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Last Updated: December 18, 2025

CLINICAL TRIALS PROFILE FOR BUDESONIDE


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505(b)(2) Clinical Trials for budesonide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00641979 ↗ New Nasal Applicator / New Formulation - User Study Completed AstraZeneca Phase 2 2002-04-01 The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
New Combination NCT03906045 ↗ A Scintigraphy Study of PT010 in COPD Patients Completed Simbec Research Phase 1 2019-04-04 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination NCT03906045 ↗ A Scintigraphy Study of PT010 in COPD Patients Completed AstraZeneca Phase 1 2019-04-04 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for budesonide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000575 ↗ Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed CAMP Steering Committee Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗ Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗ Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed Johns Hopkins Bloomberg School of Public Health Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000577 ↗ Asthma Clinical Research Network (ACRN) Withdrawn National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000577 ↗ Asthma Clinical Research Network (ACRN) Withdrawn Milton S. Hershey Medical Center Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00004842 ↗ Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis Completed Mayo Clinic Phase 1 1997-05-01 OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
NCT00004842 ↗ Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 1 1997-05-01 OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for budesonide

Condition Name

Condition Name for budesonide
Intervention Trials
Asthma 151
Chronic Obstructive Pulmonary Disease 27
Eosinophilic Esophagitis 16
Chronic Obstructive Pulmonary Disease (COPD) 12
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Condition MeSH

Condition MeSH for budesonide
Intervention Trials
Asthma 158
Pulmonary Disease, Chronic Obstructive 62
Lung Diseases 55
Lung Diseases, Obstructive 50
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Clinical Trial Locations for budesonide

Trials by Country

Trials by Country for budesonide
Location Trials
China 125
Canada 122
Germany 78
United Kingdom 49
Italy 44
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Trials by US State

Trials by US State for budesonide
Location Trials
California 61
North Carolina 45
Texas 44
Florida 41
Pennsylvania 39
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Clinical Trial Progress for budesonide

Clinical Trial Phase

Clinical Trial Phase for budesonide
Clinical Trial Phase Trials
PHASE4 15
PHASE3 6
PHASE2 5
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Clinical Trial Status

Clinical Trial Status for budesonide
Clinical Trial Phase Trials
Completed 286
Recruiting 56
Unknown status 36
[disabled in preview] 86
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Clinical Trial Sponsors for budesonide

Sponsor Name

Sponsor Name for budesonide
Sponsor Trials
AstraZeneca 113
Dr. Falk Pharma GmbH 21
GlaxoSmithKline 14
[disabled in preview] 39
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Sponsor Type

Sponsor Type for budesonide
Sponsor Trials
Other 370
Industry 319
NIH 20
[disabled in preview] 6
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Budesonide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025


Introduction

Budesonide, a synthetic corticosteroid, has established its role primarily in treating respiratory conditions and inflammatory gastrointestinal diseases. As a cornerstone in managing conditions like asthma, Crohn’s disease, and ulcerative colitis, recent developments in clinical research and evolving market dynamics highlight its ongoing significance. This article synthesizes a comprehensive update on clinical trials, analyzes current market trends, and projects future growth trajectories for budesonide, providing valuable insights for stakeholders.


Clinical Trials Update

Current Research Landscape

Recent years have marked an expansion in clinical investigations surrounding budesonide, focusing on novel delivery mechanisms, expanded indications, and combination therapies. According to ClinicalTrials.gov, over 70 active or completed studies involve budesonide as of 2023, spanning several therapeutic areas.

Novel Formulations and Delivery Methods

Innovations include push toward targeted delivery systems such as:

  • Oral controlled-release formulations for Crohn’s disease and ulcerative colitis, aiming for improved local efficacy and reduced systemic side effects.
  • Nasal sprays for allergic rhinitis and sinusitis, exploring enhanced bioavailability and patient compliance.
  • Inhalation therapies with modified-release properties for asthma management, optimizing airway deposition and minimizing systemic absorption.

One notable trial (NCT04588878) evaluated an innovative dual-release capsule designed to deliver budesonide selectively to inflamed intestinal tissues. Early results suggest promising therapeutic benefits with minimal adverse effects.

Expanded Therapeutic Applications

Beyond traditional indications, clinical trials are investigating budesonide’s role in:

  • COVID-19 management: Several studies, including the randomized trial published in The Lancet (2019), explored inhaled budesonide to reduce the progression of mild COVID-19 symptoms. Results demonstrated a reduction in urgent medical care requirements.
  • Eosinophilic esophagitis: Trials (NCT03773695) assess topical budesonide as an effective treatment with fewer systemic effects than systemic corticosteroids.
  • Immune-mediated disorders: Emerging research evaluates budesonide's potential in treating inflammatory bowel diseases (IBD) overlapping with other autoimmune conditions.

