| Drug ID: | Drug113 |
|---|---|
| Drug Name: | Fidaxomicin |
| CID: | 10034073 |
| DrugBank ID: | DB08874 |
| Modality: | Small Molecule |
| Groups: | approved |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT06794944 |
| Molecular Formula: | C52H74Cl2O18 |
| Molecular Weight: | 1058.0 g/mol |
| Isomeric SMILES: | CC[C@H]1/C=C(/[C@H](C/C=C/C=C(/C(=O)O[C@@H](C/C=C(/C=C(/[C@@H]1O[C@H]2[C@H]([C@H]([C@@H](C(O2)(C)C)OC(=O)C(C)C)O)O)\\C)\\C)[C@@H](C)O)\\CO[C@H]3[C@H]([C@H]([C@@H]([C@H](O3)C)OC(=O)C4=C(C(=C(C(=C4O)Cl)O)Cl)CC)O)OC)O)\\C |
| Synonyms: | Fidaxomicin; Dificlir; 873857-62-6; Lipiarmicin; Difimicin; Clostomicin B1; R-Tiacumicin B; Lipiarmycin A 3; fidaxomicine; Fidaxomicina |
| Phase 0: | 0 |
| Phase 1: | 2 |
| Phase 2: | 4 |
| Phase 3: | 10 |
| Phase 4: | 11 |
| Description: | One of the first narrow spectrum macrocyclic antibiotic, it is a natural compound and is structurally similar to compounds in lipiarmycin-a fermentation mixture. FDA approved on May 27, 2011. |
Molecular Structure
Knowledge Graph
- 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 | |
|---|---|---|---|---|---|---|---|
| NCT06794944 | Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients with Inflammatory Bowel Disease | PHASE4 | NOT_YET_RECRUITING | Brigham and Women's Hospital | Inflammatory Bowel Disease (IBD)|Clostridioides D… | DRUG: Vancomycin (POC)|DRUG: Fidaxomicin | Details |
| NCT02437591 | Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI) | PHASE4 | Not recruiting | Astellas Pharma Europe Ltd. | Inflammatory Bowel Disease (IBD);Clostridium Diff… | Drug: fidaxomicin | Details |
| EUCTR2014-003002-32-CZ | Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) - PROFILE | PHASE3|PHASE4 | Not Recruiting | Astellas Pharma Europe Ltd. | Clostridium Difficile Infection (CDI) also known … | Trade Name: Dificlir Product Name: DIFICLIR 200 m… | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| 1.0 | Crohn's disease | An intestinal disease that involves inflammation located_in intestine. | disease of anatomical entity gastrointestinal system disease, intestinal disease, inflammatory bowel disease | Obiltoxaximab; Budesonide; Hydrocortisone acetate; Sulfasalazine; Ursodeoxycholic acid; Pegunigalsidase alfa; Imiglucerase; Bictegravir; Taliglucerase alfa; Etelcalcetide; Cimetidine; Desonide | Crohn's disease is a relapsing systemic inflammatory diseas… | Details |
| 2.0 | ulcerative colitis | A colitis that is predominantly confined to the mucosa located_in colon and includes characteristic ulcers, or open sores. | disease of anatomical entity, gastrointestinal system disease, autoimmune disease of gastrointestinal tract; intestinal disease, inflammatory bowel disease, colitis; disease, primary immunodeficiency disease, autoimmune disease, autoimmune disease of gastrointestinal tract | Mirikizumab; Olsalazine; Balsalazide; Sulfasalazine; Budesonide; Hydrocortisone acetate; Tixocortol; Kappadione; Teicoplanin; Atezolizumab; Gamolenic acid; Upadacitinib | No abstract available | Details |
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S01 | Anti-inflammatory | inflammatory | 5-Aminosalicylates (5-ASAs); corticosteroids | Crohn's disease and ulcerative colitis are the two main com… | Details |
| S02 | Immunosuppression | Classic immunosuppressive drugs | azathioprine; 6-mercaptopurine; methotrexate; ciclosporin-A; tacrolimus | Ciclosporin-A and tacrolimus bind to specific intracellular… | Details |
| S03 | Anti-TNF agents | Tumor necrosis factor | infliximab; adalimumab; golimumab; certolizumab pegol | TNF is produced by various immune and non-immune cells in t… | Details |
| S04 | T-cell homing and retention | T-cell trafficking | vedolizumab; anti-MAdCAM1 antibodies ; etrolizumab | Inhibition of the interaction between α4β7 integrins on T c… | Details |
| S05 | Angiogenesis | cell proliferation; vascular permeability | ozanimod | The bioactive lipid S1P has been shown to activate NF-κB an… | Details |
| S07 | Blockade of cytokine | Cytokine signalling | apremilast; roflumilast; filgotinib; tofacitinib; ABT494; ABT-874; ustekinumab; isankizumab; LY-2525623; AMG139; MEDI2079; guselkumab | Various T-cell subsets, their differentiation pathways and … | Details |
| 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 |
Fidaxomicin Treatment of Clostridioides difficile Infections and Recurrences in…
PMID: 40482880
Year: 2025
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: To report the effectiveness and tolerability of treating children with primary and recurrent Clostridioides difficile infection (CDI) with…
Fidaxomicin Reduces Collagen Expression in Intestinal Fibroblasts Via Platelet-…
PMID: 40398622
Year: 2025
Relationship Type:
Treatment
Score: 6.5
INTRODUCTION: About 30%-50% of patients with Crohn's disease (CD) eventually develop intestinal strictures, with intestinal fibrosis being a major co…
Fidaxomicin for Clostridioides difficile infection in patients with inflammator…
PMID: 40168072
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) patients with Clostridioides difficile infection (CDI) are at increased risk of adverse outcome…
Fidaxomicin treatment for Clostridioides difficile infection in patients with i…
PMID: 37337469
Year: 2023
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIM: Although fidaxomicin is an effective first-line treatment for Clostridioides difficile infection, it has not been well studied in…
Correction to: Fidaxomicin for the treatment of Clostridium difficile infection…
PMID: 30406879
Year: 2019
Relationship Type:
Treatment
Score: 6.5
The article "Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-risk patients with inflammatory bowel disease, fulminant CD…
Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-ri…
PMID: 30099637
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Information is limited or lacking on fidaxomicin treatment of Clostridium difficile infection (CDI) in patients with inflammatory bowel disease, fulm…
Outcomes With Fidaxomicin Therapy in Clostridium difficile Infection
PMID: 28009682
Year: 2018
Relationship Type:
Treatment
Score: 6.3
BACKGROUND AND GOALS: Fidaxomicin is a new antibiotic used to treat Clostridium difficile infection (CDI). Given limited clinical experience with fid…