budesonide
Trade name: rhinocort
Approved
Feb 14, 1994
Budesonide is a glucocorticoid used in the management of asthma, the treatment of various skin disorders, allergic rhinitis and ulcerative colitis. The precise mechanism of corticosteroid actions on inflammation in asthma is not well known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic- and non-allergic-mediated inflammation. The anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma. Commonly reported side effects of budesonide include: acne vulgaris, moon face, and bruise. Other side effects include: ankle edema, hirsutism, weakness, arthralgia, nausea, and rhinitis. Ketoconazole, a potent inhibitor of cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4), the main metabolic enzyme for corticosteroids, increased plasma levels of orally ingested budesonide. — NCATS
Clinical trial activity
579 trials · 403 clinical orgs · 33 marketing orgs
Earliest trial started Sep 1, 1991 (NCT00000575)
Timeline
1990s
- Jan 1, 1991
Earliest Phase 3 Sponsor(trial)
- Feb 14, 1994
AstraZeneca — Earliest FDA Approval
- Feb 14, 1994
AstraZeneca — NDA Organization
- Feb 14, 1994
AstraZeneca — NDA Secondary Org
- Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1998
Earliest Phase 2 Sponsor(trial)
- Oct 1, 1999
Johnson and Johnson — Marketing Organization
- Oct 1, 1999
Johnson and Johnson — NDA Secondary Org
2000s
- Oct 2, 2001
Perrigo — NDA Secondary Org
- Oct 2, 2001
Padagis Us — Marketing Organization
- Oct 2, 2001
Padagis Us — NDA Secondary Org
- Jul 12, 2006
CheplaPharm — Marketing Organization
- Nov 18, 2008
Teva — Marketing Organization
- Mar 30, 2009
Apotex — Marketing Organization
- Mar 30, 2009
Nephron Pharmaceuticals Corporation — Marketing Organization
2010s
- May 16, 2011
Aurobindo Pharma — Marketing Organization
- May 16, 2011
Mylan — Marketing Organization
- Jul 31, 2012
Impax Laboratories — Marketing Organization
- Jan 14, 2013
Bausch Health Companies — NDA Secondary Org
- Jan 14, 2013
Salix — NDA Secondary Org
- Sep 27, 2013
Sandoz — Marketing Organization
- Sep 27, 2013
Novartis — Marketing Organization
- Apr 2, 2014
Barr Laboratories — Marketing Organization
- Apr 8, 2016
Mayne Pharma — Marketing Organization
- Apr 8, 2016
Dr. Reddy's Laboratories — Marketing Organization
- Nov 23, 2016
Alvogen — Marketing Organization
- Nov 23, 2016
Natco Pharma — Marketing Organization
- Apr 7, 2017
Appco Pharma — Marketing Organization
- Apr 7, 2017
Rising Pharmaceuticals — Marketing Organization
- May 4, 2017
Zydus Discovery DMCC — Marketing Organization
- Jul 31, 2017
Amneal Pharmaceuticals — Marketing Organization
- Sep 28, 2017
Sciecure Pharma Inc — Marketing Organization
- Nov 16, 2017
Cipla — Marketing Organization
- Jul 3, 2018
Actavis — Marketing Organization
- Jul 3, 2018
Allergan PLC (2015) — Marketing Organization
- Nov 9, 2018
Lupin — Marketing Organization
- Jan 30, 2019
Sun Pharmaceuticals — NDA Secondary Org
- Jun 13, 2019
Sun Pharmaceuticals — Marketing Organization
2020s
- Dec 15, 2021
Calliditas Therapeutics — Marketing Organization
- Dec 15, 2021
Calliditas Therapeutics — NDA Secondary Org
- Nov 29, 2023
Eugia Pharma — Marketing Organization
- Feb 9, 2024
Takeda — Marketing Organization
Indications
Approved for
Studied for
- Acute Chest Syndrome · Phase 1
- Acute Lung Injury · Phase 4
- Aged · Phase 4
- Air Pollution · Phase 4
- Airway Management · Phase 4
- Allergy and Immunology · Phase 4
- Altitude Sickness · Phase 3
- Anemia, Sickle Cell · Phase 1
- Anosmia · Phase 3
- Arthroplasty, Replacement, Hip · Phase 3
- Aspergillosis, Allergic Bronchopulmonary · Phase 2/Phase 3
- Asthma · Phase 4
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome · Phase 4
