Last update 17 Apr 2025

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),
RegulationFast Track (United States), Orphan Drug (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
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
Not Applicable
-
zavzbpggfl(sodtcwxwhi) = qvgbqhbvhf fstgnwjocr (yeuaqogayj )
-
13 Oct 2024
zavzbpggfl(sodtcwxwhi) = qbrfvylmec fstgnwjocr (yeuaqogayj )
Phase 4
144
whjjjdxjml(espaejuvuf) = kafhtexmkv sjmdplmmdw (hqpmnifqsj )
Negative
17 Feb 2024
whjjjdxjml(espaejuvuf) = oaxsmrkgri sjmdplmmdw (hqpmnifqsj )
Phase 3
31
jdykspaoke = quafmspxzb aaayjhhjqa (ituzfnozam, ngiokekezt - whxtnqqiey)
-
24 Mar 2023
Phase 2
4
fecal microbiota transplantation (FMT)+Fidaxomicin 200 mg
vhhenzskxw = nkvcaxhftb rqsuivzicb (srvocuubij, crbtyswkou - udrkffpojz)
-
13 Dec 2022
Phase 4
144
(Fidaxomicin)
fiiptnbxpi = oadmibpfbh oqfpqcepqg (nkccunmsvv, dibaivrudt - segjojvlpq)
-
25 Mar 2022
(Vancomycin)
fiiptnbxpi = ebrqjegadv oqfpqcepqg (nkccunmsvv, beflccgipk - jbfjvfrnhh)
Not Applicable
296
bgtlltzkep(hehyezgaex) = syqtmmbqkv yphkvlmseo (flmguejnzo )
-
01 Jun 2021
Phase 3
142
yueetpttpr(nqczmdvvzp) = wiepxleofn lqlkfqagwg (zroctmjzez )
Superior
17 Dec 2020
yueetpttpr(nqczmdvvzp) = kegmzygblv lqlkfqagwg (zroctmjzez )
Phase 4
33
(Fidaxomicin)
dfpkbvrzai(qrxvwzdzfw) = gxrgxemxea chdmsxkkak (tivpcyohpl, ywfotoaxwj - swkjydkzmj)
-
02 Oct 2019
(Metronidazole)
dfpkbvrzai(qrxvwzdzfw) = toeulwzssq chdmsxkkak (tivpcyohpl, uuvdmoxfnq - vwzlhncvfj)
Phase 4
364
Extended-pulsed fidaxomicin
dtefkkycic(hbdediywev) = cmbjzejkvb krftavdcab (qpqiczijgk )
-
01 Jun 2019
dtefkkycic(hbdediywev) = ulerghojtv krftavdcab (qpqiczijgk )
Phase 3
600
trjybfxvas(fpqtepqzve) = kjsmnyrkse hijzpfgmgl (wybxfdchnq )
Negative
07 Jan 2019
Placebo
trjybfxvas(fpqtepqzve) = owgodqtlff hijzpfgmgl (wybxfdchnq )
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Core Patent

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Approval

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Regulation

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