| Drug ID: | Drug89 |
|---|---|
| Drug Name: | Budesonide |
| CID: | 5281004 |
| DrugBank ID: | DB01222 |
| Modality: | Small Molecule |
| Groups: | approved |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT03412682, , NCT01100112, , NCT02550418, , NCT01008423, , NCT01008410, , NCT05341401, , NCT00801723, , NCT01532648, , NCT00747110, , NCT04314375, , NCT05976802 |
| Molecular Formula: | C25H34O6 |
| Molecular Weight: | 430.5 g/mol |
| Isomeric SMILES: | CCCC1O[C@@H]2C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@@]5([C@H]4[C@H](C[C@@]3([C@@]2(O1)C(=O)CO)C)O)C |
| Synonyms: | budesonide; 51333-22-3; Entocort; Preferid; Budeson; Rhinocort Aqua; Entocort EC; Cortivent; Micronyl; Respules |
| Phase 0: | 5 |
| Phase 1: | 119 |
| Phase 2: | 134 |
| Phase 3: | 275 |
| Phase 4: | 155 |
| Description: | Budesonide is a glucocorticoid used in the management of asthma, the treatment of various skin disorders, and allergic rhinitis. [PubChem] The extended release oral tablet, marketed as Uceris, was FDA approved on January 14, 2013 for the management of ulcerative colitis. Budesonide is provided as a mixture of two epimers (22R and 22S). Interestingly, the 22R form is two times more active than the 22S epimer. The two forms do not interconvert. |
Molecular Structure
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| dt746 | 5281004 | Budesonide | 1544 | CYP1A2 | Homo sapiens (human) | None | |
| dt747 | 5281004 | Budesonide | 1576 | CYP3A4 | Homo sapiens (human) | None | |
| dt748 | 5281004 | Budesonide | 1565 | CYP2D6 | Homo sapiens (human) | None | |
| dt749 | 5281004 | Budesonide | 627 | BDNF | Homo sapiens (human) | Agonist | |
| dt750 | 5281004 | Budesonide | 2908 | NR3C1 | Homo sapiens (human) | None | |
| dt751 | 5281004 | Budesonide | 1559 | CYP2C9 | Homo sapiens (human) | None | |
| dt752 | 5281004 | Budesonide | 2908 | NR3C1 | Homo sapiens (human) | Glucocorticoid receptor agonist | |
| dt753 | 5281004 | Budesonide | 3458 | IFNG | Homo sapiens (human) | 7621058 | Budesonide results in decreased secretion of IFNG protein |
| dt754 | 5281004 | Budesonide | 3458 | IFNG | Homo sapiens (human) | 16160912 | [zafirlukast co-treated with prednisone co-treated with budesonide] inhibits the reaction [antigens results in increased secretion of IFNG protein] |
- No data available
Phase Distribution
Phase Description
- Phase 0: Exploratory trials to assess drug behavior in humans
- Phase 1: Safety trials to determine safe dosage range
- Phase 2: Efficacy trials to evaluate therapeutic effects
- Phase 3: Large-scale trials to confirm efficacy and safety
- Phase 4: Post-marketing surveillance for long-term safety and efficacy
| Trial ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| NCT01100112 | (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets | PHASE3 | COMPLETED | Bausch Health Americas, Inc. | Colitis, Ulcerative | DRUG: Budesonide | Details |
| NCT01532648 | Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) | PHASE3 | COMPLETED | Bausch Health Americas, Inc. | Ulcerative Colitis | DRUG: Budesonide MMX|DRUG: Placebo|DRUG: 5-ASA | Details |
| NCT02586259 | Effectiveness of Cortiment in Patients With Ulcerative Colitis | None | COMPLETED | Ferring Pharmaceuticals | Ulcerative Colitis | DRUG: budesonide MMX | Details |
| NCT00747110 | Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC) | PHASE3 | COMPLETED | Dr. Falk Pharma GmbH | Colitis, Ulcerative | DRUG: budesonide|DRUG: mesalazine | Details |
| NCT05976802 | Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis | PHASE4 | NOT_YET_RECRUITING | Bausch Health Americas, Inc. | Ulcerative Colitis | DRUG: High dose budesonide rectal foam|DRUG: Low … | Details |
| NCT04314375 | Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | PHASE4 | RECRUITING | Bausch Health Americas, Inc. | Ulcerative Colitis | DRUG: Low Dose Budesonide|DRUG: High Dose Budeson… | Details |
| NCT00801723 | (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis. | PHASE3 | COMPLETED | Bausch Health Americas, Inc. | Ulcerative Colitis | DRUG: Budesonide MMX 6 mg Tablet|DRUG: Placebo Ta… | Details |
