Drug ID:Drug97
Drug Name:Budesonide
CID:5360515
DrugBank ID:DB01222
Modality:Small Molecule
Groups:approved
US Approved:YES
Other Approved:YES
Identifier: NCT04314375
Molecular Formula:C20H23NO4
Molecular Weight:341.4 g/mol
Isomeric SMILES:C1CC1CN2CC[C@]34[C@@H]5C(=O)CC[C@]3([C@H]2CC6=C4C(=C(C=C6)O)O5)O
Synonyms:naltrexone; 16590-41-3; Vivitrex; N-Cyclopropylmethylnoroxymorphone; Naltrexona; Naltrexonum; Naltrexonum [INN-Latin]; Naltrexona [INN-Spanish]; CCRIS 3506; N-Cyclopropylmethyl-14-hydroxydihydromorphinone
Phase 0: 5
Phase 1: 119
Phase 2: 134
Phase 3: 175
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

2D Molecular Structure

Knowledge Graph

dtIDCIDCompound NameGene IDGene NameSpeciesPubMed IDsAction
dt821 5360515 Naltrexone 11054 OGFR Mus musculus (house mouse) 21685240 Naltrexone results in increased expression of OGFR
dt822 5360515 Naltrexone 4985 OPRD1 Rattus norvegicus (Norway rat) 7562497 Naltrexone binds to OPRD1 protein
dt823 5360515 Naltrexone 6863 TAC1 Homo sapiens (human) None
dt824 5360515 Naltrexone 581 BAX Homo sapiens (human) None
dt825 5360515 Naltrexone 319 APOF Homo sapiens (human) Inhibitor
dt826 5360515 Naltrexone 317 APAF1 Homo sapiens (human) Inhibitor
dt827 5360515 Naltrexone 2641 GCG Homo sapiens (human) None
dt828 5360515 Naltrexone 255239 ANKK1 Homo sapiens (human) None
dt829 5360515 Naltrexone 1312 COMT Homo sapiens (human) None
dt830 5360515 Naltrexone 4985 OPRD1 Homo sapiens (human) 9686407 Antagonist

  • 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 IDTitlePhaseStatusSponsorIndicationsInterventions
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
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
NCT04233463 The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease NA UNKNOWN Hillel Yaffe Medical Center Crohn Disease DIETARY_SUPPLEMENT: Modulen|DRUG: Budesonide 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
NCT02586259 Effectiveness of Cortiment® in Patients With Ulcerative Colitis NULL COMPLETED Ferring Pharmaceuticals Ulcerative Colitis DRUG: budesonide MMX® Details
NCT02550418 Budesonide 9 mg Capsules in Active UC PHASE2 COMPLETED Dr. Falk Pharma GmbH Colitis, Ulcerative DRUG: Budesonide Details
NCT06719622 Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum PHASE2|PHASE3 ENROLLING_BY_INVITATION Medical University of Warsaw Crohn Disease (CD) DRUG: budesonide|DRUG: omeprazole (proton pump in… Details
NCT01783106 Antibiotics and Hydroxychloroquine in Crohn's PHASE2 COMPLETED Royal Liverpool University Hospital Crohn's Disease DRUG: Ciprofloxacin|DRUG: Doxycycline|DRUG: Hydro… 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
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
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
NCT01086553 9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease PHASE3 COMPLETED Dr. Falk Pharma GmbH Crohn´s Disease DRUG: budesonide|DRUG: budesonide 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
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
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
NCT00747110 Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC) PHASE3 COMPLETED Dr. Falk Pharma GmbH Colitis, Ulcerative DRUG: budesonide|DRUG: mesalazine Details
NCT00679432 (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis PHASE3 COMPLETED Bausch Health Americas, Inc. Ulcerative Colitis PROCEDURE: Blood sampling, endoscopy|DRUG: budeso… Details
NCT00679380 (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis PHASE3 COMPLETED Bausch Health Americas, Inc. Ulcerative Colitis PROCEDURE: Blood sampling, endoscopy|DRUG: Budeso… Details
NCT00554710 Top Down Versus Step Up Strategies in Crohn's Disease PHASE4 COMPLETED Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW Crohn's Disease DRUG: infliximab+azathioprine|DRUG: methylprednis… Details

Disease IDDisease NameDefinitionCategoryRelated DrugsMechanism
No data available

Strategy IDTherapeutic StrategySynonymsRelated DrugsMechanism
No data available

No related literature

You can run management commands to establish drug-literature associations