Pulmicort

(Budesonide)

ApprovedSmall molecule

Budesonide is used to reduce inflammation and treat conditions like asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel disease by helping to calm down the immune system's overactive response in the lungs and digestive tract.[2] Pulmicort is currently approved and in use across 62 indications[4].[1]

Pulmicort is one of 899 small molecule programs targeting Lymphocytic Colitis. It is currently in Approved.

Indications

203

Total Trials

Active Trials

898

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Lymphocytic ColitisActive, not recruiting

MalnutritionActive, not recruiting

SnoringActive, not recruiting

EmphysemaActive, not recruiting

DyspepsiaActive, not recruiting

Respiratory System DiseaseApproved

Respiratory Distress Syndrome in Premature InfantsApproved

Bronchiolitis ObliteransApproved

Altitude SicknessActive, not recruiting

Bronchopulmonary DysplasiaApproved

Lymphocytic ColitisPhase 3

Active, not recruiting

MalnutritionPhase 2

Active, not recruiting

SnoringPhase 1

Active, not recruiting

EmphysemaApproved

Active, not recruiting

DyspepsiaApproved

Active, not recruiting

Respiratory System DiseaseApproved

Approved

Respiratory Distress Syndrome in Premature InfantsApproved

Approved

Bronchiolitis ObliteransApproved

Approved

Altitude SicknessPhase 3

Active, not recruiting

Bronchopulmonary DysplasiaApproved

Approved

Showing 10 of 59 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Pulmicort

SSalix

Approved

1 2

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 3

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 4

Chirocaine

PPurdue Pharma LP

Preclinical

1 5

Acupan

YYonsei University

Preclinical

1 6

Chantix

PPrism Pharmaceuticals

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 9

Lipegfilgrastim

Merck & Co.

Preclinical

1 10

Tianeptine

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/ARecruiting

Ulcerative Colitis

NCT05791487

Q4 2026

Phase 2Recruiting

Nasal Obstruction

NCT06830109

Phase 3Recruiting

Hematopoietic Cell Transplantation

NCT05509933

Post-ApprovalRecruiting

Dyspepsia

NCT06841406

Q4 2027

Post-ApprovalRecruiting

Treatment

NCT06334575

Phase 1Not yet recruiting

Eosinophilic Esophagitis

NCT07358234

Clinical

Trials by Indication[1]

Asthma40 trials

The Use of Fractional Exhaled Nitric Oxide in the Identification of Non-adherence in Difficult Asthma

Completed·LLiam Heaney·N/A·NCT01219036·40 enrolled

AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma

Completed·AActivaero GmbH·Phase 2·NCT01200108

Saline Challenge in Monitoring Asthma Control

Completed·KKuopio University Hospital·N/A·NCT00859274·40 enrolled

Show 37 more trials

Replication of the D58 Asthma Trial in Healthcare Claims Data

Completed·—··NCT04892732·66,581 enrolled

Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma

Completed·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT01676987·181 enrolled

Asthma Biomarkers for Predicting Response to Therapy

Unknown status·TTongji Hospital·N/A·NCT01973751·148 enrolled

Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00252785·340 enrolled

Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00855959·108 enrolled

Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma

Completed·SSyntara·Phase 2·NCT00327808·27 enrolled

The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room

Completed·KKing Saud University·Phase 2/3·NCT01524198·945 enrolled

Adults With Moderate to Severe Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00642122·900 enrolled

Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00504062·240 enrolled

Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

Completed· GSK logo

GSK··NCT01328964·9,906 enrolled

Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

Terminated·—·Phase 4·NCT01070888·6 enrolled

Efficacy Of Doxophylline As A Sparing Treatment For Inhaled Corticosteroids In Mexican Children With Asthma

Unknown status·UUniversidad Autonoma de Nuevo Leon·Phase 3·NCT03879590·60 enrolled

The Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations

Terminated·—·N/A·NCT00706446·255 enrolled

Role of microRNAs in T Cell-Driven Inflammation in Asthma

Completed·UUniversity of California, San Francisco·N/A·NCT01484691·55 enrolled

Short- and Long Term Growth in Children With Asthma

Completed·CChildren´s Clinic, Randers·Phase 4·NCT00380484·52 enrolled

Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma

Completed· GSK logo

GSK·Phase 3·NCT01687283·316 enrolled

Low Exhaled NO and ICS in Suspected Asthma

Unknown status·UUniversity of Nottingham·Phase 4·NCT02771717·165 enrolled

Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

Completed·HHat Yai Medical Education Center·Phase 3·NCT02725242·77 enrolled

Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00646529·175 enrolled

Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)

Completed·OOrganon and Co·Phase 4·NCT00092092·71 enrolled

Effect of Symbicort on GR Localisation in Asthma

Completed·IImperial College London·N/A·NCT00159263·10 enrolled

Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma

Completed·RRevalesio Corporation·Phase 1·NCT01511302·65 enrolled

Nebulized Budesonide Combined With Systemic Corticosteroid in Acute Severe Asthma

Unknown status·UUniversity of Monastir·Phase 1·NCT04016220·60 enrolled

Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma

Terminated· Novartis logo

Novartis·Phase 4·NCT01912872·112 enrolled

Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641914·6,800 enrolled

Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma

Completed·MMedical University of Lodz·Phase 4·NCT00490243·150 enrolled

Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma

Completed·—·Phase 4·NCT01340118·93 enrolled

Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

Completed·NNorthwell Health·Phase 3·NCT00588406·95 enrolled

Inhaled Corticosteroids on Airway Smooth Muscle in Asthma

Withdrawn·IImperial College London·Phase 4·NCT00661973

The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma

Completed·—·Phase 4·NCT03034005·60 enrolled

A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma

Completed· GSK logo

GSK·Phase 3·NCT02446418·423 enrolled

A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01136382·304 enrolled

Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma

Completed·MMedical University of Lodz·Phase 4·NCT00487773·96 enrolled

Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00509028·241 enrolled

Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT00000575·1,041 enrolled

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00989833·66 enrolled

Symbicort in Asthmatic Children - SEEDLING

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00651547·405 enrolled

Budesonide15 trials

(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets

Completed·BBausch Health Americas, Inc.·Phase 3·NCT01100112·61 enrolled

Intratracheal Budesonide/Surfactant Prevents BPD

Completed·TTaipei Medical University·Phase 4·NCT03275415·310 enrolled

Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

Completed· Novartis logo

Novartis·Phase 4·NCT02055352·222 enrolled

Show 12 more trials

Efficacy of Budesonide Via Delayed Release vs Immediate Release

Withdrawn·SSt. Paul's Hospital, Canada·Phase 1·NCT04476628

In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

Completed· Novartis logo

Novartis·Phase 1·NCT05429775·12 enrolled

Budesonide 9 mg Capsules in Active UC

Completed·—·Phase 2·NCT02550418·60 enrolled

A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT06268301·20 enrolled

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01360021·214 enrolled

Epigenetic Health Benefits of Budesonide

Active, not recruiting·UUniversity of British Columbia·Phase 4·NCT04342039·20 enrolled

Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg

Completed·RReig Jofre Group·Phase 1·NCT02593500·57 enrolled

Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide

Completed·UUniversity of Miami·N/A·NCT01219738·20 enrolled

Study to Detect Oral Administration of Budesonide in Women.

Completed·PParc de Salut Mar·Phase 1·NCT03537326·4 enrolled

Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR

Completed·LLigand Pharmaceuticals·Phase 2·NCT00938613·65 enrolled

Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam

Completed·PPadagis LLC·Phase 1·NCT02800824

Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients

Completed·SSyntara·Phase 2·NCT00483743·62 enrolled

Eosinophilic Esophagitis11 trials

Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis

Completed· Takeda logo

Takeda·Phase 2·NCT00762073·82 enrolled

Budesonide for Eosinophilic Esophagitis

Completed·SSwiss EE Study Group·Phase 2·NCT00271349·28 enrolled

Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.

