Budesonide
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1994
- First approval year
- 1994
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Budesonide
- Molecular weight
- 430.54
- Structure (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
- aircort
- Aircort
- budeflam aquanase
- Budeflam aquanase
- budelin novolizer
- Budelin novolizer
- budenofalk
- Budenofalk
- budesonide
- Budesonide
- budesonide component of airsupra
- Budesonide component of airsupra
- budesonide component of breztri
- Budesonide component of breztri
- budesonide component of symbicort
- Budesonide component of symbicort
- budesonide component of uceris
- Budesonide component of uceris
- cortiment
- Cortiment
- duoresp spiromax
- Duoresp spiromax
- entocort
- Entocort
- entocort cr
And 37 more, listed on the interactive page.
- (RS)-11β,16α,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde
- 0 135mg map0010
- 0.135mg MAP0010
- 0.25mg MAP0010
- airsupra component budesonide
- AIRSUPRA COMPONENT BUDESONIDE
- breztri component budesonide
- BREZTRI COMPONENT BUDESONIDE
- budesonida
- Budesonida
- budesonide
- Budesonide
- Budesonide (6 mg)
- Budesonide (9 mg)
- budesonide (Aircort 50 nasal spray)
- Budesonide (directly observed)
- budesonide (Pulmicort nebulizing suspension).
- budesonide (Pulmicort)
- Budesonide (Pulmicort)
- BUDESONIDE [EP MONOGRAPH]
- budesonide [INN]
- BUDESONIDE [JAN]
- BUDESONIDE [MI]
- BUDESONIDE [ORANGE BOOK]
- BUDESONIDE [USAN]
And 74 more, listed on the interactive page.
- CAS registry numbers
- 51333-22-3
- ChEMBL ID
- CHEMBL1370
- InChIKey
- VOVIALXJUBGFJZ-KWVAZRHASA-N
- PubChem compound IDs
- 5281004
- RxNorm IDs (RxCUI)
- 19831
- FDA ingredient codes (UNII)
- Q3OKS62Q6X
- A07EA06
- D07AC09
- R01AD05
- R03BA02
Sources for recorded values
- Applicant
- ASTRAZENECA
- Approval date
- 8 Aug 2000
- Application number
- NDA020929
- Status
- Authorised
- Status date
- 8 Jan 2018
- Authorisation date
- 8 Jan 2018
- Approved indications
- 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.
- Product number
- EMEA/H/C/004655
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- Yes
- Exceptional circumstances
- No
Therapeutic areas
- Esophageal Diseases
European medicines record
- Patents
- 24
- Designations
- 2
- Earliest recorded loss of exclusivity
- 23 Jan 2043
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Over the counter
- Boxed warning
- Yes
- Pharmacology name
- budesonide
- Type
- Synthetic organic
- Drug name stem
- -onide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- topical
- Action
- Agonist
- Action type
- Agonist
- Target
- Glucocorticoid receptor
- Gene symbol
- NR3C1
- Protein identifier
- P04150
- Median affinity
- 7.42
- Affinity units
- pEC50
- Primary target
- Yes
- Action
- Agonist
- Action type
- Agonist
- Target
- Progesterone receptor
- Gene symbol
- PGR
- Protein identifier
- P06401
- Median affinity
- 7.15
- Affinity units
- pEC50
- Action
- Agonist
- Action type
- Agonist
- Target
- Mineralocorticoid receptor
- Gene symbol
- NR3C2
- Protein identifier
- P08235
- Median affinity
- 7.85
- Affinity units
- pEC50
- Mechanism
- Glucocorticoid receptor agonist
- Action type
- Agonist
- Target
- Glucocorticoid receptor
- Protein identifier
- P04150
Open Targets mechanisms
- Mechanism
- Glucocorticoid receptor agonist
- Action type
- Agonist
- Target
- Glucocorticoid receptor
- Action type
- Agonist
- Gene symbol
- NR3C1
- Protein identifier
- P04150
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Agonist
- Gene symbol
- PGR
- Protein identifier
- P06401
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Agonist
- Gene symbol
- NR3C2
- Protein identifier
- P08235
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Crohn Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Emphysema
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000464
- Subject identifier
- D004646
- Condition
- Respiratory Tract Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000684
- Subject identifier
- D012140
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Sleep Apnea, Obstructive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003918
- Subject identifier
- D020181
- Condition
- Rhinitis, Allergic, Seasonal
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003956
- Subject identifier
- D006255
- Condition
- Glomerulonephritis, IGA
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004194
- Subject identifier
- D005922
- Condition
- Eosinophilic Esophagitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004232
- Subject identifier
- D057765
- Condition
- Cholangitis, Sclerosing
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004268
