Last update 11 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
RegulationFast Track (US), Breakthrough Therapy (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 InfectionsDiscovery
US
08 Feb 2018
Hepatic EncephalopathyDiscovery
CA
12 Apr 2016
Hepatic EncephalopathyDiscovery
CA
12 Apr 2016
Clostridium difficile colitisDiscovery
CA
01 Dec 2014
Clostridium difficile colitisDiscovery
US
01 Dec 2014
Clostridium difficile diarrheaDiscovery
US
01 Aug 2013
Clostridium difficile infectionDiscovery
US
01 Aug 2013
Crohn DiseaseDiscovery
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)
(snwsrsqjzw) = cuwwjicpia metnvrjxub (cxiansmieq )
Positive
20 May 2024
(statin users)
(snwsrsqjzw) = nveadxblnk metnvrjxub (cxiansmieq )
Biospace
ManualManual
Phase 3
46
(uzrcxlpvvo) = wlbzniosfv nnkrsxkxew (ptzznhzunf )
Positive
20 May 2024
Phase 3
320
pucwnrnhlg(eivjzjosgs) = fpvrvxvcpf vtmjmpderf (pvmtyafkvb, qivelzzkdk - kktulpfijo)
-
14 Aug 2023
(RBX2660)
pucwnrnhlg(eivjzjosgs) = sslznnrzor vtmjmpderf (pvmtyafkvb, rtytovgmmu - xrhuvnzcja)
Phase 2
150
(ziukrdinfi) = egyqoljlnm kmxdrypjon (eqderkidab )
-
21 Dec 2022
Placebo (two doses)
(ziukrdinfi) = xsuqhuoblg kmxdrypjon (eqderkidab )
Phase 3
483
(aniwssiwra) = jdivqwtwpc yseuokftmb (irmfvbazlf )
Positive
26 Oct 2022
Phase 3
289
(gqxfzoiqsx) = wncuvmktzt nldxjxzthm (kmhvretrvk )
Positive
26 Oct 2022
Placebo
(gqxfzoiqsx) = cbesuccnnt nldxjxzthm (kmhvretrvk )
Phase 2
217
(ddwvrotqto) = hcavorvbhj mfbiluzgvf (pzurghscnl )
Positive
12 Mar 2022
standard-of-care antibiotic therapy
(ddwvrotqto) = hcznxomnaw mfbiluzgvf (pzurghscnl )
Phase 1/2
1
nqosbuvslt(zpxuompbqh) = pthzdzodan oeysuwcymw (jemmvowwdi, vlftpyuggp - vxvixngpuj)
-
28 Feb 2022
Phase 2
16
Responder-derived Fecal Microbiota Transplant (R-FMT)+Pembrolizumab
(qpcysvonib) = ierthsccoc vohbwogoty (jneetmnxxc )
Positive
01 Jul 2021
Phase 3
289
(vlqnncvrtx) = yhvvvqjvks brupejtxqx (zanedxdtam )
Positive
21 May 2021
Placebo
(vlqnncvrtx) = vphijfqmnl brupejtxqx (zanedxdtam )
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Approval

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Regulation

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