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
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
- First Posted Date
- 2009-03-05
- Last Posted Date
- 2011-03-11
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 108
- Registration Number
- NCT00855959
- Locations
- 🇯🇵
Research Site, Tachikawa, Tokyo, Japan
🇯🇵Research City, Hino, Tokyo, Japan
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
- First Posted Date
- 2009-02-06
- Last Posted Date
- 2019-05-07
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Target Recruit Count
- 208
- Registration Number
- NCT00838214
- Locations
- 🇩🇪
Medical School Hannover, Hannover, Niedersachsen, Germany
Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
- First Posted Date
- 2009-01-23
- Last Posted Date
- 2012-01-30
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Target Recruit Count
- 17
- Registration Number
- NCT00828230
- Locations
- 🇩🇪
Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig, Braunschweig, Germany
🇩🇪Strahlentherapie, St. Vincentius-Kliniken gAG, Karlsruhe, Germany
🇩🇪Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen, Trier, Germany
Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients
- First Posted Date
- 2009-01-21
- Last Posted Date
- 2013-09-11
- Lead Sponsor
- Mahidol University
- Target Recruit Count
- 20
- Registration Number
- NCT00826163
- Locations
- 🇹🇭
Kittipong Maneechotesuwan, Bangkoknoi, BKK, Thailand
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
- First Posted Date
- 2008-10-07
- Last Posted Date
- 2009-04-21
- Lead Sponsor
- Calliditas Therapeutics AB
- Target Recruit Count
- 20
- Registration Number
- NCT00767221
- Locations
- 🇸🇪
Linköping University Hospital, Linköping, Sweden
🇸🇪Uppsala University Hospital, Uppsala, Sweden
🇸🇪Huddinge University Hospital, Stockholm, Sweden
Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
- First Posted Date
- 2008-09-30
- Last Posted Date
- 2021-06-11
- Lead Sponsor
- Shire
- Target Recruit Count
- 82
- Registration Number
- NCT00762073
- Locations
- 🇺🇸
Stanford University Medical Center, Palo Alto, California, United States
🇺🇸The Center for Human Nutrition, Omaha, Nebraska, United States
🇺🇸Carilion Pediatric Gastroenterology, Roanoke, Virginia, United States
Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)
- Conditions
- Interventions
- First Posted Date
- 2008-09-04
- Last Posted Date
- 2020-01-28
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Target Recruit Count
- 62
- Registration Number
- NCT00746486
- Locations
- 🇩🇪
Universitätsklinikum Bonn, Bonn, NRW, Germany
🇫🇷Hôpital Saint-Antoine, Paris, France
Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
- First Posted Date
- 2008-09-04
- Last Posted Date
- 2012-06-26
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Target Recruit Count
- 343
- Registration Number
- NCT00747110
- Locations
- 🇩🇪
Klinikum St. Marien, Amberg, Germany
The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
- Conditions
- Interventions
- First Posted Date
- 2008-08-05
- Last Posted Date
- 2016-01-14
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 51
- Registration Number
- NCT00728481
- Locations
- 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
The Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations
- Conditions
- Interventions
- First Posted Date
- 2008-06-27
- Last Posted Date
- 2017-05-31
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 255
- Registration Number
- NCT00706446
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
Drug Development Updates
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