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Dificid, Dificlir(fidaxomicin)
Dificid, Dificlir (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
infectionsD007239
digestive system diseasesD004066
Trade Name
FDA
EMA
Dificid
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
DIFICIDCubist PharmaceuticalsN-201699 RX2011-05-27
1 products, RLD, RS
DIFICIDCubist PharmaceuticalsN-213138 RX2020-01-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dificidNew Drug Application2021-02-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
pseudomembranous enterocolitisEFO_1001314D004761A04.7
Agency Specific
FDA
EMA
Expiration
Code
FIDAXOMICIN, DIFICID, CUBIST PHARMS LLC
2027-01-24ODE-367
2023-07-24PED
2023-01-24NP, NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Fidaxomicin, Dificid, Cubist Pharms Llc
98085302034-05-28DP
73785082027-07-31DS, DP
78632492027-07-31DS, DP
88595102027-07-31U-319, U-2741
79064892027-03-04U-319, U-2741
85865512023-07-15DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AA: Antibiotics, intestinal
— A07AA12: Fidaxomicin
HCPCS
No data
Clinical
Clinical Trials
28 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 infectionsD003015EFO_1000874A05.2—155314
Clostridioides difficileD016360NCBITaxon_1496—113—5
DiarrheaD003967HP_0002014R19.7—121—4
ClostridiumD003013———1—1
Inflammatory bowel diseasesD015212EFO_0003767———1—1
Spinal cord injuriesD013119EFO_1001919———1—1
EnterocolitisD004760EFO_1001481———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——1——1
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 interactionsD0043471————1
Intestinal absorptionD0074081————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFIDAXOMICIN
INNfidaxomicin
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 classantibiotics (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-ID873857-62-6
RxCUI1111103
ChEMBL IDCHEMBL1255800
ChEBI ID—
PubChem CID10034073
DrugBankDB08874
UNII IDZ5N076G8YQ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Dificid - Merck Sharp & Dohme
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,157 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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115,151 adverse events reported
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