| 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 |
Acute pancreatitis in an ulcerative colitis patient treated with vedolizumab an…
PMID: 38847300
Year: 2024
Relationship Type:
Association
Score: 6.5
Faecal Microbiota Transplantation Engraftment After Budesonide or Placebo in Pa…
PMID: 38572716
Year: 2024
Relationship Type:
Association
Score: 6.5
Effectiveness and Safety Profile of Budesonide Maintenance in Microscopic Colit…
PMID: 37589651
Year: 2024
Relationship Type:
Association
Score: 6.5
Oral liposomal delivery of an activatable budesonide prodrug reduces colitis in…
PMID: 36861451
Year: 2023
Relationship Type:
Association
Score: 6.5
Comparative Outcomes of Budesonide MMX versus Prednisolone for Ulcerative Colit…
PMID: 34640345
Year: 2021
Relationship Type:
Treatment
Score: 6.5
The aim of our work is to prepare mucoadhesive particles with biopolymers and 5-Aminosalicylic acid (5ASA) using the ionotropic gelation technique t…
Lentinan-Based Oral Nanoparticle Loaded Budesonide With Macrophage-Targeting Ab…
PMID: 34513811
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Since the beginning of vaccination programs against COVID-19 in different countries, several populations such as patients with specific immunologica…
Hot punching for loading of biodegradable microcontainers with budesonide-Solup…
PMID: 34269869
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Inflammatory bowel diseases (IBDs) are chronic disorders of the gastrointestinal tract, which manifest in recurring gastrointestinal inflammation. T…
Budesonide-Loaded Pectin/Polyacrylamide Hydrogel for Sustained Delivery: Fabric…
PMID: 34062995
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is rising constantly all over the world. However, curr…
Formulation, Development and Evaluation of Budesonide Oral Nano-sponges Using D…
PMID: 33880350
Year: 2021
Relationship Type:
Association
Score: 6.5
Not found
Real-world safety and efficacy of twice-daily budesonide 2-mg foam in patients …
PMID: 33832402
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Coronavirus disease (COVID-19), caused by SARS-CoV-2, has affected over 65 million individuals and killed over 1.5 million persons (December 8, 2020…
In Brief: Extended-release budesonide (Ortikos) for Crohn's disease
PMID: 33429405
Year: 2020
Relationship Type:
Association
Score: 6.5
A new kid on the budesonide block
PMID: 33276714
Year: 2020
Relationship Type:
Association
Score: 6.5
Preparation, characterization, and in vitro drug release behavior of thiolated …
PMID: 32727293
Year: 2020
Relationship Type:
Adverse Effect
Score: 6.5
For site-specific drug delivery in inflammatory bowel disease, reducible sodium alginate nanoparticles cross-linked with disulfide linkage were devel…
Design and in vitro characterization of multistage silicon-PLGA budesonide part…
PMID: 32283213
Year: 2020
Relationship Type:
Association
Score: 6.5
Erratum in Arthritis Care Res (Hoboken). 2021 May;73(5):764. OBJECTIVE: To estimate the incidence rate (IR) of psoriasis in children with infla…
Hold the Foam: Why Topical Budesonide Remains Relevant for IBD Therapy
PMID: 32189103
Year: 2020
Relationship Type:
Treatment
Score: 6.5
Background: Chronic inflammatory diseases (CIDs) are considered risk enhancing factors for coronary heart disease (CHD). However, sparse data exist …
Predictive factors for achievement of mucosal healing by budesonide 2-mg foam i…
PMID: 31813214
Year: 2020
Relationship Type:
Treatment
Score: 6.5
Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and …
A multicentre prospective cohort study assessing the effectiveness of budesonid…
PMID: 31700630
Year: 2019
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: Strictures are the most common Crohn's disease complication, but their natural history is unknown. This study aimed to charact…
Moving from efficacy to effectiveness: budesonide multimatrix in ulcerative col…
PMID: 31700627
Year: 2019
Relationship Type:
Association
Score: 6.5
Middle-term prognosis in patients with ulcerative colitis who achieved clinical…
PMID: 31381615
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Update of Cochrane Database Syst Rev. 2013 May 31;(5):CD006095. BACKGROUND: Antibiotics can disturb gastrointestinal microbiota which may lead …
Comparative assessment of budesonide-MMX and mesalamine in active, mild-to-mode…
PMID: 31269287
Year: 2019
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: To compare perioperative characteristics and outcomes between primary ileocolonic resection [PICR] and iterative ileocolic rese…