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
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
EUCTR2019-000852-32-NL A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn Disease that failed conventional treatment: The LDN Crohn study.__ - The LDN Crohn study PHASE2 Not Recruiting ErasmusMC Inflammatory Bowel Disease, Crohn's disease;Thera… Product Name: Naltrexone hydrochloride Pharmaceut… 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