Regulatory Engagement and Approvals

The FDA has approved several formulations—including Entocort EC for Crohn’s disease and Pulmicort for asthma—affirming regulatory confidence. Recently, discussions with regulatory authorities are underway to expand indications based on ongoing clinical evidence, particularly in pediatric populations.


Market Analysis

Current Market Landscape

The global budesonide market was valued at approximately USD 1.3 billion in 2022, with a compound annual growth rate (CAGR) near 6.8% from 2023 to 2030 (Market Research Future).

Leading players include AstraZeneca, Teva Pharmaceutical Industries, and Mylan. AstraZeneca's Pulmicort remains a dominant brand, leveraging extensive clinical data and global reach.

Market Segments & Therapeutic Classes

  • Respiratory Diseases: The largest segment, driven by asthma and COPD therapies. Pulmicort Respules alone accounts for significant market share.
  • Gastrointestinal Disorders: Growing segment due to increasing prevalence of IBD, with Entocort EC prevailing.
  • Emerging Indications: Nasal sprays and topical formulations are gaining traction, broadening market scope.

Regional Market Dynamics

  • North America: Dominates due to high diagnosis rates, advanced healthcare infrastructure, and widespread off-label use.
  • Europe: Substantial growth, driven by expanding approved indications and increasing prevalence of respiratory and gastrointestinal disorders.
  • Asia-Pacific: Fastest-growing region, with CAGR forecast at 8.5%, propelled by rising healthcare investments and increasing disease awareness.

Pricing and Reimbursement

Pricing strategies vary globally. In the U.S., inhaled budesonide (Pulmicort) remains a premium-priced inhaler, with insurance largely covering costs. Generic entry, expected by 2025, is likely to lower prices and enhance accessibility.

Competitive and Patent Landscape

Patent expirations in the mid-2020s open avenues for generic competitors, intensifying price competition. Biosimilars are also under development, potentially disrupting market share dynamics.


Market Projections and Future Trends

Growth Drivers

  • Expansion of indications: Clinical validation for new uses, notably in immune and infectious diseases.
  • Innovative formulations: Development of targeted delivery systems promises improved efficacy and safety profiles, encouraging physician adoption.
  • Regulatory approvals: Expanded approvals, especially in pediatric and geriatric populations, will enhance market penetration.
  • Emerging markets: Rapid healthcare infrastructure growth in Asia-Pacific and Latin America presents substantial opportunities.

Challenges

  • Patent Cliff & Generics: Patent expirations will pressure pricing and profit margins.
  • Side effect profile: Systemic corticosteroid concerns necessitate innovative delivery to maintain safety perceptions.
  • Competition: Entry of new inhaled corticosteroids and biologics for respiratory diseases.

Future Market Size

Projections estimate the global budesonide market could reach USD 2.3 billion by 2030, growing at a CAGR of approximately 7%. This growth is fueled by innovation, expanded indications, and regional Market development.


Conclusion

Budesonide remains a vital corticosteroid with evolving clinical and commercial relevance. Advances in targeted delivery and broadened indications position it for sustained growth. Stakeholders should monitor ongoing clinical trials, patent expirations, and emerging competitors to inform strategic planning and optimize market position.


Key Takeaways

  • Innovative formulations and expanded indications are central to budesonide’s clinical development trajectory.
  • Market growth hinges on regulatory approvals, generic entry, and regional healthcare expansion—particularly in Asia-Pacific.
  • Patent expirations in the coming years will catalyze price competition and drive generic adoption.
  • Clinical trials exploring new therapeutic uses—such as COVID-19 and eosinophilic esophagitis—could unlock additional markets.
  • Strategic focus on developing safer, more targeted delivery systems will enhance long-term market position.

FAQs

1. What are the most recent clinical trials involving budesonide?
Recent trials focus on novel delivery systems, expanded indications like COVID-19, eosinophilic esophagitis, and immune-mediated diseases, with promising early results supporting further investigation [1].

2. How will patent expirations impact the budesonide market?
Patent expirations forecasted for 2024-2025 will introduce generic competitors, likely reducing prices and increasing accessibility, which could diminish revenue for brand-name manufacturers.

3. Which regions hold the most growth potential for budesonide?
While North America and Europe remain dominant markets, Asia-Pacific is anticipated to experience the fastest growth due to increasing healthcare investments and disease prevalence.

4. Are there new formulations of budesonide under development?
Yes. Research into controlled-release capsules, nasal spray formulations, and inhalers with targeted delivery continues, aiming for enhanced efficacy and reduced systemic effects.

5. What factors could hinder budesonide’s market expansion?
Main hurdles include patent cliffs, competition from newer corticosteroids or biologics, and concerns over corticosteroid side effects, prompting the need for innovative, safer delivery systems.


References

[1] ClinicalTrials.gov. (2023). Search results for "budesonide."
[2] Market Research Future. (2022). Global Corticosteroid Market Analysis.
[3] The Lancet. (2021). "Inhaled budesonide reduces COVID-19 progression."

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