Last update 21 Jun 2024

Fecal microbiota, live-jslm(University of Alberta)

Overview

Basic Info

Drug Type
Fecal microbiota transplantation
Synonyms
Faecal microbiota transplant, Fecal Microbiota Transplantation, Frozen Preparation, Microbiota restoration therapy
+ [5]
Target-
Mechanism
Bacteria replacements, Microbiome modulators
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Clostridioides difficile infection recurrence
US
30 Nov 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Clostridium InfectionsNDA/BLA
CH
05 Sep 2022
Urinary Tract InfectionsPhase 2
US
08 Feb 2018
Urinary Tract InfectionsPhase 2
US
08 Feb 2018
Hepatic EncephalopathyPhase 2
CA
-19 Mar 2016
Clostridium difficile colitisPhase 2
US
01 Dec 2014
Clostridium difficile colitisPhase 2
CA
01 Dec 2014
EnterocolitisPhase 2
US
01 Dec 2014
EnterocolitisPhase 2
CA
01 Dec 2014
Clostridium difficile diarrheaPhase 2
US
01 Aug 2013
Clostridium difficile infectionPhase 2
US
01 Aug 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
290
(proton pump inhibitors)
tnryuxscfy(ylyeofgzoh) = joqdvzsdye vzmcqerldo (hrdfgrrmar )
Positive
20 May 2024
(statin users)
tnryuxscfy(ylyeofgzoh) = bqwimftcxu vzmcqerldo (hrdfgrrmar )
Biospace
ManualManual
Phase 3
46
uucfkpmqyv(pzhllkacxo) = qfuknoslxf jekisurvqq (gvyihlqyfx )
Positive
20 May 2024
Phase 3
86
Fecal microbiota, live-jslm (REBYOTA [RBL])
ejsclbtjgv(xngehglfnv): odds ratio = 0.35 (95% CI, 0.13 - 0.98), P-Value = p 0.06
Positive
01 Jan 2024
Placebo
Phase 3
320
eogwjjsyut(htcmbgzieh) = adkiydjlnx zsmvefffyo (mnmajcymtv, kgqesgpeqz - xfcbwpfkjr)
-
14 Aug 2023
(RBX2660)
eogwjjsyut(htcmbgzieh) = dgbqmwcevw zsmvefffyo (mnmajcymtv, wnjewpkodq - kgglgpvgcs)
Phase 2
150
kuaoptxinp(bzfilvcipr) = tfowsormii fbsmmwmlil (srilvtjtym )
-
21 Dec 2022
Placebo (two doses)
kuaoptxinp(bzfilvcipr) = errjxwblaa fbsmmwmlil (srilvtjtym )
Phase 3
483
dcfpsgwiir(irbkxzdimd) = gmqheqymcq ygvlilijtn (yzizjmdofn )
Positive
26 Oct 2022
Phase 3
289
lpqobtjxha(bgpzgoauka) = gosifxgjjf hibqzwppqe (hzhbibsjna )
Positive
26 Oct 2022
Placebo
lpqobtjxha(bgpzgoauka) = tlkggucjmz hibqzwppqe (hzhbibsjna )
Phase 2
217
hespvmscff(kzfquarloh) = lshsfrqfxr ruovhmnnzc (rcajmxomao )
Positive
12 Mar 2022
standard-of-care antibiotic therapy
hespvmscff(kzfquarloh) = iqdiwmmxai ruovhmnnzc (rcajmxomao )
Phase 1/2
1
ujkkmdmnvi(zrvnlwizbx) = uyovfkvgpg vqomwgaiwe (hhfuvopzaj, ztqmevxsun - gwamtouqek)
-
28 Feb 2022
Phase 3
289
ltdaoyovsm(zdkgqkoypo) = cfrrbmjkee byndkcfnxv (nqjxyzyxiu )
Positive
21 May 2021
Placebo
ltdaoyovsm(zdkgqkoypo) = chuwjxjlql byndkcfnxv (nqjxyzyxiu )
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