| 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 MMX(®): a review of its use in patients with mild to moderate ulcera…
PMID: 25920500
Year: 2015
Relationship Type:
Treatment
Score: 9.3
Budesonide MMX((R)) (Cortiment((R)); Uceris((R))) is a novel once-daily oral formulation of budesonide using Multi Matrix (MMX((R))) colonic delivery…
Budesonide foam induces remission in patients with mild to moderate ulcerative …
PMID: 25644096
Year: 2015
Relationship Type:
Adverse Effect
Score: 9.3
BACKGROUND & AIMS: Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional …
Once versus three times daily dosing of oral budesonide for active Crohn's dise…
PMID: 24534142
Year: 2014
Relationship Type:
Treatment
Score: 9.3
BACKGROUND: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no p…
The role of Budesonide-MMX in active ulcerative colitis
PMID: 24502535
Year: 2014
Relationship Type:
Treatment
Score: 9.3
Traditional corticosteroids represent a well-established and effective treatment for active ulcerative colitis (UC). However, the severity of their s…
Budesonide multi-matrix system formulation for treating ulcerative colitis
PMID: 24484392
Year: 2014
Relationship Type:
Treatment
Score: 9.3
Budesonide is a corticosteroid characterized by high topical activity and low systemic effect associated with fewer glucocorticoid-related adverse ev…
Colon specific delivery of budesonide based on triple coated pellets: in vitro/…
PMID: 23470347
Year: 2012
Relationship Type:
Association
Score: 9.1
Three layered pellets of budesonide were prepared for colon delivery by the extrusion-spheronization method. The coatings consisted of hydroxypropylm…
Once-daily budesonide MMX® extended-release tablets induce remission in patient…
PMID: 22892337
Year: 2012
Relationship Type:
Adverse Effect
Score: 9.1
BACKGROUND & AIMS: Budesonide is a corticosteroid with minimal systemic corticosteroid activity due to first-pass hepatic metabolism. Budesonide MMX(…
Efficacy and tolerability of oral budesonide in Japanese patients with active C…
PMID: 22766525
Year: 2013
Relationship Type:
Treatment
Score: 9.1
BACKGROUND AND AIMS: Current treatments for Japanese patients with active Crohn's disease have not proved optimal, and new treatment options are requ…
Development and evaluation of a novel pellet-based tablet system for potential …
PMID: 22577558
Year: 2012
Relationship Type:
Treatment
Score: 9.1
Budesonide, a potent glucocorticoid, is used for the treatment of inflammatory bowel diseases. Current available oral formulations of budesonide have…
Impact of budesonide on liver function tests and gut inflammation in patients w…
PMID: 22398056
Year: 2012
Relationship Type:
Treatment
Score: 9.1
BACKGROUND AND AIM: Budesonide has been studied in patients with primary sclerosing cholangitis (PSC). This study was designed to evaluate the effica…
Budesonide in the treatment of inflammatory bowel disease
PMID: 21790284
Year: 2011
Relationship Type:
Treatment
Score: 9.1
Inflammatory bowel disease, including Crohn's disease and ulcerative colitis, features recurrent episodes of inflammation of the GI tract. The treatm…
3g mesalazine granules are superior to 9mg budesonide for achieving remission i…
PMID: 21453882
Year: 2011
Relationship Type:
Treatment
Score: 9.1
BACKGROUND AND AIMS: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate no…
Central composite design for the formulation and optimization of a multi-unit p…
PMID: 21434575
Year: 2011
Relationship Type:
Treatment
Score: 9.1
Budesonide is a potent glucocorticoid with high affinity for the glucocorticoid receptor, which is used for the treatment of inflammatory bowel disea…
Microencapsulation of budesonide with dextran by spray drying technique for col…
PMID: 21171817
Year: 2011
Relationship Type:
Treatment
Score: 9.1
The aim of this study was developing colon targeted-delivery of budesonide for ulcerative colitis. Microcapsules were prepared using spray drying tec…
Clinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX® …
PMID: 21122499
Year: 2010
Relationship Type:
Adverse Effect
Score: 9.1
BACKGROUND: Ulcerative colitis (UC) is a chronic inflammatory disease with relapses. Many patients need systemic corticosteroids to induce clinical r…
Preparation of budesonide-dextran conjugates using glutarate spacer as a colon-…
PMID: 20429772
Year: 2011
Relationship Type:
Treatment
Score: 9.1
An oral colon-targeted formulation of budesonide was developed for treatment of ulcerative colitis. Budesonide conjugates were prepared using glutara…
Locally Acting Budesonide-Loaded Solid Self-Microemulsifying Drug Delivery Syst…
PMID: 39558914
Year: 2024
Relationship Type:
Association
Score: 6.5
[Survey on Patient Satisfaction with the Usability and Formulation of Budesonid…
PMID: 39358251
Year: 2024
Relationship Type:
Association
Score: 6.5
Author's reply: "Oral Budesonide and low serum albumin levels at surgery: Assoc…
PMID: 39277509
Year: 2024
Relationship Type:
Association
Score: 6.5
Impact of twice-daily budesonide foam administration on early clinical response…
PMID: 39098867
Year: 2024
Relationship Type:
Association
Score: 6.5