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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | |||
2024/12/02 | Phase 4 | 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 | 1/8/2018 |
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 |
|---|---|---|---|---|---|
| Budesonide Enteric Capsules | 国药准字HJ20230130 | 化学药品 | 胶囊剂 | 11/21/2023 | |
| Budesonide Pressurised Inhalation Solution | H20120320 | 化学药品 | 吸入气雾剂 | 2/13/2020 | |
| Budesonide Pressurised Inhalation Solution | 国药准字H20010552 | 化学药品 | 吸入气雾剂 | 6/3/2020 | |
| Budesonide Pressurised Inhalation Solution | 国药准字H20030987 | 化学药品 | 吸入气雾剂 | 5/20/2020 | |
| 布地奈德粉雾剂 | 国药准字H20080316 | 化学药品 | 粉雾剂 | 12/8/2022 | |
| Budesonide Suspension for Inhalation | 国药准字HJ20140474 | 化学药品 | 吸入混悬液 | 11/30/2023 | |
| Budesonide Suspension for Inhalation | 国药准字H20203343 | 化学药品 | 吸入混悬剂 | 7/21/2020 | |
| Budesonide Suspension for Inhalation | 国药准字H20213286 | 化学药品 | 吸入制剂 | 4/13/2021 | |
| Budesonide Suspension for Inhalation | 国药准字HJ20140475 | 化学药品 | 吸入混悬液 | 11/30/2023 | |
| Budesonide Suspension for Inhalation | 国药准字H20244983 | 化学药品 | 吸入制剂 | 9/26/2024 |
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 |