| 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 |
Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-modera…
PMID: 27239329
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Not found
Clinical, endoscopic and histopathological evaluation of the efficacy of budeso…
PMID: 27096800
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Mesalamine has been successfully used as a maintenance treatment in inflammatory bowel diseases such as ulcerative colitis and Crohn's disease for y…
[Topical budesonide for the intestines approved]
PMID: 26731860
Year: 2015
Relationship Type:
Association
Score: 6.3
Budesonide Loaded PLGA Nanoparticles for Targeting the Inflamed Intestinal Muco…
PMID: 26718953
Year: 2016
Relationship Type:
Association
Score: 6.3
Inflammation-induced jejunal cell death and oxidative stress have been observed in inflammatory bowel disease (IBD), but now, there is still no syst…
Twice-daily Budesonide 2-mg Foam Induces Complete Mucosal Healing in Patients w…
PMID: 26577683
Year: 2016
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Intestinal fibrosis is mainly associated with Crohn's disease and is defined as a progressive and excessive deposition of extracellular …
Solubility Enhancement of Budesonide and Statistical Optimization of Coating Va…
PMID: 26556190
Year: 2014
Relationship Type:
Treatment
Score: 6.3
Purpose. Crohn's disease (CD) and ulcerative colitis (UC), the two major forms of inflammatory bowel disease (IBD), have histopathologically and im…
Budesonide for induction of remission in Crohn's disease
PMID: 26039678
Year: 2015
Relationship Type:
Treatment
Score: 6.3
INTRODUCTION: CT-P13 is the first biosimilar to infliximab that has been approved for the same indications as its originator infliximab. No data are…
Formulation and characterization of ORMOSIL particles loaded with budesonide fo…
PMID: 25708004
Year: 2015
Relationship Type:
Treatment
Score: 6.3
Immune-mediated inflammatory diseases encompass a variety of different clinical syndromes, manifesting as either common diseases such as rheumatoid …
Low-dose budesonide for maintenance of clinical remission in collagenous coliti…
PMID: 25425655
Year: 2016
Relationship Type:
Treatment
Score: 6.3
OBJECTIVE: The aim of the study was to assess the safety and efficacy of high- and low-dose oral, delayed-release mesalamine in a randomized, double…
Budesonide for maintenance of remission in Crohn's disease
PMID: 25141071
Year: 2014
Relationship Type:
Treatment
Score: 6.3
Update of Cochrane Database Syst Rev. 2012;12:CD003459. BACKGROUND: Although corticosteroids are effective for induction of remission of Crohn'…
Letter: budesonide MMX for ulcerative colitis?
PMID: 24849158
Year: 2014
Relationship Type:
Association
Score: 6.3
Budesonide loaded nanoparticles with pH-sensitive coating for improved mucosal …
PMID: 24685705
Year: 2014
Relationship Type:
Association
Score: 6.3
We evaluated whether a simplified human microbiota consortium (SIHUMI) induces colitis in germfree (GF) 129S6/SvEv (129) and C57BL/6 (B6) interleuk…
Review article: integrating budesonide-MMX into treatment algorithms for mild-t…
PMID: 24641622
Year: 2014
Relationship Type:
Treatment
Score: 6.3
Recently, genetic associations have been described in intestinal transplants. Namely, Crohn's disease susceptibility gene NOD2 polymorphisms have be…
Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: resul…
PMID: 23436336
Year: 2014
Relationship Type:
Association
Score: 6.3
BACKGROUND & AIMS: Small-intestine contrast ultrasonography (SICUS) is a radiation-free technique that can detect intestinal damage in patients with…
Randomized, controlled trial of budesonide and prednisone for the treatment of …
PMID: 24112400
Year: 2013
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Immunosuppressed patients with inflammatory bowel disease (IBD) are at risk for vaccine preventable illnesses. Our aim was to develop a …
Budesonide-loaded nanostructured lipid carriers reduce inflammation in murine D…
PMID: 23694806
Year: 2013
Relationship Type:
Association
Score: 6.1
BACKGROUND AND AIM: Neutrophil gelatinase associated lipocalin (NGAL) is a recently identified molecule, which is bacteriostatic, has tissue destruc…
Systemic secondary amyloidosis in a 70-year-old patient with Crohn's disease: t…
PMID: 23478807
Year: 2013
Relationship Type:
Treatment
Score: 6.1
Reply: budesonide
PMID: 23357061
Year: 2013
Relationship Type:
Association
Score: 6.1
Budesonide MMX and mesalamine to induce remission in patients with ulcerative c…
PMID: 23352592
Year: 2013
Relationship Type:
Association
Score: 6.1
Plasma concentrations and therapeutic effects of budesonide in dogs with inflam…
PMID: 23270349
Year: 2013
Relationship Type:
Treatment
Score: 6.1
Tumor necrosis factor (TNF)-like cytokine 1A (TL1A)/TNF superfamily member 15 (TNFSF15) is a proinflammatory cytokine and TNFα superfamily member th…