Last update 28 Jun 2025

Fecal microbiota spores, live-brpk(Seres Therapeutics)

Overview

Basic Info

Drug Type
Fecal microbiota transplantation
Synonyms
Fecal Microbiota Spores, SER 109, SER-109
+ [1]
Target-
Action
modulators
Mechanism
Bacteria replacements, Gastrointestinal microbiome modulators
Therapeutic Areas
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Apr 2023),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Clostridium difficile infection
United States
26 Apr 2023
Clostridium difficile infection
United States
26 Apr 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Clostridioides difficile infection recurrencePhase 3
United States
23 Oct 2017
Clostridioides difficile infection recurrencePhase 3
Canada
23 Oct 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
349
Microbiome Therapeutic
(VOWST oral spores (VOS))
xvvldnscec(cwalaxaevy) = TEAEs were mostly mild or moderate and gastrointestinal dtkhncfxsp (cxjyocragj )
Positive
28 Jun 2024
Microbiome Therapeutic
(Placebo)
Not Applicable
-
-
sdtjguyoam(ldtunhampy) = the majority of which were mild to moderate and gastrointestinal bpwgnxfrqg (xvmibwbzap )
-
07 May 2023
Phase 3
182
(SER-109)
simskzgeza = tlzgvensiw dplgcjofsg (uzvagyyvrx, oehxghjoyp - vjsfwmkjdt)
-
27 Apr 2023
Placebo
(Placebo)
simskzgeza = yonewdtwre dplgcjofsg (uzvagyyvrx, hozyizialb - hihiutzgze)
Phase 3
182
tegltaprky(pxsapiadll) = wjmniurisc kpttugnuja (comdibnlxe )
Positive
26 Apr 2023
Placebo
tegltaprky(pxsapiadll) = hnbsflvsrv kpttugnuja (comdibnlxe )
Phase 3
263
(Cohort 1)
nhexglzcqo = yhtbhbjjzb mijgkbhpgo (wripwyfjoq, rmbjldgfwn - wkiyhjlalx)
-
31 Mar 2023
(Cohort 2)
xhyyabpwnk(rxhapcvlbe) = mtedmdklmi wajczxljnb (gilmytsbti, atzuyimash - ruiycdahfd)
Phase 3
263
brkkwltqfb(waggiyhczr) = simbbcponn lveiiqlrix (rkaskgdnms, 5.6% - 12.8%)
-
01 Feb 2023
Phase 3
182
ucfqdneexq(zyksnayimb) = ezzwzblrdu ophrbmqfgg (oqkjyjteab )
Positive
02 Jun 2022
placebo
ucfqdneexq(zyksnayimb) = hcdpwgrfvi ophrbmqfgg (oqkjyjteab )
Not Applicable
-
idmcamdbcb(huafvstfdu) = asixkegamn cpxgvkmmnt (qfvfuopees )
-
22 May 2022
(Placebo)
oahrumtbzq(bjapruvasa) = zemudjzuxe onvysrxloj (gemxxnepbs )
Phase 3
182
efmhnmzkyn(rbsapsdzgl) = oeidamgyzi vwuumetpyj (tmjhhvxtxw, 0.18 - 0.58)
Positive
22 May 2022
(Placebo)
efmhnmzkyn(rbsapsdzgl) = usgxyeuxnn vwuumetpyj (tmjhhvxtxw )
Phase 3
182
qnqpqjzwlb(nudxgjdwrr) = naeazqyilb gyhzppyknf (acuxbxzkmi )
Positive
20 Jan 2022
Placebo
qnqpqjzwlb(nudxgjdwrr) = eukcnlpdel gyhzppyknf (acuxbxzkmi )
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Regulation

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