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Budesonide

Generic Name
Budesonide
Brand Names
Airsupra, Breyna, Breztri, Cortiment, Entocort, Pulmicort, Pulmicort Turbuhaler, Rhinocort, Symbicort, Tarpeyo, Uceris, Jorveza, Kinpeygo
Drug Type
Small Molecule
Chemical Formula
C25H34O6
CAS Number
51333-22-3
Unique Ingredient Identifier
Q3OKS62Q6X
Background

Budesonide is a glucocorticoid that is a mix of the 22R and 22S epimer used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis.

Budesonide was granted FDA approval on 14 February 1994. It is also available in a combination product with formoterol.

Indication

Budesonide extended release capsules are indicated for the treatment and maintenance of mild to moderate Crohn’s disease. Various inhaled budesonide products are indicated for prophylactic therapy in asthma and to reduce exacerbations of COPD. A budesonide nasal spray is available over the counter for symptoms of hay fever and upper respiratory allergies. Extended-release capsules are indicated to induce remission of mild to moderate ulcerative colitis and a rectal foam is used for mild to moderate distal ulcerative colitis. In addition, a delayed-release capsule formulation of budesonide is indicated to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression. In Europe, budesonide is indicated to treat eosinophilic esophagitis (EoE) in adults.

Associated Conditions
Allergic Reaction, Allergic Rhinitis (AR), Asthma, Bronchoconstriction, Chronic Obstructive Pulmonary Disease (COPD), Collagenous Colitis, Crohn's Disease (CD), Eosinophilic Esophagitis, Exacerbation of asthma, Nasal Congestion, Nasal Polyps, Proteinuria, Pruritus, Rhino Sinusitis, Ulcerative Colitis, Vasomotor Rhinitis, Corticosteroid-responsive dermatoses, Mild Crohn’s Disease, Moderate Crohn’s Disease
Associated Therapies
Maintenance therapy

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Phase 3
Recruiting
Conditions
Eosinophilic Esophagitis
Interventions
First Posted Date
2024-09-19
Last Posted Date
2025-04-23
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
308
Registration Number
NCT06596252
Locations
🇺🇸

Dr. Falk Investigational Site, Harlingen, Texas, United States

🇪🇸

Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain

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

Phase 1
Completed
Conditions
Healthy
Interventions
Other: Activated Charcoal
First Posted Date
2024-09-19
Last Posted Date
2024-11-08
Lead Sponsor
Unither Pharmaceuticals, France
Target Recruit Count
24
Registration Number
NCT06595121
Locations
🇹🇷

Farmagen IKU Merkezi, Gaziantep, Turkey

Replication of the NefIgArd Trial of TRF-budesonide in Primary IgAN

Completed
Conditions
Primary IgA Nephropathy
Interventions
First Posted Date
2024-09-10
Last Posted Date
2024-09-10
Lead Sponsor
Ruijin Hospital
Target Recruit Count
200
Registration Number
NCT06589752
Locations
🇨🇳

Ruijin hospital, Shanghai, China

Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure

Phase 4
Recruiting
Conditions
COPD Bronchitis
Pollution Related Respiratory Disorder
Interventions
First Posted Date
2024-08-26
Last Posted Date
2024-08-26
Lead Sponsor
National Institute of Respiratory Diseases, Mexico
Target Recruit Count
128
Registration Number
NCT06571942
Locations
🇲🇽

Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas", Ciudad de México, Tlalpan, Mexico

Exacerbations Among Patients Receiving Breztri (EROS Study)

Completed
Conditions
Chronic Obstructive
Retrospective Studies
Pulmonary Disease
Interventions
First Posted Date
2024-07-23
Last Posted Date
2024-12-13
Lead Sponsor
AstraZeneca
Target Recruit Count
2409
Registration Number
NCT06514144
Locations
🇺🇸

AstraZeneca, Wilmington, Delaware, United States

Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]

Recruiting
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
First Posted Date
2024-07-19
Last Posted Date
2025-05-13
Lead Sponsor
AstraZeneca
Target Recruit Count
200
Registration Number
NCT06511193
Locations
🇨🇦

Research Site, Windsor, Ontario, Canada

Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD

Recruiting
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
First Posted Date
2024-04-16
Last Posted Date
2025-04-15
Lead Sponsor
AstraZeneca
Target Recruit Count
250
Registration Number
NCT06368427
Locations
🇷🇴

Research Site, Timisoara, Romania

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

Phase 1
Recruiting
Conditions
Neutrophil Extracellular Trap Formation
Inflammatory Response
Preterm Birth
Neonatal Respiratory Distress Syndrome
Premature Lungs
Interventions
First Posted Date
2024-04-16
Last Posted Date
2024-04-16
Lead Sponsor
Ain Shams University
Target Recruit Count
60
Registration Number
NCT06367881
Locations
🇪🇬

Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517, Cairo, Egypt

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

Phase 4
Recruiting
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
First Posted Date
2024-03-28
Last Posted Date
2025-03-12
Lead Sponsor
Maria Joyera Rodríguez
Target Recruit Count
135
Registration Number
NCT06334575
Locations
🇩🇪

Philips University of Marburg, Marburg, Germany

🇳🇱

Academisch Ziekenhuis Groningen, Groningen, Netherlands

🇪🇸

Clínic Barcelona, Barcelona, Spain

and more 3 locations

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

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2024-02-20
Last Posted Date
2024-12-02
Lead Sponsor
Takeda
Target Recruit Count
20
Registration Number
NCT06268301
Locations
🇺🇸

Celerion, Lincoln, Nebraska, United States

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