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: C_₂₅H_₃₄O_₆

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

Clinical Trials

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

Phase 3

Recruiting

Conditions: Asthma

Interventions: Drug: QMF149
Drug: Budesonide

First Posted Date: 2022-09-30

Last Posted Date: 2025-05-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 200

Registration Number: NCT05562466

Locations: 🇪🇸
Novartis Investigative Site, Madrid, Spain

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

Not Applicable

Recruiting

Conditions: Chronic Rhinosinusitis (Diagnosis)

Interventions: Drug: Placebos
Drug: Budesonide Nasal

First Posted Date: 2022-09-15

Last Posted Date: 2022-09-15

Lead Sponsor: Universidade Estadual de Londrina

Target Recruit Count: 60

Registration Number: NCT05541419

Locations: 🇧🇷
Marco Aurelio Fornazieri, Londrina, Paraná, Brazil

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

Phase 1

Completed

Conditions: Healthy Subjects
Human Volunteers
Healthy Participants
Bioequivalence

Interventions: Drug: Cortiment
Drug: Budesonide

First Posted Date: 2022-08-29

Last Posted Date: 2022-08-29

Lead Sponsor: Abbott

Target Recruit Count: 56

Registration Number: NCT05519514

Locations: 🇮🇳
Study Site, Mangalore, India

Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

Phase 3

Recruiting

Conditions: Engraftment Syndrome

Interventions: Drug: Budesonide

First Posted Date: 2022-08-22

Last Posted Date: 2025-04-29

Lead Sponsor: Henry Ford Health System

Target Recruit Count: 110

Registration Number: NCT05509933

Locations: 🇺🇸
Henry Ford Health System, Detroit, Michigan, United States

A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: BDA MDI
Drug: AS MDI

First Posted Date: 2022-08-18

Last Posted Date: 2024-08-29

Lead Sponsor: Bond Avillion 2 Development LP

Target Recruit Count: 2517

Registration Number: NCT05505734

Locations: 🇺🇸
Genesis Clinical Research and Consulting, LLC, Fall River, Massachusetts, United States
🇺🇸
Meridian Clinical Research, LLC, Lincoln, Nebraska, United States
🇺🇸
Mankato Clinic, Mankato, Minnesota, United States

and more 48 locations