- Asthma, Exercise-Induced · Phase 4
- Autoimmune Diseases · Phase 4
- Breast Neoplasms · Phase 3
- Bronchiectasis · Phase 4
- Bronchiolitis Obliterans · Phase 2
- Bronchitis · Phase 4
- Bronchoalveolar Lavage Fluid · Phase 4
- Bronchopulmonary Dysplasia · Phase 4
- Budesonide · Phase 4
- Celiac Disease · Phase 4
- Cholangitis, Sclerosing · Phase 1
- Colitis · Phase 3
- Colitis, Collagenous · Phase 3
- Colitis, Lymphocytic · Phase 3
- Colitis, Microscopic · Phase 3
- Colitis, Ulcerative · Phase 4
- Collagenous Sprue · Phase 4
- Conjunctivitis, Allergic · Phase 3
- Coronavirus Infections · Phase 4
- COVID-19 · Phase 3
- Crohn Disease · Phase 4
- Cryptogenic Organizing Pneumonia · Phase 2
- Cytokines · Phase 4
- Deglutition Disorders · Early Phase 1
- Diabetes Mellitus · Phase 2
- Diarrhea · Phase 2/Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Dyspepsia · Phase 4
- Emphysema · Phase 3
- Environmental Exposure · Phase 4
- Eosinophilic Esophagitis · Phase 4
- Esophageal Stenosis · Phase 2
- Estradiol · Phase 2/Phase 3
- Exercise · Phase 4
- Extracellular Traps · Phase 1
- Fasting · Phase 1
- Gastritis · Phase 3
- Gastroesophageal Reflux · Phase 2/Phase 3
- Gastroparesis · Phase 1
- General Surgery · Phase 4
- Genetic Diseases, Inborn · Phase 4
- Glomerulonephritis, IGA · Phase 4
- Glucocorticoids · Phase 4
- Graft Rejection · Phase 4
- Graft vs Host Disease · Phase 3
- Healthy Volunteers · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 2
- Hepatitis, Autoimmune · Phase 2/Phase 3
- Hypersensitivity · Phase 2/Phase 3
- Hypoxia · Phase 3
- IgA Vasculitis · Phase 4
- Infant, Extremely Premature · Phase 4
- Infant, Premature · Phase 4
- Infant, Premature, Diseases · Phase 4
- Infections · Phase 2/Phase 3
- Inflammation · Phase 4
- Inflammatory Bowel Diseases · Phase 2
- Intestinal Diseases · Phase 4
- Intestinal Neoplasms · Phase 2
- Intestinal Polyposis · Phase 3
- Intubation · Phase 1/Phase 2
- Kidney Diseases · Phase 3
- Leukemia · Phase 3
- Leukemia, Lymphoid · Phase 4
- Ligaments, Articular · Phase 1
- Liver Cirrhosis, Biliary · Phase 3
- Liver Transplantation · Phase 4
- Lung Diseases · Phase 4
- Lung Diseases, Interstitial · Phase 2
- Lung Diseases, Obstructive · Phase 2
- Lung Neoplasms · Phase 4
- Malaria, Vivax · Phase 1
- Medication Adherence · Phase 4
- Melanoma · Phase 2
- Mouth Breathing · Phase 3
- Multiple Myeloma · Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 1
- Nasal Obstruction · Phase 2
- Nasal Polyps · Phase 4
- Neonatology · Phase 3
- Neoplasm Metastasis · Phase 2
- Olfaction Disorders · Phase 3
- Olfactory Nerve Diseases · Phase 4
- Osteoporosis · Phase 4
- Paranasal Sinus Diseases · Phase 2/Phase 3
- Pharmacokinetics · Phase 1
- Pharyngitis · Phase 2/Phase 3
- Pneumonia · Phase 3
- Precancerous Conditions · Phase 1
- Premature Birth · Phase 1
- Primary Prevention · Phase 1/Phase 2
- Proctitis · Phase 3
- Proctocolitis · Phase 3
- Protein-Losing Enteropathies · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Quality of Life · Phase 4
- Radiation Pneumonitis · Phase 2
- Renal Insufficiency, Chronic · Phase 4
- Respiratory Distress Syndrome · Phase 4
- Respiratory Distress Syndrome, Newborn · Phase 1
- Respiratory Sounds · Phase 1
- Respiratory Syncytial Virus Infections · Phase 1
- Respiratory Tract Infections · Phase 2
- Rhinitis · Phase 4
- Rhinitis, Allergic · Phase 4
- Rhinitis, Allergic, Perennial · Phase 4
- Rhinitis, Allergic, Seasonal · Phase 3
- SARS-CoV-2 · Phase 3
- Severe Acute Malnutrition · Phase 2
- Severe Acute Respiratory Syndrome · Phase 1/Phase 2
- Sinusitis · Phase 4
- Sleep Apnea, Obstructive · Phase 4
- Sleep Disorders, Intrinsic · Phase 3
