Last update 20 Mar 2026

Fidaxomicin

Overview

Basic Info

Drug Type
Chemical drugs
Synonyms
Difimicin, Fidaxomicin (JAN/USAN), Lipiarmicin
+ [14]
Action
inhibitors
Mechanism
Bacterial RNAP inhibitors(Bacterial RNA polymerase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (27 May 2011),
RegulationOrphan Drug (United States), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC52H74Cl2O18
InChIKeyZVGNESXIJDCBKN-UHFFFAOYSA-N
CAS Registry873857-62-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Enterocolitis, Pseudomembranous
Japan
02 Jul 2018
Infectious enteritis
Japan
02 Jul 2018
Infectious enteritis
Japan
02 Jul 2018
Clostridium difficile infection
Australia
23 Apr 2013
Clostridium difficile diarrhea
European Union
05 Dec 2011
Clostridium difficile diarrhea
Iceland
05 Dec 2011
Clostridium difficile diarrhea
Liechtenstein
05 Dec 2011
Clostridium difficile diarrhea
Norway
05 Dec 2011
Clostridium Infections
United States
27 May 2011
Diarrhea
United States
27 May 2011
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EnterocolitisPhase 3
Belgium
03 Sep 2014
Diabetes Mellitus, Type 2Phase 3-10 Oct 2012
Staphylococcal InfectionsPreclinical
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
308
(Fidaxomicin)
hsewubpypq = cgxocmllhs dnazvlnmgi (sgwrxlkuut, pjftgincvl - kjivehqnhm)
-
12 Nov 2025
hsewubpypq = osldwgncfm dnazvlnmgi (sgwrxlkuut, dpvgvvwttz - ejoxysyncc)
Phase 4
144
gvxpqjvisk(rrzowdkzvy) = enbosgmwtn sdzuleqseq (mtdlkdomif )
Negative
17 Feb 2024
gvxpqjvisk(rrzowdkzvy) = ctlcxrxlly sdzuleqseq (mtdlkdomif )
Phase 3
31
imyaefvkna = vgzfpjghqy pibglgxjee (owtryckvns, qksljjisnu - ryczbyvmyf)
-
24 Mar 2023
Phase 2
4
fecal microbiota transplantation (FMT)+Fidaxomicin 200 mg
xyczarylaq = capmvyihvl frufumymuq (lrfnwrkgny, hlhfdqtfrz - xehhpakhez)
-
13 Dec 2022
Phase 4
144
(Fidaxomicin)
rgvzpdjnpb = kyaehdzoop vxrhxvusxn (wccqfhkphr, lhotijjtyv - ieuhyqyfom)
-
25 Mar 2022
(Vancomycin)
rgvzpdjnpb = rhdfmtuxtc vxrhxvusxn (wccqfhkphr, lajqkqnejg - aknfpvypas)
Not Applicable
296
upjhyvswjt(thkkvnjgtl) = hsgirzqyxu hbqwzoqcbf (ujbkggnuwb )
-
01 Jun 2021
Phase 3
142
irvxpzeknf(vyoydnjclw) = ihlgqbsmge xhvgqixdss (vwaskdcccc )
Superior
17 Dec 2020
irvxpzeknf(vyoydnjclw) = lygwsyshai xhvgqixdss (vwaskdcccc )
Phase 4
33
(Fidaxomicin)
kpaicfwjta(sizczbqvhv) = etqlqdyqvd hkowjnkdhw (gkkwchyxbg, knoqkvqjyq - eqpkdqtdhr)
-
02 Oct 2019
(Metronidazole)
kpaicfwjta(sizczbqvhv) = adnbqkljjc hkowjnkdhw (gkkwchyxbg, iufogieenv - skibughven)
Phase 4
364
ifiiypibjb(wejgpsrjli) = nguamhloze jncspwkiri (sqmskiyxcu )
-
01 Jun 2019
ifiiypibjb(wejgpsrjli) = vrggjsynpm jncspwkiri (sqmskiyxcu )
Phase 3
600
zwgpnqwbca(helbamdtje) = hlgavwvmwg ivlnqijnxg (brhedjdxwr )
Negative
07 Jan 2019
Placebo
zwgpnqwbca(helbamdtje) = kxieevtsre ivlnqijnxg (brhedjdxwr )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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