| NCT02550418 | Budesonide 9 mg Capsules in Active UC | PHASE2 | COMPLETED | Dr. Falk Pharma GmbH | Colitis, Ulcerative | DRUG: Budesonide | Details |
| NCT01349673 | The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis | PHASE3 | TERMINATED | Bausch Health Americas, Inc. | Proctitis|Proctosigmoiditis | DRUG: Budesonide Foam | Details |
| NCT01008423 | Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis | PHASE3 | COMPLETED | Bausch Health Americas, Inc. | Proctitis|Proctosigmoiditis | DRUG: Budesonide|DRUG: Placebo | Details |
| NCT01008410 | Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis | PHASE3 | COMPLETED | Bausch Health Americas, Inc. | Proctitis|Proctosigmoiditis | DRUG: Budesonide|DRUG: Placebo | Details |
| NL-OMON25521 | Microbiota targeted therapy as alternative for prednisolone and biologicals in IBD patients during the current COVID-19 threat: a prospective study addressing the safety of Budesonide in combination with rifaximin or the Crohns Disease Exclusion Diet (CDED) | Not Available | No | Nestlé 23/08/2021 | None | The results of this prospective study may result … | Details |
| NL-OMON49003 | A randomised controlled trial comparing FMT (fecal microbiota transplantation) after budesonide or placebo in patients with active ulcerative colitis: ;Acronym: the FECBUD trial __ - FMT for ulcerative colitis after initiation of budesonide | Not Available | Not Recruiting | Leids Universitair Medisch Centrum | inflammatory bowel disease ulcerative colitis;10… | Intervention Patients with active ulcerative coli… | Details |
| JPRN-UMIN000031016 | Efficacy and safety of local budesonide for pouchitis - Efficacy of budesonide for pouchitis | PHASE1 | Not Recruiting | Hyogo College of Medicine Department of Inflammatory Bowel Disease | ulcerative colitis pouchitis | None | Details |
| NL-OMON44482 | A randomised controlled trial comparing FECal Microbiota Transplantation after BUDesonide or placebo induction in patients with ulcerative colitis; the FECBUD trial__ - FMT for ulcerative colitis after initiation of budesonide | Not Available | None | Haaglanden Medisch Centrum | inflammatory bowel disease ulcerative colitis;10… | Intervention Patients with active ulcerative coli… | Details |
| NCT05791487 | Combination of Diet and Oral Budesonide for Ulcerative Colitis | None | RECRUITING | Wolfson Medical Center | Ulcerative Colitis|Ulcerative Colitis Chronic Mil… | OTHER: Ulcerative colitis Exclusion Diet|OTHER: P… | Details |
| NCT05341401 | Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis | PHASE2|PHASE3 | UNKNOWN | Assiut University | Ulcerative Colitis Chronic | DRUG: Budesonide MMX|DRUG: Prednisolone | Details |
| NCT00805285 | The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis | PHASE2 | TERMINATED | University of Maryland, Baltimore | Inflammatory Bowel Disease|Ulcerative Colitis | DRUG: Combination Oral Budesonide and Rectal Hydr… | Details |
| NCT03412682 | To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis | PHASE3 | COMPLETED | Ferring Pharmaceuticals | Colitis, Ulcerative | DRUG: Budesonide (6 mg)|DRUG: Budesonide (9 mg)|D… | Details |
| JPRN-UMIN000030000 | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis. | PHASE1 | Not Recruiting | Department of Inflammatory Bowel Disease Hyogo College of Medicine | ulcerative colitis pouchitis | Topical budesonido 2weeks of 2mg daily Topical … | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S08 | Strengthening barrier function | Modulation of barrier function | phosphatidylcholine (lecithin); imiquimod; mongersen | Escherichia coli Nissle (EcN) is a nonpathogenic Gram-negat… | Details |
| S11 | Improveming Intestinal Microecology | the intestinal microbiota | antibiotics; probiotics; prebiotics; postbiotics; synbiotics; fecal microbiota transplantation (FMT) | The imbalance between beneficial bacteria and harmful patho… | Details |