Not yet recruiting·MMayo Clinic·Phase 1·NCT07358234·60 enrolled

Show 8 more trials

Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)

Terminated· Takeda logo

Takeda·Phase 3·NCT03245840·133 enrolled

Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis

Completed·—·Phase 3·NCT02493335·204 enrolled

Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Terminated·—·Phase 2·NCT01821898·3 enrolled

Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)

Withdrawn·BBazell Pharma AG·Phase 2·NCT05214599

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)

Completed· Takeda logo

Takeda·Phase 3·NCT02736409·219 enrolled

A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved

Completed· Takeda logo

Takeda·Phase 3·NCT02605837·318 enrolled

Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

Completed·—·Phase 3·NCT02434029·88 enrolled

Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

Completed·AAzienda Policlinico Umberto I·Phase 4·NCT01846962·64 enrolled

Chronic Rhinosinusitis10 trials

Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.

Completed·—·Phase 3·NCT03687515·91 enrolled

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

Completed·SSanotize Research and Development corp.·Phase 2·NCT04163978·56 enrolled

Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis

Completed·PPari Pharma GmbH·Phase 1/2·NCT01955980·19 enrolled

Show 7 more trials

Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi

Completed·PPari Pharma GmbH·Phase 1/2·NCT01946711·14 enrolled

Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels

Unknown status·—·Phase 3·NCT02668861·40 enrolled

Use of Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis.

Unknown status·UUniversidade Estadual de Londrina·N/A·NCT05541419·60 enrolled

The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis

Completed·KKafrelsheikh University·Phase 2/3·NCT05931744·120 enrolled

The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery

Completed·UUniversity of Vermont Medical Center·N/A·NCT02562924·40 enrolled

Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates

Withdrawn·KKaiser Permanente·Phase 2/3·NCT03519061

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Completed·WWashington University School of Medicine·Phase 4·NCT02696850·80 enrolled

Allergic Rhinitis5 trials

Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Unknown status·SShiraz University of Medical Sciences·N/A·NCT04561687·66 enrolled

Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis

Unknown status·—·N/A·NCT04002349·80 enrolled

Airway Inflammation in Children With Allergic Rhinitis and Intervention

Completed·GGuangzhou Institute of Respiratory Disease·N/A·NCT02352168·68 enrolled

Show 2 more trials

Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

Completed·IIstituto per la Ricerca e l'Innovazione Biomedica·Phase 4·NCT02409563·39 enrolled

Children, Perennial Allergic Rhinitis (PAR), l-t Growth

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641212·209 enrolled

76 more indications

COVID-195 trials

Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19

Terminated·AAmanda Stapleton·Phase 1/2·NCT04964414·20 enrolled

Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms

Recruiting·CCardresearch·Phase 3·NCT04727424·7,819 enrolled

Vitamin D Nasal Drops in Post COVID-19 Parosmia

Unknown status·MMenoufia University·Phase 2·NCT05269017·60 enrolled

Show 2 more trials

Ivermectin Nasal Drops in Post COVID-19 Parosmia

Unknown status·MMenoufia University·Phase 2·NCT05269030·60 enrolled

Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity

Completed·FFondation Ophtalmologique Adolphe de Rothschild·Phase 3·NCT04361474·120 enrolled

Collagenous Colitis4 trials

Budesonide for Maintenance Treatment of Collagenous Colitis

Completed·TTechnische Universität Dresden·Phase 3·NCT00180076·75 enrolled

Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

Completed·—·Phase 3·NCT00450086·92 enrolled

SOIBD Collagenous Colitis Maintenance Study

Completed·—·Phase 3·NCT01278082·92 enrolled

Show 1 more trial

Long-Term Treatment of Collagenous Colitis With Budesonide

Unknown status·—·Phase 3·NCT00139165·36 enrolled

Efficacy and Safety4 trials

A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 2·NCT02986321·1,130 enrolled

Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01555099·353 enrolled

Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00421122·315 enrolled

Show 1 more trial

Assess the Efficacy and Safety of Rhinocort Aqua

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00641693·650 enrolled

Efficacy3 trials

Efficacy of SLITone in House Dust Mite Allergic Patients

Completed·AALK-Abelló A/S·Phase 2/3·NCT00633919·124 enrolled

Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00651651·450 enrolled

Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00652002·450 enrolled

Crohn's Disease3 trials

The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

Unknown status·HHillel Yaffe Medical Center·N/A·NCT04233463·50 enrolled

Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum

Enrolling by invitation·MMedical University of Warsaw·Phase 2/3·NCT06719622·114 enrolled