- Subject identifier
- D015209
- Condition
- Proctitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005628
- Subject identifier
- D011349
- Condition
- Hepatitis, Autoimmune
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005676
- Subject identifier
- D019693
- Condition
- Rhinitis, Allergic, Seasonal
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005854
- Subject identifier
- D006255
- Condition
- Bronchitis, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0006505
- Subject identifier
- D029481
- Condition
- Aspergillosis, Allergic Bronchopulmonary
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007140
- Subject identifier
- D001229
- Condition
- Bronchiolitis Obliterans
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007183
- Subject identifier
- D001989
- Condition
- Sinusitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007486
- Subject identifier
- D012852
- Condition
- Malnutrition
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008572
- Subject identifier
- D044342
- Condition
- Status Asthmaticus
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008590
- Subject identifier
- D013224
- Condition
- Esophageal Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0009544
- Subject identifier
- D004935
- Condition
- Nasal Polyps
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000391
- Subject identifier
- D009298
And 23 more, listed on the interactive page.
- Condition identifier
- EFO_0000341
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000464
- Condition identifier
- EFO_0000684
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003767
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003918
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003956
- Condition identifier
- EFO_0004194
- Condition identifier
- EFO_0004232
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005414
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005628
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005676
- Condition identifier
- EFO_0005854
- Condition identifier
- EFO_0006505
- Condition identifier
- EFO_0007140
- Condition identifier
- EFO_0007183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007486
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008572
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009544
- Condition identifier
- EFO_0009661
- Condition identifier
- EFO_0009837
- Condition identifier
- EFO_0009909
- Highest recorded phase
- 3
- Condition identifier
- EFO_0022917
And 75 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- asthma
- Reports
- 2,559
- Reporting signal score
- 6,828.25
- Event
- asthma-chronic obstructive pulmonary disease overlap syndrome
- Reports
- 50
- Reporting signal score
- 201.373
- Event
- blood count abnormal
- Reports
- 524
- Reporting signal score
- 1,265.67
- Event
- blood test abnormal
- Reports
- 146
- Reporting signal score
- 247.551
- Event
- breath sounds abnormal
- Reports
- 130
- Reporting signal score
- 313.073
- Event
- bronchiectasis
- Reports
- 204
- Reporting signal score
- 501.459
- Event
- chest discomfort
- Reports
- 710
- Reporting signal score
- 861.808
- Event
- chronic obstructive pulmonary disease
- Reports
- 516
- Reporting signal score
- 876.933
- Event
- cough
- Reports
- 1,328
- Reporting signal score
- 1,331.21
- Event
- cushing's syndrome
- Reports
- 169
- Reporting signal score
- 401.87
- Event
- dysphonia
- Reports
- 274
- Reporting signal score
- 275.243
- Event
- dyspnoea
- Reports
- 2,651
- Reporting signal score
- 2,506.89
- Event
- dyspnoea exertional
- Reports
- 242
- Reporting signal score
- 256.884
- Event
- eosinophil count increased
- Reports
- 183
- Reporting signal score
- 366.221
- Event
- full blood count abnormal
- Reports
- 94
- Reporting signal score
- 218.963
- Event
- gastrooesophageal reflux disease
- Reports
- 328
- Reporting signal score
- 305.267
- Event
- growth failure
- Reports
- 57
- Reporting signal score
- 220.049
- Event
- intentional device misuse
- Reports
- 89
- Reporting signal score
- 332.995
- Event
- loss of personal independence in daily activities
- Reports
- 426
- Reporting signal score
- 821.783
- Event
- macular degeneration
- Reports
- 124
- Reporting signal score
- 236.133
- Event
- nasal congestion
- Reports
- 234
- Reporting signal score
- 221.314
- Event
- nasal polyps
- Reports
- 114
- Reporting signal score
- 346.637
- Event
- obstructive airways disorder
- Reports
- 556
- Reporting signal score
- 1,649.26
- Event
- poor quality device used
- Reports
- 564
- Reporting signal score
- 1,865.04
- Event
- productive cough
- Reports
- 423
- Reporting signal score
- 684.88
And 8 more, listed on the interactive page.
