Drug

Budesonide

Approved · EMA

ClassGlucocorticoid receptor agonistEmerging researchLate-stage developmentSteady momentum

Also known as Airsupra, Breyna, Breztri, Entocort+10 more

Airsupra, Breyna, Breztri, Entocort, Eohilia, Ortikos, Pulmicort, Rhinocort, Rhinocort Aqua, Symbicort, Tarpeyo, Uceris, Budesónida, budesonida.

RxNorm19831 ChEMBLCHEMBL1370 ATCA07EA06 ATCR03BA02 ATCD07AC09 ATCR01AD05UNIIQ3OKS62Q6X

Research papers

Active clinical trials

Glucocorticoid receptor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

Clinical trial2026-07-10Results expected Q4 2026 · ClinicalTrials.gov

Investigating Sinonasal Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis Patients With Nasal Polyposis

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

Clinical trial2026-06-05Results expected Q1 2028 · ClinicalTrials.gov

Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

Recall (Class II): BUDESONIDE

Regulatory2026-05-29FDA

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

Clinical trial2026-03-05Results expected Q4 2027 · ClinicalTrials.gov

Long-term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: A 4-Year, Phase 3, Open-Label Study.

Research2025-02-13Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Approval: Kinpeygo (EMA)

Regulatory2022-07-15EMA

Accelerated approval: Jorveza (EMA)

Regulatory2018-01-08EMA

Corticosteroids for pneumonia.

Research2017-12-13The Cochrane database of systematic reviews

Daily or intermittent budesonide in preschool children with recurrent wheezing.

Research2011-11-01The New England journal of medicine

Oral budesonide in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid.

Research2000-02-01Hepatology (Baltimore, Md.)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Budesonide

Aliases & brands

AirsupraBreynaBreztriEntocortEohiliaOrtikosPulmicortRhinocortRhinocort AquaSymbicortTarpeyoUcerisBudesónidabudesonida

RxNorm CUI

19831

ChEMBL ID

CHEMBL1370

ATC codes

A07EA06R03BA02D07AC09R01AD05

UNII

Q3OKS62Q6X

Primary mechanism

Glucocorticoid receptor agonist

Regulatory jurisdictions

emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Glucocorticoid receptor

NR3C1 · P04150

AGONISTGlucocorticoid receptor agonist

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-01-08

Latest approval

2022-07-15

Authorities

FDA · EMA

Total events

fdaU.S. Food and Drug Administration· 1 event

2026-05-29RecallSafety

Recall (Class II): BUDESONIDE

Evidence ↗

emaEuropean Medicines Agency· 2 events

2022-07-15Approval

Approval: Kinpeygo (EMA)

Indication: Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio… Show full indication

Kinpeygo is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).

Evidence ↗

2018-01-08Accelerated approval

Accelerated approval: Jorveza (EMA)

Indication: Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). Jorveza 0.2 mg/mL oral suspension is indicated for the… Show full indication

Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

175 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

175

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

120

Late-stage (III+)

123

Completed

Discontinued

PHASE DISTRIBUTIONn = 175

Early Phase 13Phase 114Phase 1 / 24Phase 234Phase 2 / 39Phase 353Phase 436Phase N / A22

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IVMaria Joyera Rodríguezn=1352027

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

RecruitingPH IVBausch Health Americas, Inc.n=702027

Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia

RecruitingPH IVUniversitaire Ziekenhuizen KU Leuvenn=562026

Diesel Exhaust Induces Glucocorticoid Resistance

RecruitingPH IVUniversity of British Columbian=302025

Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy

Unknown statusPH IVAssiut Universityn=872025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids

CompletedPH IIISanofin=632024

A Study of Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

CompletedPH IINational Cancer Institute (NCI)n=102024

Comparative Bioavailability Study of Budesonide After Inhalation of Budesonide 1 Mg / 2 Ml Nebuliser Suspension (Test Product 08P1707F0): Administration Without and with Activated Charcoal and Inhalation of Pulmicort® 1.0 Mg / 2 Ml Suspension (Reference Product) in Healthy Subjects

CompletedPH IUnither Pharmaceuticals, Francen=242024

Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis

CompletedPH IVUniversity Hospitals Cleveland Medical Centern=232023

Acupuncture Therapy for COVID-Related Olfactory Loss

CompletedN/AMayo Clinicn=302023

A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Budesonide Oral Suspension in Healthy Adult Participants

CompletedPH ITakedan=202023

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20002025

Most influential

Corticosteroids for pneumonia.

The Cochrane database of systematic reviews · 2017 · 157 cites

Daily or intermittent budesonide in preschool children with recurrent wheezing.

The New England journal of medicine · 2011 · 146 cites

Oral budesonide in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid.

Hepatology (Baltimore, Md.) · 2000 · 118 cites

Long-term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: A 4-Year, Phase 3, Open-Label Study.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025 · 4 cites

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dexamethasone

Acts on the same molecular target as Budesonide, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Hydrocortisone

Acts on the same molecular target as Budesonide, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Prednisolone

Acts on the same molecular target as Budesonide, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Ampicillin

Studied across the same disease area as Budesonide in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.