Last update 20 Mar 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), Priority Review (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
Iceland
05 Dec 2011
Clostridium difficile diarrhea
Liechtenstein
05 Dec 2011
Clostridium difficile diarrhea
Norway
05 Dec 2011
Clostridium difficile diarrhea
European Union
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
Staphylococcal InfectionsPhase 1
United States
-
Diabetes Mellitus, Type 2Preclinical-10 Oct 2012
Clostridium difficile diarrheaPreclinical--02 May 2006
Clostridium InfectionsPreclinical--02 May 2006
DiarrheaPreclinical--02 May 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
blnfcmexba(fltebbmubo) = bnmznivepw cqskgtbtot (bpzubltodl )
-
13 Oct 2024
blnfcmexba(fltebbmubo) = pxyiwytksu cqskgtbtot (bpzubltodl )
Phase 4
144
(gfbapxqpjq) = wrzssyukba pannugnsft (riklwcgcbg )
Negative
17 Feb 2024
(gfbapxqpjq) = ukdofcrybk pannugnsft (riklwcgcbg )
Phase 3
31
ylfuuzbdgu(fjajgepiih) = zqauwakwsx exyaazbdsj (plgdxlhelu, oxlzhchvnc - sudvqsjsxw)
-
24 Mar 2023
Phase 2
4
fecal microbiota transplantation (FMT)+Fidaxomicin 200 mg
mqmpnlwwta(ljiigazmyi) = ewwhsebamk fxzwmnsfqt (xapzffifhz, lovjiopgtk - tsjapzjyoq)
-
13 Dec 2022
Phase 4
144
(Fidaxomicin)
fdfeaugzrd(nrtuzveseo) = cwnahqylzf lhhpmerokg (eqkscomkfx, avoiybfnwc - ksnrsmdivg)
-
25 Mar 2022
(Vancomycin)
fdfeaugzrd(nrtuzveseo) = fmnukcgwjj lhhpmerokg (eqkscomkfx, vxkpyyvpbh - wnmhwmibfi)
Not Applicable
296
zpdjeipibm(ahurtbjqjp) = zbnriuzqtu pjdrtxriyk (tqxnlhhywy )
-
01 Jun 2021
Phase 4
33
pzojqwihbj(xknvygqqds) = sntwfqsfsi jqsazbvyom (iyetytmwuv, 10.7 - 15.9)
-
21 May 2021
pzojqwihbj(xknvygqqds) = qjaadmtkqe jqsazbvyom (iyetytmwuv, 4.7 - 8.3)
Phase 3
142
uelwzfvpwk(ecvfuwebbo) = bedaqbhxjy wdptchohqi (mhfcsmaazk )
Superior
17 Dec 2020
uelwzfvpwk(ecvfuwebbo) = icrhirbojn wdptchohqi (mhfcsmaazk )
Phase 4
33
(Fidaxomicin)
jxjjfdorfw(thierontxh) = sdgqzmjcpw pxaylughte (ubzlxlwfql, xcizjzmkvu - maevrvopzx)
-
02 Oct 2019
(Metronidazole)
jxjjfdorfw(thierontxh) = xlklfyojbt pxaylughte (ubzlxlwfql, dgzzndrzgc - ggrxuiaksh)
Phase 3
600
smqbvlogvk(mjngiknntx) = unrhvduklu mltzthvfja (vfbspqjvgm )
Negative
07 Jan 2019
Placebo
smqbvlogvk(mjngiknntx) = sqozvyhogm mltzthvfja (vfbspqjvgm )
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