60371 otic suspension

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

Start: Nov 2014Est. completion: Jan 20150

Phase 1Withdrawn

NCT03890107 PhotoniCareOtoSight Middle Ear Scope

Clinical Evaluation of the OtoSight

Start: Apr 2019Est. completion: Apr 2022110 patients

N/ACompleted

NCT03503591 Preceptis MedicalHummingbird Tympanostomy Tube System

Study of the Hummingbird TTS™ Tympanostomy Tube System

Start: Jan 2016Est. completion: Aug 2021109 patients

N/ACompleted

NCT02165384 Preceptis MedicalEar tube placement with the Hummingbird TTS

Hummingbird TTS Ear Tube Delivery Study

Start: Jan 2014Est. completion: Mar 2018199 patients

N/ACompleted

NCT01611246 Integra LifeSciencesIontophoresis System With Earset

Earset Healthy Volunteer Study

Start: May 2012Est. completion: Aug 201222 patients

N/ACompleted

NCT01496287 Integra LifeSciencesTube Delivery System

Tympanostomy Tube Placement in Children in the Office (Inova Study)

Start: Dec 2011Est. completion: Apr 201270 patients

N/ACompleted

NCT01444391 Integra LifeSciencesTympanostomy tube placement

inVENT-visIOn Study

Start: Oct 2011Est. completion: Jun 201242 patients

N/ACompleted

NCT01324271 Integra LifeSciencesAcclarent Tympanostomy Tube Delivery system

inVENT-In-Office Study

Start: Jan 2011Est. completion: May 201285 patients

N/ACompleted

NCT02150044 Integra LifeSciencesAcclarent Tympanostomy Tube Delivery System

Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

Start: Feb 2010Est. completion: Nov 201029 patients

N/ACompleted

NCT01046877 Integra LifeSciencesTympanostomy Tube Delivery System

Singapore Tympanostomy Tube Delivery System Study

Start: Dec 2008Est. completion: Jun 201125 patients

N/ACompleted

NCT00768534 PfizerStudy Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Start: Oct 2008Est. completion: Oct 20152,138 patients

N/ACompleted

NCT00365092 Human BioSciencesInsertion of tympanostomy tubes

Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11

Start: Apr 2002Est. completion: Mar 2005400 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

4 late-stage (Phase 3) programs, potential near-term approvals

16 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.