Dificid, Dificlir(fidaxomicin)
Dificid, Dificlir, Fidaxomicin (fidaxomicin) is a small molecule pharmaceutical. Fidaxomicin was first approved as Dificid on 2011-05-27. It is used to treat bacterial infections and pseudomembranous enterocolitis in the USA. It has been approved in Europe to treat clostridium infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Dificid (discontinued: Fidaxomicin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fidaxomicin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DIFICID | Cubist Pharmaceuticals | N-201699 RX | 2011-05-27 | 1 products, RLD, RS |
| DIFICID | Cubist Pharmaceuticals | N-213138 RX | 2020-01-24 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dificid | New Drug Application | 2024-10-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial infections | — | D001424 | A49 |
| pseudomembranous enterocolitis | EFO_1001314 | D004761 | A04.7 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FIDAXOMICIN, DIFICID, CUBIST PHARMS LLC | |||
| 2027-01-24 | ODE-367 | ||
| 2023-07-24 | PED | ||
| 2023-01-24 | NP, NPP | ||
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | — | 3 | 12 | 9 | 6 | 30 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 7 | 7 | 5 | 20 |
| Communicable diseases | D003141 | — | — | — | 1 | 7 | 4 | 3 | 15 |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | — | 2 | 1 | 5 | 2 | 10 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 2 | 5 | 1 | — | 8 |
| Enterocolitis | D004760 | EFO_1001481 | — | — | — | — | 2 | — | 2 |
| Clostridium | D003013 | — | — | — | — | — | 1 | — | 1 |
| Enterococcus | D016983 | — | — | — | — | — | 1 | — | 1 |
| Organ transplantation | D016377 | — | — | — | — | — | 1 | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | 2 | — | 1 | 3 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Intestinal absorption | D007408 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fecal microbiota transplantation | D000069467 | — | — | — | — | — | — | 1 | 1 |
| Geriatric assessment | D015577 | — | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fidaxomicin |
| INN | fidaxomicin |
| Description | Fidaxomicin, sold under the brand name Dificid among others, is the first member of a class of narrow spectrum macrocyclic antibiotic drugs called tiacumicins. It is a fermentation product obtained from the actinomycete Dactylosporangium aurantiacum subspecies hamdenesis.
Fidaxomicin is minimally absorbed into the bloodstream when taken orally, is bactericidal, and selectively eradicates pathogenic Clostridioides difficile with relatively little disruption to the multiple species of bacteria that make up the normal, healthy intestinal microbiota. The maintenance of normal physiological conditions in the colon may reduce the probability of recurrence of Clostridioides difficile infection.
|
| Classification | Small molecule |
| Drug class | antibiotics (Micromonospora strains) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCc1c(Cl)c(O)c(Cl)c(O)c1C(=O)O[C@H]1[C@H](O)[C@H](OC)[C@H](OC/C2=C\C=C\C[C@H](O)/C(C)=C/[C@H](CC)[C@@H](O[C@@H]3OC(C)(C)[C@@H](OC(=O)C(C)C)[C@H](O)[C@@H]3O)/C(C)=C/C(C)=C/C[C@@H]([C@@H](C)O)OC2=O)O[C@@H]1C |
Identifiers
| PDB | — |
| CAS-ID | 873857-62-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1255800 |
| ChEBI ID | — |
| PubChem CID | 10034073 |
| DrugBank | DB08874 |
| UNII ID | Z5N076G8YQ (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Dificid – Merck & Co
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,647 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,715 adverse events reported
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