9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

Completed·—·Phase 3·NCT01086553·471 enrolled

Chronic Obstructive Pulmonary Disease3 trials

Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

Completed·NNational Jewish Health·Phase 4·NCT01253473·46 enrolled

Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed·MMahidol University·Phase 3·NCT00826163·20 enrolled

Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)

Completed·QQueen's University·Phase 4·NCT00202189·4 enrolled

Ulcerative Colitis3 trials

Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

Completed·—·Phase 3·NCT00747110·343 enrolled

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Completed· Ferring logo

Ferring·Phase 3·NCT03412682·274 enrolled

Combination of Diet and Oral Budesonide for Ulcerative Colitis

Recruiting·WWolfson Medical Center·N/A·NCT05791487·90 enrolled

Lymphocytic Colitis3 trials

Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Terminated·MMayo Clinic·Phase 2/3·NCT00217022·16 enrolled

Budesonide Treatment for Lymphocytic Colitis

Completed·TTechnische Universität Dresden·Phase 3·NCT00180050·40 enrolled

Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Completed·—·Phase 3·NCT01209208·57 enrolled

Treatment3 trials

Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

Recruiting·MMaria Joyera Rodríguez·Phase 4·NCT06334575·135 enrolled

Compare the Effect of INS Alone and Added LTRA in Treatment of SAR

Completed·—·Phase 1·NCT04077892·46 enrolled

Small Airways Evaluation and Treatment

Unknown status·ZZhujiang Hospital·Phase 4·NCT02526758·90 enrolled

Lung Cancer2 trials

Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD

Unknown status·XXiuyi Zhi·Phase 4·NCT02504801·73 enrolled

Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00321893·225 enrolled

Rhinitis2 trials

Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis

Withdrawn·EEurofarma Laboratorios S.A.·Phase 3·NCT02972866

A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution

Completed·JJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·Phase 4·NCT04132570·206 enrolled

Steroid2 trials

NasoNeb Delivery of an Intranasal Steroid

Completed·UUniversity of Chicago·Phase 4·NCT01270256·41 enrolled

Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD

Completed·CCantonal Hosptal, Baselland·Phase 4·NCT00860938·90 enrolled

Graft Versus Host Disease2 trials

Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease

Terminated·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT01950507·15 enrolled

Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation

Completed·RRafa Laboratories·Phase 3·NCT00128739·24 enrolled

Proctosigmoiditis2 trials

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Completed·BBausch Health Americas, Inc.·Phase 3·NCT01008410·265 enrolled

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Completed·BBausch Health Americas, Inc.·Phase 3·NCT01008423·281 enrolled

Primary Biliary Cirrhosis2 trials

Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis

Withdrawn·MMayo Clinic·N/A·NCT00587119

Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)

Terminated·—·Phase 3·NCT00746486·62 enrolled

Complication2 trials

Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients

Unknown status·IIsfahan University of Medical Sciences·N/A·NCT01786070·70 enrolled

Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients

Unknown status·SSaeed Abbasi·N/A·NCT01854515·90 enrolled

Obstructive Sleep Apnea2 trials

Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome

Completed·UUniversity of Louisville·Phase 4·NCT00560586·62 enrolled

Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

Completed·UUniversity of Bologna·Phase 4·NCT00912171·45 enrolled

Adult2 trials

New Version Pulmicort Turbuhaler USA Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00642187·525 enrolled

Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.

Completed·IIntech Biopharm Ltd.·Phase 1·NCT02165046·24 enrolled

Bronchopulmonary Dysplasia2 trials

Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.

Unknown status·HHospital Central "Dr. Ignacio Morones Prieto"·Phase 4·NCT03521063·108 enrolled

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Completed·UUniversity Children's Hospital Tuebingen·Phase 3·NCT01035190·863 enrolled

Sinusitis2 trials

Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis

Recruiting·DDaniel Merenstein·Phase 4·NCT06076304·3,720 enrolled

Evaluation of Inhaled Treatment in Sinusitis

Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·Phase 2/3·NCT01907204·50 enrolled

Proctitis2 trials

Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

Completed·—·Phase 2·NCT01966783·320 enrolled

Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Terminated·—·Phase 2·NCT00828230·17 enrolled

