Rhinitis, Allergic, Seasonal

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 (4)

Approved therapies currently available

ALVESCOApproved

ciclesonide

Unknown Company

inhalation2008

LEVOCETIRIZINE DIHYDROCHLORIDEApproved

levocetirizine dihydrochloride

Unknown Company

oral2013

OMNARISApproved

ciclesonide

Unknown Company

nasal2006

ZETONNAApproved

ciclesonide

Unknown Company

nasal2012

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

UCB PharmaBelgium - Brussels

4 programs

levocetirizine dihydrochloridePhase 41 trial

LevocetirizinePhase 31 trial

levocetirizine dihydrochloridePhase 31 trial

Levocetirizine dihydrochlorideN/A1 trial

Active Trials

NCT00521040Completed459Est. Jul 2004

NCT00315523Completed403Est. Oct 2006

NCT00544388Completed570Est. Jul 2004

+1 more trials

AstraZenecaCAMBRIDGE, United Kingdom

2 programs

CiclesonidePhase 35 trials

Ciclesonide Nasal SprayPhase 31 trial

Active Trials

NCT02155881Completed80Est. Nov 2014

NCT01455194Completed520Est. Aug 2014

NCT01369563Completed1,630Est. May 2012

+3 more trials

SandozAustria - Kundl

2 programs

Fluticasone furoate 27.5 mcg/actuation nasal sprayPhase 31 trial

Mometasone furoate 50 mcg/actuation nasal sprayPhase 31 trial

Active Trials

NCT01279057CompletedEst. Feb 2011

NCT01038427CompletedEst. Feb 2010

Hal AllergyNetherlands - Leiden

1 program

SUBLIVAC® Grasses/Placebo treatmentPhase 31 trial

Active Trials

NCT00422149Completed350Est. Oct 2007

Dynavax TechnologiesCA - Emeryville

2 programs

Amb a 1 Immunostimulatory Oligoribonucleotide ConjugatePhase 21 trial

Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugatePhase 21 trial

Active Trials

NCT00537355Completed271Est. May 2008

NCT00387738Terminated738Est. Mar 2008

AstellasChina - Shenyang

1 program

ASP4070Phase 21 trial

Active Trials

NCT03101267Completed150Est. Oct 2018

Boehringer IngelheimINGELHEIM, Germany

1 program

BI 67100 ED 25 mgPhase 21 trial

Active Trials

NCT01007721Completed146

Rigel PharmaceuticalsSOUTH SAN FRANCISCO, CA

1 program

R926112Phase 21 trial

Active Trials

NCT00115089CompletedEst. Sep 2005

Johnson & JohnsonNEW BRUNSWICK, NJ

1 program

C-1266-7Phase 11 trial

Active Trials

NCT01500629Completed21Est. Dec 2012

Stallergenes GreerFrance - Antony

1 program

Sublingual tablet of ragweed pollen allergen extractPhase 11 trial

Active Trials

NCT01224834Completed60Est. Oct 2009

Merck & Co.RAHWAY, NJ

1 program

loratadineN/A1 trial

Active Trials

NCT00762983Completed1,003Est. Feb 2009

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

AstraZenecaCiclesonide

UCB Pharmalevocetirizine dihydrochloride

AstraZenecaCiclesonide

SandozFluticasone furoate 27.5 mcg/actuation nasal spray

SandozMometasone furoate 50 mcg/actuation nasal spray

AstraZenecaCiclesonide Nasal Spray

AstraZenecaCiclesonide

Hal AllergySUBLIVAC® Grasses/Placebo treatment

AstraZenecaCiclesonide

UCB PharmaLevocetirizine

AstraZenecaCiclesonide

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 20,561 patients across 50 trials

NCT00404547 AstraZenecaCiclesonide

Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)

