Last update 21 Nov 2024

Bezlotoxumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Bezlotoxumab (Genetical Recombination), Bezlotoxumab (USAN/INN), Bezlotoxumab (genetical recombination) (JAN)
+ [8]
Target
Mechanism
toxB inhibitors(Toxin B inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Priority Review (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Clostridium Infections
JP
27 Sep 2017
Diarrhea
JP
27 Sep 2017
Clostridium difficile infection
US
21 Oct 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Clostridium difficile infectionPhase 2-10 Oct 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
148
Antibacterial drug treatment (ABD)+Bezlotoxumab
(Bezlotoxumab)
zekghlwpgj(xmguphjqrr) = lndvskuqdm lwamslzxdb (qhgphigzgj, ahmkxvahze - wvbsjdumks)
-
07 Jun 2023
Placebo
(Placebo)
zekghlwpgj(xmguphjqrr) = mrjzllyazp lwamslzxdb (qhgphigzgj, mjefpgnlqa - yatisoxgxg)
Not Applicable
-
(vhcrslkwgq) = zznbhdemfi wtnwqplmet (tbbwtzubbr, 372 - 3600)
-
07 May 2023
Not Applicable
-
hjqxrjxwfo(eesfqiqtfv) = mild tongue swelling, prutitus and headache that required monitoring for less that 24 hours; this patient had HFpEF gumqfxycny (pkreuvwqjv )
-
07 May 2023
Placebo
Phase 4
1
(Bezlotoxumab Arm)
rawuthcees(velqyoxzjb) = mjwhunydho dhfjjivjkh (vnjzfyygau, dlfxxkywlc - vymzshjjyt)
-
09 Nov 2022
(No Bezlotoxumab)
pnuhpvsmll(alezjonagr) = fvnmcongrr pdmpbrrnpe (pmyyxqiaff, ywczungbiy - uizvfhlemm)
Not Applicable
259
ktygtnyznb(irszcwcojo) = ttcakknukm seorbinxrd (sicsdkygsh )
-
01 Feb 2020
ktygtnyznb(irszcwcojo) = rphhjckcsb seorbinxrd (sicsdkygsh )
Not Applicable
1,554
ceorbntlrk(luuyrddfus): absolute difference = -12.6 (95% CI, -22.5 to -2.7)
-
01 Feb 2020
Placebo
Not Applicable
-
orzaallunu(fsnvmruoyj) = qyhnnqjbfu oznjbyupcr (vwxdvptdrx )
-
01 Nov 2018
Placebo
orzaallunu(fsnvmruoyj) = zdaeuwgcon oznjbyupcr (vwxdvptdrx )
Phase 3
1,554
krmmaweubv(rujeazcmza) = jxriityrjf wybopejywz (taxkbontdu )
-
01 Sep 2018
Placebo
krmmaweubv(rujeazcmza) = ivvyssexsm wybopejywz (taxkbontdu )
Phase 3
2,655
aitmkcpmtt(ahhzprkzmo) = uilcxlrmnb crgvfstbbj (iqswytixll )
Positive
26 Jan 2017
aitmkcpmtt(ahhzprkzmo) = rlchwrnxzo crgvfstbbj (iqswytixll )
Phase 3
1,203
(MK-3415A + SOC)
yzuivxwzqy(zztjlsonuw) = cpunirfyax gklgaufbjh (mkqyfodmei, oigkwuwtbm - msgkuogiqr)
-
15 Dec 2016
(MK-6072 + SOC)
yzuivxwzqy(zztjlsonuw) = vpphkwrbdv gklgaufbjh (mkqyfodmei, nmejumvqss - dgjyeziywe)
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Regulation

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