- Snoring · Phase 3
- Status Asthmaticus · Phase 2/Phase 3
- Stem Cell Transplantation · Phase 1
- Therapeutic Equivalency · Phase 1
- Tonsillectomy · Phase 4
- Transient Tachypnea of the Newborn · Phase 2
- Vascular Grafting · Phase 3
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Combination products
airsupra
with albuterol
breztri aerosphere
with glycopyrronium, formoterol
symbicort
with formoterol
Approval history
- approvedFeb 14, 1994
Chemistry & pharmacology
SMILES
CCCC1O[C@@H]2C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@]5(C)[C@H]4[C@@H](O)C[C@]3(C)[C@]2(C(=O)CO)O1- Mol. weight
- 430.54 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Topical
- Availability
- Over the Counter
Oral
Yes
Parenteral
No
Topical
Yes
Sources
- WikipediaBudesonide/formoterol ↗
- NCATSQ3OKS62Q6X ↗
- ChEMBLCHEMBL1586 ↗
- ChEMBLCHEMBL1370 ↗
- WikipediaBudesonide ↗
Also known as
- (11beta,16alpha)-16,17-(butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione
- (11beta,16alpha)-16,17-(butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione
- aircort
- barazone
- budeflam aquanase
- budelin novolizer
- budenofalk
- budenofalk
- budensonide
- budesomide
- budeson
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide
- budesonide / formoterol
- budesonide / formoterol fumarate dihydrate
- budesonide-formoterol mixt
- budesonide / salmeterol
- budicort
- cortiment
- cortiment
- duoresp spiromax
- entocort
- entocort
- entocort cr
- entocort ec
- entocort ec
- neumoterol
- preferid
- preferid
- pt009
- pt010
- pulmaxan
- pulmaxan
- pulmicort
- pulmicort
- pulmicort
- pulmicort flexhaler
- pulmicort flexhaler
- pulmicort l.s.
- pulmicort respules
- pulmicort respules
- qvar
- rhinocort
- rhinocort
- rhinocort
- rhinocort
- rhinocort
- rhinocort
- rhinocort aqua
- rhinocort aqua
- rhinocort aqua 64
- s-1320
- s-1320
- symbicort
- symbicort
- symbicort
- uceris
- uceris
- uceris
- uceris
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07270302 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2025 | Washington University in St. Louis |
| NCT06860542 | Phase 2 | Dec 1, 2025 | University of Calgary |
| NCT07267130 | Phase 1 | Nov 25, 2025 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT07073950 | Phase 4 | Nov 14, 2025 | AstraZeneca, Parexel |
| NCT06895460 | Phase 3 | Jun 20, 2025 | Nanjing Medical University |
| NCT06940700 | Phase 2 | Apr 30, 2025 | Hengrui Therapeutics, Inc. |
| NCT06890260 | N/A | Apr 11, 2025 | Zhejiang University |
| NCT06837051 | N/A | Mar 14, 2025 | Peking University |
| NCT06756243 | N/A | Mar 1, 2025 | Zhejiang University |
| NCT06785662 | Phase 4 | Feb 12, 2025 | Siriraj Hospital |
| NCT06723756 | Phase 1 | Jan 23, 2025 | AstraZeneca, Parexel |
| NCT06590740 | N/A | Dec 30, 2024 | AstraZeneca, Guangzhou Medical University |
| NCT06924190 | N/A | Dec 30, 2024 | Lunan Better Pharmaceutical Co., LTD., Wuxi People's Hospital |
| NCT06712407 | Phase 4 | Dec 15, 2024 | Calliditas Therapeutics, Worldwide Clinical Trials |
| NCT06597682 | N/A | Nov 30, 2024 | Fudan University |
| NCT06676384 | Phase 4 | Nov 30, 2024 | Christian Medical College, Vellore, India, India Alliance, Medical Research Council, University of Leicester, University of Queensland |
| NCT06676319 | Phase 2 | Nov 11, 2024 | Sanofi |
| NCT06340581 | Phase 1 | Oct 17, 2024 | AstraZeneca, Parexel |
| NCT06830109 | Phase 2 | Oct 15, 2024 | Washington University in St. Louis |
| NCT06473779 | Phase 3 | Sep 30, 2024 | AstraZeneca, Fortrea |
Organizations
Research & Development (403)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 153 | 124 | 5 | 1996 |
| Dr. Falk Pharma GmbH | For profit | 21 | 17 | 3 | 2001 |