Liver Transplant2 trials

Budesonide for Liver Transplant Immune Suppression

Completed·UUniversity of Cincinnati·Phase 2·NCT03304626·40 enrolled

Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects

Withdrawn·MMontefiore Medical Center·Phase 4·NCT03315052

Tics1 trial

Effects of Symbicort on the Ventilatory Kinematics

Terminated·—·Phase 4·NCT01712854·9 enrolled

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT04294641·10 enrolled

Current Smoker1 trial

Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia

Completed·BBritish Columbia Cancer Agency·Phase 2·NCT00005880

Acupuncture Therapy1 trial

Acupuncture Therapy for COVID-Related Olfactory Loss

Completed·MMayo Clinic·N/A·NCT04952389·30 enrolled

Esophagitis1 trial

Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT05444543·23 enrolled

Malnutrition1 trial

Therapeutic Approaches to Malnutrition Enteropathy

Completed·QQueen Mary University of London·Phase 2·NCT03716115·125 enrolled

IgA Nephropathy1 trial

Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

Completed·CCalliditas Therapeutics AB·Phase 2·NCT00767221·20 enrolled

Wheezing1 trial

CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT00675584·278 enrolled

Respiratory Distress Syndrome1 trial

Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Completed·—·N/A·NCT02013115·300 enrolled

Acute Graft Versus Host Disease1 trial

Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract

Withdrawn·WWake Forest University Health Sciences·Phase 2·NCT02425813

Glucocorticoids1 trial

The Effects of Inhaled Glucocorticoids on the Postmenopausal Skeleton

Withdrawn·—·Phase 4·NCT02357277

Breast Cancer1 trial

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Completed·PPuma Biotechnology, Inc.·Phase 2·NCT02400476·563 enrolled

Neonatal1 trial

Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS

Recruiting·—·Phase 1·NCT06367881·60 enrolled

Anosmia1 trial

Coronavirus Smell Therapy for Anosmia Recovery

Withdrawn·WWashington University School of Medicine·Phase 2·NCT04422275

Autoimmune Hepatitis1 trial

Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

Completed·—·Phase 2/3·NCT00838214·208 enrolled

Adolescent1 trial

Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00646321·540 enrolled

Injury1 trial

LIPS-B: Lung Injury Prevention Study With Budesonide and Beta

Completed·MMayo Clinic·Phase 2·NCT01783821·61 enrolled

Chronic Graft vs Host Disease1 trial

Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

Completed·—·Phase 3·NCT00887263·186 enrolled

Crohn's Disease (CD)1 trial

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

Completed·—·Phase 3·NCT00300118·311 enrolled

Vaccination1 trial

Varicella Vaccination With Pulmicort

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641446·250 enrolled

Prevention1 trial

Inhaled Budesonide for Altitude Illness Prevention

Withdrawn·UUniversity of Colorado, Denver·Phase 3·NCT02941510

Adverse Effect1 trial

Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy

Unknown status·—·Phase 4·NCT06158893·87 enrolled

Sinus Surgery1 trial

Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients

Withdrawn·UUniversity of Florida·Phase 3·NCT03303677

T-ALL1 trial

Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

Completed·HHamilton Health Sciences Corporation·Phase 4·NCT00716963·7 enrolled

Snoring1 trial

Effect of Nasal Steroids in Snoring Intensity

Completed·IIoannis Koutsourelakis·Phase 1·NCT01849406·24 enrolled

Double-blind1 trial

OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Completed· Takeda logo

Takeda·Phase 2·NCT01642212·93 enrolled

COPD Exacerbation1 trial

Two Different Dosages of Nebulized Steroid Versus Parenteral Steroid in the Management of COPD Exacerbations

Completed·—·Phase 4·NCT01865500·100 enrolled

Satisfaction1 trial

Evaluation of Efficacy, Safety and Patient' Satisfaction of Therapeutic Switch From Off-Steroids to Budesonide

Completed·IIstituto Clinico Humanitas··NCT05594849·31 enrolled

Nasal Obstruction1 trial

Nasal Obstruction With Oxymetazoline and Corticosteroids

Recruiting·WWashington University School of Medicine·Phase 2·NCT06830109·80 enrolled

Stricture1 trial

Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)

