Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/05 | N/A | Completed | |||
2025/03/03 | Phase 2 | Not yet recruiting | |||
2025/02/25 | N/A | Not yet recruiting | yanmengkang | ||
2025/02/24 | Phase 4 | Recruiting | |||
2025/02/20 | Not Applicable | Not yet recruiting | |||
2025/02/17 | Phase 2 | Recruiting | |||
2024/12/20 | N/A | Completed | |||
2024/12/19 | N/A | Completed | |||
2024/12/06 | Phase 2 | ENROLLING_BY_INVITATION | Medical University of Warsaw | ||
2024/12/02 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| RPK Pharmaceuticals, Inc. | 53002-2667 | RESPIRATORY (INHALATION) | 160 ug in 1 1 | 7/24/2019 | |
| Rebel Distributors Corp | 21695-291 | RESPIRATORY (INHALATION) | 90 ug in 1 1 | 7/29/2010 | |
| Carilion Materials Management | 68151-4374 | ORAL | 3 mg in 1 1 | 3/5/2014 | |
| A-S Medication Solutions | 50090-1403 | RESPIRATORY (INHALATION) | 160 ug in 1 1 | 10/17/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-984 | RESPIRATORY (INHALATION) | 0.5 mg in 2 mL | 12/14/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-7502 | RESPIRATORY (INHALATION) | 80 ug in 1 1 | 9/24/2020 | |
| Nephron Pharmaceuticals Corporation | 0487-9601 | RESPIRATORY (INHALATION) | 0.25 mg in 2 mL | 1/11/2021 | |
| Exelan Pharmaceuticals, Inc. | 76282-640 | ORAL | 0.25 mg in 2 mL | 12/11/2020 | |
| Ritedose Pharmaceuticals, LLC | 76204-018 | RESPIRATORY (INHALATION) | 0.5 mg in 2 mL | 12/16/2022 | |
| A-S Medication Solutions | 50090-6382 | RESPIRATORY (INHALATION) | 80 ug in 1 1 | 7/24/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/28/2014 | ||
Authorised | 4/3/2020 | ||
Authorised | 12/9/2020 | ||
Authorised | 4/28/2014 | ||
Authorised | 1/6/2022 | ||
Authorised | 1/6/2022 | ||
Authorised | 1/8/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 320 MCG/9 MCG | SIN16057P | POWDER, METERED | 320 mcg / inhalation | 12/7/2020 | |
| SYMBICORT TURBUHALER INHALATION POWDER 320/9 mcg/dose | SIN12580P | POWDER, METERED | 320 mcg/dose | 8/4/2004 | |
| GIONA EASYHALER INHALATION POWDER 100 mcg/dose | SIN12618P | POWDER, METERED | 100 mcg/dose | 12/6/2004 | |
| Budesonide Nasal spray suspension 64mcg | SIN14029P | SPRAY, SUSPENSION | 64.0 mcg/dose | 10/11/2011 | |
| Frenolyn Powder for Oral Inhalation 200mcg/dose | SIN13870P | POWDER, METERED | 200mcg/dose | 10/4/2010 | |
| NEFEGAN MODIFIED RELEASE CAPSULE 4MG | SIN16972P | CAPSULE | 4.00 mg | 3/19/2024 | |
| DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 160 MCG/4.5 MCG | SIN16056P | POWDER, METERED | 160 mcg / inhalation | 12/7/2020 | |
| SYMBICORT TURBUHALER 80/4.5 mcg/dose | SIN11678P | POWDER, METERED | 80 mcg/dose | 9/24/2001 | |
| CORTIMENT MMX PROLONGED RELEASE TABLETS 9 MG | SIN15311P | TABLET, FILM COATED, EXTENDED RELEASE | 9.0 mg | 8/4/2017 | |
| PULMICORT TURBUHALER 100 mcg/dose | SIN05043P | POWDER, METERED | 100 mcg/dose | 9/6/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PULMICORT TURBUHALER 200MCG/DOSE | N/A | N/A | N/A | 8/28/1990 | |
| RHINOCORT AQ NASAL SPRAY 32MCG/DOSE | N/A | N/A | N/A | 7/31/2000 | |
| PULMICORT RESPULES 1MG/2ML | N/A | N/A | N/A | 8/18/1993 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ENTOCORT ENEMA | 02052431 | Enema
,
Tablet
,
Kit - Rectal | 2.3 MG | 12/31/1994 | |
| CORTIMENT | Ferring Inc | 02455889 | Tablet (Delayed And Extended Release) - Oral | 9 MG | 7/25/2016 |
| PULMICORT TURBUHALER | astrazeneca canada inc | 00851752 | Powder (Metered Dose) - Inhalation | 200 MCG / ACT | 12/31/1990 |
| TEVA-BUDESONIDE | teva canada limited | 02465949 | Suspension - Inhalation | 0.125 MG / ML | 11/8/2017 |
| SYMBICORT 200 TURBUHALER | astrazeneca canada inc | 02245386 | Powder - Inhalation | 200 MCG / ACT | 2/8/2002 |
| RHINOCORT AQUA 100MCG | astra pharma inc. | 01974432 | Metered-Dose Aerosol - Nasal | 100 MCG / ACT | 12/31/1993 |
| RHINOCORT TURBUHALER 100 MCG/DOSE | astrazeneca canada inc | 02035324 | Powder - Nasal
,
Inhalation | 100 MCG / ACT | 12/31/1993 |
| MYLAN-BUDESONIDE AQ | Mylan Pharmaceuticals ULC | 02241003 | Spray, Metered Dose - Nasal | 64 MCG / ACT | 11/23/1999 |
| MYLAN-BUDESONIDE AQ | Mylan Pharmaceuticals ULC | 02230648 | Spray, Metered Dose - Nasal | 100 MCG / ACT | 2/12/1997 |
| BREZTRI AEROSPHERE | astrazeneca canada inc | 02518058 | Aerosol, Metered Dose - Inhalation | 160 MCG / ACT | 12/3/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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