- NCT00000575
- NCT00092092
- NCT00189436
- NCT00228475
- NCT00232648
- NCT00234390
- NCT00235911
- NCT00238784
- NCT00242411
- NCT00242775
- NCT00244608
- NCT00252785
- NCT00252824
- NCT00252863
- NCT00255255
- NCT00259766
- NCT00259792
- NCT00272753
- NCT00288379
- NCT00290264
- NCT00319306
- NCT00326053
- NCT00327808
- NCT00380484
- NCT00385593
And 286 more, listed on the interactive page.
- Dose
- 0.5 mg
- Route
- Inhalation
- How often
- Once daily or twice daily in divided doses
Conditions of use
- For inhalation use via compressed air driven jet nebulizers only
- Hydrogen bond acceptors
- 6
- Hydrogen bond donors
- 2
- Polar surface area
- 93.06
- Calculated partition coefficient (ALogP)
- 2.72
- Calculated partition coefficient (XLogP)
- 2.5
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 31
- Molecular formula
- C25H34O6
- Monoisotopic mass
- 430.23553880
- Natural product
- Yes
- 0093-6815
- 0093-6816
- 0093-6817
- 0115-1687
- 0115-1689
- 0186-0370
- 0186-0372
- 0186-1988
- 0186-1989
- 0186-1990
- 0310-4616
- 0310-6616
- 0310-7370
- 0310-7372
- 0310-9080
- 0378-4500
- 0378-7502
- 0378-7503
- 0480-3080
- 0480-3081
- 0487-9601
- 0487-9701
- 0574-9855
- 0591-2510
- 0904-7313
And 59 more, listed on the interactive page.
- Recorded assays
- 2,853
- Active assays
- 162
- Confirmatory
- Other
- Screening
- Summary
- Anti-Inflammatory Agents
- Bronchodilator Agents
- Glucocorticoids
Distribution coefficient (LogD)
- Median
- 3.4
- Mean
- 3.4
- Minimum
- 3.4
- Maximum
- 3.4
- Unit
- unitless
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- LogD
Solubility
- Median
- 28
- Mean
- 28
- Minimum
- 28
- Maximum
- 28
- Unit
- ug/mL
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- Solubility
Oral bioavailability
- Median
- 11
- Mean
- 11
- Minimum
- 11
- Maximum
- 11
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (540)
- (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
- (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
- (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
- (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
- 9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease
- A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
- A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD
- A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
- A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
- A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block
- A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
- A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
- A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.
- A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
- A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers
- A Comparative Study Between Foraseq and Formoterol/Budesonide Inhalation Capsules in Patients with Asthma
- A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)
- A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
- A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
- A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
Approved for (12)
- Allergic rhinitis
- Asthma
- Chronic bronchitis
- Chronic obstructive pulmonary disease
- Crohn disease
- Esophageal disorder
- IgA glomerulonephritis
- Obstructive lung disease
- Perennial allergic rhinitis
- Pulmonary emphysema
- Seasonal allergic rhinitis
- Ulcerative colitis
In development for (34)
- Acute respiratory distress syndrome Phase 2
- Allergic bronchopulmonary aspergillosis Phase 2
- Allergic disease Phase 2
- Altitude sickness Phase 3
- Anosmia Phase 2
- Autoimmune hepatitis Phase 2
- Breast cancer Phase 2
- Bronchiolitis obliterans syndrome Phase 2
- Bronchopulmonary dysplasia Phase 3
- Chronic graft versus host disease Phase 3
- Collagenous colitis Phase 3
- COVID-19 Phase 3
- Diarrheal disease Phase 2
- Eosinophilic esophagitis Phase 3
- Graft versus host disease Phase 3
- Inflammatory bowel disease Phase 2
- Lung cancer Phase 2
- Lymphocytic colitis Phase 3
- Melanoma Phase 2
- Microscopic colitis Phase 3
Other linked conditions (2)
- Bronchitis
- Chronic rhinosinusitis
Targets (1)
- NR3C1 Glucocorticoid receptor agonist