Start: Nov 2006Est. completion: Dec 20081,121 patients

Phase 4Completed

NCT00542607 UCB Pharmalevocetirizine dihydrochloride

Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

Start: Sep 2002Est. completion: Dec 200294 patients

Phase 4Completed

NCT02155881 AstraZenecaCiclesonide

Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia

Start: Aug 2014Est. completion: Nov 201480 patients

Phase 3Completed

NCT01455194 AstraZenecaCiclesonide

Effect of High Dose Ciclesonide on Asthma Control

Start: Nov 2011Est. completion: Aug 2014520 patients

Phase 3Completed

NCT01279057 SandozFluticasone furoate 27.5 mcg/actuation nasal spray

A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Start: Dec 2010Est. completion: Feb 2011

Phase 3Completed

NCT01038427 SandozMometasone furoate 50 mcg/actuation nasal spray

A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Start: Dec 2009Est. completion: Feb 2010

Phase 3Completed

NCT00384475 AstraZenecaCiclesonide Nasal Spray

A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)

Start: Oct 2006Est. completion: Jan 2007500 patients

Phase 3Completed

NCT00384189 AstraZenecaCiclesonide

A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma

Start: Sep 2006Est. completion: Aug 20081,080 patients

Phase 3Completed

NCT00422149 Hal AllergySUBLIVAC® Grasses/Placebo treatment

Twin SUBLIVAC® Grasses Clinical Efficacy Study

Start: Sep 2006Est. completion: Oct 2007350 patients

Phase 3Completed

NCT00392288 AstraZenecaCiclesonide

Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.

Start: Sep 2006Est. completion: Feb 2008528 patients

Phase 3Completed

NCT00315523 UCB PharmaLevocetirizine

Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

Start: Jul 2006Est. completion: Oct 2006403 patients

Phase 3Completed

NCT00306163 AstraZenecaCiclesonide

Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

Start: May 2006Est. completion: Sep 200837 patients

Phase 3Completed

NCT00305487 AstraZenecaCiclesonide

Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

Start: Mar 2006Est. completion: Oct 2006660 patients

Phase 3Completed

NCT00305461 AstraZenecaCiclesonide

Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

Start: Feb 2006Est. completion: Feb 2008101 patients

Phase 3Completed

NCT00261287 AstraZenecaCiclesonide

Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

Start: Nov 2005Est. completion: Jun 2006102 patients

Phase 3Completed

NCT00163449 AstraZenecaCiclesonide

Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

Start: Nov 2005Est. completion: May 20071,000 patients

Phase 3Completed

NCT00163371 AstraZenecaCiclesonide

Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)

Start: Sep 2005Est. completion: Dec 200528 patients

Phase 3Completed

NCT00163436 AstraZenecaCiclesonide

Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

Start: Sep 2005Est. completion: Jan 2006450 patients

Phase 3Completed

NCT00659503 AstraZenecaCiclesonide

Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)

Start: Feb 2005Est. completion: Nov 2005420 patients

Phase 3Completed

NCT00163488 AstraZenecaCiclesonide

Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Start: Jan 2005Est. completion: Aug 2005106 patients

Phase 3Completed

NCT00163293 AstraZenecaCiclesonide

Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)

Start: Jan 2005Est. completion: Apr 2010240 patients

Phase 3Completed

NCT00659048 AstraZenecaCiclesonide

Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)

Start: Dec 2004Est. completion: Dec 2005106 patients

Phase 3Completed

NCT00659594 AstraZenecaCiclesonide

Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406)

Start: Nov 2004Est. completion: Sep 2005500 patients

Phase 3Completed

NCT00163423 AstraZenecaCiclesonide

Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

Start: Nov 2004Est. completion: Jan 2006480 patients

Phase 3Completed

NCT00163462 AstraZenecaCiclesonide

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

Start: Oct 2004Est. completion: Nov 2005750 patients

Phase 3Completed

NCT00658918 AstraZenecaCiclesonide

To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)