Unknown status·SSt. Justine's Hospital·N/A·NCT03999008·60 enrolled

Pilot Study1 trial

Pharmacokinetic Pilot Study on Budesonide/Formoterol

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·N/A·NCT01457716·17 enrolled

Children1 trial

New Version Pulmicort Turbuhaler USA Children

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00642161·430 enrolled

Altitude Sickness1 trial

Altitude Sickness Prevention and Efficacy of Comparative Treatments

Completed·SStanford University·Phase 3·NCT02604173·103 enrolled

Hematopoietic Cell Transplantation1 trial

Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Recruiting·HHenry Ford Health System·Phase 3·NCT05509933·110 enrolled

CRSwNP1 trial

Dupilumab in Chinese Adult Participants With CRSwNP

Completed· Sanofi logo

Sanofi·Phase 3·NCT05878093·63 enrolled

Esophageal stricture1 trial

Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

Completed·MMayo Clinic·Phase 2·NCT02069847·90 enrolled

Adult Subject1 trial

Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects

Completed·AAbbott·Phase 1·NCT05519514·56 enrolled

Combination Therapy1 trial

Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction

Completed·HHamilton Health Sciences Corporation·Phase 3·NCT00462592·18 enrolled

Dexamethasone1 trial

Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children

Unknown status·HHospital Israelita Albert Einstein·N/A·NCT02056379·70 enrolled

Stem Cell Transplantation1 trial

Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

Completed·TTechnische Universität Dresden·Phase 3·NCT00180089·242 enrolled

Antibiotics1 trial

Antibiotics and Hydroxychloroquine in Crohn's

Completed·RRoyal Liverpool University Hospital·Phase 2·NCT01783106·59 enrolled

Cognitive Deficit1 trial

Assessing Improvement in Cognitive Deficit in CRS in Patients Treated With Medical Vs Surgical Management

Unknown status·SSt. Paul's Hospital, Canada·N/A·NCT04291118·150 enrolled

Cohort Study1 trial

Comparing Budesonide Via MAD or INSI Prospective Cohort Study

Unknown status·SSt. Paul's Hospital, Canada·Phase 1·NCT04267042·60 enrolled

Stridor1 trial

Predicting Post Extubation Stridor After Maxillomandibular Fixation

Recruiting·MMansoura University·N/A·NCT05839756·62 enrolled

Gastroesophageal Reflux Disease1 trial

The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

Completed·MMayo Clinic·Phase 2/3·NCT00728481·51 enrolled

Nebulization1 trial

Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps

Completed·—·Phase 2/3·NCT02024659·57 enrolled

Sclerosing Cholangitis1 trial

Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 1·NCT00004842·22 enrolled

Moderate to Severe COPD1 trial

Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD

Completed·PPulmagen Therapeutics·Phase 2·NCT00634413·91 enrolled

Glucocorticoid1 trial

Diesel Exhaust Induces Glucocorticoid Resistance

Recruiting·UUniversity of British Columbia·Phase 4·NCT03615742·30 enrolled

Chronic Lung Disease1 trial

Prevention of Chronic Lung Disease (CLD) in Preterm Infants

Unknown status·—·Phase 4·NCT00883532·300 enrolled

Dyspepsia1 trial

Budesonide as a Treatment for Functional Dyspepsia

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT06841406·56 enrolled

Unspecified9 trials

A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block

Completed·IIntech Biopharm Ltd.·Phase 1·NCT04494321·99 enrolled

SHARE - Symbicort and Health Economics in a Real Life Evaluation

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00259766·1,970 enrolled

Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00702325·311 enrolled

Show 6 more trials

Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)

Completed·UUnither Pharmaceuticals, France·Phase 1·NCT06595121·24 enrolled

A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block

Completed·IIntech Biopharm Ltd.·Phase 1·NCT02850484·99 enrolled

Cortiment® MMX Pharmacokinetic Study

Completed· Ferring logo

Ferring·Phase 1·NCT04080713·24 enrolled

Rhinocort Aqua Versus Placebo and Fluticasone Propionate

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00641680·750 enrolled

Little Lungs Study

Not yet recruiting·UUniversity of Wisconsin, Madison·Phase 1/2·NCT06855043·24 enrolled

New Nasal Applicator / New Formulation - User Study

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00641979·200 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 14, 1994