Screening of budesonide nanoformulations for treatment of inflammatory bowel di…
PMID: 22847255
Year: 2012
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Patients with Inflammatory Bowel disease (IBD) are frequently exposed to diagnostic medical radiation for the diagnosis and evaluation o…
Budesonide use in pediatric Crohn disease
PMID: 22258289
Year: 2012
Relationship Type:
Association
Score: 6.1
The human microbiome plays a key role in a wide range of host-related processes and has a profound effect on human health. Comparative analyses of t…
Infliximab-induced autoimmune hepatitis in Crohn's disease treated with budeson…
PMID: 21987301
Year: 2011
Relationship Type:
Association
Score: 6.1
Severe adrenal insufficiency complicating budesonide therapy for Crohn's disease
PMID: 20629105
Year: 2011
Relationship Type:
Treatment
Score: 6.1
Budesonide for maintenance of remission in Crohn's disease
PMID: 19160212
Year: 2009
Relationship Type:
Association
Score: 6.1
We have recently proposed a two-dimensional Wavelet Encoding-Spectroscopic Imaging (WE-SI) technique as an alternative to Chemical Shift Imaging (CS…
Budesonide induction and maintenance therapy for Crohn's disease during pregnan…
PMID: 18680195
Year: 2009
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Portal-mesenteric vein thrombosis, pylephlebitis and liver abscesses are rare complications of inflammatory bowel disease (IBD). The pur…
Budesonide for induction of remission in Crohn's disease
PMID: 18646064
Year: 2008
Relationship Type:
Association
Score: 6.1
OBJECTIVES: Multiple established Crohn's disease (CD) and ulcerative colitis (UC) risk factors including family history, tobacco use, Jewish ethnici…
Oral budesonide for the therapy of post-liver transplant de novo inflammatory b…
PMID: 18618676
Year: 2008
Relationship Type:
Treatment
Score: 6.1
Immunosuppressors used in inflammatory bowel disease (IBD) are useful in refractory, chronic, active, steroid-dependent, or steroid-resistant IBD, b…
Budesonide for ulcerative colitis
PMID: 16944997
Year: 2006
Relationship Type:
Treatment
Score: 6.1
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) that often involve organs other than those of the ga…
Budesonide versus prednisolone for the treatment of active Crohn's disease in c…
PMID: 15095852
Year: 2004
Relationship Type:
Treatment
Score: 6.1
Not found
Budesonide in collagenous colitis: a double-blind placebo-controlled trial with…
PMID: 11781276
Year: 2002
Relationship Type:
Mechanism
Score: 6.1
In this review, I hope to have highlighted that cytokines are of crucial importance in the normal homeostasis of the gut immune system, the interact…
Association of HLA-DR genotypes and IL-1ra gene polymorphism with treatment fai…
PMID: 11742191
Year: 2001
Relationship Type:
Treatment
Score: 6.1
Comment in J Pediatr Gastroenterol Nutr. 2001 Jul;33(1):11-3. BACKGROUND: Calprotectin is an abundant neutrophil protein, which is extremely st…
Effects of local budesonide treatment on the cell-mediated immune response in a…
PMID: 9824145
Year: 1998
Relationship Type:
Treatment
Score: 6.1
We describe an extension of Risch's [(1990a,b) Am J Hum Genet 46:222-228, 229-241] method of linkage detection and exclusion for complex genetic tra…
Combination Immunotherapy Use and Withdrawal in Pediatric Inflammatory Bowel Di…
PMID: 34621712
Year: 2021
Relationship Type:
Treatment
Score: 5.5
Ulcerative colitis (UC) is a global, chronic, and refractory disease. Corticosteroids are first-line drugs for the treatment of UC but also cause a…
MicroRNA-146b improves intestinal injury in mouse colitis by activating nuclear…
PMID: 23813877
Year: 2013
Relationship Type:
Adverse Effect
Score: 5.1
OBJECTIVE: Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. T…
Serologic investigations in children with inflammatory bowel disease and food a…
PMID: 20037744
Year: 2009
Relationship Type:
Treatment
Score: 5.1
BACKGROUND: There is no standard approach for the medical management of Crohn's disease (CD) during pregnancy and there is limited data regarding sa…