Start: Sep 2004Est. completion: Nov 2005120 patients

Phase 3Completed

NCT00163514 AstraZenecaCiclesonide

Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

Start: May 2004Est. completion: Jul 2005636 patients

Phase 3Completed

NCT00544388 UCB Pharmalevocetirizine dihydrochloride

Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

Start: Apr 2004Est. completion: Jul 2004570 patients

Phase 3Completed

NCT00163397 AstraZenecaCiclesonide

Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)

Start: Jan 2004Est. completion: Jul 2005120 patients

Phase 3Completed

NCT00163384 AstraZenecaCiclesonide

Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)

Start: Jan 2004Est. completion: May 2005240 patients

Phase 3Completed

NCT00659750 AstraZenecaCiclesonide

To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)

Start: Dec 2003Est. completion: Apr 2005418 patients

Phase 3Completed

NCT00659841 AstraZenecaCiclesonide

To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)

Start: Dec 2003Est. completion: Feb 2005302 patients

Phase 3Completed

NCT00163345 AstraZenecaCiclesonide

Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

Start: Sep 2003Est. completion: May 200620 patients

Phase 3Completed

NCT00163358 AstraZenecaCiclesonide

Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

Start: Sep 2003Est. completion: Oct 2005630 patients

Phase 3Completed

NCT00163410 AstraZenecaCiclesonide

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

Start: Apr 2003Est. completion: Dec 2004500 patients

Phase 3Completed

NCT00163332 AstraZenecaCiclesonide

Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

Start: Mar 200330 patients

Phase 3Completed

NCT00546520 AstraZenecaCiclesonide

Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

Start: Apr 2002Est. completion: Jun 200221 patients

Phase 3Completed

NCT03101267 AstellasASP4070

A Dose-finding Study of ASP4070

Start: Apr 2017Est. completion: Oct 2018150 patients

Phase 2Completed

NCT01007721 Boehringer IngelheimBI 67100 ED 25 mg

Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season

Start: Oct 2009146 patients

Phase 2Completed

NCT00537355 Dynavax TechnologiesAmb a 1 Immunostimulatory Oligoribonucleotide Conjugate

An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber

Start: Sep 2007Est. completion: May 2008271 patients

Phase 2Completed

NCT00807053 AstraZenecaCiclesonide

Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)

Start: Apr 2007Est. completion: Jul 2007480 patients

Phase 2Completed

NCT00387738 Dynavax TechnologiesAmb a 1 immunostimulatory oligodeoxyribonucleotide conjugate

Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults

Start: Apr 2006Est. completion: Mar 2008738 patients

Phase 2Terminated

NCT00314509 AstraZenecaCiclesonide

Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

Start: Jul 2005Est. completion: Jan 2006240 patients

Phase 2Completed

NCT00115089 Rigel PharmaceuticalsR926112

7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis

Start: Jul 2005Est. completion: Sep 2005

Phase 2Completed

NCT01500629 Johnson & JohnsonC-1266-7

Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever

Start: Jan 2012Est. completion: Dec 201221 patients

Phase 1Completed

NCT01224834 Stallergenes GreerSublingual tablet of ragweed pollen allergen extract

Safety and Tolerability Study of Ragweed SLIT Tablets

Start: Jan 2009Est. completion: Oct 200960 patients

Phase 1Completed

NCT01369563 AstraZenecaCiclesonide

Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis

Start: Aug 2011Est. completion: May 20121,630 patients

N/ACompleted

NCT00762983 Merck & Co.loratadine

Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)

Start: Mar 2008Est. completion: Feb 20091,003 patients

N/ACompleted

NCT00608218 AstraZenecaCiclesonide

Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma

Start: Jan 2008Est. completion: Aug 20082,100 patients

N/ACompleted

NCT00521040 UCB PharmaLevocetirizine dihydrochloride

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Start: Feb 2004Est. completion: Jul 2004459 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

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

11 companies competing in this space