CLINICAL TRIALS PROFILE FOR BUDESONIDE

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.

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.

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

Condition MeSH

Condition MeSH for budesonide
Intervention	Trials
Asthma	159
Pulmonary Disease, Chronic Obstructive	62
Lung Diseases	55
Lung Diseases, Obstructive	50

Clinical Trial Locations for budesonide

Trials by Country

Trials by Country for budesonide
Location	Trials
China	128
Canada	122
Germany	78
United Kingdom	49
Italy	44

Trials by US State

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

Clinical Trial Progress for budesonide

Clinical Trial Phase

Clinical Trial Phase for budesonide
Clinical Trial Phase	Trials
PHASE4	15
PHASE3	7
PHASE2	5

Clinical Trial Status

Clinical Trial Status for budesonide
Clinical Trial Phase	Trials
Completed	286
RECRUITING	56
Unknown status	36

Clinical Trial Sponsors for budesonide

Sponsor Name

Sponsor Name for budesonide
Sponsor	Trials
AstraZeneca	113
Dr. Falk Pharma GmbH	21
GlaxoSmithKline	14

Sponsor Type

Sponsor Type for budesonide
Sponsor	Trials
Other	373
Industry	320
NIH	20

Budesonide: Clinical-Trial Update, Market Analysis, and Projection

Last updated: April 27, 2026

What does “budesonide” cover in the market?

Budesonide is an inhaled and nasal corticosteroid used for inflammatory airway and ENT diseases. Commercially, it spans multiple product forms that compete differently by indication and delivery device:

• Asthma / COPD (inhaled corticosteroid, ICS): Nebulized suspensions and inhalers.
• Allergic rhinitis / nasal inflammatory disease (intranasal): Sprays and irrigations.
• GI inflammatory disease (budesonide formulations for Crohn’s and ulcerative colitis phenotypes): Multi-matrix oral controlled-release products and rectal formulations in some geographies.

Because budesonide is off-patent in most major markets and has long-established branded and generic competition, “clinical trial updates” in practice concentrate on: 1) new drug-device combinations and formulation tweaks that can extend commercial life, and
2) life-cycle indications with differentiated dosing or controlled release.

What clinical trial signals matter right now?

A complete, indication-by-indication live clinical-trial update requires current registry-by-registry extraction (ClinicalTrials.gov, EU CTR, ISRCTN) and harmonized molecule listing by salt/formulation and brand. With no trial identifiers, sponsor lists, phases, or endpoints provided, a precise update cannot be produced without risking incorrect trial attribution to “budesonide” broadly.

What is the market size anchor for budesonide?

Budesonide’s market is driven by:

• Chronic maintenance use in asthma and COPD (ICS class),
• High prevalence of rhinitis and sinus inflammation,
• Pipeline-lite dynamics typical of older corticosteroids: competition is dominated by generics, rebates, and device performance rather than novel MoA.

A credible market analysis and projection requires at least one of:

• a baseline global or regional market size for budesonide specifically (not “ICS”), or
• a validated spend proxy (IMS/IQVIA category-level data) tied to budesonide SKUs.

No market-size baseline, source, geography, or forecast horizon is supplied, so a complete and accurate projection cannot be generated.

Which competitive forces shape budesonide pricing and volume?

Even without a quantified forecast baseline, the structural drivers for budesonide remain consistent across regions:

1) Generic penetration and switching

• Budesonide is an established active with extensive generic availability in inhaled and nasal forms.
• Pricing pressure comes from formulary substitution and tender dynamics in public health systems.

2) Device and formulation as the differentiator

• For inhaled use, performance depends on delivered dose, plume characteristics, and patient technique.
• For nasal use, spray particle size and suspension stability matter for real-world adherence and outcomes.

3) Indication mix

• Asthma maintenance and rhinitis treatment are volume heavy.
• GI controlled-release formulations are often smaller but may support premium positioning where patent-protected brand histories exist in some markets, depending on local patent status and exclusivities.

How should you project budesonide performance?

A projection normally uses:

• Unit demand model (patients, dosing frequency, adherence),
• Share model (formulation and device share within ICS or intranasal classes),
• Price erosion curve (generic entry dates, tender cycles, rebate compression),
• Regulatory and reimbursement constraints (step-therapy, substitution rules, formulary access).

Without a supplied baseline (current sales, share by geography, or forecast method inputs), a numerical projection cannot be produced.

What can be concluded operationally without live trial and sales inputs?

For decision-making, budesonide should be treated as a:

• class-stable molecule with recurring demand from chronic inflammatory disease,
• category-competitive product, where differentiated commercial value typically comes from device/formulation execution and formulary access rather than late-stage novelty.

That said, a “clinical trials update, market analysis and projection” in the strict, data-forward sense requires explicit datasets and numeric anchors that are not present here.

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Key Takeaways

• Budesonide’s market is shaped by ICS and intranasal demand, with generic-driven pricing pressure and device/formulation performance as practical differentiators.
• A precise clinical-trial update requires live registry extraction by indication, phase, and sponsor; none is provided.
• A precise market projection requires a current sales baseline and forecast horizon; none is provided.

FAQs

1. Is budesonide patent-protected in major markets?
   In most large geographies, budesonide’s core molecule is off-patent; differentiation typically comes from formulation, device, and local branded histories.

2. Which indications contribute most to budesonide demand?
   Asthma and COPD (inhaled) and allergic rhinitis (intranasal) drive the largest chronic volume use.

3. Do budesonide trials focus on new mechanism-of-action?
   Most late-stage relevance is generally in formulation/device improvements or life-cycle indication strategies rather than MoA innovation, given the class maturity.

4. What most affects budesonide forecasting accuracy?
   Formulary access (share), generic price erosion timing, and patient adherence driven by device usability and dosing schedules.

5. Where can differentiation still exist for budesonide products?
   In delivery systems (inhaler technique sensitivity), particle engineering for nasal delivery, and controlled-release profiles for GI inflammation cohorts.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. Medicines data and information. https://www.ema.europa.eu/