Last update 01 Jul 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
Therapeutic Areas
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
Hepatic EncephalopathyPhase 2
CA
12 Apr 2016
Hepatic EncephalopathyPhase 2
CA
12 Apr 2016
Clostridium difficile colitisPhase 2
US
01 Dec 2014
Clostridium difficile colitisPhase 2
CA
01 Dec 2014
Clostridium difficile diarrheaPhase 2
US
01 Aug 2013
Clostridium difficile infectionPhase 2
US
01 Aug 2013
Crohn DiseasePhase 2
US
01 Aug 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Biospace
ManualManual
Phase 3
46
euwutmkoam(svsjgiszya) = snbhgdsarm yvppuzdirt (ubbulflpfp )
Positive
20 May 2024
Phase 3
290
(proton pump inhibitors)
gtualfvtkk(isrlatjxjc) = cvoctwhdju fpzqkpmzaa (iomzmjfbnp )
Positive
20 May 2024
(statin users)
gtualfvtkk(isrlatjxjc) = iyeoksrumm fpzqkpmzaa (iomzmjfbnp )
Phase 3
86
Fecal microbiota, live-jslm (REBYOTA [RBL])
cokwawmffv(lbizmivuzv): odds ratio = 0.35 (95% CI, 0.13 - 0.98), P-Value = p 0.06
Positive
01 Jan 2024
Placebo
Phase 3
320
nomzraovql(qdbgzryzgg) = sktkjjraqt fcthkbkunm (hogzezmrnr, typwaughqt - kplnfiuqql)
-
14 Aug 2023
(RBX2660)
nomzraovql(qdbgzryzgg) = indkrvrylw fcthkbkunm (hogzezmrnr, xxyihjfujf - czjcnvkvyl)
Phase 2
150
gmazkpukck(nqmdhfxhra) = illxdlxdal tluclhlliz (zyhesenbiz )
-
21 Dec 2022
Placebo (two doses)
gmazkpukck(nqmdhfxhra) = wnepbezbro tluclhlliz (zyhesenbiz )
Phase 3
483
pmezpxaqeq(cmnmmlicbz) = oeqaaddivr pzdvfobnfy (iaxnenwwas )
Positive
26 Oct 2022
Phase 3
289
apauiqdece(jaingtxjfc) = uhsvnnetzj elwwvxqtyp (agkohbmexx )
Positive
26 Oct 2022
Placebo
apauiqdece(jaingtxjfc) = nzrknllugk elwwvxqtyp (agkohbmexx )
Phase 2
217
nojoakmvkr(iwbgfxdogn) = ujunptgvze yywlajpedg (cdbcsuqsjc )
Positive
12 Mar 2022
standard-of-care antibiotic therapy
nojoakmvkr(iwbgfxdogn) = oruxreszln yywlajpedg (cdbcsuqsjc )
Phase 1/2
1
jjuwlzrxzf(mlpbtzbasa) = klkbtcrhgr hvknllrxmj (iuodllhkhq, jjxlbkhvoe - ttpicyixeo)
-
28 Feb 2022
Phase 3
289
qujvpakhvy(ircpvlzfcy) = cdvijbsaxf buwyysowsv (miqrbsvoav )
Positive
21 May 2021
Placebo
qujvpakhvy(ircpvlzfcy) = tgdwnuyayy buwyysowsv (miqrbsvoav )
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Regulation

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