RHINOCORT

NDA NDA020233

Jun 24, 1997

PULMICORT

NDA NDA020441

Aug 8, 2000

PULMICORT RESPULES

NDA NDA020929

Oct 2, 2001

ENTOCORT EC

NDA NDA021324

Jul 12, 2006

PULMICORT FLEXHALER

NDA NDA021949

Jan 14, 2013

UCERIS

NDA NDA203634

Oct 7, 2014

UCERIS

NDA NDA205613

Mar 23, 2015

RHINOCORT ALLERGY

NDA NDA020746

Jun 13, 2019

ORTIKOS

NDA NDA211929

Dec 15, 2021

TARPEYO

NDA NDA215935

Feb 9, 2024

EOHILIA

NDA NDA213976

Sources

References

[1]
ClinicalTrials.gov — 203 trial records for Budesonide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pulmicort drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Budesonide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Budesonide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213976). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Pulmicort. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Salix company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSalix

Patent Landscape[6]

Patent Cliff

Nov 9, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9119863Nov 9, 2026

8497258Nov 9, 2026

8679545Nov 9, 2026

8975243Nov 9, 2026

11413296Nov 9, 2026

19 more patents

11197822Nov 9, 2026

11357859Nov 12, 2028

10293052Nov 22, 2028

8491932May 7, 2029

9050368Aug 1, 2029

8324192Aug 3, 2029

9192581Sep 7, 2031

8895064Sep 7, 2031

10660858Sep 7, 2031

10307375Sep 7, 2031

9132093Sep 7, 2031

10172802Sep 9, 2036

9707182Sep 9, 2036

11564934Jan 10, 2039

11260064Jan 10, 2039

11896719Jan 23, 2043

12171882Jan 23, 2043

12311057Jan 23, 2043

12171883Jan 23, 2043

Pulmicort

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q4 2027

Trials by Indication[1]

Asthma40 trials

Budesonide15 trials

Eosinophilic Esophagitis11 trials

Chronic Rhinosinusitis10 trials

Allergic Rhinitis5 trials

COVID-195 trials

Collagenous Colitis4 trials

Efficacy and Safety4 trials

Efficacy3 trials

Crohn's Disease3 trials

Chronic Obstructive Pulmonary Disease3 trials

Ulcerative Colitis3 trials

Lymphocytic Colitis3 trials

Treatment3 trials

Lung Cancer2 trials

Rhinitis2 trials

Steroid2 trials

Graft Versus Host Disease2 trials

Proctosigmoiditis2 trials

Primary Biliary Cirrhosis2 trials

Complication2 trials

Obstructive Sleep Apnea2 trials

Adult2 trials

Bronchopulmonary Dysplasia2 trials

Sinusitis2 trials

Proctitis2 trials

Liver Transplant2 trials

Tics1 trial

Acute Respiratory Distress Syndrome1 trial

Microscopic Colitis1 trial

Chronic Graft Versus Host Disease1 trial

Current Smoker1 trial

Acupuncture Therapy1 trial

Esophagitis1 trial

Malnutrition1 trial

IgA Nephropathy1 trial

Wheezing1 trial

Respiratory Distress Syndrome1 trial

Acute Graft Versus Host Disease1 trial

Glucocorticoids1 trial

Breast Cancer1 trial

Neonatal1 trial

Anosmia1 trial

Autoimmune Hepatitis1 trial

Adolescent1 trial

Injury1 trial

Chronic Graft vs Host Disease1 trial

Crohn's Disease (CD)1 trial

Vaccination1 trial

Prevention1 trial

Adverse Effect1 trial

Sinus Surgery1 trial

T-ALL1 trial

Snoring1 trial

Double-blind1 trial

COPD Exacerbation1 trial

Satisfaction1 trial

Nasal Obstruction1 trial

Stricture1 trial

Pilot Study1 trial

Children1 trial

Altitude Sickness1 trial

Hematopoietic Cell Transplantation1 trial

CRSwNP1 trial

Esophageal stricture1 trial

Adult Subject1 trial

Combination Therapy1 trial

Dexamethasone1 trial

Stem Cell Transplantation1 trial

Antibiotics1 trial

Cognitive Deficit1 trial

Cohort Study1 trial