| 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 |
Budesonide treatment for microscopic colitis: systematic review and meta-analys…
PMID: 31211724
Year: 2019
Relationship Type:
Treatment
Score: 6.5
The ESPRESSO study constitutes a novel approach to examine the etiology and prognosis of gastrointestinal disease in which histopathology plays a pr…
Budesonide MMX: efficacy and safety profile in the treatment of ulcerative coli…
PMID: 31106602
Year: 2019
Relationship Type:
Treatment
Score: 6.5
IL-12 and IL-23 are closely related cytokines with important roles in the regulation of tissue inflammation. Converging evidence from studies in mic…
An altered composition of the microbiome in microscopic colitis is driven towar…
PMID: 31009268
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Cytotoxic T lymphocyte-associated protein 4 (CTLA-4) is a co-inhibitory molecule expressed by T cells and is required for immune regulation and infl…
Efficacy of budesonide-loaded mesoporous silica microparticles capped with a bu…
PMID: 30817986
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Intestinal exocrine secretory cells, including Paneth and goblet cells, have a pivotal role in intestinal barrier function and mucosal immunity. Dys…
Development of novel zero-order release budesonide tablets for the treatment of…
PMID: 30414898
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Lysophosphatidylinositols (LPI) are bioactive lipids that are implicated in several pathophysiological processes such as cell proliferation, migrati…
Budesonide for the Induction and Maintenance of Remission in Crohn's Disease: S…
PMID: 30656288
Year: 2018
Relationship Type:
Treatment
Score: 6.3
There is a considerable body of evidence indicating that chronic adverse experience, especially chronic psychosocial stress/trauma, represents a maj…
Mucus-penetrating budesonide nanosuspension enema for local treatment of inflam…
PMID: 30236840
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Not found
Author's reply: can budesonide form be alterative treatment for ulcerative proc…
PMID: 29616332
Year: 2018
Relationship Type:
Treatment
Score: 6.3
A proposed treatment algorithm for mild to moderate ulcerative colitis-with an …
PMID: 29616331
Year: 2018
Relationship Type:
Treatment
Score: 6.3
The effect of budesonide on the expression of Ki-67 and PCNA and the apoptotic …
PMID: 29611642
Year: 2017
Relationship Type:
Treatment
Score: 6.3
OBJECTIVES: Peripheral blood eosinophilia (PBE) in inflammatory bowel disease (IBD) is associated with ulcerative colitis (UC) and active disease. L…
Redox-sensitive nanoparticles based on 4-aminothiophenol-carboxymethyl inulin c…
PMID: 29580419
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Erratum in Front Immunol. 2017 Dec 13;8:1769. Activation of the TNF-α receptor (TNFR) leads to an inflammatory response, and anti-TNF therapy h…
A safety evaluation of budesonide MMX for the treatment of ulcerative colitis
PMID: 29473429
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Comment in Gut. 2018 Dec;67(12):2229-2230. Crohn's disease (CD) is a chronic progressive destructive inflammatory bowel disease. As in rheumato…
Correction to: Complete mucosal healing of distal lesions induced by twice-dail…
PMID: 29027564
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Solute carrier family 7 member 2 (SLC7A2, also known as CAT2) is an inducible transporter of the semi-essential amino acid L-arginine (L-Arg), which…
Complete mucosal healing of distal lesions induced by twice-daily budesonide 2-…
PMID: 28779419
Year: 2018
Relationship Type:
Association
Score: 6.3
BACKGROUND AND AIM: Disease recurs frequently after Crohn's disease resection. The role of serological antimicrobial antibodies in predicting recurr…
Budesonide MMX in Paediatric Patients With Ulcerative Colitis
PMID: 28505293
Year: 2017
Relationship Type:
Association
Score: 6.3
Corrigendum: Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, M…
PMID: 28453665
Year: 2017
Relationship Type:
Association
Score: 6.3
Budesonide MMX Add-on to 5-Aminosalicylic Acid Therapy in Mild-to-Moderate Ulce…
PMID: 28333203
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Glucocorticoids are standard of care for many chronic inflammatory conditions, including juvenile dermatomyositis (JDM) and anti-neutrophil cytoplas…
Central Serous Chorioretinopathy in a Patient with Ulcerative Colitis with Pouc…
PMID: 28328626
Year: 2017
Relationship Type:
Association
Score: 6.3
Budesonide Use and Hospitalization Rate in Crohn's Disease: Results From a Coho…
PMID: 27635174
Year: 2016
Relationship Type:
Association
Score: 6.3
Comment in Angiology. 2017 May;68(5):462. Angiology. 2017 May;68(5):463. We evaluated the differences in major markers of cardiovascular (CV…
Severe perianal shingles during azathioprine and budesonide treatment for Crohn…
PMID: 27440857
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Infliximab (IFX) is commonly used to induce and maintain remission in inflammatory bowel disease (IBD). We report the first 2 cases of children with…