| Boehringer Ingelheim | For profit | 19 | 19 | 3 | 1998 |
| Pearl Therapeutics | For profit | 15 | 15 | 3 | 2013 |
| Parexel | For profit | 14 | 0 | 3 | 2012 |
| GlaxoSmithKline | For profit | 13 | 12 | 4 | 2002 |
| Orion Corporation | For profit | 11 | 11 | 5 | 2009 |
| Washington University in St. Louis | Academic/Hospital | 11 | 7 | 4 | 1991 |
| Bausch Health Companies | For profit | 10 | 10 | 2 | 2008 |
| Guangzhou Medical University | Academic/Hospital | 10 | 7 | 3 | 2007 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 10 | 3 | 4 | 1991 |
| Chiesi | For profit | 9 | 9 | 2 | 2004 |
| Harvard University | Academic/Hospital | 9 | 3 | 4 | 1991 |
| Mayo Clinic | Academic/Hospital | 9 | 7 | 5 | 1997 |
| University of British Columbia | Academic/Hospital | 9 | 8 | 5 | 2000 |
| Capital Medical University | Academic/Hospital | 8 | 5 | 4 | 2010 |
| University of Arizona | Academic/Hospital | 8 | 3 | 4 | 2001 |
| Eurofarma Laboratorios S.A. | For profit | 7 | 7 | 1 | 2010 |
| University of Colorado, Denver | Academic/Hospital | 7 | 3 | 3 | 1991 |
| Allergan | For profit | 6 | 6 | 3 | 2005 |
Marketing (48)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Jul 3, 2018 |
| Allergan PLC (2015) | For profit | MKTG | Jul 3, 2018 |
| Alvogen | For profit | MKTG | Nov 23, 2016 |
| Alvogen | For profit | SYN | Nov 23, 2016 |
| Amneal Pharmaceuticals | For profit | MKTG | Jul 31, 2017 |
| Apotex | For profit | MKTG | Mar 30, 2009 |
| Appco Pharma | For profit | MKTG | Apr 7, 2017 |
| Appco Pharma | For profit | SYN | Apr 7, 2017 |
| AstraZeneca | For profit | SYN | Oct 1, 1999 |
| AstraZeneca | For profit | NDA | Feb 14, 1994 |
| AstraZeneca | For profit | NDA2 | Feb 14, 1994 |
| AstraZeneca | For profit | SYN | Jul 23, 2020 |
| Aurobindo Pharma | For profit | MKTG | May 16, 2011 |
| Barr Laboratories | For profit | MKTG | Apr 2, 2014 |
| Bausch Health Companies | For profit | NDA2 | Jan 14, 2013 |
| Calliditas Therapeutics | For profit | MKTG | Dec 15, 2021 |
| Calliditas Therapeutics | For profit | NDA2 | Dec 15, 2021 |
| CheplaPharm | For profit | MKTG | Jul 12, 2006 |
| Cipla | For profit | MKTG | Nov 16, 2017 |
| Dr. Reddy's Laboratories | For profit | MKTG | Apr 8, 2016 |
| Eugia Pharma | For profit | MKTG | Nov 29, 2023 |
| Impax Laboratories | For profit | MKTG | Jul 31, 2012 |
| Johnson and Johnson | For profit | MKTG | Oct 1, 1999 |
| Johnson and Johnson | For profit | NDA2 | Oct 1, 1999 |
| Lupin | For profit | SYN | Nov 9, 2018 |
| Lupin | For profit | MKTG | Nov 9, 2018 |
| Mayne Pharma | For profit | MKTG | Apr 8, 2016 |
| Mylan | For profit | SYN | Mar 5, 2021 |
| Mylan | For profit | MKTG | May 16, 2011 |
| Natco Pharma | For profit | MKTG | Nov 23, 2016 |
| Nephron Pharmaceuticals Corporation | For profit | MKTG | Mar 30, 2009 |
| Novartis | For profit | MKTG | Sep 27, 2013 |
| Padagis Us | For profit | MKTG | Oct 2, 2001 |
| Padagis Us | For profit | SYN | Apr 12, 2023 |
| Padagis Us | For profit | NDA2 | Oct 2, 2001 |
| Perrigo | For profit | NDA2 | Oct 2, 2001 |
| Rising Pharmaceuticals | For profit | MKTG | Apr 7, 2017 |
| Salix | For profit | NDA2 | Jan 14, 2013 |
| Sandoz | For profit | MKTG | Sep 27, 2013 |
| Sandoz | For profit | SYN | Sep 27, 2013 |
| Sciecure Pharma Inc | For profit | MKTG | Sep 28, 2017 |
| Sun Pharmaceuticals | For profit | NDA2 | Jan 30, 2019 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 14, 2021 |
| Sun Pharmaceuticals | For profit | MKTG | Jun 13, 2019 |
| Takeda | For profit | MKTG | Feb 9, 2024 |
| Teva | For profit | MKTG | Nov 18, 2008 |
| Teva | For profit | SYN | Mar 8, 2016 |
| Zydus Discovery DMCC | For profit | MKTG | May 4, 2017 |